SIST EN 16602-70-58:2015

Space product assurance - Bioburden control of cleanrooms

This standard establishes the principles and basic methodology for microbiological control of cleanrooms and associated controlled environments with planetary protection constraints.
This standard does not address:
•   the microbiological contamination control of  spaceflight hardware;
•   molecular contamination control. Reference is made to other documents;
•   fire and safety regulations; for these, see regulatory requirements and other national or local documentation.
This standard does not lay down the methods for determining the microbiological and particulate cleanliness levels. Reference is made to other documents.
This standard may be tailored for the specific characteristic and constrains of a space project in conformance with ECSS-S-ST-00.

Raumfahrtproduktsicherung - Kontrolle der Gesamtkeimzahl in Reinräumen

Assurance produit des projets spatiaux - Contrôle de la charge microbienne des salles blanches

La présente norme établit les principes et la méthodologie de base pour le contrôle microbiologique des salles blanches et des milieux contrôlés associés avec des contraintes de protection planétaire.
La présente norme ne traite pas :
•   du contrôle de la contamination microbiologique du matériel de vol ;
•   du contrôle de la contamination moléculaire. D'autres documents sont cités ;
•   des règlements en matière d'incendie et de sécurité ; voir les exigences règlementaires et autres documentations nationales ou locales.
La présente norme ne spécifie pas les méthodes de détermination des niveaux de propreté microbiologique ou particulaire. D'autres documents sont cités.
La présente norme peut être adaptée aux caractéristiques et contraintes spécifiques d'un projet spatial conformément à l'ECSS-S-ST-00.

Zagotavljanje varnih proizvodov v vesoljski tehniki - Kontrola biološke obremenitve čistih prostorov

Ta standard vzpostavlja načela in osnovno metodologijo za mikrobiološki nadzor čistih sob in povezanih nadziranih okolij z omejitvami planetarne zaščite. Ta standard ne obravnava: • nadzora mikrobiološke onesnaženosti strojnih delov vesoljskih plovil; • nadzora molekularne onesnaženosti. Vključeni so sklici na druge dokumente; • predpisov o požarni varnosti (glej regulativne zahteve in drugo nacionalno ali lokalno dokumentacijo). Ta standard ne določa metod za ugotavljanje ravni mikrobiološke čistosti in ravni čistosti delcev. Vključeni so sklici na druge dokumente. Ta standard se lahko prilagodi posameznim lastnostim in omejitvam vesoljskega projekta v skladu s standardom ECSS-S-ST-00.

General Information

• Status: Published
• Public Enquiry End Date: 29-Jul-2014
• Publication Date: 18-Oct-2015
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• ICS: 49.140 - Space systems and operations
• Technical Committee: I13 - Imaginarni 13
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 06-Oct-2015
• Due Date: 11-Dec-2015
• Completion Date: 19-Oct-2015
• Mandate: M/496 - Mandate addressed to CEN, CENELEC and ETSI to develop standardisation regarding space industry (Phase 3 of the process)
• Ref Project: EN 16602-70-58:2015 - Space product assurance - Bioburden control of cleanrooms

Overview

EN 16602-70-58:2015 - "Space product assurance - Bioburden control of cleanrooms" (CEN) defines principles and a basic methodology for microbiological control of cleanrooms and associated controlled environments where planetary protection constraints apply. It is intended to ensure procedures are in place to control viable microbial contamination (bioburden) in facilities supporting space projects, while noting explicit exclusions (see Related Standards).

Key topics and requirements

• Scope & exclusions
  • Focuses on microbiological control of cleanrooms; does not cover microbiological control of spaceflight hardware, molecular contamination, fire/safety regulations, or prescribe methods for determining cleanliness levels.
• Formal bioburden control system
  • Requires a documented system (DRD-style deliverables) describing objectives, responsibilities, expected responses and tailoring to project-specific constraints.
• Operational controls
  • Cleanroom classification applicability, access restrictions, bioburden monitoring, environmental sampling plans, personnel training and gowning requirements.
• Action and alert levels
  • Establishes the concept of alert (early warning) and action (required response) levels for microbiological excursions and associated investigation procedures.
• Commissioning & documentation
  • Normative annexes provide templates and requirements for cleanroom commissioning requests, work proposals, commissioning reports and the formal system description.
• Design & operational guidance (informative)
  • Practical guidance on cleanroom layout, airflow, storage, maintenance, sampling frequency, gowning and access control to minimise bioburden.

Practical applications - who uses this standard

• Space agencies and contractors developing planetary-protection-sensitive missions
• Cleanroom managers and facility engineers responsible for controlled environments
• Quality assurance, product assurance and contamination control teams (space product assurance)
• Microbiology laboratories that support environmental monitoring and bioburden analysis
• Project managers who must tailor contamination-controls to mission constraints in conformance with ECSS-S-ST-00

Use cases include developing a bioburden monitoring program, preparing cleanroom commissioning deliverables, training personnel in gowning and sampling protocols, and establishing alert/action response procedures.

Related standards and references

• EN 16602-70-58:2015 originates from ECSS-Q-ST-70-58C and references other ECSS and ISO standards for detailed methods, notably:
  • ECSS-Q-ST-70-55 (Microbial examination of flight hardware and cleanrooms)
  • ISO 14644 (cleanroom classification and monitoring)
  • ECSS system glossary and QA standards for tailoring and integration Note: For molecular contamination, particulate cleanliness metrics or hardware decontamination methods, consult the referenced ECSS/ISO documents and national safety regulations.

Keywords: EN 16602-70-58:2015, bioburden control, cleanrooms, space product assurance, planetary protection, cleanroom commissioning, bioburden monitoring.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.RORãNHRaumfahrtproduktsicherung - Kontrolle der Gesamtkeimzahl in ReinräumenAssurance produit des projets spatiaux - Contrôle de la charge microbienne des salles blanchesSpace product assurance - Bioburden control of cleanrooms49.140Vesoljski sistemi in operacijeSpace systems and operations13.040.35Brezprašni prostori in povezana nadzorovana okoljaCleanrooms and associated controlled environmentsICS:Ta slovenski standard je istoveten z:EN 16602-70-58:2015SIST EN 16602-70-58:2015en,fr,de01-november-2015SIST EN 16602-70-58:2015SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16602-70-58
September 2015 ICS 49.140
English version
Space product assurance - Bioburden control of cleanrooms
Assurance produit des projets spatiaux - Contrôle de la charge microbienne des salles blanches
Raumfahrtproduktsicherung - Kontrolle der Gesamtkeimzahl in Reinräumen This European Standard was approved by CEN on 25 October 2014.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels © 2015 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN 16602-70-58:2015 E SIST EN 16602-70-58:2015

Figures Figure 4-1: (Bioburden Control in Cleanrooms) examination process overview . 12 Figure E-1 : Cleanroom environment schematic . 32
The objective of this Standard is to ensure that the proper procedures to control the microbiological contamination in controlled environments are in place to meet the planetary protection constraints. SIST EN 16602-70-58:2015

spaceflight hardware; • molecular contamination control. Reference is made to other documents; • fire and safety regulations; for these, see regulatory requirements and other national or local documentation. This standard does not lay down the methods for determining the microbiological and particulate cleanliness levels. Reference is made to other documents. This standard may be tailored for the specific characteristic and constrains of a space project in conformance with ECSS-S-ST-00.
EN reference Reference in text Title EN 16601-00-01 ECSS-S-ST-00-01 ECSS system – Glossary of terms EN 16602-10-09 ECSS-Q-ST-10-09 Space product assurance – Nonconformance control system EN 16602-20 ECSS-Q-ST-20 Space product assurance – Quality assurance EN 16602-20-07 ECSS-Q-ST-20-07 Space product assurance – Quality assurance for test centres EN 16602-70-55 ECSS-Q-ST-70-55 Space product assurance - Microbial Examination of Flight Hardware and Cleanrooms
ISO 14644 part 1:1999 Cleanrooms and associated controlled environments - Part 1:Classification of air cleanliness
ISO 14644 part 2:2000 Cleanrooms and associated controlled environments - Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
In practice, it is usually described as a probability. 3.2.4 biobarrier(s) barrier surrounding an item which prevents biological recontamination subsequent to microbial reduction procedures 3.2.5 bioburden quantity of viable microorganisms measured with a specified assay 3.2.6 bioburden controlled defined zone or facility in which bioburden is controlled by specified means 3.2.7 bioburden reduction process or processes used to reduce the viable microbial population on an item to an acceptable limit
Disinfection does not necessarily sterilize a surface or object. 3.2.13 formal system system of biocontamination control with established and documented procedures 3.2.14 occupancy states condition where the installation is complete with all services connected and functioning, but with no production equipment, materials or personnel present 3.2.15 occupancy states condition where the installation is complete with equipment installed and operating in a manner agreed upon by the customer and supplier, but with no personnel present 3.2.16 occupancy states condition where the installation is functioning in the specified manner, with the specified number of personnel present and working in the manner agreed upon 3.2.17 planetary protection policy and the technical implementations to prevent forward and backward contamination 3.2.18 sporicide substance capable of destroying bacterial spores SIST EN 16602-70-58:2015

In practice, it is usually described as a probability. 3.2.20 sterilization validated process used to render product free from viable micro-organisms [ISO 11139] 3.3 Abbreviated terms For the purpose of this Standard, the abbreviated terms from ECSS-S-ST-00-01 and the following apply:
Abbreviation Meaning AIV
assembly, integration, and verification CFU colony forming unit COSPAR
Committee On Space Research DHMR
dry heat microbial reduction ESA
European Space Agency ESD
electrostatic discharge EGSE electrical ground support equipment FMECA
failure mode effects and critical analysis GSE
ground support equipment HEPA
high efficiency particulate air HVAC
heating, ventilation, air conditioning, and cooling IPA
isopropyl alcohol (isopropanol) ISO
International Organization for Standardization MGSE mechanical ground support equipment NASA
National Aeronautics and Space Administration PP planetary protection WFI water for injection SIST EN 16602-70-58:2015

commissioning Work Proposal for cleanroom commissioning (including test specification and procedure (Annex C) Cleanroom commissioning results (including identified deviations, if any)Report for cleanroom commissioning (Annex D) Request for cleanroom commissioning
(Annex B) Customer approvalNCR (if any identified deviation)Bioburden control formal system description (Annex A)
Figure 4-1: (Bioburden Control in Cleanrooms) examination process overview Clause 5.1 provides the requirements for bioburden control, clause 5.2 the operational requirements, and clause 5.3 provides the requirements for preparing, performing, recording and reporting cleanroom commissioning. NOTE
Additional information can be found in ISO 14698 Part 1 and Part 2. SIST EN 16602-70-58:2015

The formal system assesses and controls factors that can affect the microbiological quality of the controlled environment. 5.1.1.2 Verification of the formal system a. The result of bioburden monitoring as described in the formal system shall be examined with the periodicity established in conformance with Annex A.2.1, in order to verify that the formal system in use is functioning in conformance with the established procedures and the specified requirements have been fulfilled. NOTE
In some cases, the effective operation of the formal system cannot be appropriately verified without the establishment of supplementary tests and procedures, such as auditing, random sampling and analysis. This can also include the systematic verification of all working steps and equipment to ensure the system is functioning properly. b. If verification indicates deviations from the established limits or a change in the microbiological status of the bioburden controlled environment, corrective actions as specified in the formal system per Annex A shall be initiated. SIST EN 16602-70-58:2015

• Action levels as per “Assay Procedure 2” in ECSS-Q-ST-70-55 for a bioburden controlled environment “during operations” are: − Â 10 CFU/m3 for air samples; − Â 2000 CFU/m2 for surfaces; − Â 1 CFU/glove print (5 fingers). • Action levels as per “Assay Procedure 2” in ECSS-Q-ST-70-55 “during aseptic operations” are: − < 1 CFU/m3 for air samples − < 400 CFU/m2 for surfaces; − < 1 CFU/glove print (5 fingers). NOTE 2 Aseptic operations cannot be ensured without laminar air flow. This can cause undesirable electrostatic charging effects and needs to be managed properly. b. Alert levels shall be compatible with the action levels and the facility commissioning phase. c. The use of statistical methods and trend analysis shall be applied to establish alert and action levels and for routine monitoring. NOTE
See Annex E.1 for commissioning phase and Annex E.2 for guidelines on alert and action level. d. The appropriate representative responsible for control of bioburden controlled environments shall be notified
in case of alert and action level events. 5.1.2.2 Investigation of alert and action level events a. In the case of an alert level event, the following shall be performed: 1. Review of record of laboratory tests and deviations, equipment performance, training of personnel, trend analysis, and any possible contributory anomalies or discrete events. 2. A deviation report. SIST EN 16602-70-58:2015

See Annex E.2 for guidelines on elements to be covered with the investigation. c. Three consecutive alert level events shall be treated as action level event. 5.2 Operational requirements 5.2.1 Cleanroom class a. Bioburden controlled environments shall be equivalent at least to airborne particulate cleanliness class ISO 7 “in operation” in conformance with ISO 14644- Part 1. NOTE 1 This airborne particulate cleanliness class is applicable to cleanrooms or clean zones within cleanrooms. NOTE 2 Achieving the airborne particulate cleanliness class is not necessarily a matter of changes in the cleanroom or clean zone design or HVAC system but can potentially be achieved by applying proper access control, gowning, and procedures. b. Bioburden controlled environments shall be continuously monitored in conformance with ISO 14644- Part 2. NOTE 1 In some cases, aseptic operations can only be ensured if a more stringent particulate control (e.g. ISO 5) is applied. Normally such conditions are provided by laminar air flow environments with a controlled environment in the background. NOTE 2 For commissioning of bioburden controlled environment, see Annex E.1. SIST EN 16602-70-58:2015

5.2.3.1 Equipment a. All equipment used for bioburden control (including HVAC system) shall be subject to validation and planned maintenance. b. The return to use of all equipment used for bioburden control shall be subject to approval of appropriate representatives responsible for the bioburden control of the environment and/or formal revalidation of the environment. c. The layout of equipment shall provide for ergonomics that optimize comfort and movement of operators. d. Material flow shall be optimized to prevent unnecessary activities that could increase the potential for introducing contaminants. e. The design of equipment used in bioburden controlled environments should limit the number and complexity of bioburden controlled interventions by personnel. f. Equipment design shall be appropriate to facilitate ease of sterilization. g. The effect of equipment design on the cleanroom environment shall be addressed. h. Horizontal surfaces or ledges that accumulate particles shall be avoided to the extent practicable. i. Equipment shall not obstruct airflow and, in critical areas, its design shall not disturb unidirectional airflow. 5.2.3.2 Cleaning solutions a. Cleaning solutions used shall be sterile prior to use. NOTE
See Annex E.5.15.8 for guidelines on cleaning solutions. b. A cleanroom cleaning program shall be implemented in each controlled environment. SIST EN 16602-70-58:2015

d. Preparatory activities (e.g. adhesive mixing) shall be conducted in dedicated external or peripheral areas, with due regard to requirements for spacecraft microbial contamination requirements. 5.2.4 Bioburden monitoring of cleanroom environment a. The biodiversity in bioburden controlled environments shall be characterized at the commissioning phase. b. The bioburden shall be monitored with active air sampling and active surface sampling devices. c. For routine testing of airborne bioburden either impaction/impingement sampler or filtration sampler shall be used. NOTE
As per procedure in ECSS-Q-ST-70-55. d. For routine testing of airborne bioburden the total sample volume shall not be less than 1 m3. e. For routing testing of surface bioburden either swabs, wipes, or contact plates shall be used. NOTE
As per procedure in ECSS-Q-ST-70-55. f. For routine testing of surface bioburden the total sample area for swabs and contact plates shall be on the order of 0,0025 m2 (25 cm2).
g. For routine testing of surface bioburden the total sample area for wipes shall be between 2/3 m2 and 1 m2 maximum. h. All bioburden and biodiversity assays shall be according to ECSS-Q-ST-70-55. 5.2.5 Sampling plan 5.2.5.1 General a. A sampling plan shall be developed through the formal system (i.e., in the commissioning phase), and documented in conformance with Annex A. SIST EN 16602-70-58:2015

a. The frequencies of sampling shall be developed using the selected formal system. b. This system shall encompass:
1. initial monitoring (i.e. during commissioning phase), 2. routine monitoring, and
3. contingencies for contamination events. 5.2.5.3 Sampling sites a. Sampling sites shall be determined through the selected formal system, and included in the sampling plan. NOTE
The sampling locations are established based on the risk assessment performed leading to the identification of risk zones and operational steps at risk. b. The location of the designated sampling sites shall be selected in order to ensure all potential contamination sources are monitored. NOTE 1 That means, in addition to the “risk zone”, the designation and identification in the plan of areas such as access points, storage areas with significant levels of material or hardware and significant impedance to air flow, or areas of heavy personnel traffic. NOTE 2 More than one sample can be taken at each site and different numbers of samples can be taken at different locations. c. Sampling shall be carried out at the bioburden control points defined in a written procedure which identifies the locations and frequency of sampling under nominal and non-nominal scenarios. NOTE
A schematic representation (map) of the facility showing the samples locations is considered to be essential. 5.2.5.4 Identification of samples a. The labelling of each sample shall carry the information or coding to provide traceability of the sample. b. The labelling of each sample shall include the following information as a minimum: 1. Collection site (facility). 2. Sampling location within facility. 3. Occupancy state at time of sampling. 4. No. of personnel present at time of sampling. 5. Date and time of collection. SIST EN 16602-70-58:2015

Bioburden and biodiversity trend analysis shall be provided. 5.2.6 Training a. A training programme shall be established in due time to allow appropriate training of all personnel. NOTE
See Annex E.3 for guidelines on the training programme. b. Cleaning personnel shall be dedicated people.
NOTE
‘Regular’ cleaning personnel from the site cleaning service provider are not necessarily appropriate. 5.2.7 Personnel a. All personnel shall undergo regular medical screening to establish that they do not have a medical condition that can compromise the integrity of the bioburden controlled environment. NOTE
See Annex E.5.11 for examples of medical conditions of concern. b. Hygiene programmes should be established and should include procedures relating to the health, hygiene practices and clothing of personnel. c. Only personnel with the appropriate level of training and medical clearance shall access the bioburden controlled environments, including. personnel for cleaning and maintenance. d. Non-essential personnel shall not be permitted in the bioburden controlled environment. SIST EN 16602-70-58:2015

See Annex E.5.11 for guidelines
5.2.8 Cleanroom garments a. Garments shall be compatible with ISO 7 cleanroom standards, or better. NOTE
The particulate filtration efficiency of the garment material should be at least equivalent to the class of cleanroom employed. b. Sterile gloves shall be compatible with repeated alcohol washes (IPA 70% or ethanol 70%) washes. NOTE
The glove material should not contaminate the solvents by leaching, or degrade due to contact. 5.3 Cleanroom commissioning a. The customer shall request a cleanroom commissioning in conformance with Annex B. b. For safety and security, the test centre shall be in conformance with ECSS-Q-ST-20-07, clause 9. NOTE
Example of safety requirements are hazard and health requirements. Example of security requirements are access control requirements. c. The supplier shall respond to the request specified in requirement 5.3a with a cleanroom commissioning proposal in conformance with Annex C for customer approval. d. The supplier shall run the approved cleanroom commissioning campaign as described in Annex C. NOTE
An example of an approved cleanroom commissioning approach is given in Annex E. e. The supplier shall submit the Cleanroom commissioning report in conformance with Annex D to the customer for approval
NOTE
For example: Process FMECA. 6. Description of the training procedures and access constraints established in conformance with clause 5.2.6. 7. Documentation to be established and maintained. SIST EN 16602-70-58:2015

For example: Logbooks. 9. Periodic reviews/audits to be performed. 10. Maintenance status of
equipment. 11. Cleanroom cleaning programme. 12. A training programme. 13. Description of the sampling plan, including at least: (a) The cleanliness level of the cleanroom to be applied and the appropriate degree of bioburden control for the activity being conducted. (b) The sampling location(s) identified in conformance with clause 5.2.5.3, including the location of the primary “risk zone”; i.e.; the work area immediately adjacent to any contamination-critical hardware and the work activities/personnel associated with this location. (c) The minimum number of samples to be taken in order to ensure representative results. NOTE
This number is dependant on the sample size/ volume. For small sample sizes, representativeness of the results cannot be guaranteed if this number is not significantly increased. (d) Frequency of initial monitoring sampling, established in conformance with requirement 5.2.5.2b.1. (e) Frequency of normal routine sampling, established in conformance with requirement 5.2.5.2b.2. (f) Frequency of sampling for specific cases, established in conformance with requirement 5.2.5.2b.3, including at least the following cases: − Suspected contamination events. − Action levels are exceeded. − Alert levels are exceeded (consecutively). − A change in the biodiversity. − After prolonged shut-down of activities. − After any significant maintenance work has been undertaken on the cleanroom. NOTE 1 For example: Maintenance on ventilation system, changes to furnishings or fittings, introduction of significant quantities of new hardware or equipment. − After changes to the process that affect the cleanroom environment. SIST EN 16602-70-58:2015

Ambient temperature, lead-time to processing of samples. e. The impact of operations, personnel and equipment, which contribute to contamination. A.2.2 Special remarks None. SIST EN 16602-70-58:2015

B.2.1 Scope and content a. The request for cleanroom commissioning shall include or refer to the following information: 1. reference in making ECSS-Q-ST-20 and ECSS-Q-ST-10-09 applicable, 2. objective of the cleanroom commissioning, 3. background and justification to the cleanroom commissioning, 4. cleanroom to be commissioned, 5. description of cleanroom commissioning activity, and 6. deliverables. B.2.2 Special remarks None. SIST EN 16602-70-58:2015

For example:
...