Page 66 - MNU PM502 Ph. Micreo practical

Pharm D- Clinical Pharmacy Program Third Level Pharmaceutical Microbiology& Antimicrobials (PM 502)

➢ They should show growth of these microorganisms.

Negative control: Test for sterility of the media

➢ Consists of: Tubes without any organism.

➢ It should show no growth

Sampling for sterility testing

• Number of units taken from the produced batch:

Number of units taken for sterility testing:

1- If total number ≤1000---- 2% of the batch are taken.

2- If total number >1000---- 2% of the first 1000 units are taken and

additional 2 units for each 1000 units beyond the first 1000 are also taken.

Or using the equation:

Number of units taken = 0.4 √ (no of units in the batch).

• Weight or volume taken from each unit.
1- For solid units: (Ex: Powder)

Weight of unit Minimum taken amount Volume of medium

of unit

<300mg Entire sample 30ml or more

>300mg 300mg 40ml or more

2- For liquid units: (Ex: Water for injection)

Minimum taken amount
Volume of unit Volume of medium
of unit

1ml or less. The whole content 15ml

1-10ml. 1ml. 15ml
10-50ml. 5ml. 40ml

>50ml. 10ml. 60ml

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