Bsi bs en 16602 70 56 2015

BSI Standards PublicationSpace product assurance — Vapour Phase Bioburden Reduction for Flight Hardware... English version Space product assurance - Vapour Phase Bioburden Reduction for

BSI Standards Publication

Space product assurance — Vapour Phase Bioburden Reduction for Flight Hardware

© The British Standards Institution 2015.

Published by BSI Standards Limited 2015ISBN 978 0 580 86643 2

Amendments/corrigenda issued since publication

Date Text affected

English version Space product assurance - Vapour Phase Bioburden Reduction

for Flight Hardware

Assurance produit des projets spatiaux - Réduction en

phase gazeuse de la charge microbienne des matériels de

vol

Raumfahrtproduktsicherung - Reduktion der Gesamtkeimzahl bei Dampfphase für Flughardware

This European Standard was approved by CEN on 16 November 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

Table of contents

European foreword 3

Introduction 3

1 Scope 5

2 Normative references 6

3 Terms and abbreviated terms 7

3.1 Terms from other standards 7

3.2 Terms specific to the present standard 7

3.3 Abbreviated terms 8

3.4 Nomenclature 9

4 Principles 10

5 Requirements 12

5.1 General requirements 12

5.2 Product requirements 12

5.2.1 Product compatibility with process 12

5.2.2 Product cleanliness 12

5.2.3 Product packaging 13

5.2.4 Product release 13

5.3 Process requirements 14

5.3.1 Procedure requirements 14

5.3.2 Bioburden reduction cycle requirements 15

5.4 Equipment requirements 15

Annex A (normative) Hydrogen peroxide bioburden reduction specification - DRD 17

Annex B (normative) Hydrogen peroxide bioburden reduction proposal - DRD 19

Annex C (normative) Hydrogen peroxide bioburden reduction report - DRD 21

Bibliography 23

European foreword

This document (EN 16602-70-56:2015) has been prepared by Technical

Committee CEN/CLC/TC 5 “Space”, the secretariat of which is held by DIN

This standard (EN 16602-70-56:2015) originates from ECSS-Q-ST-70-56C

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

Introduction

The UN Outer Space Treaty of 1967 sets up the general principles applicable tothe exploration and use of outer space Article IX of the Outer Space Treatyconstitutes 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 allowfuture exobiology research The Committee On Space Research (COSPAR) hasestablished some planetary protection guidelines, based on the Outer SpaceTreaty These guidelines impose requirements on spaceflight missionsaccording to target body/mission type combinations

The objective of this Standard is to ensure that proper procedures for reducingthe microbiological contamination on flight hardware are in place to meet theplanetary protection constraints

1 Scope

This standard specifies procedures for the reduction of microbiological

contamination of flight hardware using hydrogen peroxide vapour

The procedures specified in this standard cover:

vacuum environments

This standard also specifies requirements for the conditioning of the flight

hardware, bioburden reduction cycle development, and equipment to be used

for applying a bioburden reduction procedure

This standard may be tailored for the specific characteristics and constraints of a

space project in conformance with ECSS-S-ST-00C

2 Normative references

The following normative documents contain provisions which, throughreference in this text, constitute provisions of this ECSS Standard For datedreferences, subsequent amendments to, or revision of any of these publications

do not apply However, parties to agreements based on this ECSS Standard areencouraged to investigate the possibility of applying the more recent editions ofthe normative documents indicated below For undated references, the latestedition of the publication referred to applies

EN reference Reference in text Title

information management

system

compatibility tests for sterilization processes

flight hardware and cleanrooms

cleanrooms

product cleanliness levels and contamination control program

3 Terms and abbreviated terms

3.1 Terms from other standards

For the purpose of this Standard, the terms and definitions from ECSS-S-ST-00-01apply

For the purpose of this Standard, the terms and definitions from ECSS-M-ST-40,ECSS-Q-ST-70-01, ECSS-Q-ST-70-55 and ECSS-Q-ST-70-58 apply, and inparticular the following:

Bioburden Bioburden reduction Cleanliness level Product item

3.2 Terms specific to the present standard

3.2.1 biological indicators

viable microorganisms providing a defined resistance to a specific process

reduction

3.2.2 controlled ambient conditions

1000 hPa pressure, temperature from 25 °C to 45 °C and relative humidity from

3 % to 50 %, as measured at 35 °C

3.2.3 controlled vacuum conditions

temperature from 25 °C to 45 °C and pressure from 1,3 hPa to 13,3 hPa

3.2.4 cycle

sequence of individual steps

steps are preconditioning, bioburden reductionCt-value and venting Each step has associatedcontrol and monitoring parameters like timeand hydrogen peroxide vapour concentration

3.2.5 exposed surfaces

internal and external surfaces free for gas exchange

exterior surfaces, interior surfaces of boxes withventing holes, surfaces of honeycomb cells,surfaces of the outer and inner plies of multi-layer insulation, open cell foam

bioburden reduction with heat (temperatureand time record sufficient, no need forbiological test) but is not acceptable for

(biological test for process monitoring ismandatory)

COSPAR Committee on Space Research

b The word “should” is used in this standard to express recommendations.

All the recommendations are expressed with the word “should”

recommendations in this document are eitherconverted into requirements or tailored out

positive and negative permissions respectively All the positivepermissions are expressed with the word “may” All the negativepermissions are expressed with the words “need not”

possibilities, and therefore, if not accompanied by one of the previouswords, it implies descriptive text

different meaning: “may” is normative(permission) and “can” is descriptive

of fact, and therefore they imply descriptive text

4 Principles

It is expected that every project specifies the high level planetary protectionrequirements (as needed)

requirements are specified in ESSB-ST-U-001

The following series of ECSS standards describe the processes and procedures

to respond to those bioburden requirements:

currently approved bioburden reduction processes, i.e dry heat andvapour hydrogen peroxide, respectively

environment, like a cleanroom, for the assembly and testing of bioburdencontrolled flight hardware

on flight hardware and in bioburden controlled environments

with different bioburden reduction processes

The activities related to hydrogen peroxide bioburden reduction are shown inFigure 4-1 The related requirements are captured in clause 5 The process can

be summarized as follows:

input for the supplier “work proposal for bioburden reduction”

process taking as inputs the hardware requiring bioburden reduction, thequality requirements and the work proposal (output of the previousactivity)

results against the work proposal for bioburden reduction

Background information for using biological indicators can be found in ISO

Preparing and performing process

Quality Requirements

Recording and reporting process

Bioburden reduction results (including identified deviations, if any)

Bioburden reduction report (Annex C)

NCR (if any identified deviation)

Hardware

Bioburden reduced hardware

5 Requirements

5.1 General requirements

specification in conformance with the DRD in Annex A

proposal in conformance with the DRD in Annex B for the customerapproval

hydrogen peroxide bioburden reduction

report in conformance with the DRD in Annex C

5.2 Product requirements

5.2.1 Product compatibility with process

hydrogen peroxide bioburden reduction

5.2.2 Product cleanliness

and molecular cleanliness level of ≤ 300A, in conformance withrequirements from the IEST-STD-CC1246D, before the bioburdenreduction process is applied

requirements from the ECSS-Q-ST-70-55 before the bioburden reductionprocess is applied

b The packaging shall be compatible with the cleanliness levels of the

product as defined by the customer in the Request for hydrogen peroxide

bioburden reduction in conformance with the DRD in Annex A

is used

5.2.4 Product release

reduction process shall be used

for process monitoring

hydrogen peroxide bioburden reduction is not

a process with parametric release BIs are used

to confirm the process efficacy

medium used for the bioburden reduction process control are in good

order

stearothermophilus, culture collection reference DSM 5934 or ATCC 7953,

within the stated expiration date

also used without barrier and vice versa

for processes specified in the requirements from the clause 5.3.1.1 and

clause 5.3.1.2 shall be at the same level as the required bioburden

reduction level

the documentation of the supplier of the BI orbiological assay of the user

for processes specified in the requirements from the clause 5.3.1.3 shall be

the documentation of the supplier of the BI orbiological assay of the user

5.3 Process requirements

5.3.1 Procedure requirements

5.3.1.1 Procedure for controlled ambient environment

order of magnitude bioburden reduction

achieved by multiplying the respective D-value

in requirement 5.3.1.1c by a factor of 2 to 6,respectively

reduction under controlled ambient conditions shall be ≥ 1,1 mg/L

conditions shall be 200 (mg/L)sec

a 5 order of magnitude bioburden reduction in

a controlled ambient environment, the D-value

in requirement 5.3.1.1c is multiplied by a factor

of 5, i.e 200 (mg/L)sec time 5 = 1000 (mg/L)sec

5.3.1.2 Procedure for controlled vacuum environment

order of magnitude bioburden reduction

achieved by multiplying the respective D-value

in requirement 5.3.1.2c by a factor of 2 to 6,respectively

reduction under controlled vacuum conditions shall be from 0,5 mg/L to1,1 mg/L

conditions shall be 200 (mg/L)sec

a 5 order of magnitude bioburden reduction in

a controlled vacuum environment, the D-value

in requirement 5.3.1.2c is multiplied by a factor

of 5, i.e 200 (mg/L)sec time 5 = 1000 (mg/L)sec

5.3.1.3 Procedure for overkill

5.3.2 Bioburden reduction cycle requirements

shall be in locations on the product for which it is most difficult toachieve the specified procedure values

concentration can be paired up with the BIs, i.e

so there are always both methods for verifyingthe efficacy of the cycle

vapour concentration shall be after the required minimum concentrationspecified in the requirements from the clause 5.3.1 is reached in thelocations selected in the requirement 5.3.2a

the system used for bioburden reduction shall be performed anddemonstrate that the system performs in accordance with the bioburdenreduction procedure and cycle requirements

5.4 Equipment requirements

the equipment has been installed according to the manufacturer’sspecifications

qualification see chapter 9 in ISO 20857

the equipment operates according to design specifications

the installation and operational qualifications are valid for the activitiesduration

uniform distribution of the hydrogen peroxide vapour

holders

record the following process parameters:

4 Humidity, if applicable

calibrated

used within the valid range and time period of the calibration

requirements from the clause 5.1 of the ECSS-Q-ST-10-09

ECSS-Q-ST-10-09

Annex A (normative) Hydrogen peroxide bioburden reduction

specification - DRD

A.1 DRD identification

This DRD is called from ECSS-Q-ST-70-56, requirement 5.1b

The purpose of the specification is to request a service to reduce the bioburden

of a product This specification describes the product, constraints to be metduring the processing of the product and the bioburden levels that need to beachieved at the end of the bioburden reduction process The specification iswritten by the customer, which is usually the owner of the product

A.2 Expected response

bioburden reduction

conformance with requirements from the clause 5.3.1 and the value to be used

necessary before, during and after the bioburden reduction process

is applied