ISO/FDIS 11607-3

Packaging for terminally sterilized medical devices — Part 3: Requirements for process development for forming, sealing and assembly

This document specifies requirements for process development for forming, sealing and assembly of packaging for medical devices to be terminally sterilized, when utilizing heat sealing technologies. This document recommends minimum heat sealing equipment features to support subsequent validation, process control and monitoring. This document applies to both preformed sterile barrier systems and sterile barrier systems. This document utilizes the sterile barrier system specification to develop the process specification using the principles of risk management. This document is intended to be used prior to process validation. NOTE ISO 11607-2 provides requirements for process specification and process validation.

Emballages des dispositifs médicaux stérilisés au stade terminal — Partie 3: Exigences relatives à la mise au point des procédés de formage, scellage et assemblage

General Information

• Status: Not Published
• ICS: 11.080.30 - Sterilized packaging
• Technical Committee: ISO/TC 198 - Sterilization of health care products
• Drafting Committee: ISO/TC 198 - Sterilization of health care products
• Current Stage: 5000 - FDIS registered for formal approval
• Start Date: 22-Apr-2026
• Completion Date: 16-Mar-2026

Relations

• Consolidates: prEN ISO 11607-3 - Packaging for terminally sterilized medical devices - Part 3: Requirements for process development for forming, sealing and assembly (ISO/DIS 11607-3:2025)
• Effective Date: 12-Feb-2026
• Consolidates: ISO 24409-4:2023 - Ships and marine technology — Design, location and use of shipboard safety signs, fire control plan signs, safety notices and safety markings — Part 4: Escape plan signs used for general emergency information
• Effective Date: 07-Jan-2025

Standards Content (Sample)

FINAL DRAFT
International
Standard
ISO/TC 198
Packaging for terminally sterilized
Secretariat: ANSI
medical devices —
Voting begins on:
2026-06-02
Part 3:
Requirements for process
Voting terminates on:
2026-07-28
development for forming, sealing
and assembly
Emballages des dispositifs médicaux stérilisés au stade
terminal —
Partie 3: Exigences relatives à la mise au point des procédés de
formage, scellage et assemblage
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
ISO/TC 198
Packaging for terminally sterilized
Secretariat: ANSI
medical devices —
Voting begins on:
Part 3:
Requirements for process
Voting terminates on:
development for forming, sealing
and assembly
Emballages des dispositifs médicaux stérilisés au stade
terminal —
Partie 3: Exigences relatives à la mise au point des procédés de
formage, scellage et assemblage
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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Published in Switzerland Reference number
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
4.1 Quality systems .3
4.2 Risk management .3
4.3 Sampling .3
4.4 Test methods .3
4.5 Documentation .3
5 Process development. 3
5.1 General .3
5.2 Process development activities .4
5.3 Predetermined SBS specification(s) .5
5.4 Draft process specification . .5
5.5 Initial process risk analysis .6
5.6 Process variables .6
5.7 Initial process control and monitoring plans .7
5.8 Process specification .7
5.9 Process risk management plan .7
6 Process equivalence . 7
Annex A (informative) Guidance on establishing process parameters .10
Annex B (informative) First principles of heat sealing materials . 14
Annex C (informative) Minimum heat sealing equipment features to support subsequent
validation, process control and monitoring .18
Annex D (informative) Example of FMEA on SBS heat sealing process .22
Annex E (informative) Guidance on evaluating the equivalence of sealing outputs .24
Bibliography .27

iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO’s adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products, in
collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 102,
Sterilizers and associated equipment for processing of medical devices, in accordance with the Agreement on
technical cooperation between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 11607 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
Introduction
ISO 11607-1 and ISO 11607-2 specify requirements for the design and validation of sterile barrier systems for
terminally sterilized medical devices, and the validation requirements for manufacturing processes of sterile
barrier systems, respectively. The heat sealing of a sterile barrier system is critical to the maintenance of
sterile barrier integrity to the point of use; however, there is little content available for process development
in the current edition of ISO 11607-2.
This document specifies requirements for the development of heat sealing processes to meet sterile barrier
seal design requirements. A thorough development process with a high-quality output is an important
input to an efficient validation of the process. While a successful validation is essential to ensure the
safety of terminally sterilized medical devices, there is no intention to imply that the process development
approach proposed in this document is the only valid approach. Users of this document can use the activities
described in this standard to control risks associated with heat sealing processes, if they find it appropriate.
Additionally, this document specifies a process for documenting the equivalence of heat sealing processes
which can be a benefit to users in support of change control activities since it can create the basis to leverage
the efforts over a range of heat sealing equipment or over a sterile barrier system family.
This document is intended for use by industrial manufacturers engaged in the design and development of
sterile barrier systems and heat sealing processes. Effective application of the requirements described in
this document requires proficiency in design of experiment (DOE) methodologies and access to the requisite
testing resources for result evaluation. Producers of preformed sterile barrier systems, as well as medical
device manufacturers, rely heavily on heat sealing, among other techniques, to create sterile barrier
systems that ensure device integrity and sterility at various stages of distribution and handling of sterile
devices until the point of use and aseptic presentation. This process often involves the operation of multiple,
interchangeable heat sealers to produce commercial quantities of sterile barrier systems.
For healthcare facilities (e.g. hospitals), ISO/TS 16775:2021, Annex B contains all relevant guidance for
sterile barrier system closure technologies including sealing, reusable container closures and wrapping
processes.
v
FINAL DRAFT International Standard ISO/FDIS 11607-3:2026(en)
Packaging for terminally sterilized medical devices —
Part 3:
Requirements for process development for forming, sealing
and assembly
1 Scope
This document specifies requirements for process development for forming, sealing and assembly of
packaging for medical devices to be terminally sterilized, when utilizing heat sealing technologies.
This document recommends minimum heat sealing equipment features to support subsequent validation,
process control and monitoring.
This document applies to both preformed sterile barrier systems and sterile barrier systems.
This document utilizes the sterile barrier system specification to develop the process specification using the
principles of risk management.
This document is intended to be used prior to process validation.
NOTE ISO 11607-2 provides requirements for process specification and process validation.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 11607-2:2019, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
ISO 11607-2:2019/Amd 1:2023, Packaging for terminally sterilized medical devices — Part 2: Validation
requirements for forming, sealing and assembly processes — Amendment 1: Application of risk management
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
assembly
process of putting together all components of a sterile barrier system, including packaging
materials and contents
3.2
control
regulation of variables within specified limits
[SOURCE: ISO 11139:2018, 3.63]
3.3
forming
process of bringing materials into contact with each other or into the necessary position for
heat sealing or closure processes to create a sterile barrier system
Note 1 to entry: Forming in this context does not include thermoforming, cold-forming, forming thermoform portion
of form-fill-seal, fabrication of the material.
3.4
monitoring
continual checking, supervising, critically observing or determining the status in order to identify change
from the performance level required or expected
[SOURCE: ISO 31073:2022, 3.3.40, modified — Note to entry has been deleted.]
3.5
process parameter
specified value for a process variable
Note 1 to entry: The specification for a process includes the process parameters and their tolerances.
[SOURCE: ISO 11139:2018, 3.211]
3.6
process specification
documented procedure that includes all equipment, process parameters, monitors and materials required
to manufacture a product that consistently meets requirements
[SOURCE: ISO 11607-2:2019, 3.15]
3.7
process variable
chemical or physical attribute within a cleaning, disinfection, packaging or sterilization process, changes in
which can alter its effectiveness
EXAMPLE Time, temperature, pressure, concentration, humidity, wavelength.
[SOURCE: ISO 11139:2018, 3.213]
3.8
seal
result of joining surfaces together by fusion to form a microbial barrier
Note 1 to entry: For sealing by thermal fusion, this can include multiple heat sealing equipment technologies, but not
cold sealing.
[SOURCE: ISO 11139:2018, 3.244, modified — Note 1 to entry has been added.]
3.9
sterile barrier system
SBS
minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation of
the sterile contents at the point of use
[SOURCE: ISO 11139:2018, 3.272]

4 General requirements
4.1 Quality systems
The activities described within this document shall be carried out within a formal quality system.
NOTE ISO 9001 and ISO 13485 contain requirements for suitable quality systems. Additional requirements can
be specified by a country or region.
4.2 Risk management
A risk management process conforming with the requirements of ISO 11607-2/Amd 1:2023 shall be
implemented.
4.3 Sampling
Sampling plans based upon a statistically valid rationale is required for validation per ISO 11607-2.
Application of statistical aspects for sampling plans used in development of heat sealing processes is helpful.
This can include a rationale on statistical aspects regarding the materials, risks and sterile barrier systems
being evaluated.
NOTE Statistically valid indicates the use of a methodology that ensures the sample size and selection process are
appropriate for drawing reliable and accurate conclusions.
4.4 Test methods
Test methods used for activities described in this document shall meet the test method validation
requirements of ISO 11607-2. Process development may include preliminary evaluation methods which do
not require validation.
NOTE Preliminary evaluation methods focus on understanding the characteristics, attributes, or qualities of a
product or process (e.g. visual scoring method for heat seals which includes estimating attributes of a heat seal). See
Annex A, particularly A.2.4.
4.5 Documentation
Documentation of activities described in this document shall meet the documentation requirements of
ISO 11607-2:2019, 4.5.
5 Process development
5.1 General
5.1.1 The requirements of this document are intended to be applied to heat sealing processes that have
not yet been validated. Existing SBS and preformed SBS heat sealing processes that have successfully
met the validation requirements of ISO 11607-2 may be regarded as sufficient evidence that appropriate
process development has occurred; therefore, no additional process development activities according to this
document shall be required.
NOTE 1 The heat sealing processes of interest are those for SBS seals that establish a microbial barrier. Other types
of seals, such as those used for containment or spot welds for wraps bonding, are not used to create a microbial barrier
and are not covered in this document.
NOTE 2 This document provides an approach that meets the process development requirements for consistency;
however, there can be other valid approaches.
5.1.2 When process development is conducted prior to installation qualification (IQ), a documented
rationale should assess any risk with production equivalence and impact to process input and design output.

5.2 Process development activities
The process development activities as illustrated in Figure 1 shall be followed in an iterative way (not
linearly) until the objective is achieved. Process development concludes when an acceptable level of risk
has been achieved prior to proceeding to process validation. If the risk is not yet acceptable, the process
development activities shall be reviewed and improved until the risk level is acceptable.
NOTE Additional detailed information for each step of the process is provided in 5.3 through 5.9.
Figure 1 — Process development activities

5.3 Predetermined SBS specification(s)
5.3.1 Process development shall be based on predetermined SBS specification requirements:
a) SBS forming and assembly requirements (e.g. top/bottom web overlap, free from wrinkles or creases
that can impact seal quality, sequence of assembly operations);
b) SBS seal requirements (e.g. seal width, seal strength);
c) packaging materials (e.g. trays, lids, preformed SBS, roll stock, retainers to keep product in place);
d) SBS contents (if applicable).
NOTE Annex B provides information on heat sealing materials to assist process development.
5.3.2 Process development may be leveraged across families of similar SBSs, SBS specifications, or process
specifications. The rationale for such families shall be documented.
5.4 Draft process specification
5.4.1 Process elements and production provisions required to achieve process outputs shall be identified.
NOTE In this document, production provisions refer to the surrounding conditions and supporting arrangements
necessary to consistently achieve the specified process outputs.
5.4.1.1 Process elements can include but are not limited to:
a) equipment [e.g. heat sealer, form-fill-seal (FFS) machine];
b) equipment accessories (e.g. heating plates, tooling, fixtures, gaskets, product positioning guides);
c) measurement (e.g. test equipment, gauges);
d) workflow equipment (e.g. conveyors, tables, bins, verification device to confirm material is correct);
e) process consumables (e.g. seal jaw tape, mats, web cleaners).
5.4.1.2 Production provisions can include, but are not limited to:
a) environmental conditions (e.g. temperature, humidity, cleanroom requirements, inspection lighting);
b) utilities (e.g. compressed air, electrical supply);
c) process for using cleaning agents, disinfectants;
d) procedures for installation, operation, and maintenance of equipment if available;
e) personal protective equipment (e.g. gloves, cleanroom gowns);
f) personnel.
NOTE 1 A well-developed heat sealing process window is essential. However, SBS integrity issues can be caused by
the elements and provisions surrounding the heat sealing process.
NOTE 2 Annex C provides guidance on equipment features to enable process validation, monitoring, and control.
5.4.2 Process outputs and acceptance criteria based on predetermined SBS specifications shall be
documented in the process specification.

5.5 Initial process risk analysis
5.5.1 An initial process risk analysis shall be performed to identify potential process failure modes that
prevent the process outputs from meeting predetermined SBS specifications. Performing initial risk analysis
can facilitate accomplishment of the Process Risk Management Plan in 5.9 of this document.
NOTE Risk analysis tools can aid in the establishment of input and output relationships during process
development, see Annex D for an example of a failure modes and effects analysis (FMEA) for an SBS heat sealing
process.
Example failure modes include, but are not limited to:
a) seal strength out of specification (e.g. weak or strong seal);
b) narrow seal (e.g. voids within the seal area, seal not meeting dimensional specification);
c) channels or open seals;
d) damaged SBS materials (e.g. punctures, tears, excessive melting, deformation);
e) unintended material delamination for seals designed to be opened by peeling;
f) any known risk from previous validations if using an existing process.
5.5.2 A previously documented process risk analysis can be leveraged; in this case an initial risk analysis
according to 5.5 may be omitted.
NOTE 1 ISO 11607-2:2019/Amd 1:2023, Table B.1 includes possible contributing factors of process provisions that
can result in a hazardous situation.
NOTE 2 Labelling can be considered if it creates a risk to the sealing process. Otherwise it is not in scope of this
document.
5.5.3 Initial process risk analysis shall identify process related causes of failure modes for all process
elements and production provisions in 5.4.1.
Example causes include, but are not limited to:
a) contamination of seal tool or seal bar (e.g. debris, lack of cleanliness);
b) contamination of SBS material (e.g. residues of cleaning agents, contaminated gloves);
c) incorrect sealing equipment output (e.g. wrong parameter setting, calibration offset issue, pneumatic
loss, poor heat distribution);
d) damaged process elements (e.g. seal bar, gasket, improper maintenance);
e) incorrect tool or equipment accessory (e.g. alignment guide);
f) incorrect set up (e.g. web tension, web alignment, web position, poor line clearance).
5.5.4 Initial process risk analysis shall identify process variables and the controls or monitoring of those
variables that can be required to mitigate process related failure modes.
5.6 Process variables
5.6.1 The process variables required to achieve the required process outputs shall be identified.
Examples of process variables can include, but are not limited to:
a) temperature;
b) contact pressure;
c) dwell time or line speed.
NOTE Process time between heat seal cycles can affect the process output.
5.6.2 Process variables shall be evaluated by:
a) determining the effect of the identified process variables on the process outputs;
NOTE Design of experiments (DOE) is an approach often used to efficiently study process variables. Further
guidance can be found in Annex A.
b) determining the upper and lower limits of process variables that produce the required process outputs.
NOTE Some materials have a wide process window which produces the desired process outputs, making it of
little added value to determine the absolute upper and lower limits.
5.6.3 Process parameters to be used in process validation activities shall be determined.
5.7 Initial process control and monitoring plans
5.7.1 Process parameters required to consistently meet required process outputs shall be documented, as
well as the means of monitoring or controlling as appropriate.
NOTE Heat sealing equipment can include systems to set, control or monitor process variables. Systems can
include alarms, warnings or machine stops in the event a process variable exceeds limits.
5.7.2 Process outputs to be monitored including the frequency of monitoring, sample size, test method,
acceptance criteria and reaction plans shall be documented.
NOTE A control plan is an example of an approach that can be used to define how process outputs and variables
are monitored.
5.8 Process specification
The process specification shall be established based on the outputs of the activities completed in 5.4 through
5.7, meeting the requirements of ISO 11607-2.
NOTE 1 ISO 11607-2 includes requirements for the process specification to be documented as an output of process
development, traceable to the predetermined design specification and as the basis for process validation.
NOTE 2 The process specification can be a document or series of documents.
5.9 Process risk management plan
The output of process development activities supports the risk management plan.
NOTE ISO 11607-2:2019/Amd 1:2023, Annex B contains requirements for sterile barrier system process risk
management. ISO 11607-2/Amd 1:2023 includes the permission to combine risk management plans and related
records and documentation for forming, sealing and assembly of sterile barrier systems with those for the medical
device.
6 Process equivalence
6.1 Processes run on alternate sealing equipment may be considered equivalent if all requirements below
(as illustrated in Figure 2) are met:

NOTE 1 The term “alternate” is intended to cover multiple scenarios for deploying sealing equipment at a
manufacturing location including, but not limited, to new machines, used machines, refurbished machines, or machines
that have been moved to a new location that can affect machine output, such as a geography with a different electrical
power system.
a) SBS specification requirements shall be the same.
b) Alternate heat sealing equipment shall be based on equivalent heat sealing technology. The heat sealing
technology may be considered equivalent when it is within the same category (e.g. constant heat bar
sealer, rotary sealer, blister tray sealer), regardless of model or manufacturer.
NOTE 2 Relevant tolerances of process variables of alternate heat sealing equipment are an important
consideration in the assessment of equivalence. Equivalent process variables can have a bias in settings due to
temperature measurement, dwell time or pressure output as documented in equipment calibration, see Annex C.
This can result in different settings on alternate equipment to run the equivalent process.
c) Alternate heat sealing equipment shall use equivalent process elements.
d) Alternate heat sealing equipment shall not introduce any new, different, unique or increased risks
related to heat sealing which would require new risk controls or risk management plan.
e) Process outputs on alternate equipment shall meet SBS specifications.
NOTE 3 Statistical analysis of process outputs can be used to support process equivalence to leverage prior SBS
testing. Guidance on statistical equivalence evaluation is contained in Annex E.
6.2 In case of documented process equivalence based on 6.1, previous process development may be
leveraged. Validation activities on the alternate equipment shall meet the requirements of ISO 11607-2 in
alignment with change controls.
6.3 For processes documented as equivalent, previous testing activities such as those that demonstrate
conformity to ISO 11607-1:2019, Clause 8 are not impacted and may be considered as still valid.
NOTE 1 It is possible that alternate heat sealing equipment can require modifications or adjustments to process
variables or settings to achieve the same sealing energy. However, the focus of the equivalency assessment is on the
ability of the sealing process output to meet the SBS specification.
NOTE 2 ISO 11607-1 contains requirements for change management and revalidation if changes are made to the
design, contents, packaging materials, or configurations that compromise the original validation and can affect the
integrity of the sterile barrier system.

Figure 2 — Equivalence decision tree

Annex A
(informative)
Guidance on establishing process parameters
A.1 General
This annex is applicable to industrial manufacturers of both preformed SBSs and SBSs.
Process parameters, including ranges and tolerances, are necessary to ensure that a product satisfies the
defined requirements under all the anticipated conditions of manufacturing. These parameters should be
established using statistically valid techniques. Examples of approaches that can be used include:
— design of experiments (DOE);
— heat seal curve analysis;
— scoring of visual attributes of heat seals.
A.2 Example of forming and sealing an SBS (lidded tray)
A.2.1 Design of experiments (DOE)
Design of experiments is used to optimize the process parameter window and identify the process conditions
that will ensure that good quality product is consistently produced. The more detailed information obtained
at this stage, the easier it is to maintain control of the process. DOE activities can start with process
characterization to identify key process inputs that influence process outputs prior to full DOE.
Heat sealing a lid to a formed tray requires consideration of temperature, pressure, and dwell time. The DOE
activity should identify the range of process conditions that will have the minimum effect on the resulting
SBS.
For example, the process conditions necessary to ensure an acceptable seal when heat sealing the lid should:
— be sufficiently removed from those process conditions which will result in failure of the seal;
— produce a seal meeting specifications;
— show acceptable variation in seal strength.
Various levels of experiments can be conducted which could be simple, linear screening studies (sometimes
referred to as process characterization) to determine the relative effect of various parameters on the
resulting seal or highly complex, fractional factorial quadratic studies. Often a simple, linear experiment
is conducted to confirm the significance of parameters, potentially followed by a more complex study with
centre points to ensure a good mathematical model of the process is generated which fits the data. It is often
found that temperature is the most important variable, followed by time and then pressure.
The approaches used to establish the optimum conditions for heat seals are:
— heat seal curve analysis;
— scoring of visual attributes of heat seals;
— a combination of the heat seal curve analysis and scoring of visual attributes;
— initial analysis of process variability in support of process capability;

— evaluation of seal integrity.
NOTE For information on visual inspection of seals, see ASTM F1886/F1886M.
A.2.2 Heat seal curve analysis (process range assessment)
This procedure involves evaluating how a matrix of temperature, pressure and dwell time will impact
the material characteristics for seal strength. Curves constructed to determine the effects of the various
parameters normally show that varying pressure and dwell time have less of an effect on seal strength,
so these are kept constant while the temperature is varied. The heat seal curve analysis can support the
development of process limits over the range where the seal strength meets specification. These limits should
be established in a way that seal strength is maintained and other visually undesirable seal characteristics
are minimized (see Figure A.1, Tables A.1 and A.2). For additional details on how to create heat seal curves,
see ASTM F2029.
NOTE 1 Depending on the type of equipment, temperature and time are inversely correlated. Pressure is also
important but often fixed. Sealants and heat seal coatings will soften or melt at a certain temperature. At temperatures
above that softening or melting point, higher temperature settings can enable shorter dwell times, while longer
dwell times can be needed at lower temperature settings. Sealant squeeze out can be the result of applying too much
pressure.
NOTE 2 Heat seal curve analysis is often performed on a calibrated sealing device, with a precise adjustment,
control and monitoring of process parameters. Settings illustrated on heat seal curves obtained on a lab sealing device
can be different from settings on production equipment.
Key
X temperature
Y seal strength
1 proposed process limits
Figure A.1 — Heat seal curve for optimum process parameters

A.2.3 Visual scoring method for heat seals
Seals should be scored for visual observations and defects at both ends of the process range. Higher scores
indicate better quality. Specific acceptance criteria for visual scoring should be established. The following
tables provide visual scoring examples:
a) lower end of heat sealing range (see Table A.1);

Table A.1 — Lower end of sealing range
Score Visual seal observations
0 Open seals
Spotty or nonhomogeneous seals resulting in seal width less than 50 % of the specified value (spotty
appearance caused by incomplete softening or melting of the sealant material)
2 Spotty or nonhomogeneous seals resulting in seal width between 50 % and 74 % of the specified value
3 Spotty or nonhomogeneous seals resulting in seal width between 75 % and 94 % of the specified value
4 Seal width >95 % of the specified value with sporadic spotty or nonhomogeneous spots
5 Full intended seal (>95 % of the specified value), fully continuous and homogenous
b) upper end of heat sealing range (see Table A.2).
Table A.2 — Upper end of sealing range
Score Visual seal observations
0 Holes in materials
Welded seals or melted polymer
Severe curl of the flange of the tray
Severe transparentization of polymer based nonwoven lids
Severe fibre tearing of paper-based lids
Moderate curl of the flange of the tray
2 Moderate transparentization of polymer based nonwoven lids
Significant fibre tear of paper-based lids
Mottled (also spotty appearance but due to overactivation of the material) seals
3 Minor transparentization of polymer based nonwoven lids
Moderate fibre tearing of paper-based lids
Slight curl of the flange of the tray
Slight transparentization of polymer based nonwoven lids
Occasional mottling
Slight fibre tearing of paper-based lids
5 Good quality seals
A.2.4 Combining heat seal curve analysis and visual scoring
The results obtained from the analysis of heat seals can be combined with those obtained using the visual
scoring method to produce a graph as represented in Figure A.2.

Key
X temperature
Y1 seal strength
Y2 visual seal quality
1 proposed process limits
2 specification limits
Figure A.2 — Seal strength and visual seal quality vs. temperature

Annex B
(informative)
First principles of heat sealing materials
B.1 General
Heat sealing is a critical process in the forming of a sterile barrier system. The process joins one flexible SBS
material to another, or a flexible SBS material to a rigid SBS material. A basic discussion of SBS materials
is presented to provide a general understanding of the function of materials used to create seals. This
information is intended to add value to the development of heat sealing processes.
B.2 Fundamentals of heat-seal materials
B.2.1 General
There are two main ways for creating a sealable surface on an SBS material: films with sealant layers and
heat seal coatings.
B.2.2 Sealant films
Film sealant layers are used extensively in the creation of both peelable and weld seals. In most cases,
the nonporous film used to create a SBS is a multilayer structure comprising two or more layers that are
combined by coextrusion, adhesive lamination, extrusion coating or extrusion lamination. Multilayer films
offer many advantages for creating a robust SBS. One layer of the film can be used to provide mechanical
strength to the film while another layer is used to enhance barrier properties. The inner layer (product
facing) of such a composite film is the heat seal layer.
For peelable seals, the sealant layer includes a mixture of two polymers, a base sealant polymer and a second
immiscible polymer. The base sealant polymer creates the seal while the second polymer is used to control
the point of fracture, or controlled point of failure when the SBS is peeled open. This formulation of the
second polymer is what drives the cohesive strength.
Some film sealant layers are designed and formulated to create a weld seal, or a non-peelable seal. A non-
peelable seal is not intended to be opened by the end user.
B.2.3 Heat seal coatings or treatments
Heat seal coatings or treatments are thermoplastic, polymer-based materials that can be applied to porous
and nonporous substrates and are designed to adhere to and peel cleanly from common materials of
construction for SBS packaging. The interface between a heat seal coating or treatment and the SBS web
materials will be a sharp interface in most cases.
During heat sealing the coating or treatment is heated and melted to fully wet the companion web surface
to create a seal with integrity. The adhesive strength is dependent on intermolecular forces, or the chemical
similarity that makes the materials attracted to one another resulting in the adhesive force being greater
than the cohesive force or strength of the adhesive material. The cohesive force or strength is designed to be
the weak point of the SBS seal ensuring peelability without creating particulate upon opening.
Porous web surface treatment is a technology where the heat seal adhesive is applied simultaneously during
the creation of the breathable webs using specialized surface treatment machinery, rather than being
applied offline as a layer coating after the breathable web manufacturing process.
NOTE See also EN 868-7 and EN 868-10 for coated material applications.

The adhesive weight can influence the cohesive or adhesive failure modes of the seal during peeling, which
can affect the consistency of seal strength and the coating transfer appearance between two substrates.
B.3 Fundamentals of heat sealing
B.3.1 General
Heat sealing creates a bond between two materials through melting of the polymers at the seal interface,
polymer chain entanglement at the interface, and through chemical attractions. As a rule, polymers of
similar chemistry are required to create good heat seals. For example, low-density polyethylene (LDPE)
will seal well to other polyethylene materials, but not to polypropylene. In typical SBS applications, thermal
energy (heat) is used to initiate and complete the heat seal. In many cases, the webs that are sealed together
are multi-layer structures such as laminated films or coextruded films. An example of two webs before and
after sealing is shown in Figure B.1.
Key
seal interface
Figure B.1 — Unsealed and sealed structures (not to scale)
B.3.2 Molecular attraction
Adhesive force is a function of molecular attraction that acts between the heat seal coating or sealant and
the adherend material. There are several mechanisms available to create this force, primarily this adhesive
force is driven by chemical similarity of the materials. The materials of the of heat seal coating or sealant and
the adherends, when in very close proximity, will create intermolecular forces which hold the two materials
together at the interface. During heat sealing, the seal created will have a diffuse interface, a sharp interface
or a mechanical bond.
B.3.3 Interface
For the development of heat sealing processes, an understandi
...

ISO/TC 198/WG 7
Secretariat: ANSI
Date: 2026-04-2105-18
Packaging for terminally sterilized medical devices — —
Part 3:
Requirements for process development for forming, sealing and
assembly
Emballages des dispositifs médicaux stérilisés au stade terminal —
Partie 3: Exigences relatives à la mise au point des procédés de formage, scellage et assemblage
FDIS stage
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ISO/DIS FDIS 11607-3:20252026(en)
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
EmailE-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
4.1 Quality systems . 3
4.2 Risk management . 3
4.3 Sampling . 3
4.4 Test methods . 3
4.5 Documentation . 3
5 Process development . 3
5.1 General . 3
5.2 Process development activities . 4
5.3 Predetermined SBS specification(s) . 5
5.4 Draft process specification . 6
5.5 Initial process risk analysis . 7
5.6 Process variables . 7
5.7 Initial process control and monitoring plans . 8
5.8 Process specification . 8
5.9 Process risk management plan . 8
6 Process equivalence . 9
Annex A (informative) Guidance on establishing process parameters . 11
Annex B (informative) First principles of heat sealing materials . 15
Annex C (informative) Minimum heat sealing equipment features to support subsequent
validation, process control and monitoring . 19
Annex D (informative) Example of FMEA on SBS heat sealing process . 24
Annex E (informative) Guidance on evaluating the equivalence of sealing outputs . 26
Bibliography . 29

iii
ISO/DIS FDIS 11607-3:20252026(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of
ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO'sISO’s adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products, in
collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 102,
Sterilizers and associated equipment for processing of medical devices, in accordance with the Agreement on
technical cooperation between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 11607 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
Introduction
ISO 11607-1 and ISO 11607-2 specify requirements for the design and validation of sterile barrier systems for
terminally sterilized medical devices, and the validation requirements for manufacturing processes of sterile
barrier systems, respectively. The heat sealing of a sterile barrier system is critical to the maintenance of
sterile barrier integrity to the point of use; however, there is little content available for process development
in the current edition of ISO 11607-2.
This document specifies requirements for the development of heat sealing processes to meet sterile barrier
seal design requirements. A thorough development process with a high-quality output is an important input
to an efficient validation of the process. While a successful validation is essential to ensure the safety of
terminally sterilized medical devices, there is no intention to imply that the process development approach
proposed in this document is the only valid approach. Users of this document can use the activities described
in this standard to control risks associated with heat sealing processes, if they find it appropriate. Additionally,
this document specifies a process for documenting the equivalence of heat sealing processes which can be a
benefit to users in support of change control activities since it can create the basis to leverage the efforts over
a range of heat sealing equipment or over a sterile barrier system family.
This document is intended for use by industrial manufacturers engaged in the design and development of
sterile barrier systems and heat sealing processes. Effective application of the requirements described in this
document requires proficiency in design of experiment (DOE) methodologies and access to the requisite
testing resources for result evaluation. Producers of preformed sterile barrier systems, as well as medical
device manufacturers, rely heavily on heat sealing, among other techniques, to create sterile barrier systems
that ensure device integrity and sterility at various stages of distribution and handling of sterile devices until
the point of use and aseptic presentation. This process often involves the operation of multiple,
interchangeable heat sealers to produce commercial quantities of sterile barrier systems.
For healthcare facilities (e.g. hospitals), ISO/TS 16775:2021, Annex B contains all relevant guidance for sterile
barrier system closure technologies including sealing, reusable container closures and wrapping processes.
v
FINAL DRAFT International Standard ISO/FDIS 11607-3:2026(en)

Packaging for terminally sterilized medical devices —
Part 3:
Requirements for process development for forming, sealing and
assembly
1 Scope
This document specifies requirements for process development for forming, sealing and assembly of
packaging for medical devices to be terminally sterilized, when utilizing heat sealing technologies.
This document recommends minimum heat sealing equipment features to support subsequent validation,
process control and monitoring.
This document applies to both preformed sterile barrier systems and sterile barrier systems.
This document utilizes the sterile barrier system specification to develop the process specification using the
principles of risk management.
This document is intended to be used prior to process validation.
NOTE ISO 11607-2 provides requirements for process specification and process validation.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 11607-2:2019 & Amd -2:2019, Packaging for terminally sterilized medical devices — Part 2: Validation
requirements for forming, sealing and assembly processes
ISO 11607-2:2019/Amd 1:2023, Packaging for terminally sterilized medical devices — Part 2: Validation
requirements for forming, sealing and assembly processes & — Amendment 1: Application of Risk
Managementrisk management
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— — ISO Online browsing platform: available at https://www.iso.org/obp
— — IEC Electropedia: available at https://www.electropedia.org/
3.1 3.1
assembly
process of putting together all components of a sterile barrier system, including packaging
materials and contents
3.2 3.2
control
regulation of variables within specified limits
[SOURCE: ISO 11139:2018, 3.63]
3.3 3.3
forming
process of bringing materials into contact with each other or into the necessary position for heat
sealing or closure processes to create a sterile barrier system
Note 1 to entry: Forming in this context does not include thermoforming, cold-forming, forming thermoform portion of
form-fill-seal, fabrication of the material.
3.4 3.4
monitoring
continual checking, supervising, critically observing or determining the status in order to identify change from
the performance level required or expected
[SOURCE: ISO 31073:2022, 3.3.40, modified — Note to entry has been deleted.]
3.5 3.5
process parameter
specified value for a process variable
Note 1 to entry: The specification for a process includes the process parameters and their tolerances.
[SOURCE: ISO 11139:2018, 3.211]
3.6 3.6
process specification
documented procedure that includes all equipment, process parameters, monitors and materials required to
manufacture a product that consistently meets requirements
[SOURCE: ISO 11607-2:2019, 3.15]
3.7 3.7
process variable
chemical or physical attribute within a cleaning, disinfection, packaging or sterilization process, changes in
which can alter its effectiveness
EXAMPLE Time, temperature, pressure, concentration, humidity, wavelength.
[SOURCE: ISO 11139:2018, 3.213]
3.8 3.8
seal
result of joining surfaces together by fusion to form a microbial barrier
Note 1 to entry: For sealing by thermal fusion, this can include multiple heat sealing equipment technologies, but not cold
sealing.
[SOURCE: ISO 11139:2018, 3.244, modified — Note 1 to entry has been added.]
3.9 3.9
sterile barrier system
SBS
minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation of the
sterile contents at the point of use
[SOURCE: ISO 11139:2018, 3.272]
4 General requirements
4.1 Quality systems
The activities described within this document shall be carried out within a formal quality system.
NOTE ISO 9001 and ISO 13485 contain requirements for suitable quality systems. Additional requirements can be
specified by a country or region.
4.2 Risk management
A risk management process conforming with the requirements of ISO 11607-2/Amd 1:2023 shall be
implemented.
4.3 Sampling
Sampling plans based upon a statistically valid rationale is required for validation per ISO 11607-2.
Application of statistical aspects for sampling plans used in development of heat sealing processes is helpful.
This can include a rationale on statistical aspects regarding the materials, risks and sterile barrier systems
being evaluated.
NOTE Statistically valid indicates the use of a methodology that ensures the sample size and selection process are
appropriate for drawing reliable and accurate conclusions.
4.4 Test methods
Test methods used for activities described in this document shall meet the test method validation
requirements of ISO 11607-2. Process development may include preliminary evaluation methods which do
not require validation.
NOTE Preliminary evaluation methods focus on understanding the characteristics, attributes, or qualities of a
product or process (e.g. visual scoring method for heat seals which includes estimating attributes of a heat seal). See
Annex AAnnex A,, particularly A.2.4A.2.4.
4.5 Documentation
Documentation of activities described in this document shall meet the documentation requirements of
ISO 11607-2:2019, 4.5.
5 Process development
5.1 General
5.1.1 5.1.1 The requirements of this document are intended to be applied to heat sealing processes that
have not yet been validated. Existing SBS and preformed SBS heat sealing processes that have successfully met
the validation requirements of ISO 11607-2 may be regarded as sufficient evidence that appropriate process
development has occurred; therefore, no additional process development activities according to this
document shall be required.
NOTE 1 The heat sealing processes of interest are those for SBS seals that establish a microbial barrier. Other types of
seals, such as those used for containment or spot welds for wraps bonding, are not used to create a microbial barrier and
are not covered in this document.
NOTE 2 This document provides an approach that meets the process development requirements for consistency;
however, there can be other valid approaches.
5.1.2 5.1.2 When process development is conducted prior to installation qualification (IQ), a documented
rationale should assess any risk with production equivalence and impact to process input and design output.
5.2 Process development activities
The process development activities as illustrated in Figure 1Figure 1 shall be followed in an iterative way (not
linearly) until the objective is achieved. Process development concludes when an acceptable level of risk has
been achieved prior to proceeding to process validation. If the risk is not yet acceptable, the process
development activities shall be reviewed and improved until the risk level is acceptable.
NOTE Additional detailed information for each step of the process is provided in 5.35.3 through 5.95.9.
Figure 1 — Process development activities
5.3 Predetermined SBS specification(s)
5.3.1 5.3.1 Process development shall be based on predetermined SBS specification requirements:
a) a) SBS forming and assembly requirements (e.g. top/bottom web overlap, free from wrinkles or
creases that can impact seal quality, sequence of assembly operations);
b) b) SBS seal requirements (e.g. seal width, seal strength);
c) c) packaging materials (e.g. trays, lids, preformed SBS, roll stock, retainers to keep product in
place);
d) d) SBS contents (if applicable).
NOTE Annex BAnnex B provides information on heat sealing materials to assist process development.
5.3.2 5.3.2 Process development may be leveraged across families of similar SBSs, SBS specifications, or
process specifications. The rationale for such families shall be documented.
5.4 Draft process specification
5.4.1 5.4.1 Process elements and production provisions required to achieve process outputs shall be
identified.
NOTE In this document, production provisions refer to the surrounding conditions and supporting arrangements
necessary to consistently achieve the specified process outputs.
5.4.1.1 5.4.1.1 Process elements can include but are not limited to:
a) a) equipment ([e.g. heat sealer, form-fill-seal (FFS) machine);];
b) b) equipment accessories (e.g. heating plates, tooling, fixtures, gaskets, product positioning
guides);
c) c) measurement (e.g. test equipment, gauges);
d) d) workflow equipment (e.g. conveyors, tables, bins, verification device to confirm material is
correct);
e) e) process consumables (e.g. seal jaw tape, mats, web cleaners).
5.4.1.2 5.4.1.2 Production provisions can include, but are not limited to:
a) a) environmental conditions (e.g. temperature, humidity, cleanroom requirements, inspection
lighting);
b) b) utilities (e.g. compressed air, electrical supply);
c) c) process for using cleaning agents, disinfectants;
d) d) procedures for installation, operation, and maintenance of equipment if available;
e) e) personal protective equipment (e.g. gloves, cleanroom gowns);
f) f) personnel.
NOTE 1 A well-developed heat sealing process window is essential. However, SBS integrity issues can be caused by
the elements and provisions surrounding the heat sealing process.
NOTE 2 Annex CAnnex C provides guidance on equipment features to enable process validation, monitoring, and
control.
5.4.2 5.4.2 Process outputs and acceptance criteria based on predetermined SBS specifications shall be
documented in the process specification.
5.5 Initial process risk analysis
5.5.1 5.5.1 An initial process risk analysis shall be performed to identify potential process failure modes
that prevent the process outputs from meeting predetermined SBS specifications. Performing initial risk
analysis can facilitate accomplishment of the Process Risk Management Plan in 5.9subclause 5.9 of this
document.
NOTE Risk analysis tools can aid in the establishment of input and output relationships during process development,
see Annex DAnnex D for an example of an a failure modes and effects analysis (FMEA) for aan SBS heat sealing process.
Example failure modes include, but are not limited to:
a) a) seal strength out of specification (e.g. weak or strong seal);
b) b) narrow seal (e.g. voids within the seal area, seal not meeting dimensional specification);
c) c) channels or open seals;
d) d) damaged SBS materials (e.g. punctures, tears, excessive melting, deformation);
e) e) unintended material delamination for seals designed to be opened by peeling;
f) f) any known risk from previous validations if using an existing process.
5.5.2 5.5.2 A previously documented process risk analysis can be leveraged; in this case an initial risk
analysis according to 5.55.5 may be omitted.
NOTE 1 ISO 11607-2:2019/Amd 1:2023, Table B.1 includes possible contributing factors of process provisions that
can result in a hazardous situation.
NOTE 2 Labelling can be considered if it creates a risk to the sealing process. Otherwise it is not in scope of this
document.
5.5.3 5.5.3 Initial process risk analysis shall identify process related causes of failure modes for all process
elements and production provisions in 5.4.15.4.1.
Example causes include, but are not limited to:
a) a) contamination of seal tool or seal bar (e.g. debris, lack of cleanliness);
b) b) contamination of SBS material (e.g. residues of cleaning agents, contaminated gloves);
c) c) incorrect sealing equipment output (e.g. wrong parameter setting, calibration offset issue,
pneumatic loss, poor heat distribution);
d) d) damaged process elements (e.g. seal bar, gasket, improper maintenance);
e) e) incorrect tool or equipment accessory (e.g. alignment guide);
f) f) incorrect set up (e.g. web tension, web alignment, web position, poor line clearance).
5.5.4 5.5.4 Initial process risk analysis shall identify process variables and the controls or monitoring of
those variables that can be required to mitigate process related failure modes.
5.6 Process variables
5.6.1 5.6.1 The process variables required to achieve the required process outputs shall be identified.
Examples of process variables can include, but are not limited to:
a) a) temperature;
b) b) contact pressure;
c) c) dwell time or line speed.
NOTE Process time between heat seal cycles can affect the process output.
5.6.2 5.6.2 Process variables shall be evaluated by:
a) a) determining the effect of the identified process variables on the process outputs;
NOTE Design of experiments (DOE) is an approach often used to efficiently study process variables. Further
guidance can be found in Annex AAnnex A.
b) b) determining the upper and lower limits of process variables that produce the required process
outputs.
NOTE Some materials have a wide process window which produces the desired process outputs, making it of little
added value to determine the absolute upper and lower limits.
5.6.3 5.6.3 Process parameters to be used in process validation activities shall be determined.
5.7 Initial process control and monitoring plans
5.7.1 5.7.1 Process parameters required to consistently meet required process outputs shall be
documented, as well as the means of monitoring or controlling as appropriate.
NOTE Heat sealing equipment can include systems to set, control or monitor process variables. Systems can include
alarms, warnings or machine stops in the event a process variable exceeds limits.
5.7.2 5.7.2 Process outputs to be monitored including the frequency of monitoring, sample size, test
method, acceptance criteria and reaction plans shall be documented.
NOTE A control plan is an example of an approach that can be used to define how process outputs and variables are
monitored.
5.8 Process specification
The process specification shall be established based on the outputs of the activities completed in 5.45.4
through 5.75.7,, meeting the requirements of ISO 11607-2.
NOTE 1 ISO 11607-2 includes requirements for the process specification to be documented as an output of process
development, traceable to the predetermined design specification and as the basis for process validation.
NOTE 2 The process specification can be a document or series of documents.
5.9 Process risk management plan
The output of process development activities supports the risk management plan.
NOTE ISO 11607-2:2019/Amd1Amd 1:2023, Annex B contains requirements for sterile barrier system process risk
management. ISO 11607-2/Amd1Amd 1:2023 includes the permission to combine risk management plans and related
records and documentation for forming, sealing and assembly of sterile barrier systems with those for the medical device.
6 Process equivalence
6.1 6.1 Processes run on alternate sealing equipment may be considered equivalent if all requirements
below (as illustrated in Figure 2Figure 2)) are met:
NOTE 1 The term “alternate” is intended to cover multiple scenarios for deploying sealing equipment at a
manufacturing location including, but not limited, to new machines, used machines, refurbished machines, or machines
that have been moved to a new location that can affect machine output, such as a geography with a different electrical
power system.
a) SBS specification requirements shall be the same.
b) Alternate heat sealing equipment shall be based on equivalent heat sealing technology. The heat sealing
technology may be considered equivalent when it is within the same category (e.g. constant heat bar
sealer, rotary sealer, blister tray sealer), regardless of model or manufacturer.
NOTE 2 Relevant tolerances of process variables of alternate heat sealing equipment are an important
consideration in the assessment of equivalence. Equivalent process variables can have a bias in settings due to
temperature measurement, dwell time or pressure output as documented in equipment calibration, see
Annex CAnnex C. This can result in different settings on alternate equipment to run the equivalent process.
c) Alternate heat sealing equipment shall use equivalent process elements.
d) Alternate heat sealing equipment shall not introduce any new, different, unique or increased risks related
to heat sealing which would require new risk controls or risk management plan.
e) Process outputs on alternate equipment shall meet SBS specifications.
NOTE 3 Statistical analysis of process outputs can be used to support process equivalence to leverage prior SBS
testing. Guidance on statistical equivalence evaluation is contained in Annex EAnnex E.
6.2 6.2 In case of documented process equivalence based on 6.16.1,, previous process development
may be leveraged. Validation activities on the alternate equipment shall meet the requirements of ISO 11607-
2 in alignment with change controls.
6.3 6.3 For processes documented as equivalent, previous testing activities such as those that
demonstrate conformity to ISO 11607-1:2019, Clause 8 are not impacted and may be considered as still valid.
NOTE 1 It is possible that alternate heat sealing equipment can require modifications or adjustments to process
variables or settings to achieve the same sealing energy. However, the focus of the equivalency assessment is on the
ability of the sealing process output to meet the SBS specification.
NOTE 2 ISO 11607-1 contains requirements for change management and revalidation if changes are made to the
design, contents, packaging materials, or configurations that compromise the original validation and can affect the
integrity of the sterile barrier system.
Figure 2 — Equivalence decision tree
Annex A
(informative)
Guidance on establishing process parameters
A.1 General
This annex is applicable to industrial manufacturers of both preformed SBSs and SBSs.
Process parameters, including ranges and tolerances, are necessary to ensure that a product satisfies the
defined requirements under all the anticipated conditions of manufacturing. These parameters should be
established using statistically valid techniques. Examples of approaches that can be used include:
— — design of experiments (DOE);
— — heat seal curve analysis;
— — scoring of visual attributes of heat seals.
A.2 Example of forming and sealing an SBS (lidded tray)
A.2.1 Design of experiments (DOE)
Design of experiments is used to optimize the process parameter window and identify the process conditions
that will ensure that good quality product is consistently produced. The more detailed information obtained
at this stage, the easier it is to maintain control of the process. DOE activities can start with process
characterization to identify key process inputs that influence process outputs prior to full DOE.
Heat sealing a lid to a formed tray requires consideration of temperature, pressure, and dwell time. The DOE
activity should identify the range of process conditions that will have the minimum effect on the resulting SBS.
For example, the process conditions necessary to ensure an acceptable seal when heat sealing the lid should:
— — be sufficiently removed from those process conditions which will result in failure of the seal;
— — produce a seal meeting specifications;
— — show acceptable variation in seal strength.
Various levels of experiments can be conducted which could be simple, linear screening studies (sometimes
referred to as process characterization) to determine the relative effect of various parameters on the resulting
seal or highly complex, fractional factorial quadratic studies. Often a simple, linear experiment is conducted
to confirm the significance of parameters, potentially followed by a more complex study with centre points to
ensure a good mathematical model of the process is generated which fits the data. It is often found that
temperature is the most important variable, followed by time and then pressure.
The approaches used to establish the optimum conditions for heat seals are:
— — heat seal curve analysis;
— — scoring of visual attributes of heat seals;
— — a combination of the heat seal curve analysis and scoring of visual attributes;
— — initial analysis of process variability in support of process capability;
— — evaluation of seal integrity.
NOTE For information on visual inspection of seals, see ASTM F1886/F1886M.
A.2.2 Heat seal curve analysis (process range assessment)
This procedure involves evaluating how a matrix of temperature, pressure and dwell time will impact the
material characteristics for seal strength. Curves constructed to determine the effects of the various
parameters normally show that varying pressure and dwell time have less of an effect on seal strength, so
these are kept constant while the temperature is varied. The heat seal curve analysis can support the
development of process limits over the range where the seal strength meets specification. These limits should
be established in a way that seal strength is maintained and other visually undesirable seal characteristics are
minimized (see Figure A.1Figure A.1, Tables A.2, Tables A.1 and A.2A.3).). For additional details on how to
create heat seal curves, see ASTM F2029.
NOTE 1 Depending on the type of equipment, temperature and time are inversely correlated. Pressure is also
important but often fixed. Sealants and heat seal coatings will soften or melt at a certain temperature. At temperatures
above that softening or melting point, higher temperature settings can enable shorter dwell times, while longer dwell
times can be needed at lower temperature settings. Sealant squeeze out can be the result of applying too much pressure.
NOTE 2 Heat seal curve analysis is often performed on a calibrated sealing device, with a precise adjustment, control
and monitoring of process parameters. Settings illustrated on heat seal curves obtained on a lab sealing device can be
different from settings on production equipment.

Key
X temperature
Y seal strength
1 proposed process limits
X temperature
Y seal strength
1 proposed process limits
Figure A.1 — Heat seal curve for optimum process parameters
A.2.3 Visual scoring method for heat seals
Seals should be scored for visual observations and defects at both ends of the process range. Higher scores
indicate better quality. Specific acceptance criteria for visual scoring should be established. The following
tables provide visual scoring examples:
a) a) lower end of heat sealing range (see Table A.1Table A.2););

Table A.21 — Lower end of sealing range
Score Visual seal observations
0 Open seals
Spotty or nonhomogeneous seals resulting in seal width less than 50 % of the specified value (spotty
appearance caused by incomplete softening or melting of the sealant material)
2 Spotty or nonhomogeneous seals resulting in seal width between 50 % and 74 % of the specified value
3 Spotty or nonhomogeneous seals resulting in seal width between 75 % and 94 % of the specified value
4 Seal width >95 % of the specified value with sporadic spotty or nonhomogeneous spots
5 Full intended seal (>95 % of the specified value), fully continuous and homogenous

b) b) upper end of heat sealing range (see Table A.2Table A.3).).
Table A.3 2 — Upper end of sealing range
Score Visual seal observations
0 Holes in materials
Welded seals or melted polymer
Severe curl of the flange of the tray
Severe transparentization of polymer based nonwoven lids
Severe fibre tearing of paper-based lids
Moderate curl of the flange of the tray
2 Moderate transparentization of polymer based nonwoven lids
Significant fibre tear of paper-based lids
Mottled (also spotty appearance but due to overactivation of the material) seals
3 Minor transparentization of polymer based nonwoven lids
Moderate fibre tearing of paper-based lids
Slight curl of the flange of the tray
Slight transparentization of polymer based nonwoven lids
Occasional mottling
Slight fibre tearing of paper-based lids
Score Visual seal observations
5 Good quality seals
A.2.4 Combining heat seal curve analysis and visual scoring
The results obtained from the analysis of heat seals can be combined with those obtained using the visual
scoring method to produce a graph as represented in Figure A.2Figure A.2.

Key
X temperature
Y1 seal strength
Y2 visual seal quality
1 proposed process limits
2 specification limits
X temperature
Y1 seal strength
Y2 visual seal quality
1 proposed process limits
2 specification limits
Figure A.2 — Seal strength and visual seal quality vs. temperature
Annex B
(informative)
First principles of heat sealing materials
B.1 General
Heat sealing is a critical process in the forming of a sterile barrier system. The process joins one flexible SBS
material to another, or a flexible SBS material to a rigid SBS material. A basic discussion of SBS materials is
presented to provide a general understanding of the function of materials used to create seals. This
information is intended to add value to the development of heat sealing processes.
B.2 Fundamentals of heat-seal materials
B.2.1 General
There are two main ways for creating a sealable surface on an SBS material: films with sealant layers and heat
seal coatings.
B.2.2 Sealant films
Film sealant layers are used extensively in the creation of both peelable and weld seals. In most cases, the
nonporous film used to create a SBS is a multilayer structure comprising two or more layers that are combined
by coextrusion, adhesive lamination, extrusion coating or extrusion lamination. Multilayer films offer many
advantages for creating a robust SBS. One layer of the film can be used to provide mechanical strength to the
film while another layer is used to enhance barrier properties. The inner layer (product facing) of such a
composite film is the heat seal layer.
For peelable seals, the sealant layer includes a mixture of two polymers, a base sealant polymer and a second
immiscible polymer. The base sealant polymer creates the seal while the second polymer is used to control
the point of fracture, or controlled point of failure when the SBS is peeled open. This formulation of the second
polymer is what drives the cohesive strength.
Some film sealant layers are designed and formulated to create a weld seal, or a non-peelable seal. A non-
peelable seal is not intended to be opened by the end user.
B.2.3 Heat seal coatings or treatments
Heat seal coatings or treatments are thermoplastic, polymer-based materials that can be applied to porous
and nonporous substrates and are designed to adhere to and peel cleanly from common materials of
construction for SBS packaging. The interface between a heat seal coating or treatment and the SBS web
materials will be a sharp interface in most cases.
During heat sealing the coating or treatment is heated and melted to fully wet the companion web surface to
create a seal with integrity. The adhesive strength is dependent on intermolecular forces, or the chemical
similarity that makes the materials attracted to one another resulting in the adhesive force being greater than
the cohesive force or strength of the adhesive material. The cohesive force or strength is designed to be the
weak point of the SBS seal ensuring peelability without creating particulate upon opening.
Porous web surface treatment is a technology where the heat seal adhesive is applied simultaneously during
the creation of the breathable webs using specialized surface treatment machinery, rather than being applied
offline as a layer coating after the breathable web manufacturing process.
NOTE See also EN 868-7 and EN 868-10 for coated material applications.
The adhesive weight can influence the cohesive or adhesive failure modes of the seal during peeling, which
can affect the consistency of seal strength and the coating transfer appearance between two substrates.
B.3 Fundamentals of heat sealing
B.3.1 General
Heat sealing creates a bond between two materials through melting of the polymers at the seal interface,
polymer chain entanglement at the interface, and through chemical attractions. As a rule, polymers of similar
chemistry are required to create good heat seals. For example, low-density polyethylene (LDPE) will seal well
to other polyethylene materials, but not to polypropylene. In typical SBS applications, thermal energy (heat)
is used to initiate and complete the heat seal. In many cases, the webs that are sealed together are multi-layer
structures such as laminated films or coextruded films. An example of two webs before and after sealing is
shown in Figure B.1Figure B.1.

Key
seal interface
Figure B.1 — Unsealed and sealed structures (not to scale)
B.3.2 Molecular attraction
Adhesive force is a function of molecular attraction that acts between the heat seal coating or sealant and the
adherend material. There are several mechanisms available to create this force, primarily this adhesive force
is driven by chemical similarity of the materials. The materials of the of heat seal coating or sealant and the
adherends, when in very close proximity, will create intermolecular forces which hold the two materials
together at the interface. During heat sealing, the seal created will have a diffuse interface, a sharp interface
or a mechanical bond.
B.3.3 Interface
For the development of heat sealing processes, an understanding of the interface of the two materials at the
sealed area is helpful. In general, there are multiple types of interfaces common in medical device packaging
applications: sharp, diffuse, and mechanical bonds.
Heat seals with a sharp interface are those with a clear and distinct boundary between two joined materials.
When the heat is applied, typically only one surface melts and wets the other surface, allowing them to adhere
at the interface. Unlike a diffuse interface, where the boundary is gradual and blended, a sharp interface results
in a precise line of adhesion between the two materials, such as when sealing a flexible lid to a rigid tray.
Heat seals with a diffuse interface are those in which it is difficult, if not impossible, to discern a sharp
boundary between the two materials after they have been joined. This transition zone occurs because the heat
applied causes the materials to soften, allowing polymer chains at the interface to entangle, creating a blended
region rather than a distinct boundary. As the interface region blends, polymer chain segments diffuse across
the interface and begin to create molecular entanglements as a joined structure.
Heat seals with a mechanical bond interface are characterized by adhesion that is achieved primarily through
physical interlocking rather than mol
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