Bacteriology Testing

Sterility Testing

Study Design

All bacteriology assays and studies are performed according to customer specific protocols. These protocols are based on standard testing methods. The methods used are adapted to the specifics of the customer product and its company’s standards. Depending on the testing purpose, the tests are performed under cGMP and/or GLP standards

Upon the request of a customer, the routine studies are performed according to the European Pharmacopoeia or the United States Pharmacopeia or CPMP/ICH/294/95. The tests are performed in an isolator, according to Good Manufacturing Practice (GMP) standards as described in the EU GMP guidelines, Annex 1 or GLP

Two kinds of test can be performed:

Membrane filtration method using the Millipore Steritest® system for all filterable products.
The method does not depend on product type, container volume or concentration of microorganisms to provide a statistically valid sample. With membrane filtration, the entire volume can be filtered, which captures all the microorganisms present, removes product components that could cause the growth medium to appear turbid and can decrease the inhibition of microorganism growth due to antimicrobial agents in the product since they are filtered away during this method.
Direct inoculation method applicable to non-filterable products and cell banks.
With direct inoculation, a small sample can be taken and then added to a growth medium and incubated.

Validation of the method for the product to be tested can be performed prior or in parallel with the test.
Assay Duration: 14- 18 days
Sample Requirement: Dependent upon production size and volume

Regulatory Compliance

EP 2.6.1
USP <71>
CPMP/ICH/294/95 (ICH Topic Q5D Quality of Biotechnological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products section 2.3.2).

Custom Assays

We understand that no production plant is identical and that every process is unique. Using a combination of practical experience and a scientific approach, we will customize sterility testing methods to meet your specific requirements including scientifically sound data that will be accepted by regulatory authorities around the globe.

Technical Library

Data Sheet

Antimicrobial Activity Assay

Study Design

Assay consists of the cylinder plate method using a specific test organism and USP reference solution. This method depends upon diffusion of antibiotic from a vertical cylinder through a solidified agar layer in a petri dish to an extent such that growth of the added microorganism is prevented entirely in a circular area or “zone” around the cylinder containing a solution of the antibiotic. The product will be tested against a reference concentration (S3). Test will be performed in duplicate on two different days.

Assay Duration: 5 days
Sample Requirement: depends on product supplied by the customer

Regulatory Compliance

United States Pharmacopeia <81> Antibiotics – Microbial Assay
Note: Before the test is performed, trial studies are conducted to determine the appropriateness of USP method described in the USP, and will be modified if necessary.

Custom Assays

We understand that no production plant is identical and that every process is unique. Using a combination of practical experience and a scientific approach, we will customize antimicrobial activity assay testing methods to meet your specific requirements including scientifically sound data that will be accepted by regulatory authorities around the globe.

Technical Library

Data Sheet

Other Bacteriology Testing Services Offered:

Growth promotion
Biological indicators
Endotoxin
Total viable count
Mycobacterium

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