MSR-PPS document title/ titre du document
ARS AMPLE ETURN
LANETARY ROTECTION PECIFICATION FOR HASE YSTEM TUDY
prepared by/préparé par G. Kminek reference/réference Aurora/GK/EE/005.04 issue/édition Draft revision/révision 1 date of issue/date d’édition April 2006 status/état Document type/type de document Specification Distribution/distribution
a ESTEC Keplerlaan 1 - 2201 AZ Noordwijk - The Netherlands Tel. (31) 71 5656565 - Fax (31) 71 5656040
MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 2 of 29
APPROVAL
Title Mars Sample Return Planetary Protection Specification Draft revision 1 titre issue revision
author Gerhard Kminek date April 2006 auteur date
Approved by date Approuvé by date
CHANGE LOG reason for change /raison du changement issue/issue revision/revision date/date Updated, including ECSS and Special Regions Draft 1 April 2006 activities
CHANGE RECORD
Issue: DRAFT Revision: 1 reason for change/raison du changement page(s)/page(s) paragraph(s)/paragraph(s)
MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 3 of 29
This document was prepared with the support of Andre Debus, CNES Planetary Protection Official Representative, and J. Andy Spry, Beagle II Planetary Protection Manager. MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 4 of 29
T ABLE O F C ONTENTS
1. INTRODUCTION...... 6 1.1 SCOPE...... 6 1.2 APPLICATION...... 6 1.3 MSR MISSION OVERVIEW...... 6 1.4 TERMINOLOGY ...... 6 1.5 ACRONYMS ...... 7 1.6 REQUIREMENTS IDENTIFICATION...... 8 2. DOCUMENTS...... 9 2.1 REFERENCE DOCUMENTS ...... 9 3. PLANETARY PROTECTION MANAGEMENT...... 11 4. IDENTIFICATION OF MSR PLANETARY PROTECTION CATEGORY ...... 12 5. PLANETARY PROTECTION REQUIREMENTS FOR THE MSR MISSION...... 13 5.1 GENERAL MISSION REQUIREMENTS ...... 13 5.2 REQUIREMENTS FOR THE LAUNCH VEHICLE...... 14 5.3 REQUIREMENTS FOR ORBITER MODULE ...... 14 5.4 REQUIREMENTS FOR LANDED SYSTEM...... 14 5.5 REQUIREMENTS FOR SAMPLE CONTAINMENT, PRESERVATION, AND RETRIEVAL ...... 15 6. METHODS AND PROCEDURES ...... 17 6.1 BIOBURDEN LEVEL ESTIMATE...... 17 6.1 BIOBURDEN ASSESSMENT PROCEDURES ...... 17 6.2 BIOBURDEN REDUCTION PROCEDURES ...... 17 7. PLANETARY PROTECTION DOCUMENTATION AND REVIEWS ...... 19 7.1 PLANETARY PROTECTION CATEGORY ASSIGNMENT REQUEST (CATEGORY I-V) ...... 19 7.2 PLANETARY PROTECTION PLAN (CATEGORY II-V) ...... 19 7.3 EARTH SAFETY ANALYSIS PLAN (CATEGORY V, RESTRICTED EARTH RETURN)...... 20 7.4 CONTAMINATION ANALYSIS PLAN (CATEGORY III*-IV) ...... 21 7.5 BIOBURDEN ASSAY PLAN (CATEGORY III*-IV)...... 22 7.6 BIOBURDEN REDUCTION PLAN (CATEGORY III*-IV) ...... 23 7.7 BIOHAZARD ASSESSMENT PROTOCOL (CATEGORY V, RESTRICTED EARTH RETURN)...... 24 7.8 PRE-LAUNCH PLANETARY PROTECTION REPORT (CATEGORY II-IV)...... 24 7.9 POST-LAUNCH PLANETARY PROTECTION REPORT (CATEGORY II-IV)...... 24 7.10 EARTH RETURN PLANETARY PROTECTION REPORT (CATEGORY V, RESTRICTED EARTH RETURN)..... 25 7.11 SAMPLE RECEIVING FACILITY COMMISSIONING REPORT (CATEGORY V, RESTRICTED EARTH RETURN) ...... 25 MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 5 of 29
7.12 EARTH RETURN PRE-ENTRY PLANETARY PROTECTION REPORT (CATEGORY V, RESTRICTED EARTH RETURN) ...... 25 7.13 EARTH RETURN POST-LANDING PLANETARY PROTECTION REPORT (CATEGORY V, RESTRICTED EARTH RETURN) ...... 25 7.14 SAMPLE PRE-RELEASE PLANETARY PROTECTION REPORT (CATEGORY V, RESTRICTED EARTH RETURN) ...... 26 7.15 MISSION EXTENSION PLANETARY PROTECTION REPORT (CATEGORY I-V)...... 26 7.16 END OF MISSION PLANETARY PROTECTION REPORT (CATEGORY I-V) ...... 26 APPENDIX 1: STERILIZATION METHODS ...... 27 1.1 DRY HEAT STERILIZATION ...... 27 1.2 GAMMA RADIATION STERILIZATION ...... 27 1.3 HYDROGEN PEROXIDE GAS PLASMA STERILIZATION ...... 28 1.4 ALCOHOL WIPING ...... 28 APPENDIX 2: SUMMARY OF MILESTONES AND DELIVERIES ...... 29
MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 6 of 29
1. Introduction
1.1 Scope The 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 and 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 5 categories of target body/mission type combinations [RD 1].
This MSR Planetary Protection Specification defines the rules which have to be respected in order to comply with the internationally accepted planetary protection requirements.
1.2 Application This MSR Planetary Protection Specification is applicable to: The MSR spacecraft modules (e.g., Carrier, Orbiter, DM, MAV, ERC);
The MSR launch vehicle(s);
All mission phases until delivery of the returned hardware and samples to a dedicated MSR Receiving Facility.
1.3 MSR Mission Overview The MSR mission is the second proposed flagship mission of the Aurora program of the European Space Agency. The objective of the MSR mission is to collect and return Martian samples to Earth [RD 2].
1.4 Terminology Aseptic: The state of having eliminated all detectable viable microorganisms. Backward contamination: For the purpose of planetary protection, contamination of the terrestrial biosphere, including the Moon, by extraterrestrial life forms in the course of space missions. Bacterial Spores: A resistant body produced by a vegetative bacterial cell. Capable to survive extreme environmental conditions. Generally used as reference microorganisms for the qualification of sterilisation methods. For the purpose of this document, the term bacterial spore describes aerobic mesophilic bacterial spores. Bioassay: Sampling technique to derive an estimate of the bioburden associated with the item of interest. Bioburden: Quantity of viable microorganisms. For the purpose of this document, the term bioburden describes the quantity of bacterial spores. Bioburden reduction: Operation used in order to reduce bioburden. Bioburden reduction can be achieved by cleaning and/or sterilization. MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 7 of 29
Biohazard: For the purpose of this document, an extraterrestrial life form that has the capability to produce deleterious effects on the terrestrial biosphere. Specifically excluded are toxins as they have only local effects and are treated by laboratory safety measures. Biological Containment System: For the purpose of this document, system designed to safely contain potential biological extraterrestrial material. Biological Safety Level: Containment classification. Level 4 is the most stringent class and is applicable for work with dangerous and exotic agents that pose a high individual risk of life-threatening disease, which may be transmitted via the aerosol route and for which there is no available vaccine or therapy. Chemical Contamination: For the purpose of this document, contamination by biologically relevant organic molecules. Cleaning: A process that removes contaminants (organic compounds and microorganisms) but does not sterilize the item of interest. Deleterious effects: Either pathogenic (via toxicity and infectivity) or ecological effects. Disinfection: Destruction of vegetative forms of harmful microorganisms. Disinfection might be less effective in destroying bacterial spores. Disinfection does not necessarily sterilize. Encapsulated bioburden: Bioburden buried inside non-metallic spacecraft material. Exposed surfaces: Internal and external surfaces whose bioburden will likely get into Martian environment from a lander with no anomalies. For the use of DHMR, intent is free for gas exchange. Extraterrestrial life form: An extraterrestrial replicating biological entity. This definition is not limited to self replicating entities but includes also non self replicating entities (e.g., viruses, prions, etc.). False positive: A false positive indication in a life detection and biohazard determination protocol could prevent distribution of the sample from containment and could lead to unnecessary rigor in the requirements for all subsequent Mars missions. Forward contamination: For the purpose of planetary protection, contamination of solar system bodies other than the Earth by terrestrial life, including organic constituents, in the course of space missions. Mated surfaces: A matched join by fasteners rather than by adhesives. Organic Compounds: Compounds (including materials and molecules) containing carbon, oxygen, hydrogen, and nitrogen. These compounds could affect the search for extraterrestrial life by giving false positives or masking an extraterrestrial signature. Planetary Protection: Term used to describe the policy and the technical implementations to prevent forward and backward contamination. Spacecraft module: Carrier, Orbiter, DM, MAV, ERC. Sporicide: A substance capable to destroy bacterial spores. Sterility: Complete absence of viable microorganisms. Sterilization: A process that completely destroys or eliminates viable microorganisms. Terrestrial biosphere: Defined as the Earth-Moon system to avoid planetary protection requirements for missions to the Moon. Total bioburden: Total of exposed, mated, and encapsulated bioburden. Viable: Capable of reproduction (term includes vegetative and dormant forms of microorganisms). Vegetative: Metabolically active (in contrast to dormant spores).
1.5 Acronyms PPO Aurora Planetary Protection Officer BSL Biological Safety Level CDR Critical Design Review MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 8 of 29
COSPAR Committee On Space Research DHMR Dry Heat Microbial Reduction DM Descent Vehicle ECSS European Cooperation for Space Standardization EDL Entry, descend, and landing ERC Earth Return Vehicle ESA European Space Agency FRR Flight Readiness Review ISO International Organisation for Standardization kGy Kilo Gray (radiation dose: 1 Gy = 100 Rad) MAV Mars Ascent Vehicle MSR Mars Sample Return NASA National Aeronautics and Space Administration PDR Preliminary Design Review PPWG Planetary Protection Working Group PRR Preliminary Requirements Review Rh Relative humidity RHU Radioactive Heating Unit RTG Radioisotope Thermal Generator SAL Sterility Assurance Level UV Ultraviolet Radiation
1.6 Requirements Identification The numbering of the mandatory requirements follows the following scheme: PP #, with the following significance: #: Identifier for requirement.
A requirement may be followed by comments. This is intended to assist the understanding of the requirement or its origin. This text is indicated in italic characters and starts with “C:”. MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 9 of 29
2. Documents Unless explicitly mentioned otherwise the documents mentioned under 2.1 are available from the Aurora FTP site (ftp://ftp.estec.esa.nl/pub/aurora/MSR/Planetary_Protection).
2.1 Reference Documents The Contractor shall consult the following documents as they contain relevant information for the understanding of this document. In the event of a conflict between this Document and Reference Documents, this Document shall have precedence.
[RD 1] COSPAR Planetary Protection Policy (20. October 2002). [RD 2] MSR Executive Summary, MSR-VRP-Al-0004. [RD 3] NASA NPR 8020.12C Planetary Protection provisions for robotic extra-terrestrial missions. [RD 4] WHO/CDS/CSR/LYO/2005.22: Guidance on regulations for the transport of infectious substances. World Health Organisation, September 2005. [RD 5] NASA NPG 5340.1D NASA Standard procedures for the microbiological examination of space hardware. [RD 6] NASA CP/2002-211842: A draft test protocol for detecting possible biohazards in martian samples returned to Earth, October 2002. [RD 7] CNES MA1-PO-0-0321-2845-CN Mars Project – Planetary protection program – Hydrogen peroxide plasma gas sterilization procedure. [RD 8] ESA STM-269 Sterilisation Processes and Methodology. [RD 9] ESA STM-270 Sterilisation by Irradiation. [RD 10] ESA STM-271 Processes for Use and Maintenance of Clean Rooms in Sterile Conditions. [RD 11] ESA-STM 274: Materials Compatibility Testing with Hydrogen Peroxide, ISBN 92-9092-390-3, 2005. [RD 12] ESA CR(P)-4482: Lessons Learned from the Planetary Protection Activities on the Beagle 2 Spacecraft, 2005. [RD 13] ISO 14644-1, Cleanrooms and Associated Controlled Environments – part 1: Classification of air cleanliness. [RD 14] ISO 14644-2, Cleanrooms and Associated Controlled Environments – part 2: Specification for testing and monitoring to prove continued compliance with ISO 14644-1. [RD 15] ISO 14644-4, Cleanrooms and Associated Controlled Environments – part 4: Design, construction and start-up. [RD 16] ISO 14644-5, Cleanrooms and Associated Controlled Environments – part 5: Operations. [RD 17] ISO 14644-7, Cleanrooms and Associated Controlled Environments – part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments). [RD 18] ISO 14698-1, Cleanrooms and Associated Controlled Environments – Biocontamination control: General principles and methods. [RD 19] ISO 14698-2, Cleanrooms and Associated Controlled Environments – Biocontamination control: Evaluation and interpretation of biocontamination data. MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 10 of 29
[RD 20] ISO 14698-3, Cleanrooms and Associated Controlled Environments – Biocontamination control: Measurement of the efficiency of processes of cleaning and/or disinfection of inert surfaces bearing biocontaminated wet soiling or biofilms. [RD 21] ISO 8573-7, Compressed air –part 7: Test method for viable microbiological contaminant content. [RD 22] IEST-RP-CC023.2: Microorganisms in Cleanrooms, January 2006.
MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 11 of 29
3. Planetary Protection Management PP 01 The industrial prime contractor shall nominate a Planetary Protection Representative.
PP 02 The industrial Planetary Protection Representative shall prepare and provide all relevant and required documents related to planetary protection.
PP 03 The industrial Planetary Protection Representative shall implement the planetary protection program inside the industrial project team, including sub-contractors.
PP 04 The point of contact for the industrial Planetary Protection Representative on all matters regarding planetary protection shall be the PPO.
PP 05 The final planetary protection responsibility of the mission shall reside with ESA.
MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 12 of 29
4. Identification of MSR Planetary Protection Category The MSR planetary protection categorization is in agreement with the COSPAR Planetary Protection Policy [RD 1].
PP 06 The MSR mission is classified as Planetary Protection Category V, Restricted Earth Return. C: The mission and the spacecraft design must provide a method to break the chain of contact with Mars.
PP 07 The outbound leg of the MSR mission is classified as Planetary Protection Category IVb. C: This provision is intended to avoid false positive indications in a life detection and biohazard determination protocol or in the search for life in the sample after it is returned to Earth. A false positive could prevent distribution of the sample from containment and could lead to unnecessary rigor in the requirements for all subsequent Mars missions. Access to special regions has additional constraints.
MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 13 of 29
5. Planetary Protection Requirements for the MSR Mission The following requirements are derived from the NASA Planetary Protection Standard [RD 3], and work performed in the ECSS working group Q-40-01 on planetary protection. The requirements are in agreement with the COSPAR Planetary Protection Policy [RD 1], and endorsed by the ESA Planetary Protection Working Group (PPWG).
5.1 General Mission Requirements All values for bioburden limits specified in the requirements are values for bioburden at launch. No credit can be taken for in-flight environment or surface conditions on Mars that could reduce the bioburden.
All values for bioburden limits specified in the requirements represent maximum values and are independent of the surface area or size of the spacecraft modules.
PP 08 All necessary information concerning planetary protection shall be available for report to COSPAR.
PP 09 The mission and the spacecraft design shall provide a method to break the chain of contact between Earth and Mars. No uncontained hardware that contacted Mars, directly or indirectly, shall be returned to Earth.
PP 10 A redundant fail safe containment with a method for verification of its operation before committing for Earth return shall be required. C: The term containment means in this context biological containment.
PP 11 If the mission cannot be safely returned to Earth, it shall be abandoned avoiding any collision with the Earth-Moon system. C: This would be the case if the verification of the containment described in PP 10 is either not conclusive or has a negative result.
PP 12 Any Martian material shall be considered as biohazard and classified as infectious substances of category A according to [RD 4] until proven otherwise. C: The Biohazard Assessment Protocol describes how to evaluate the potential biohazardous nature of martian material.
PP 13 The probability for contaminating Earth with a potential martian biohazard shall be less than 10-6. C: This probability covers all mission phases until the returned hardware and samples are contained in the MSR Receiving Facility.
PP 14 An organic materials inventory of bulks constituents present in quantities of 1 kg or more shall be provided for all launched hardware. In addition, a 50-g sample of any organic material of which 25 kg or more is used shall be archived for at least 50 years from launch.
MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 14 of 29
PP 15 Final disposition and status of all launched hardware shall be provided as accurately as mission constraints permit.
5.2 Requirements for the Launch Vehicle PP 16 The probability of an impact on Mars by any part of the launch vehicle shall not exceed 10-4. C: This requirement is also applicable to a cruise stage/carrier that delivers spacecraft modules to Mars. In case the cruise stage/carrier has been assembled and maintained in ISO level 8 cleanrooms, requirements for Mars orbiter modules apply.
5.3 Requirements for Orbiter Module The orbiter module includes all separable systems, such as the ERC.
PP 17 The orbiter module shall be assembled and maintained in ISO level 8 cleanrooms, or better.
PP 18 An orbiter module with a total bioburden of less than 5x105 bacterial spores shall not be required to meet impact or orbital lifetime requirements. C: The total bioburden includes surface, mated, and encapsulated bioburden.
PP 19 In case the orbiter module does not meet the bioburden levels described in PP 18, the probability of an impact on Mars by the orbiter module shall not exceed 10-2 for the first 20 years after launch, and shall not exceed 5x10-2 for the time between 20 and 50 years after launch.
5.4 Requirements for Landed System The landed system include all landed modules and separable equipment such as DM, MAV, parachute, back-cover, balance weights, and heat-shield in a single landing event. A single landing event is one when the predicted landing location of the modules and equipment cannot be shown pre-launch to be disparate at the 3 sigma level.
PP 20 The landed system shall be assembled and maintained in ISO level 8 cleanrooms, or better.
PP 21 The total bioburden of the landed system making a planned hard landing and/or having a non- nominal impact requirement shall be less than 5x105 bacterial spores. C: The total bioburden includes surface, mated, and encapsulated bioburden. Landed system elements making a planned hard landing are for example balance weights, back-shell, and heat shield. Non-nominal impact requirements are related to special regions.
PP 22 The bioburden of the landed system shall be less than 30 bacterial spores on exposed internal and external surfaces, or at a level driven by the nature and sensitivity of the particular life detection experiments, whichever are more stringent, OR the subsystems which are involved in the acquisition, delivery, and analysis of samples used for life detection shall have a bioburden of less than 30 bacterial spores on exposed internal and external surfaces, and a method of preventing recontamination of the aseptic subsystems and the contamination of the samples to be analyzed is in place. MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 15 of 29
C: This is the Planetary Protection Category IVb requirement. For the purpose of this document, the sensitivity of the life detection experiments is described in the Biohazard Assessment Protocol.
PP 23 If the landing site is within a special region, the bioburden of the landed system shall be less than 30 bacterial spores on exposed internal and external surfaces. C: This is part of the Planetary Protection Category IVc requirement. A martian region may be categorized as non-special if the temperature will remain below -20°C or the water activity (equivalent to Rh/100) will remain below 0.5 for a period of 100 years after spacecraft arrival on Mars. Environments that are categorized as special regions are: recent gullies, mid-latitude mantels, low-latitude slope-streaks, high latitude glaciers, young volcanic environments, young impact craters, and modern outflow channels. All these features have a surface representation that is accessible through current remote sensing capabilities. Most areas in the plus/minus 30 deg latitudinal band around the equator can be considered as non-special, with the notable exceptions of the environments mentioned above. If a flight project decides not to access a special region, it will have to show that there is no special region within the pre-launch 3 sigma landing ellipse.
PP 24 If a special region is accessed through horizontal or vertical mobility, either the bioburden of the landed system shall be less than 30 bacterial spores on exposed internal and external surfaces, OR the subsystems which directly contact the special region shall have a bioburden of less than 30 bacterial spores on exposed internal and external surfaces, and a method of preventing recontamination of the aseptic subsystems is in place.
PP 25 If an off-nominal condition (such as hard landing) would cause a high probability of inadvertent contamination of a special region, the bioburden of the entire landed system shall be less than 30 bacterial spores on exposed internal and external surfaces. C: As a practical consideration, for evaluating accidental impact scenarios it is considered sufficient to consider maximum crater depth to be less than 5 meters for impacting hardware of less than 2400 kg. Impact scenarios must include failure of composite separation (i.e. total mass of Mars arriving composite with arrival velocity) as well as EDL failure.
PP 26 An analysis of spacecraft induced special regions shall be provided. C: Spacecraft in that context means all mission modules, including orbiter module and landed systems. A spacecraft can induce a special region even in a non- special region mostly by providing a long-term heat source. This is typically the case for nuclear powered systems. As a practical consideration, the spacecraft induced effect is insignificant if the temperature is raised to 5°C for less than one sol per martian year (potentially excluding temperature excursion during sample acquisition).
5.5 Requirements for Sample Containment, Preservation, and Retrieval PP 27 The integrity of the samples shall be ensured. MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 16 of 29
C: If sample integrity is not preserved, resulting contamination or changes in sample material properties may induce false results in the biohazard assessment protocol. Requirements for the sample preservation are defined in the Biohazard Assessment Protocol.
PP 28 All parts that come in direct or indirect contact with the samples shall satisfy the cleanliness level specified in the Biohazard Assessment Protocol. C: The cleanliness level in this context is focused on biological molecules of relevance for the life detection and biohazard assessment process.
PP 29 The sample containment shall consist of three biological barriers. C: This system shall ensure that the probability for the release of potential biological particles with a size greater than 10 nanometers is less than 10-11. This probability applies to the use of the entire system and not to the individual biological barriers. Biological barriers are not necessarily equivalent to a gas tight seal.
PP 30 The ERC with the martian samples shall be located and retrieved in a reasonable amount of time. C: It should be noted that a delayed retrieval has to be covered by the probability of Earth contamination of 10-6, as described in PP 13.
PP 31 The MSR Receiving Facility shall be commissioned before committing for Earth return.
PP 32 The MSR Receiving Facility shall have a containment equivalent to BSL-4, or better..
MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 17 of 29
6. Methods and Procedures
6.1 Bioburden Level Estimate PP 33 Estimation of the total bioburden included in the spacecraft shall be performed using the following values or monitored during tests [RD 3]:
Average encapsulated spores density: Nonmetallic portions of the spacecraft :130/cm3
Source specific encapsulated spore density: Electronic piece parts : 3-150/cm3 Other nonmetallic materials : 1-30/cm3
Source specific enclosed surface spore density: Clean room-highly controlled : 0.05-0.5cm2 Clean room-normal control : 0.5-10/cm2 Uncontrolled manufacturing : 10-100/cm2
Highest number must be used in the absence of microbial assay or sterilization processing history data.
Average surface spore density (exposed and mated but non-encapsulated): ISO class 7 cleanroom or better, highly controlled : 50 spores/m2 ISO class 7 cleanroom or better, normally controlled : 500 spores/m2 ISO class 8 cleanroom, highly controlled : 1 000 spores/m2 ISO class 8 cleanroom, normally controlled : 10 000 spores/m2 Uncontrolled manufacturing : 105 spores/m2
These data are only applicable for bacterial spores estimation, and not for the definition of a terminal sterilization process. For estimating surface densities for vegetative microorganisms, the above values shall be multiplied by a factor of 10.
6.1 Bioburden Assessment Procedures PP 34 All bioassays shall be performed according to the NASA procedure [RD 5]. C: The number of surface samples obtained per assay can be specified in the individual projects. Typically, for spacecraft in the 50 – 500 m2 range, there will be approximately 250 surface samples (each about 25 cm2 in area) taken per assay.
PP 35 Any use of another bioassay procedure has to be evaluated by the PPO before use. C: Alternative bioassays have to demonstrate to be at least equivalent to the NASA procedure. It is up to the proposer to demonstrate the equivalence.
6.2 Bioburden Reduction Procedures PP 36 Each bioburden reduction procedure shall be monitored for its ability to control the bioburden. MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 18 of 29
C: The monitoring of a certified sterilization procedure can be done by process indicators. No assay of the sterilized hardware is required.
The detailed description of the sterilization and cleaning processes, to be specified in the Microbial Reduction Plan, shall be based on the following guidelines:
PP 37 DHMR is the only certified sterilization process for spacecraft hardware [RD 3].
PP 38 Any use of non-certified sterilization processes has to be evaluated by the PPO before use. C: Non-certified sterilization processes have to be validated compared to the DHMR process. It is up to the proposer to demonstrate the equivalence.
PP 39 Systems for which it is demonstrated that a minimum temperature of 500°C is reached for at least half a second during atmospheric entry on Mars do not have to be sterilized. [RD 3]. C: Practically, this requirement can possibly be used for back-shell and heat-shield if appropriate simulation can show that the required values are reached.
MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 19 of 29
7. Planetary Protection Documentation and Reviews Planetary protection reviews may be incorporated in broader project reviews. The scope of planetary protection reviews is defined by the description of the required documentation.
A summary of planetary protection reviews and deliverable documentation at each milestone is given in Appendix 2.
7.1 Planetary Protection Category Assignment Request (Category I-V) This document is the first planetary protection document in any solar system mission.
PP 40 The Planetary Protection Category Assignment Request shall include, but is not limited to, the following items: A. Mission description 1. Scientific objectives 2. Mission type (i.e. fly-by, orbiter, lander, Earth return, etc.) 3. Identification of targeted and/or encountered solar system bodies 4. Identification of the use of perennial heat sources (i.e., RHU, RTG) B. Proposed planetary protection category C. Justification for proposed planetary protection category
PP 41 The Planetary Protection Category Assignment Request shall be released for the Planetary Protection Mission Certification Review, but no later than PRR.
7.2 Planetary Protection Plan (Category II-V) PP 42 The Planetary Protection Plan shall be the primary planning document describing how a project will be conducted so as to meet the appropriate planetary protection requirements.
PP 43 The Planetary Protection Plan shall include, but is not limited to, the following items: A. General 1. Mission description a. Scientific objectives b. Mission type (i.e., fly-by, orbiter, lander, Earth return, etc.) c. Identification of targeted and/or encountered solar system bodies d. Identification of the use of perennial heat sources (i.e., RHU, RTG) 2. Planetary protection constraints a. Designation of planetary protection category b. Category specific planetary protection specifications 3. General approach to planetary protection compliance, including if applicable: a. Probability of impact, including aero-breaking and/or aero capture manoeuvres b. Contamination control B. Planetary protection management and organisation 1. Organisation description 2. Responsibilities and relationships MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 20 of 29
3. System Interface management 4. Contractor management 5. Data management This chapter shall specifically include a description of the launcher interface, in all appropriate items listed. C. Documentation 1. Identification of references and applicable documents 2. Identification of planetary protection documents to be produced D. Facilities 1. Identification and description of controlled facilities 2. Activities performed 3. Hardware affected E. Schedules 1. Identification of project milestones 2. Schedule for planetary protection documents to be produced
PP 44 In addition, the following subsidiary plans shall be prepared when required for the particular category assigned: 1. Contamination Analysis Plan 2. Bioburden Assay Plan 3. Bioburden Reduction Plan 4. Earth Safety Analysis Plan
PP 45 Preliminary subsidiary plans, if applicable, shall be included in the Planetary Protection Plan.
Required Chapter per Mission Category:
Chapters Category A II-V B III-V C II-V D III-V E II-V
PP 46 The Planetary Protection Plan shall be released for the Planetary Protection Review, but no later than PDR.
7.3 Earth Safety Analysis Plan (Category V, Restricted Earth Return) PP 47 The Earth Safety Analysis Plan shall be the primary planning document covering the Earth return part of a restricted Earth return mission.
PP 48 The plan shall include a detailed description of the Biohazard Assessment Protocol and shall cover all relevant events from sample acquisition until completion of the Biohazard Assessment Protocol. MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 21 of 29
PP 49 The Earth Safety Analysis Plan shall be the interface document between the flight segment (sample acquisition, containment, and transport to the Earth) and the ground segment (sample retrieval, transport, and containment inside the Sample Receiving Facility) of a restricted Earth return mission.
A. General 1. Identification 2. Rational and assumption B. Potential contamination sources 1. Sample containment approach 2. Decontamination approach 3. Earth entry plan C. Probability of contamination model 1. Mission probability of contamination equation 2. Critical parameters 3. Contamination source analysis a. Analytical techniques b. Assumptions c. Substantiation of parameter values 4. Probability of contamination allocation model a. Level of risk b. System allocation D. Analysis documentation
Required subsidiary plans according to mission category
Subsidiary Plan Category Contamination Analysis Plan III*-IV Bioburden Assay Plan III*-IV Bioburden Reduction Plan III*-IV Earth Safety Analysis Plan† V‡
*Probability of impact out of specification †Plan is due at PDR ‡Restricted Earth return
PP 50 The Earth Return Analysis Plan shall be released for the PDR.
7.4 Contamination Analysis Plan (Category III*-IV) PP 51 The Contamination Analysis Plan shall be the primary planning document covering the major analysis which are performed by the project to demonstrate that the project is meeting the planetary protection requirements on bioburden.
MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 22 of 29
PP 52 The Contamination Analysis Plan shall include, but is not limited to, the following items: A. General 1. Introduction 2. Rational and assumptions B. Potential contamination sources C. Bioburden estimate model 1. Contamination source analysis a. Analytical techniques b. Assumptions c. Substantiation of parameter values 2. Allocation model a. Systems allocations (spacecraft, launch vehicle, etc.) b. Subsystem and lower level allocations D. Analysis documentation
PP 53 The Contamination Analysis Plan shall be released for the Subsidiary Plans Review, but no later than CDR. A preliminary Contamination Analysis Plan shall be included in the Planetary Protection Plan.
PP 54 In case of a restricted Earth return mission, the Contamination Analysis Plan shall describe limits for contamination in order not to compromise the Biohazard Assessment Protocol, described in the Earth Safety Analysis Plan.
7.5 Bioburden Assay Plan (Category III*-IV) PP 55 The Bioburden Assay Plan shall identify the space vehicle hardware, facilities, and associated environments which are to be subject to bioburden assay, and shall describe the rational, concepts, and detailed procedures pertaining to such assays.
PP 56 The plan shall describe the bioburden quality assurance procedures used to ensure validity of the assay results.
PP 57 In case a non-standard bioburden assay is used, any information showing the equivalence of the non-standard bioburden assay with the standard bioburden assay shall be described.
PP 58 The Bioburden Assay Plan shall include, but not be limited to, the following items: A. General 1. Introduction 2. Rational and assumptions B. Assay methods 1. Description of assay procedure used 2. Laboratory assay procedures 3. Sampling procedures 4. Provision for verification assays 5. Quality assurance provisions C. Facilities MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 23 of 29
1. Controlled facilities a. Assay laboratories b. Hardware areas 2. Uncontrolled facilities a. Monitoring b. Environmental estimates D. Space hardware (flight) assay and control 1. Identification 2. Hardware exceptions 3. Contingency planning E. Assay data 1. Traceability 2. Analysis and interpretation 3. Management and handling
PP 59 The Bioburden Assay Plan shall be released for the Subsidiary Plans Review, but no later than CDR.
7.6 Bioburden Reduction Plan (Category III*-IV) PP60 The Bioburden Reduction Plan shall identify space vehicle hardware which must have their bioburden reduced to a specified or measured (assayed) level.
PP 61 The plan shall describe the implementation procedures to achieve and maintain the reduced bioburden. This shall specifically include a detailed description of the sterilization processes and the use of bio-barriers.
PP 62 In case a non-standard sterilization process is used, any information showing the equivalence of the non-standard sterilization process with the standard sterilization process shall be described.
PP 63 The Bioburden Reduction Plan shall include, but not be limited to, the following items:
A. General 1. Introduction 2. Rational and assumptions B. Spacecraft hardware subject to bioburden reduction processes 1. Identification 2. Exceptions C. Process analysis 1. Analytical techniques 2. Assumptions 3. Process parameters 4. Process modification D. Process verification and control 1. Process description and boundaries 2. Process qualification MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 24 of 29
3. Equipment and facilities qualification 4. Acceptance criteria 5. Process interruption and modification 6. Quality assurance provisions E. Maintaining reduced bioburden level 1. Monitoring/assaying 2. Using bio-barriers 3. Controlling macro-organisms (insect, animal, etc.) 4. Contingency planning
PP 64 The Bioburden Reduction Plan shall be released for the Subsidiary Plans Review, but no later than CDR.
7.7 Biohazard Assessment Protocol (Category V, Restricted Earth Return) PP 65 The Biohazard Assessment Protocol shall define:
A. Investigations to detect potential life and/or biohazard in extraterrestrial samples B. Sample preservation requirements during all mission phases cleanliness requirements C. Functional requirements of the sample receiving facility
PP 66 A draft version of the protocol shall be part of the Earth Safety Analysis Plan. The final version of the protocol shall be released for the Subsidiary Plans Review, but no later than CDR.
7.8 Pre-Launch Planetary Protection Report (Category II-IV) PP 67 The Pre-Launch Planetary Protection Report shall be the basic document used by the project to provide verification that planetary protection requirements have been met, and that the project can continue to satisfy them throughout the mission.
PP 68 The report shall include, but not be limited to, an update on the planetary protection compliance: 1. Orbital lifetime 2. Results of contamination control measures 3. Deviation from Planetary Protection Plan 4. Organic Inventory List.
PP 69 The Pre-Launch Planetary Protection Plan shall be released for the Pre-Launch Planetary Protection Review, but no later than the FRR.
7.9 Post-Launch Planetary Protection Report (Category II-IV) PP 70 The Post-Launch Planetary Protection Report shall be based on the Pre-Launch Planetary Protection Report, but updated to include the effects of events from the submission of the Pre- Launch Planetary Protection Report.
PP 71 The report shall include, but not be limited to, the following items: MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 25 of 29
1. Ground processing 2. Last access assay results 3. Launch events
PP 72 The Post-Launch Planetary Protection Report shall be released for the Post-Launch Planetary Protection Review.
7.10 Earth Return Planetary Protection Report (Category V, Restricted Earth Return) PP 73 The Earth Return Planetary Protection Report shall provide verification that planetary protection requirements outlined in the Earth Safety Analysis Plan have been met and that the project can and will continue to satisfy the throughout the Earth return portion of the mission.
PP 74 The plan shall include the Sample Receiving Facility Commissioning Report.
PP 75 The plan shall be released before committing the inbound phase of a restricted Earth return mission for the Planetary Protection Safety Analysis Review.
7.11 Sample Receiving Facility Commissioning Report (Category V, Restricted Earth Return) PP 76 The Sample Receiving Facility Commissioning Report shall describe the commissioning of the Sample Receiving Facility.
PP 77 The report shall be released for the Planetary Protection Safety Analysis Review.
7.12 Earth Return Pre-Entry Planetary Protection Report (Category V, Restricted Earth Return) PP 78 The Earth Return Pre-Entry Planetary Protection Report shall be based on the Earth Return Planetary Protection Report, updated for effects of events from submission of the Earth Return Planetary Protection Report.
PP 79 The Earth Return Pre-Entry Report shall be released for the Earth Return Pre-Entry Planetary Protection Review.
7.13 Earth Return Post-Landing Planetary Protection Report (Category V, Restricted Earth Return) PP 80 The Earth Return Post-Landing Planetary Protection Report shall be based on the Earth Return Pre-Entry Planetary Protection Report, updated for effects of events from submission of the Earth Return Pre-Entry Planetary Protection Report.
PP 81 The Earth Return Post-Landing Planetary Protection Report shall be released for the Earth Return Post-Landing Planetary Protection Review. MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 26 of 29
7.14 Sample Pre-Release Planetary Protection Report (Category V, Restricted Earth Return) PP 82 The report shall verify that the Biohazard Assessment Protocol has been executed and that the extraterrestrial samples are free from hazards to the terrestrial biosphere and are, therefore, safe for release. The report shall be provided for the Sample Pre-Release Planetary Protection Review.
7.15 Mission Extension Planetary Protection Report (Category I-V) PP 83 The Mission Extension Planetary Protection Report shall demonstrate the continued compliance with planetary protection requirements.
PP 84 The Mission Extension Planetary Protection Report shall be released for the Mission Extension Planetary Protection Review.
7.16 End of Mission Planetary Protection Report (Category I-V) PP 85 The End of Mission Planetary Protection Report shall provide the degree to which the project has met the planetary protection requirements throughout the complete mission and reports on disposition of all launched hardware.
PP 86 The End of Mission Planetary Protection Report shall be released for the End of Mission Planetary Protection Review.
MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 27 of 29
Appendix 1: Sterilization Methods A sterilization process is a carefully designed and monitored process that will assure the probability of an item being contaminated to be equal or less than the Sterility Assurance Level (SAL). The typical SAL in medical procedures is SAL-6. This means that the probability of a microorganisms surviving on an item subjected to the sterilization procedure is less than one in one million. The PPWG has recommended the following sterilization methods and bio-indicators:
• Steam (bio-indicator: B. stearothermophilus, ATCC 7953); • Dry heat (bio-indicator: B. subtilis var. niger, ATCC 9372); • Gamma radiation (bio-indicator: B. pumilus, ATCC 27142); • Hydrogen peroxide plasma (bio-indicator: B. stearothermophilus, ATCC 7953).
UV-radiation is not an appropriate sterilization process. The PPWG will provide more information on the qualification of sterilization processes in due time. Some of the more widely used sterilization techniques are described in the following paragraphs.
1.1 Dry Heat Sterilization Dry heat sterilization is a bulk sterilization method. The minimal sterilization temperature using dry heat is 105°C. The absolute humidity during the procedure corresponds to a relative humidity of less than 25 % at standard conditions of 0°C and 760 torr pressure. A thermal study must be performed in order to verify that the required temperature is reached at all points of the equipment or probe.
Time/temperature equivalences for SAL-6. Temperature Time T(°C) T(K) t(h) 105 378 300 115 388 60 125 398 48 135 408 12 160 433 1.5 180 453 0.5
1.2 Gamma Radiation Sterilization Gamma radiation sterilization is a bulk sterilization procedure. The sterilization dose for gamma-radiation to reach SAL-6 using a 60Co source is 25 kGy. MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 28 of 29
1.3 Hydrogen Peroxide Gas Plasma Sterilization Hydrogen peroxide sterilization is only efficient on exposed surfaces. A specific procedure has been validated using the Sterrad 100® process (Johnson and Johnson medical process). The procedure was used with reduced plasma phase (time = 0) and has been validated for a SAL-6 level.
® H2O2 gas plasma (Sterrad 100 process) cycle validated for the Mars 96 mission. STERILIZATION CYCLE PRESSURE (mT) Temperature = 45°C P atm
depressurization flushing-out cycle
diffusion plasma < 14 000 phase
TIME 500 gas hydrogen 300 peroxide injection (mn) 5 6 44 0 4
1.4 Alcohol Wiping Alcohols (isopropyl or ethyl alcohol) cannot be used for sterilization. However, alcohol wiping may be used to remove a proportion of microorganisms from contaminated surfaces. Isopropyl alcohol is preferred to ethyl alcohol by virtue of its (limited) sporicidal activity.
MSR– Planetary Protection Specification DRAFT revision 1 – April 2006 Aurora/GK/EE/005.04 page 29 of 29
Appendix 2: Summary of Milestones and Deliveries All Earth return missions have to provide documentation for the outbound leg of the mission. Restricted Earth return missions have to provide additional documentation for the inbound leg of the missions.
Mission Category Documentation Review 1 2 3 4 5* PP Assignment Request PP Mission Certification Review X X X X X (PRR**) PP plan PP plan review (PDR**) X X X X Earth Safety Analysis Plan PP plan review (PDR**) X Contamination analysis plan PP subsidiary plan review (CDR**) X† X X‡ Bioburden assay plan PP subsidiary plan review (CDR**) X† X X‡ Bioburden reduction plan PP subsidiary plan review (CDR**) X† X X‡ Biohazard assessment protocol PP subsidiary plan review (CDR**) X Pre launch PP report Pre launch PP review (FRR**) X X X X‡ Post launch PP report Post Launch PP Review X X X X‡ Earth return PP report Earth Safety Analysis Review X SRF commissioning report Earth Safety Analysis Review X Earth return pre-entry PP report Earth return pre entry PP Review X Earth return post landing PP report Earth return post landing PP Review X Sample pre-release PP report Sample pre-release PP Review X Extended mission PP report Extended mission PP Review X X X X X End of mission PP Report End of mission PP Review (EOM**) X X X X X
(*) For restricted Earth return only. (**)Reports/plans shall be released for dedicated planetary protection review, but no later than indicated project review. † Probability of impact out of specification. ‡ As part of requirements for the outbound leg.