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GTP for Bioburden Testing of Prefiltered Solution by Membrane Filtration

  • To lay down the procedure for determining the total aerobic microbial counts in product solution by membrane filtration method.
  • If the product is known to have to antimicrobial activity give washings to the membrane with peptone water.

Sterilized SCDA Agar / m (HPC)
Product sample
Sterilized Membranes
 Sterilized Forceps
Sterilized Filter cups.


Total Bacterial Count by membrane Filtration Method
  • Collect 100ml of the prefilter solution being tested in a sterilized bottle.
  • Filter the prefilter solution through 0.45 membrane having 47 mm diameter by applying vacuum.
  • If the product being an antibiotic wash each filter membrane with three quantities each of about 100 ml of a suitable medium such as 0.1 % sterile peptone water containing 0.1 ml of ß-lactamase enzyme containing 100000 units.
  • Transfer the membrane filter onto the surface of preincubated SCD / m (HPC) agar.
  • Incubate the plate at 30 – 35ºC for 48 hrs for bacterial enumeration followed by 20 – 25ºC for 72 hrs for yeasts and molds enumeration.
  • Count the CFU and report as CFU per 100 ml.
  • Prepare the negative control plate by filtering 100 ml sterile water through the membrane and place the membrane on the surface of the media and incubate along with the test sample.

SCD-Soya bean casein digest
m(HPC) – membrane Heterotrophic plate count agar

Sterile drug products produced by Aseptic process – cGMP guidelines (September 2004)

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