Approval Block. Prepared by: Signature Date. Margaret Crouse 18 JUN Reviewed by: Signature Date. Brian Flynn 18 JUN 2014

Transcription

1 ATS-SOI-5941 Page: 1 of 7 1. Purpose Approval Block Prepared by: Signature Date Margaret Crouse 18 JUN 2014 Reviewed by: Signature Date Brian Flynn 18 JUN 2014 Approved by: Signature Date Kristal Jewell 18 JUN 2014 This document provides instruction for the receipt, tracking and disposal of reagents and kits received in support of the cleanroom facility. 2. Scope This procedure shall be followed by personnel receiving laboratory reagents and kits associated with the cleanroom facility. 3. References 1. ATS-QAM-9001 ATS Quality Manual 2. ATS-SOI-5715 Rev (A) Standard Operating Instruction for the Operation of the Thermo Scientific Revco Laboratory Refrigerator 3. ATS-SOI-5825 Rev (A) Decontamination Workflow 4. ATS-SOI-5880 Rev (A) Standard Operating Instruction: Gowning Procedures 5. ATS-SOI-5900 Rev (A) Logbook Entries 4. Equipment and Materials Equipment: 1. Appropriate GMP Stickers 2. Cleanroom Supply Receipt log 3. Writing material

2 ATS-SOI-5941 Page: 2 of 7 5. Safety 1. Refer to manufacturer s safety precautions and Material Safety Data Sheet (MSDS) for appropriate protective equipment and safe handling procedures when using chemicals. 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) performing this task to follow this instruction. 7. Preliminary Operations 1. Collect all materials and equipment necessary to conduct the project. 8. Receipt of Materials 1. Upon receipt of laboratory reagents and kits a visual inspection shall be performed by appropriately trained staff. Appropriately trained staff include those who are trained on ATS-SOI Received materials are placed on the Receiving shelf. 3. If there are any obvious deformities or issues such as ripped packaging or missing packaging slip, refuse delivery from the delivering agent. Notify Quality Manager of package condition and submit packing slip to the Office Manager. Disposition records are reviewed for trends in vendor performance and to ensure high quality materials and supplies are 4. A Quarantine label will be placed on the materials until full inspection by qualified laboratory staff can be performed. Certify the label is initialed and dated. 5. Trained laboratory staff shall be notified. Appropriately trained laboratory staff are trained on SOIs 5880, 5900 and After initial acceptance, trained laboratory staff shall open the shipping container and inspect the material.

3 ATS-SOI-5941 Page: 3 of 7 Remove any certificates of sterility or MSDS sheets which may be provided. Storing reagents and kits at a temperature other than the designated temperature may cause media to fail QC. 6. Fill out the Cleanroom Supply Receipt Log as detailed in Section The Microbiologist shall maintain an inventory of laboratory reagents and kits and reorder when the reorder levels have been reached. The Microbiologist will perform a monthly inventory. 8. Logbooks shall be reviewed periodically. Any discrepancies shall be noted in writing and the individual responsible shall be retrained on proper entry for the applicable log book. Repeated errors shall require disciplinary action at the discretion of the President. 9. After initial acceptance, open the shipping container and inspect the material. 10. Determine is additional QC is required before the item can be released using Table 1 below. If additional QC is required place a Quarantine label on the item. Certify the label is initialed and dated. Ensure that all items are stored as directed by the manufacturer during quarantine, QC, and once released.

4 ATS-SOI-5941 Page: 4 of 7 Table 1: QC Requirements for Release Test QC required before release Gram Stain Additional QC required Spore Stain API kits, including Staph, Strep, 50CH, Coryne, 20 NE, 20 E, and 20 C. Lactophenol blue Stain ASI Staphslide Latex Test Potassium Hydroxide (3%) KOH Catalase (% H 2 O 2 ) Coagulase Oxidase Additional QC required Additional QC required 11. If no additional QC is required before release, place a Released label onto the item. Released label templates are located in the Avery templates folder in the Viable Lab Paperwork folder on the network. The stickers must be easily visible and include date received, lot or model number and expiration date. Materials shall not be used until they have a Released label. The stickers must be easily visible and include date received, lot or model number and expiration date. 12. For items requiring additional QC before release, QC using the organisms listed in Table 2 below.

5 ATS-SOI-5941 Page: 5 of 7 Table 2: QC Organisms and Acceptance Criteria for Release Test QC Organism(s) Acceptance criteria Gram Stain S. aureus ATCC 6538 E. coli ATCC 8739 Stain purple Stain pink/red Spore Stain B. subtilis ATCC 6633 E. coli ATCC 8739 Pink vegetative cells with green spores Pink vegetative cells API Staph S. aureus ATCC 6538 Correct Genus species API Step S. equi ATCC Correct Genus species API 50CH B. subtilis ATCC 6633 Correct Genus species API Coryne C. renale ATCC Correct Genus species API 20 NE P. aeruginosa ATCC Correct Genus species API 20 E E. coli ATCC 8739 Correct Genus species API 20 C C. albicans ATCC Correct Genus species 13. Upon successful QC, a green QC label with the technician s initials and date will be placed on the item. A Released label will be then placed on the item. Released label templates are located in the Avery templates folder in the Viable Lab Paperwork folder on the network. The stickers must be easily visible and include date received, lot or model number and expiration date. Materials shall not be used until they have a Released label. The Released stickers must be easily visible and include date received, lot or model number and expiration date. Nothing may be used until it has been released. 14. Laboratory reagents and kits will be stored inside the ISO Class 7 area of the cleanroom facility until ready for use. Gown appropriately following ATS-SOI Prior to use, the end-user will again perform a visual inspection to ensure that the material has not become compromised while in storage or that the material has expired. At any time, any personnel may question the quality of any material.

6 ATS-SOI-5941 Page: 6 of 7 The material will be taken out of service until quality control re-evaluates the condition of the item. 16. If the item is rejected before being exhausted, it will be disposed of properly, based on level of exposure and composition. 17. Expired goods will be disposed of in accordance with manufacturers recommendations. 9. Cleanroom Supply Receipt Log 1. Record the date received. 2. Record the name of the item and quantity. 3. Record the ATS part number. ATS part numbers are listed on the Cleanroom Supply Part Numbers list located in the Viable Lab Paperwork folder on the network. It is a password-protected document controlled by the Microbiologist. A controlled copy of the Cleanroom Supply Part Numbers list is located on the anteroom bookshelf with the Cleanroom Supply Receipt Log. 4. Record the Supplier and catalog number. 5. Record the manufacturers lot number. 6. Record the ATS lot number. ATS lot numbers are generated chronologically for general laboratory supplies. Bacterial organisms have a leading 1 before a chronologically generated number specific to bacterial organisms. Gowning supplies have a leading 2 before the chronologically generated number specific to gowning supplies. 7. Record the expiration date. If manufacturers expiration date is not provided an internal expiration date will be given of four years.

7 ATS-SOI-5941 Page: 7 of Disposal 1. Unexhausted kits and reagents shall be disposed of properly, based on manufacturers guidelines. 2. Exposed kits and reagents will be decontaminated and disposed of by the Microbiologist as per ATS-SOI-5825.