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What is Microbial Limit Testing and Analysis for Finished Product, Raw Materials and API's?

Finished Products, Raw Materials, API’s and intermediates often have specified microbiological limits associated with their release. In order to comply with these release specifications, bioburden analysis must be performed at each stage of the process. Depending on the route of administration of a product, absence of specified organisms is also required for these products.

Why do we do it?

It is a regulatory required defined within every pharmacopoeia that products, both sterile and non-sterile, must be assessed for their microbiological quality. Micro-organisms can pose a serious risk to human health when administered in certain conditions and routes. As such, each product must have an associated, validated method for bioburden analysis which is performed routinely. This ensures the microbiological quality of the manufactured material, to ensure the safety of the end user.

How can we help assure compliance?

Over the course of 25 years, our industry experts have enabled us to provide full cGMP product analytical support right from the method development and validation through to the routine microbiological testing. If a method has already been validated, we are also experts in analytical method transfer enabling a quick change over from an alternate laboratory.

We are able to provide microbiological testing methodologies to comply with client defined specifications using:

Total viable count (TVC) via membrane filtration

Total viable count (TVC) via pour plate

Limulus Amebocyte Lysate (LAL) turbidometric kinetic assay for the detection of endotoxins, also known as an Endotoxin test

Any absence of objectionable organism tests defined by our clients 

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