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Pharma method validation – Technical Information

Test: Validation of TVC and / or Test for specified micro-organisms

(also called Suitability of the counting method in the presence of product)

MCS test reference:  TMPh7

Quantity of sample required:  50 g

Total test time:  10 days

Information required:

We will require a microbiological specification for the product.

Sending samples:

Send samples to the address at the bottom of this page.  Include a completed Test Request Form.

Test process:

Specific known organisms are spiked into the product.  The test methods are then followed to attempt to recover those organisms.

Where this is not initially successful, the test process is modified to attempt to provide a method that is capable of recovering the introduced organisms.


Written reports are provided upon completion of the test.  These are typically sent as scanned pdf documents.  Results are interpreted as either meeting or failing to meet the requirements of the European Pharmacopoeia.