SIST EN 16602-70-58:2015
(Main)Space product assurance - Bioburden control of cleanrooms
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
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
SIST EN 16602-70-58:2015
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
EN 16602-70-58:2015 (E) 2 Table of contents European foreword . 5 Introduction . 5 1 Scope . 7 2 Normative references . 8 3 Terms, definitions and abbreviated terms . 9 3.1 Terms defined in other standards . 9 3.2 Terms specific to the present standard . 9 3.3 Abbreviated terms. 11 4 Principles . 12 5 Requirements . 13 5.1 Bioburden control . 13 5.1.1 Formal system . 13 5.1.2 Action and alert levels . 14 5.2 Operational requirements . 15 5.2.1 Cleanroom class . 15 5.2.2 Applicability of bioburden control . 16 5.2.3 Restrictions . 16 5.2.4 Bioburden monitoring of cleanroom environment . 17 5.2.5 Sampling plan . 17 5.2.6 Training . 19 5.2.7 Personnel . 19 5.2.8 Cleanroom garments . 20 5.3 Cleanroom commissioning . 20 Annex A (normative) Bioburden control formal system description - DRD. 21 A.1 DRD identification . 21 A.1.1 Requirement identification and source document . 21 A.1.2 Purpose and objective . 21 A.2 Expected response . 21 SIST EN 16602-70-58:2015
EN 16602-70-58:2015 (E) 3 A.2.1 Scope and content . 21 A.2.2 Special remarks . 23 Annex B (normative) Request for cleanroom commissioning - DRD . 24 B.1 DRD identification . 24 B.1.1 Requirement identification and source document . 24 B.1.2 Purpose and objective . 24 B.2 Expected response . 24 B.2.1 Scope and content . 24 B.2.2 Special remarks . 24 Annex C (normative) Cleanroom commissioning specifications and procedures (Work Proposal) - DRD . 25 C.1 DRD identification . 25 C.1.1 Requirement identification and source document . 25 C.1.2 Purpose and objective . 25 C.2 Expected response . 25 C.2.1 Scope and content . 25 C.2.2 Special remarks . 26 Annex D (normative) Cleanroom commissioning report - DRD . 27 D.1 DRD identification . 27 D.1.1 Requirement identification and source document . 27 D.1.2 Purpose and objective . 27 D.2 Expected response . 27 D.2.1 Scope and content . 27 D.2.2 Special remarks . 27 Annex E (informative) Cleanroom operation . 28 E.1 Commissioning activities. 28 E.1.1 Elements . 28 E.2 Action and alert level events . 29 E.2.1 Investigation . 29 E.2.2 Sampling error . 29 E.2.3 Inconclusive findings . 29 E.2.4 Microorganism Identity . 30 E.2.5 Frequency . 30 E.3 Training programme . 30 E.3.1 Overview . 30 E.3.2 Training levels . 30 SIST EN 16602-70-58:2015
EN 16602-70-58:2015 (E) 4 E.3.3 Sampling and analysis . 31 E.3.4 Training verification . 31 E.3.5 Training content . 31 E.4 General guidelines for cleanroom design and operation . 31 E.4.1 Design; general . 31 E.4.2 Airflow . 32 E.4.3 Access . 32 E.4.4 Layout design . 33 E.4.5 Storage space . 33 E.4.6 Monitoring . 34 E.5 Operational guidelines . 34 E.5.1 Surveillance . 34 E.5.2 Communications . 34 E.5.3 Packaging . 34 E.5.4 Flight hardware . 34 E.5.5 Maintenance . 34 E.5.6 Personnel access records . 35 E.5.7 Task planning . 35 E.5.8 Garments . 35 E.5.9 Microbiological laboratory. 35 E.5.10 Cleanroom bioburden sampling. 35 E.5.11 Medical monitoring of personnel. 35 E.5.12 Bioburden monitoring . 36 E.5.13 Gowning . 36 E.5.14 Entering cleanroom . 38 E.5.15 Cleanroom cleaning . 39 E.6 Cleanroom working disciplines . 40 E.6.1 Overview . 40 E.6.2 Access control . 41 E.6.3 Working practises . 42 Bibliography . 44
Figures Figure 4-1: (Bioburden Control in Cleanrooms) examination process overview . 12 Figure E-1 : Cleanroom environment schematic . 32
SIST EN 16602-70-58:2015
EN 16602-70-58:2015 (E) 5 European foreword This document (EN 16602-70-58:2015) has been prepared by Technical Committee CEN/CLC/TC 5 “Space”, the secretariat of which is held by DIN. This standard (EN 16602-70-58:2015) originates from ECSS-Q-ST-70-58C. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2016, and conflicting national standards shall be withdrawn at the latest by March 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. This document has been developed to cover specifically space systems and has therefore precedence over any EN covering the same scope but with a wider domain of applicability (e.g. : aerospace). According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: 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 the United Kingdom. SIST EN 16602-70-58:2015
EN 16602-70-58:2015 (E) 6 Introduction The UN Outer Space Treaty of 1967 sets up the general principles applicable to the exploration and use of outer space. Article IX of the Outer Space Treaty constitutes the primary statement of international law: “States parties shall pursue studies of outer space, including the Moon and other celestial bodies, and conduct exploration of them so as to avoid their harmful contamination and also adverse changes in the environment of the Earth resulting from the introduction of extraterrestrial matter and, when necessary, adopt appropriate measures for this purpose”. Harmful contamination in that sense is defined as biological contamination, including organic-constituents, to protect the environment in order to allow future exobiology research. The Committee On Space Research (COSPAR) has established some planetary protection guidelines, based on the Outer Space Treaty. These guidelines impose requirements on spaceflight missions according to target body/mission type combinations.
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
EN 16602-70-58:2015 (E) 7 1 Scope 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.
SIST EN 16602-70-58:2015
EN 16602-70-58:2015 (E) 8 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this ECSS Standard. For dated references, subsequent amendments to, or revision of any of these publications do not apply, However, parties to agreements based on this ECSS Standard are encouraged to investigate the possibility of applying the more recent editions of the normative documents indicated below. For undated references, the latest edition of the publication referred to applies.
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
SIST EN 16602-70-58:2015
EN 16602-70-58:2015 (E) 9 3 Terms, definitions and abbreviated terms 3.1 Terms defined in other standards For the purpose of this Standard, the terms and definitions from ECSS-S-ST-00-01 apply. 3.2 Terms specific to the present standard 3.2.1 action level level set by the user in the context of controlled environment, and associated to specific requirements in the case that it is exceeded 3.2.2 alert level level set by the user in the context of controlled environments, giving early warning of a drift from normal conditions, which, when exceeded, increased attention to the process is expected 3.2.3 aseptic state of being free from all living microorganisms (i.e. free of bioburden) NOTE
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
SIST EN 16602-70-58:2015
EN 16602-70-58:2015 (E) 10 3.2.8 biocontamination contamination of materials, devices, individuals, surfaces, liquids, gases or air with viable particles 3.2.9 biodiversity identification of species of micro-organism, measured with specified assays 3.2.10 commissioning planned and documented series of inspections, adjustments and tests carried out systematically to set the installation into the specified technical operation 3.2.11 controlled environment defined zone in which contamination is controlled by specified means 3.2.12 disinfection a process which destroys vegetative forms of microorganisms NOTE
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
EN 16602-70-58:2015 (E) 11 3.2.19 sterile state of being free from all living microorganisms (i.e. free of bioburden) NOTE
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
EN 16602-70-58:2015 (E) 12 4 Principles The activities related to requirements for bioburden control in cleanrooms, specifications, procedures and reports are described in Figure 4-1, and the related standardization requirements are captured in clause 5. Specifying commissioning Preparing and performing commissioningQuality RequirementsRecording and reporting
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
EN 16602-70-58:2015 (E) 13 5 Requirements 5.1 Bioburden control 5.1.1 Formal system 5.1.1.1 Establishment of a formal system a. A formal system of bioburden control shall be established, formally approved, implemented, documented in conformance with Annex A, and maintained within bioburden controlled cleanrooms and associated environments. NOTE
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
EN 16602-70-58:2015 (E) 14 5.1.2 Action and alert levels 5.1.2.1 General a. The user of the cleanroom shall set microbiological alert and action levels in accordance with the cleanroom cleanliness level and operations, and include them in the formal system specified in Annex A. NOTE 1 The following action levels can be used as a guideline:
• 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
EN 16602-70-58:2015 (E) 15 NOTE 1 Additional information on the state of the environment (e.g. particulate level) should be evaluated. NOTE 2 Alert level events can be associated to corrective action, or not, depending on whether the cause is under control or not. b. In the case of an action level event, an investigation shall be performed, which includes: 1. Root cause analysis. 2. Corrective action. 3. Impact on hardware. 4. A deviation report. NOTE
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
EN 16602-70-58:2015 (E) 16 5.2.2 Applicability of bioburden control a. Bioburden control shall apply to all items entering a bioburden controlled environment. NOTE 1 This includes e.g. any (compressed) gases, liquids, equipment, and garment. NOTE 2 Bioburden control is either via cleaning/sterilization and assays and/or isolation with biobarriers. NOTE 3 Bioburden control for the regular air supply of the cleanroom is through HEPA filters. 5.2.3 Restrictions
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 p
...
SLOVENSKI STANDARD
kSIST FprEN 16602-70-58:2014
01-julij-2014
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Space product assurance - Bioburden control of cleanrooms
Raumfahrtproduktsicherung - Kontrolle der Gesamtkeimzahl in Reinräumen
Assurance produit des projets spatiaux - Contrôle de la charge microbienne des salles
blanches
Ta slovenski standard je istoveten z: FprEN 16602-70-58
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
49.140 Vesoljski sistemi in operacije Space systems and
operations
kSIST FprEN 16602-70-58:2014 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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kSIST FprEN 16602-70-58:2014
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kSIST FprEN 16602-70-58:2014
EUROPEAN STANDARD
FINAL DRAFT
FprEN 16602-70-58
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2014
ICS 49.140
English version
Space product assurance - Bioburden control of cleanrooms
Assurance produit des projets spatiaux - Contrôle de la Raumfahrtproduktsicherung - Kontrolle der
charge microbienne des salles blanches Gesamtkeimzahl in Reinräumen
This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical
Committee CEN/CLC/TC 5.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN and CENELEC 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.
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 supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
CEN-CENELEC Management Centre:
Avenue Marnix 17, B-1000 Brussels
© 2014 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. FprEN 16602-70-58:2014 E
worldwide for CEN national Members and for CENELEC
Members.
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kSIST FprEN 16602-70-58:2014
FprEN 16602-70-58:2014 (E)
Table of contents
Foreword . 5
Introduction . 6
1 Scope . 7
2 Normative references . 8
3 Terms, definitions and abbreviated terms . 9
3.1 Terms defined in other standards . 9
3.2 Terms specific to the present standard . 9
3.3 Abbreviated terms. 11
4 Principles . 12
5 Requirements . 13
5.1 Bioburden control . 13
5.1.1 Formal system . 13
5.1.2 Action and alert levels . 14
5.2 Operational requirements . 15
5.2.1 Cleanroom class . 15
5.2.2 Applicability of bioburden control . 16
5.2.3 Restrictions . 16
5.2.4 Bioburden monitoring of cleanroom environment . 17
5.2.5 Sampling plan . 17
5.2.6 Training . 19
5.2.7 Personnel . 19
5.2.8 Cleanroom garments . 20
5.3 Cleanroom commissioning . 20
Annex A (normative) Bioburden control formal system description - DRD. 21
A.1 DRD identification . 21
A.1.1 Requirement identification and source document . 21
A.1.2 Purpose and objective . 21
A.2 Expected response . 21
2
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kSIST FprEN 16602-70-58:2014
FprEN 16602-70-58:2014 (E)
A.2.1 Scope and content . 21
A.2.2 Special remarks . 23
Annex B (normative) Request for cleanroom commissioning - DRD . 24
B.1 DRD identification . 24
B.1.1 Requirement identification and source document . 24
B.1.2 Purpose and objective . 24
B.2 Expected response . 24
B.2.1 Scope and content . 24
B.2.2 Special remarks . 24
Annex C (normative) Cleanroom commissioning specifications and
procedures (Work Proposal) - DRD . 25
C.1 DRD identification . 25
C.1.1 Requirement identification and source document . 25
C.1.2 Purpose and objective . 25
C.2 Expected response . 25
C.2.1 Scope and content . 25
C.2.2 Special remarks . 26
Annex D (normative) Cleanroom commissioning report - DRD . 27
D.1 DRD identification . 27
D.1.1 Requirement identification and source document . 27
D.1.2 Purpose and objective . 27
D.2 Expected response . 27
D.2.1 Scope and content . 27
D.2.2 Special remarks . 27
Annex E (informative) Cleanroom operation . 28
E.1 Commissioning activities. 28
E.1.1 Elements . 28
E.2 Action and alert level events . 29
E.2.1 Investigation . 29
E.2.2 Sampling error . 29
E.2.3 Inconclusive findings . 29
E.2.4 Microorganism Identity . 30
E.2.5 Frequency . 30
E.3 Training programme . 30
E.3.1 Overview . 30
E.3.2 Training levels . 30
3
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FprEN 16602-70-58:2014 (E)
E.3.3 Sampling and analysis . 31
E.3.4 Training verification . 31
E.3.5 Training content . 31
E.4 General guidelines for cleanroom design and operation . 31
E.4.1 Design; general . 31
E.4.2 Airflow . 32
E.4.3 Access . 32
E.4.4 Layout design . 33
E.4.5 Storage space . 33
E.4.6 Monitoring . 34
E.5 Operational guidelines . 34
E.5.1 Surveillance . 34
E.5.2 Communications . 34
E.5.3 Packaging . 34
E.5.4 Flight hardware . 34
E.5.5 Maintenance . 34
E.5.6 Personnel access records . 35
E.5.7 Task planning . 35
E.5.8 Garments . 35
E.5.9 Microbiological laboratory. 35
E.5.10 Cleanroom bioburden sampling. 35
E.5.11 Medical monitoring of personnel. 35
E.5.12 Bioburden monitoring . 36
E.5.13 Gowning . 36
E.5.14 Entering cleanroom . 38
E.5.15 Cleanroom cleaning . 39
E.6 Cleanroom working disciplines . 40
E.6.1 Overview . 40
E.6.2 Access control . 41
E.6.3 Working practises . 42
Bibliography . 44
Figures
Figure 4-1: (Bioburden Control in Cleanrooms) examination process overview . 12
Figure E-1 : Cleanroom environment schematic . 32
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Foreword
This document (FprEN 16602-70-58:2014) has been prepared by Technical
Committee CEN/CLC/TC 5 “Space”, the secretariat of which is held by DIN
(Germany).
This document (FprEN 16602-70-58:2014) originates from ECSS-Q-ST-70-58C.
This document is currently submitted to the Unique Acceptance Procedure.
This document has been developed to cover specifically space systems and will
the-refore have precedence over any EN covering the same scope but with a
wider do-main of applicability (e.g. : aerospace).
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Introduction
The UN Outer Space Treaty of 1967 sets up the general principles applicable to
the exploration and use of outer space. Article IX of the Outer Space Treaty
constitutes the primary statement of international law: “States parties shall
pursue studies of outer space, including the Moon and other celestial bodies,
and conduct exploration of them so as to avoid their harmful contamination
and also adverse changes in the environment of the Earth resulting from the
introduction of extraterrestrial matter and, when necessary, adopt appropriate
measures for this purpose”. Harmful contamination in that sense is defined as
biological contamination, including organic-constituents, to protect the
environment in order to allow future exobiology research. The Committee On
Space Research (COSPAR) has established some planetary protection
guidelines, based on the Outer Space Treaty. These guidelines impose
requirements on spaceflight missions according to target body/mission type
combinations.
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.
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1
Scope
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.
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2
Normative references
The following normative documents contain provisions which, through
reference in this text, constitute provisions of this ECSS Standard. For dated
references, subsequent amendments to, or revision of any of these publications
do not apply, However, parties to agreements based on this ECSS Standard are
encouraged to investigate the possibility of applying the more recent editions of
the normative documents indicated below. For undated references, the latest
edition of the publication referred to applies.
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
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3
Terms, definitions and abbreviated terms
3.1 Terms defined in other standards
For the purpose of this Standard, the terms and definitions from ECSS-S-ST-00-01
apply.
3.2 Terms specific to the present standard
3.2.1 action level
level set by the user in the context of controlled environment, and associated to specific
requirements in the case that it is exceeded
3.2.2 alert level
level set by the user in the context of controlled environments, giving early
warning of a drift from normal conditions, which, when exceeded, increased
attention to the process is expected
3.2.3 aseptic
state of being free from all living microorganisms (i.e. free of bioburden)
NOTE 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
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3.2.8 biocontamination
contamination of materials, devices, individuals, surfaces, liquids, gases or air
with viable particles
3.2.9 biodiversity
identification of species of micro-organism, measured with specified assays
3.2.10 commissioning
planned and documented series of inspections, adjustments and tests carried
out systematically to set the installation into the specified technical operation
3.2.11 controlled environment
defined zone in which contamination is controlled by specified means
3.2.12 disinfection
a process which destroys vegetative forms of microorganisms
NOTE 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
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3.2.19 sterile
state of being free from all living microorganisms (i.e. free of bioburden)
NOTE 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
assembly, integration, and verification
AIV
colony forming unit
CFU
Committee On Space Research
COSPAR
dry heat microbial reduction
DHMR
European Space Agency
ESA
electrostatic discharge
ESD
electrical ground support equipment
EGSE
failure mode effects and critical analysis
FMECA
ground support equipment
GSE
high efficiency particulate air
HEPA
heating, ventilation, air conditioning, and cooling
HVAC
isopropyl alcohol (isopropanol)
IPA
International Organization for Standardization
ISO
mechanical ground support equipment
MGSE
National Aeronautics and Space Administration
NASA
planetary protection
PP
water for injection
WFI
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4
Principles
The activities related to requirements for bioburden control in cleanrooms,
specifications, procedures and reports are described in Figure 4-1, and the
related standardization requirements are captured in clause 5.
Bioburden control formal
system description (Annex A)
Request for cleanroom
Work Proposal for cleanroom commissioning
commissioning (Annex B)
Specifying (including test specification and procedure (Annex C)
commissioning
Customer approval
Cleanroom commissioning results
Preparing and
(including identified deviations, if any)
performing
Quality Requirements
commissioning
NCR (if any identified
deviation)
Recording and
Report for cleanroom
reporting
commissioning (Annex D)
commissioning
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.
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5
Requirements
5.1 Bioburden control
5.1.1 Formal system
5.1.1.1 Establishment of a formal system
a. A formal system of bioburden control shall be established, formally
approved, implemented, documented in conformance with Annex A, and
maintained within bioburden controlled cleanrooms and associated
environments.
NOTE 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.
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5.1.2 Action and alert levels
5.1.2.1 General
a. The user of the cleanroom shall set microbiological alert and action levels
in accordance with the cleanroom cleanliness level and operations, and
include them in the formal system specified in Annex A.
NOTE 1 The following action levels can be used as a
guideline:
• Action levels as per “Assay Procedure 2” in
ECSS-Q-ST-70-55 for a bioburden controlled
environment “during operations” are:
3
− ≤ 10 CFU/m for air samples;
2
− ≤ 2000 CFU/m for surfaces;
− ≤ 1 CFU/glove print (5 fingers).
• Action levels as per “Assay Procedure 2” in
ECSS-Q-ST-70-55 “during aseptic
operations” are:
3
− < 1 CFU/m for air samples
2
− < 400 CFU/m 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.
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NOTE 1 Additional information on the state of the
environment (e.g. particulate level) should be
evaluated.
NOTE 2 Alert level events can be associated to
corrective action, or not, depending on whether
the cause is under control or not.
b. In the case of an action level event, an investigation shall be performed,
which includes:
1. Root cause analysis.
2. Corrective action.
3. Impact on hardware.
4. A deviation report.
NOTE 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.
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5.2.2 Applicability of bioburden control
a. Bioburden control shall apply to all items entering a bioburden
controlled environment.
NOTE 1 This includes e.g. any (compressed) gases,
liquids, equipment, and garment.
NOTE 2 Bioburden control is either via
cleaning/sterilization and assays and/or
isolation with biobarriers.
NOTE
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