Page 17 - Quality control of pharmaceuticals (07-PA 704) practical

VII. MICROBIAL LIMIT TESTS

This section contains information for the quantitative enumeration of viable microorganisms and the
determination of the absence of specified microorganisms in finished pharmaceutical products and
raw materials, previously referred to as Microbial Limits Testing (MLT).
Equipment Required

LAF
Filtration Assembly
Sterile 0.45 micron membrane filter
Sterile Pipettes – 1 ml and 10 ml
Materials Required
Sterile 0.1% w/v peptone 3 X 100 ml
70% IPA solution
Sample for testing
SCDA and SCDA plates
SDA and SDA plates
SCDM 3 X 100 ml
Procedure:
A) Total Aerobic Microbial Count:
1. Collect the sample to be tested for microbial limit test as per sampling plan.
2. Use specified quantity of sample for each of the test specified in the individual

monograph and pre-treat the sample as following method:
- Water Soluble Product: Dissolve 10 gm or dilute 10 ml of sample, unless otherwise

specified, in sterile 90 ml peptone water or buffered sodium chloride-peptone solution
pH 7.0
- Product Insoluble in Water: Suspend 10 gm or 10 ml sample, unless otherwise
specified, in sterile 90 ml peptone water with 0.1% polysorbate 80 or buffered sodium
chloride-peptone solution pH 7.0
- Fatty Products: Homogenize 10 gm or 10 ml of the sample, unless otherwise
specified, with 5 g of polysorbate 80. If necessary, heat to not more than 40°C. Mix
carefully while maintaining temperature on water bath. Add 85 ml of sterile peptone
water or buffered sodium chloride-peptone solution pH 7.0

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