SOP for Disposal of Media Fill Vials : Pharmaceutical Guidelines

SOP for Disposal of Media Fill Vials

Standard operating procedure to destroy the media fill vials after incubation and observation.


       To lay down the procedure for Disposal of media fill vials.

2.0  SCOPE:

       This SOP is applicable to Disposal of media fill vials obtained after its incubation and observation.




       Head -QA & QC


5.1  Destruction of media fill vials

5.1.1  Media fill vials shall be collected after its incubation and observation.
5.1.2  Media fill vials shall be transferred from incubator to bung processor of production facility.
5.1.3  All media fill vials shall undergo for sterilization at 121.1°C for 60 minutes.
5.1.4  After completion of sterilization the sterilized vials shall be left up to cooling then open at least 20 media fill vials for post GPT of media, then perform the GPT of the sterilized media fill vials as per SOP.
5.1.5 After GPT if no growth observed then open all the sterilized vials and collect the media, transfer it to the stainless steel container having 5% Lysol /Triple 256 solution. Transfer the solution to Effluent treatment plant for its disposal. If GPT test shows growth in sterilized vials then again sterilized the vial in bung processor.
5.1.6  The vials shall be transferred for vial crushing machine.
5.1.7  The glass pieces / Seals / Rubber stoppers coming from the crushed vials shall be collected, rinsed with water and transferred to Scrap yard for its disposal.
5.1.8  The data / reports coming for entire process of disposal of media fill vials shall be filed and maintained separately.
1) Handling of glass pieces shall be done with much care to avoid any injury.
2) Proper care and safety measures shall be taken to handle the material coming after disposal.
3) Media spills shall be handled with much care and shall be decontaminated with disinfectant. 


SOP : Standard Operating Procedure
QA : Quality Assurance
QC : Quality Control
NA : Not Applicable
SS : Stainless steel
ETP : Effluent treatment plant

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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