SOP for Sterility Testing

OBJECTIVE

To lay down a procedure for Sterility Testing.

RESPONSIBILITY

Microbiologist/ Q.C Executive

ACCOUNTABILITY

Quality Control Manager

PROCEDURE

Membrane Filtration Method

1. Enter the area as per SOP
2. Carry out environmental monitoring tests as per SOP
3. Follow SOP for transferring materials inside the sterile area.
4. Disinfect the 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 the 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.

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• Collect the sample in an empty sterile flask.
• Place the sterilized filtration units on the filtration assembly under the RLAF which is connected to a collecting flask and with a vacuum pump by a tubing tightly fitted with it.

• Open the filtration units (A suitable unit consists of a closed reservoir and receptacle between which a properly supported membrane of Pore size of 0.22m and a diameter of approx. 47 mm. At a flow rate of 55 to 75ml of water per minute at a pressure of 70 cm of mercury) carefully pour the collected sample into 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 a 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 in case of liquid injections, rinse the membrane filter with 3 x 100ml of 0.1% sterile peptone water.
• After completion of the filtration, cut the membrane filter into two with the help of sterile scissors 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 an incubator for the duration mentioned in the pharmacopeia.
• Note the observations in the format as in annexure-I. For any adverse result inform Manager QC.

ABBREVIATIONS

SOP = Standard Operating Procedure

ANNEXURES

Annexures I & II

REVISION HISTORY

Nil

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