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Wednesday, May 12, 2010

Standard Operating Procedure Title: Pyrogen Testing

Purpose:
• It is established for the verification of absence of any pyrogen in the sterile Product or the Raw Material/Water thereof.
2. Scope:
• It is applicable to Microbiological Lab.
3. Responsibilities:
• Quality Control Manager
• Microbiologist
4. Procedure:
• Rabbits on which test has to be performed should be separated and kept without food for at least 18 hours prior to the test.
• Select the rabbits of weight not less than 105 Kg of either sex.
• Insert the thermometer or Electrical device showing a precision of 0.1oC to a depth of 5 cm in the rectum of each rabbit and put them in the retaining boxes,in which the animals are retained by loosely-fitting neck stock and rest of the body remains free so that rabbit can sit.
• Record the temperature of animals at least 90 min. before injection.
• Rabbits showing a temperature difference greater than 0.2oCbetween any two successive readings are with drawn from the test.
• All rabbits having an initial temperature greater than 39.8oC or lower than 38.0oC are excluded from the test.
• Take three 250 ml volumetric flasks which are previously sterilized by dry heating,at 200 o C in oven for one hour in oven for one hour in hot air oven.
• Put 1.8 g of NaCl of Anal grade in every flask.
• Take the sample of D/W 200 ml in each of three flasks.
• Sealed the flask with Al-sheet and with autoclave tape.
• Autoclave these flasks at a pressure of 15 pound for 15 minutes.
• After completion of autoclaving cool the flasks at room temperature to about 38-40oC.
• Take syringes and needles previously washed and sterilized at 200 oC for 1 hour.
• Inject the solution slowly into the marginal vein of the ear of each rabbit in accordance with the weight of rabbits i.e. 10 ml/Kg.
• Note the temperature of each rabbit for 3 hours after injection.
Interpretation Of Results.
• Note the average temperature of rabbits before injection.
• Note the maximum temperature of the rabbits after injection.
• Note the difference between the initial temperature in addition, the max temp. of each rabbit is taken to be its response.
• If the summed response is exceeded from 1.15oC button more than 2.65oC repeat the test.



Quality Record(s)/Form(s)

The following quality records shall be generated in accordance with the procedure for Control of Company Quality Records (4.12).

Required Record Form No.
Report of Pyrogen Test QF/059/01

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