- SOP on Decontamination and Disposal of Used Media
To lay down the procedure for Decontamination and Disposal of Used Media
This SOP is applicable for Decontamination and Disposal of Used Media. (Pharmaceutical Company Name).
- Microbiologist or above of Microbiology Laboratory.
- Head – Microbiology section / Nominee.
- Head – Quality Control. / Nominee.
- Abbreviations and Definitions
SOP : Standard operating procedure
No. : Number
QC : Quality Control
QA : Quality Assurance
- Wear nose mask and disposable hand gloves during scrapping and decontamination activity of used media.
- For Solidified Media(Media Used for Settle plates exposure, Surface Monitoring
test plates, Microbial limit test plates, Growth promotion test media, Sub-culture slants etc.):
- Segregate and arrange the plates showing growth of colonies into biohazard bag.
- Scrap out the media from the plates having no growth with the help of spatula into another biohazard bag.
- Place the bags in the Vertical autoclave.
- For Liquefied Media: (Sterility Tubes/canisters, Positive Control tubes, culture tubes
product enrichment tubes etc.)
- Place all the test tubes in the test tube stand and arrange them in the Vertical autoclave.
- Place the Disposable media plates/strips/media kits, used cotton plugs, gloves used
for handling of microbial cultures, lyophilized culture glass pieces, sterility test vent
filters & tubing etc in a biohazard bag and load in the vertical autoclave.
- Keep one or two deodorizing pearls (if available) in the decontamination load to prevent putrefied smell of the used media.
- Operate the vertical autoclave as per SOP No
- After sterilization, collect the media contained in tubes/ bottles and other decontaminated material into biohazard bag.
- Add 50mL of 20% Virosil solution or 2.5% Savlon to the bag containing decontaminated media and shake the bag for proper dispersion of the added disinfectant solution.
- Discard the contents of the bag into the washbasin/sink.
- Open the tap and allow the water to flow while discarding the contents.
Forms and Records (Annexures)
- Not applicable
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance, Production, Quality Control, Stores, Engineering and Human Resource
Reason for Revision
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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube