Approval Block. Prepared by: Signature Date. Evan Parnell 17 NOV Reviewed by: Signature Date. Brian Flynn 17 NOV 2014

Transcription

1 ATS-SOI-5935 Page: 1 of 5 Approval Block Prepared by: Signature Date Evan Parnell 17 NOV 2014 Reviewed by: Signature Date Brian Flynn 17 NOV 2014 Approved by: Signature Date Kristal Jewell Historical Reference Section: Section Name Section Number (i.e., 5.2.1) Revision Affected Explanation of Change References 3 B Added references Approval Block N/A B Added Approval Block Cleaning 6 C Added a table to detail cleaning schedule Non-Conforming Results 8 C Updated alert and action levels 17 NOV Purpose This document provides the schedule for cleaning the ATS cleanroom spaces and the collection of viable samples. 2. Scope This procedure shall be followed by personnel involved in cleaning or viable sampling within the ATS cleanroom.

2 ATS-SOI-5935 Page: 2 of 5 3. References 1. ATS-SOI-5815 Rev (B) Viable Sampling for ISO ATS-SOI-5880 Rev (A) Standard Operating Instruction: Gowning Procedures 3. ATS-SOI-5900 Rev (A) Logbook Entries 4. ATS-SOI-5910 Rev (A) Environmental Maintenance of the ATS Cleanroom 5. ATS-ATP-5920 Rev (A) Standard Operating Instruction: Fungal Slide Preparation 6. ATS-ATP-5925 Rev (A) Standard Operating Instruction: Identification of Microorganisms 7. ATS-ATP-5860 Rev (A) Acceptance Test Procedure: ISO Compliant Sample Analysis 8. EU Annex 1: Manufacture of Sterile Medicinal Products 4. Equipment and Materials Equipment: 1. See References Materials: 1. All applicable logbooks 2. All applicable forms and records 5. 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) performing this task to follow this procedure. 6. Cleaning 1. Cleaning shall be performed following the schedule listed below and in accordance with the procedure in reference 4.

3 ATS-SOI-5935 Page: 3 of 5 Cleaning for Cleanroom Time Period Weekly Monthly Twice per Year Agent Decon Cycle (or Decon Cycle (or Decon Clean and Decon Spore (or Areas Cleaned Walls, Floors Walls, Floors, Ceiling Walls, Floors, Ceiling 2. Each week, add approximately 10 ml of bleach to the air conditioner condensate line and check to ensure the steel wool is seated properly at the outlet drain. 3. Fill out logs and other associated records as per reference 4. Follow ATS-SOI for log entry directions. 7. Sampling 1. Viable sampling will be performed using contact plates on the gowning room s wall and floor, the cleanroom wall and floor, and the Biological Safety Cabinet (BSC) wall and floor on a weekly basis. 2. Viable air sampling will be performed using the appropriate media in the gowning room, cleanroom, and BSC on a weekly basis. 3. All sampling will be performed in accordance with reference Non-Conforming Results 1. Viable samples shall be analyzed in accordance with ATS-ATP-5860 and held to the alert and action levels listed in the table below. The action levels were derived from reference 8.

4 ATS-SOI-5935 Page: 4 of 5 Alert Levels for ATS Cleanroom Sample ISO Alert Action level/grade BSC-Air 5/A 1 1 BSC-Contact Wall 5/A 1 1 BSC-Contact Floor 5/A 1 1 Cleanroom-Air 7/C Cleanroom-Contact 7/C Wall Cleanroom-Contact 7/C Floor Gownroom-Air 8/D Gownroom-Contact Wall Gownroom-Contact Floor 8/D /D In the event of a sample reaching an alert level, report the results to the Quality Manager. The area will be re-cleaned and re-sampled as soon as is practicable. 3. In the event of a sample reaching an action level, report the results to the Quality Manager and the President. At a minimum, the area will be re-cleaned and resampled. The Cleanroom may not be used until the viable samples have completed the first incubation and are at passing levels. 4. The Microbiologist will analyze all growth following reference 7. Report results to Quality Manager using appropriate forms and documenting results on the Excel spreadsheet on the shared drive in the Viable Lab Paperwork folder. This is a password-protected document with access controlled by the Quality Manager.

5 ATS-SOI-5935 Page: 5 of 5 9. Room Schematic Main Lab ISO Class 7 BSC ISO Class 5 Airlock * Not To Scale ISO Class 8