ATS-SOI-5910 Page: 1 of 7. Approval Block. Prepared by: Signature Date. Evan Parnell 04 AUG Reviewed by: Signature Date. Brian Flynn 04 AUG 2014

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1 ATS-SOI-5910 Page: 1 of 7 Approval Block Prepared by: Signature Date Evan Parnell 04 AUG 2014 Reviewed by: Signature Date Brian Flynn 04 AUG 2014 Approved by: Signature Date Kristal Jewell 04 AUG 2014 Historical Reference Section: Section Name Section Number (i.e., 5.2.1) Revision Affected Explanation of Change References 3 A Added references Approval Block N/A A Added Approval Block 1. Purpose 1. This document provides instruction for conducting environmental cleaning/maintenance of the ATS cleanroom. A routine cleaning and disinfection schedule using defined cleaning and disinfecting agents will lower area bioburden. 2. Scope 1. This procedure is to be followed by personnel responsible for maintaining the cleanliness of the cleanrooms.

2 3. References ATS-SOI-5910 Page: 2 of 7 1. ISO Material Safety Data Sheets (MSDS) located on the office bookshelf. 3. ATS-SOI-5880 Rev (A) Standard Operating Instruction: Gowning Procedures 4. ATS-SOI-5900 Rev (A) Logbook Entries 5. ATS-SOI-5935 Rev (B) Standard Operating Instruction: Cleanroom Cleaning/Viable Sampling Schedule 4. Equipment and Materials 1. Adhesive or tacky mat(s) 2. Sponge mop refills 3. Cleanroom wipes 4. Sponge mop handle [Roll-O-Matic brand or equivalent] 5. "Wet Floor" or similar safety signs mop buckets [5 gallon capacity] 7. IPA 8. Decon Cycle 9. Decon Ahol 10. Decon Spore 11. Steri-Water 12. Appropriate logbooks 13. Writing material 14. ATS Cleanroom Checklist 5. Safety 1. Wear proper cleanroom gowning attire as described in the gowning ATS-SOI Post "Wet Floor" signs whenever the floor surface is wet due to intentional cleaning activities or an accidental spill. A wet floor can be slippery particularly when wearing disposable booties. 3. Refer to Material Safety Data Sheet (MSDS) for appropriate protective equipment and safe handling procedures when using chemicals. 4. When damp mopping the walls use extreme caution around electrical outlets and switches. If moisture gets inside these fixtures it can cause a short or electrical shock. Cleanroom tape may be placed securely over these fixtures to reduce the risk.

3 ATS-SOI-5910 Page: 3 of 7 6. Responsibility 1. It is the responsibility of the President to maintain this document and oversee these activities. 2. It is the responsibility of the individual(s) cleaning the cleanroom to follow this procedure. 7. Cleaning Procedures 1. Damp Mop Cleanroom Ceiling 1.1 Fill two buckets with 4 gallons of water. Put applicable cleanroom cleaner in one bucket as per manufacturers recommendations, leave the other with water only. Do not mix the solution with more chemical than the manufacturer recommends. Less chemical may be used if directed by supervisor Put a new mop head on the sponge mop handle Move or cover any equipment which could be damaged by getting wet Use the double bucket system when mopping the ceilings. Hand wiping may be necessary in areas too small to maneuver the sponge mop Starting from the innermost corner [see figure on page 6] damp mop the ceiling tiles and lights. DO NOT MOP OR WET THE HEPA FILTERS Complete as large a section as is possible. If necessary the ceiling can easily be subdivided using the grid lines Once a section of ceiling has been cleaned you may proceed to the walls in that area When finished dispose of the waste water in a sink. 1.9 Thoroughly rinse the buckets and mops. Wipe the buckets out with IPA and wipes. Hang the mop to dry or store it inside the bucket.

4 2. Cleanroom Walls ATS-SOI-5910 Page: 4 of Use cleanroom wipes wetted with IPA Starting from the innermost corner (see figure on page 6) wipe the walls from the top down using long strokes keeping the mop flat on the surface Lightly wet the sponge mop head, do not saturate. It may be necessary to follow with dry wipes to remove streaks. 2.4 Rinse your sponge mop every stroke or as soon as they are visually soiled Pay special attention to contamination resting on horizontal edges Complete as large a section as is possible. It is best to subdivide the project using corners. 3. Damp Mop the Cleanroom Floor 3.1. Inspect and wipe clean all mopping equipment. Fill two buckets with 4 gallons of water using the cleanest water available on site. Put detergent in the blue bucket as per manufacturers recommendations (measure - do not guess). Use the yellow bucket for your rinse bucket (water only) Change the mop head if it appears soiled or otherwise contaminated Mop the floors following the work flow pattern as described on page 6. Use the double bucket system when mopping It is best to use long (4 feet) strokes. Leave the floor as dry as possible. Do not leave puddles or streaks When finished dispose of the waste water. Thoroughly rinse the buckets and mops. Wipe the buckets out with IPA and wipes. Hang the mop to dry or store it inside the bucket.

5 ATS-SOI-5910 Page: 5 of 7 General Principals of Cleanroom Cleaning Cleaning a cleanroom is much like cleaning any environment. Your primary goal is to remove contaminants. In cleanrooms, however, the standards are much higher than other environments. The key to achieving these higher standards is planning and control in your activities. You should use specialized equipment, supplies, and chemicals designed for use in cleanroom environments. Avoid allowing the cleaning process or equipment to introduce additional contamination to the cleanroom. Above all, PLAN AHEAD, survey your work area and decide on your work plan before beginning any cleaning. 1. Before Cleaning Before any cleaning activities are started inspect your equipment and materials to insure they are in proper working order and are free of contamination Mop heads should be clean and free of visible particulate matter. Change them if necessary Inspect the mop buckets for particulate contamination and residue. Wipe clean with IPA if needed. Mop buckets are most effectively kept clean by thoroughly rinsing and wiping them out immediately after each use. 2. When Wiping or Mopping (see figure below): 2.1. Work in one direction. Avoid circular and scrubbing motions. You are more likely to miss a spot and may even be creating contamination. SURFACE TO BE CLEANED INCORRECT CORRECT 2.2 Overlap your strokes 10% to 25%. Make every effort to not miss a single spot.

6 ATS-SOI-5910 Page: 6 of Pull toward you. With your back to your exit you will be pulling contaminants out of the room and reducing the recontamination caused by your own activities In your immediate work area start at the furthest point from you and work as close to the corners and edges as possible. Keep your hand or mop flat on the surface Change your wipe or rinse your mop frequently, if not you may simply be moving the contaminants around. [4 strokes per wipe or mop rinse, immediately if visibly soiled] 3. When Cleaning a Cleanroom: 3.1. Work from the top down, use gravity and the air flow pattern to your advantage; ceilings - 1st, walls - 2nd, equipment- 3rd, floors- 4th floors (see figure below) Work from the innermost point toward the door or your exit. You are likely to be the dirtiest thing in the cleanroom, don't needlessly contaminate your own work (see figure below).

7 ATS-SOI-5910 Page: 7 of 7 4. Mixing Chemicals Mix chemicals according to the manufacturer's directions. It is acceptable to use chemicals at lower concentrations [to reduce residue] if directed by a supervisor, but it is not acceptable to use them at greater concentrations [excess residue will occur] Always measure your chemicals carefully for consistent and predictable results A general purpose clean room detergent is most appropriate for cleaning ceilings, walls, and damp mopping floors. 8. Documentation 8.1 Fill out all appropriate logbooks as per ATS-SOI Fill out ATS Cleanroom Checklist.