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SOP for Sterility Testing

OBJECTIVE
To lay down a procedure for Sterility Testing.

RESPONSIBILTY
Microbiologist/ Q.C Executive

ACCOUNTABILITY
Quality Control Manager

PROCEDURE
  • Membrane Filtration Method
  1. Enter the area as per SOP
  2. Carry out environmental monitoring test as per SOP
  3. Follow S.O.P for transferring materials inside the sterile area.
  4. Disinfect LAF station with 70% filtered IPA solution & check the manometer reading (i.e between 10 - 15 mm of water) then rinse hands with 70% filtered IPA solution followed by drying hands under the LAF before proceeding for testing.
  5. For dry powder injections:  Inject 5 - 10ml of sterile peptone water into each vial of injection (powder) by a sterile syringe after opening the flip-off seal of the vial and dissolve powder of the vial to be tested under RLAF & suck out the sample.
  6. For liquid injections:  Suck out the sample with a sterile syringe after opening the flip-off seal of the vials to be tested under LAF.
  • Collect the sample in a empty sterile flask.
  • Place the sterilized filtration units on the filtration assembly under the RLAF which is connected to a a collecting flask and with a vacuum pump by a tubing tightly fitted with it.
  • Open the filtration units (A suitable unit consist of closed reservoir and receptacle between which a properly supported membrane of Pore size of 0.22m and a diameter of approx. 47 mm. At flow rate of 55 to 75ml of water per minute at a pressure of 70 cm of mercury) carefully and pour the collected sample in the sterile filtration assembly and filter the sample.
  • Start the vacuum pump as per SOP.
  • Rinse the membrane filter with 3 x 100ml of peptone water.
  • For sterility testing for STERILE WATER FOR INJECTION or any liquid injections, rinse thoroughly the outer portion of 20 nos. of ampoules / vials and suck out water with the help of sterile syringe.
  • Collect the sample in a sterile conical flask and filter it through 0..45m membrane filter and rinse the membrane filter with 100ml of 0.1% sterile peptone water and in case of liquid injections, rinse the membrane filter with 3 x 100ml of 0.1% sterile peptone water.
  • After completion of filtration ,cut the membrane filter into two with the help of sterile scissor and forceps and inoculate each half portion of it into sterile 100ml SCDM and FTGM
  • After inoculation, close the mouth of the container tightly and incubate SCDM tubes at 20-25°C and FTGM at 30-35°C.
  • Hold the incubated tubes at the above mentioned temperature in incubator for duration as mentioned in pharmacopoeia.
  • Note the observations in the format as in annexure-I. For any adverse result inform Manager QC.

ABBREVIATIONS
SOP = Standard Operating Procedure

ANNEXURES
Annexure I & II

 
REVISION HISTORY:
Nil

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