1.0 PURPOSE
To lay down the procedure for disposal of media fill vials.2.0 SCOPE
This SOP is applicable to the disposal of media fill vials obtained after its incubation and observation.3.0 RESPONSIBILITY
Quality control and Production personnel.4.0 ACCOUNTABILITY
Head of Department5.0 PROCEDURE
5.1 Media fill vials shall be collected after its incubation and observation.5.2 Media fill vials shall be transferred from incubator to terminal sterilizer of the production facility.
5.3 All media fill vials shall undergo for terminal sterilization at 121°C for 30 minutes.
5.4 After completion of sterilization the sterilized vials shall be transferred for vial crushing.
5.5 The liquid contents coming from the crushed vials shall be collected and transferred to the effluent treatment plant for its disposal.
5.6 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.
5.7 The data/ reports coming for the entire process of disposal of media fill vials shall be filed and maintained separately.
Note: 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.
6.0 ABBREVIATIONS
6.1 SOP – Standard operating procedure6.2 °C – Degree centigrade
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