prEN ISO 11607-3
(Main)Packaging for terminally sterilized medical devices - Part 3: Requirements for process development for forming, sealing and assembly (ISO/DIS 11607-3:2025)
Packaging for terminally sterilized medical devices - Part 3: Requirements for process development for forming, sealing and assembly (ISO/DIS 11607-3:2025)
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.
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 3: Anforderungen an die Prozessentwicklung der Formgebung, Siegelung und des Zusammenstellens (ISO/DIS 11607‑3:2025)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 3: Exigences relatives à la mise au point des procédés de formage, scellage et assemblage (ISO/DIS 11607-3:2025)
Embalaža za končno sterilizirane medicinske pripomočke - 3. del: Zahteve za razvoj procesa oblikovanja, tesnjenja in sestavljanja (ISO/DIS 11607-3:2025)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2025
Embalaža za končno sterilizirane medicinske pripomočke - 3. del: Zahteve za
razvoj procesa oblikovanja, tesnjenja in sestavljanja (ISO/DIS 11607-3:2025)
Packaging for terminally sterilized medical devices - Part 3: Requirements for process
development for forming, sealing and assembly (ISO/DIS 11607-3:2025)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 3:
Anforderungen an die Prozessentwicklung der Formgebung, Siegelung und des
Zusammenstellens (ISO/DIS 11607-3:2025)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 3: Exigences
relatives à la mise au point des procédés de formage, scellage et assemblage (ISO/DIS
11607-3:2025)
Ta slovenski standard je istoveten z: prEN ISO 11607-3
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
International
Standard
ISO/DIS 11607-3
ISO/TC 198
Packaging for terminally sterilized
Secretariat: ANSI
medical devices —
Voting begins on:
Part 3: 2025-09-01
Requirements for process
Voting terminates on:
2025-11-24
development for forming, sealing
and assembly
Emballages des dispositifs médicaux stérilisés au stade
terminal —
Partie 3: Exigences relatives au développement des procédés de
formage, scellage et assemblage
ICS: 11.080.30
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
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USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 11607-3:2025(en)
DRAFT
ISO/DIS 11607-3:2025(en)
International
Standard
ISO/DIS 11607-3
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 au développement des procédés de
formage, scellage et assemblage
ICS: 11.080.30
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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Published in Switzerland Reference number
ISO/DIS 11607-3:2025(en)
ii
ISO/DIS 11607-3:2025(en)
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 .3
5.3 Predetermined SBS specification(s) .4
5.4 Draft process specification . .5
5.5 Initial process risk analysis .5
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 .11
Annex B (informative) First principles of heat sealing materials .16
Annex C (informative) Minimum heat sealing equipment features to support subsequent
validation, process control and monitoring .20
Annex D (informative) Guidance on evaluating the equivalence of sealing outputs .24
Bibliography .27
iii
ISO/DIS 11607-3:2025(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'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 for medical purposes, 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
ISO/DIS 11607-3:2025(en)
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 approach proposed in this
document is the only valid approach. User of this document can use it if they find it appropriate. Additionally,
this document specifies a process for documenting the equivalence of 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 sealing equipment.
This document is intended for use by industrial manufacturers engaged in the design and development of
sterile barrier systems and sealing processes. Effective application of the requirements within 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
sterility upon delivery to end users. This process often involves the operation of multiple, interchangeable
heat sealers to produce commercial quantities of sterile barrier systems. Documenting process equivalence
across these sealers can optimize resources and streamline efforts.
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
DRAFT International Standard ISO/DIS 11607-3:2025(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
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]
ISO/DIS 11607-3:2025(en)
3.3
forming
process of bringing materials into contact with each other or into the necessary position for
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 Guide 73:2009, 3.8.2.1, 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 adhesive sealing.
[SOURCE: ISO 11139:2018, 3.244, modified — Note 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]
ISO/DIS 11607-3:2025(en)
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 shall be implemented.
4.3 Sampling
The sampling plans used in development of heat sealing processes shall be based upon a statistically valid
rationale considering 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. Defined criteria used during process development may include qualitative
evaluations (e.g. use of specific methods, protocols and acceptance criteria) which do not require validation.
NOTE Qualitative evaluations refer to methods that focus on understanding the characteristics, attributes, or
qualities of a product or process, rather than relying on empirical data and statistical analysis (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 and its subclauses.
5 Process development
5.1 General
The requirements of this document are intended to be applied for 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 that establish a microbial barrier. Other types of seals, such
as tack seals used for containment or spot welds for wraps bonding, do not serve the same function, have the same
requirements, or present the same level of risk as seals used to create a microbial barrier.
NOTE 2 This document provides a process development process for consistency, however, there can be other valid
approaches.
5.2 Process development activities
Figure 1 illustrates process development activities. This process shall be followed in an iterative way (not
linear) until the objective is achieved. Process development culminates with an acceptable level of risk prior
to proceeding to process validation. If the risk is not yet acceptable, the process development activities
ISO/DIS 11607-3:2025(en)
should be reviewed and improved until the risk level is acceptable. Additional detailed information for each
step of the process is 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 assembly requirements (e.g. such as sequence of assembly operations);
b) SBS forming requirements (e.g. material tension);
c) SBS seal requirements (e.g. seal width, seal strength);
d) packaging materials (e.g. trays, lids, preformed SBS, roll stock, retainers to keep product in place);
e) SBS contents (if applicable).
NOTE Annex B provides information on heat sealing materials to assist process development.
ISO/DIS 11607-3:2025(en)
5.3.2 Process development may consider establishing families of similar SBS’s, SBS specifications, or
process specifications. 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.
5.4.1.1 Process elements may include but are not limited to:
a) equipment (e.g. heat sealer, form fill seal (FFS) machine);
b) fixtures (e.g. hotplates, nests, tooling, gaskets, product positioning guides);
c) measurement (e.g. test equipment, gauges);
d) workflow equipment (e.g. conveyors, tables, bins);
e) material identification (e.g. confirm material is correct as specified);
f) process consumables (e.g. seal jaw tape, mats, web cleaners).
5.4.1.2 Production provisions may 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 sealing process window is essential, however, SBS integrity issues can be caused by the
elements and provisions surrounding the 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 Perform an initial process risk analysis to identify potential process failure modes that prevent
the process outputs from meeting predetermined SBS specifications can facilitate accomplishment of the
Process Risk Management Plan (5.9).
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 opens seals;
d) damaged SBS materials (e.g. punctures, tears, excessive melting, deformation);
e) material delamination for seals designed to be opened by peeling;
ISO/DIS 11607-3:2025(en)
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 of the
process elements and process provisions in 5.4.1.
Example process related 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 energy (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 fixture (e.g. alignment tool);
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 may 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 The combination of process variables can be used to determine the energy used in the sealing process.
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 is a method often used to efficiently study process variables. Further guidance
can be found in Annex C.
b) determining the upper and lower limits of process variables that produce the required process outputs.
NOTE Creating a margin between process limits and a failure of the process output is best practice. 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.
ISO/DIS 11607-3:2025(en)
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 Sealing equipment can include systems to control, set 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 a tool that can be used to define how process outputs and variables are
monitored.
5.8 Process specification
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.
The process specification includes but is not limited to:
a) required process elements (see 5.4.1);
b) required materials (e.g. SBS materials, product);
c) required production provisions (e.g. supporting processes maintenance, cleaning);
d) required process outputs to be monitored;
e) process variables and process and/or product attributes to be monitored;
f) process parameter settings and controls.
NOTE The process specification is a document (or series of documents) used as an input to process validation; see
ISO 11607-2.
5.9 Process risk management plan
The output of process development activities complements the risk management plan.
NOTE ISO 11607-2:2019/Amd1:2023 Annex B contains requirements for sterile barrier system process risk
management. ISO 11607-2 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 in the
decision tree in Figure 2 and 6.4 through 6.8 are met.
NOTE 1 Sealing equipment of the same make or model where the elements and modules are identical can have
differences in tolerances that affect the sealing energy.
NOTE 2 The term alternate is intended to cover multiple scenarios for sealing equipment acquisition at a
manufacturing location including but not limited to new machines, acquisition of used machines, refurbishing
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.
6.2 Previous process development may be leveraged, however the process still requires validation
activities on the alternate equipment in alignment with change controls.
ISO/DIS 11607-3:2025(en)
NOTE ISO 11607-2:2019 5.1.4 includes the requirement for a rationale for the determination of process families
and validation of the worst-case configuration as a minimum.
6.3 For processes confirmed equivalent, previous testing activities such as ISO 11607-1:2019 Clause 8
packaging system performance and stability are not impacted and may be considered as still valid.
NOTE 1 It is possible that alternate 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.
ISO/DIS 11607-3:2025(en)
Figure 2 — Equivalence decision tree
6.4 SBS specification requirements shall be the same.
6.5 Alternate sealing equipment shall use the equivalent technology.
NOTE 1 Sealing equipment is considered to be equivalent technology when the alternate equipment is within the
same category (e.g. constant heat bar sealer, rotary sealer, blister tray sealer). Because of this, different sealer models
and manufacturers can be considered equivalent technology.
ISO/DIS 11607-3:2025(en)
NOTE 2 Relevant tolerances of process variables of alternate sealing equipment are an important consideration
in the assessment of equivalence. Equivalent process variables can have a bias in settings due to temperature
measurement or pressure output. This can result in different settings on new equipment to run the equivalent process.
6.6 Alternate sealing equipment shall use equivalent process elements.
6.7 Alternate sealing equipment shall not introduce any new, different or unique risks which would
require new risk controls or risk management plan.
6.8 Process outputs on alternate equipment shall meet SBS specifications.
NOTE 1 For processes on alternate equipment that are not yet validated, these process outputs can be used to
leverage previous process development.
NOTE 2 Statistical analysis of process outputs can be used to support process equivalence to leverage prior SBS
testing (see 6.3). Guidance on statistical equivalence evaluation is contained in Annex D.
6.9 If all the aspects in 6.4 through 6.8 are confirmed, process equivalence for new or alternate equipment
shall be documented.
ISO/DIS 11607-3:2025(en)
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 tools that can be used include:
— FMEA (failure modes and effects analysis);
— DOE (design of experiments);
— heat seal curve analysis;
— visual attributes.
A.2 Example of forming and sealing an SBS (lidded tray)
A.2.1 FMEA (failure modes and effects analysis)
Failure modes and effects analysis is a systematic method for studying failure. It can be used for both
product development and process control. It determines the severity and likelihood of potential failure
modes which are normally identified on the basis of past experience with similar products or processes. In
this case (process development), it is used to establish the process parameters for equipment at each stage
of the fabricating, loading, sealing and packaging.
The procedure involves the following stages:
— identifying which defects will cause the product to be rejected (failure mode);
— establishing the cause of failure and how likely it is to occur;
— establishing the consequences of each failure mode;
— grading the severity, frequency, and ease of detection of each failure mode;
— identifying the controls currently in place and the probability of detecting failure;
— calculating the Risk Priority Number (RPN) for each failure mode using the formula A.1:
RPN = Severity Number x Frequency Number x Ease of Detection Number (A.1)
— recommending actions to reduce the RPN.
Acceptance criteria should be defined for the RPN and controls put in place to reduce the RPN where
necessary. The severity cannot usually be reduced, but actions to reduce frequency or improve detection
can be employed to reduce the RPN.
An example for failure modes and effects analysis is given in Table A.1.
ISO/DIS 11607-3:2025(en)
Table A.1 — FMEA example
Failure Effect of Current Ease of
Process Function Severity Cause Frequency RPN Actions
Mode Failure Controls Detection
Incorrect
Heat sealing Product
Sealing Open seal 10 machine 1 Leak tester 3 30
materials integrity
settings
Heat sealing Channel in Product Creases in
Sealing 10 4 Visual 3 120
materials seal integrity material
Incorrect
Heat sealing Channel in Product
Sealing 10 Machine 4 Leak tester 5 200
materials seal integrity
settings
Incorrect
Heat sealing Spotty Product
Sealing 10 Machine 3 Visual 1 30
materials seals integrity
settings
Failure of
Unable to
Software or
Bar code Registration of Machine Machine
read bar 1 1 1 1
scanner packs won’t run won’t run
Poor Print
code
quality
A.2.2 Design of experiments (DOE)
Design of experiments is used to establish the optimum process parameter window. In other words, to
identify the process conditions that will ensure that good quality product is produced consistently. The
more detailed the information obtained at this stage, the easier it is to maintain control of the process.
Forming of a tray and subsequent heat sealing of the lid require consideration of temperature, pressure,
and dwell time. In both cases it is necessary to 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 according to specifications;
— show minimum variation in seal strength.
Various levels of experiments can be conducted – from simple, linear screening studies to determine the
relative effect of various parameters on resulting seal – to highly complex, fractional factorial quadratic
studies. Often a simple, linear experiment is conducted to confirm the significance of parameters – 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 tools used to establish the optimum conditions for heat seals are:
— heat seal curve analysis;
— visual assessment of the seal areas;
— a combination of the heat seal curve analysis and visual assessment;
— determination of process capability;
— evaluation of seal integrity.
A.2.3 Heat seal curve analysis (process range assessment)
This procedure involves evaluating how a matrix of temperature, pressure and dwell time will impact on
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 a less 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
ISO/DIS 11607-3:2025(en)
established in a way that seal strength is maintained and other visually undesirable seal characteristics are
minimized (see Figure A.1, Tables A.2 and A.3).
NOTE 1 Depending on the type of equipment, temperature and time are often interchangeable. Pressure is also
important but often fixed. The heat seal coating will be activated at a certain temperature or range of temperature.
The higher the temperature settings, the shorter the time. The lower the temperature, the higher the time. All this
within certain limits.
NOTE 2 Heat seal curve analysis is often performed on a sealing device, with a precise adjustment, control and
monitoring of process parameters.
Key
X temperature
Y seal strength
1 proposed process limits
Figure A.1 — Heat seal curve for optimum process parameters
A.2.4 Visual scoring method for heat seals
Seals are graded for visual defects at both ends of the process range. Higher values indicate better quality.
For example:
a) lower end of sealing range (see Table A.2);
ISO/DIS 11607-3:2025(en)
Table A.2 — Lower end of sealing range
Grade Visual Seal Observations
0 Open seals
1 Spotty or incomplete seals resulting in seal width less than 50 % of the specified
value (spotty appearance caused by incomplete activation of the seal material)
2 Spotty or incomplete seals resulting in seal width between 50-74 % of the
specified value
3 Spotty seals resulting in seal width between 75-94 % of the specified value
4 Seal width >95 % of the specified value with sporadic unsealed spots
5 Full intended seal (>95 % of the specified value), continuous (or homogenous)
and complete
b) upper end of sealing range (see Table A.3).
Table A.3 — Upper end of sealing range
Grade Visual Seal Observations
0 Holes in materials
1 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
2 Moderate curl of the flange of the tray
Moderate transparentization of polymer based nonwoven lids
Significant fibre tear of paper-based lids
3 Mottled (also spotty appearance but due to overactivation of the material) seals
Moderate fibre tearing of paper-based lids
4 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.2.5 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.
ISO/DIS 11607-3:2025(en)
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
ISO/DIS 11607-3:2025(en)
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 may join one flexible
SBS material to another, or a flexible SBS material to a rigid SBS material. A basic discussion of SBS materials
is presented as a high-level primer 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
There are two main methods for creating a sealable surface on an SBS material: sealant films and heat seal
coatings.
B.2.1 Sealant films
Film sealant layers are used extensively in the creation of both peelable and weld seal preformed SBS’s.
sealing of preformed SBSs. In most cases, the nonporous film used to create a preformed 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 may be used to provide mechanical strength to the film while another layer may be used to
enhance barrier properties. The inner layer (product facing) of such a composite film
...
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