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Bioburden Testing

By definition, a bioburden is the population of live microorganisms on a product or a sterile barrier system. Bioburden testing is an important quality control step that detects the level of contamination of a product at any stage, from initial product manufacture to final distribution.

Bioburden testing services. Scientist holding a petri plaque bacteria for bioburden testing

Our Tests

Pour Plate Method

M500

Aerobic bacteria only
1–9 samples, each
10+ samples, each

M501

Aerobic bacteria & fungi
1–9 samples, each
10+ samples, each

M502

Aerobic bacteria & spore forming
1–9 samples, each
10+ samples, each

M503

Aerobic bacteria & fungi & spores
1–9 samples, each
10+ samples, each

M504An

Anaerobic bacteria in addition to any test above

Membrane Filtration

M505

Aerobic bacteria only
1–9 samples, each
10+ samples, each

M506

Aerobic bacteria & fungi
1–9 samples, each
10+ samples, each

M507

Aerobic bacteria & spore forming
1–9 samples, each
10+ samples, each

M508

Aerobic bacteria & fungi & spores
1–9 samples, each
10+ samples, each

M509An

Anaerobic bacteria in addition to any test above

M509C

Multiple, pooled small devices for one of above tests

All of the above tests include positive and negative control testing of media and gram staining of the most predominate organism recovered.
Recovery efficiency is an important factor in calculating a true and meaningful bioburden level. Each new material or product change should undergo bioburden validation/recovery analyses. A minimum of 3 to 5 samples should be subjected to the recovery efficiency validation. Validation includes recovery-rate-correction factor, total bioburden screening, incubation grow out time, and complete documentation.

Membrane Filtration Technique

M510

Bioburden Exhaustive Rinse Validation, per unit

M511

Bioburden Inoculated Product Recovery, per unit

M512

Bioburden Validation in conjunction with other qualification programs

For products that are consumed by the nature of the test (e.g. liquids, gels, powders), please include at least one additional sample to be used as a positive control on all bioburden tests.

Sample Submission

Purchase Order

In line with current ISO/QSR purchasing requirements, all orders should be sent with a signed completed Purchase Order. This will help expedite the processing or your order. Standing Purchase Orders will be gladly accepted for routine continuing orders.

Sample Submission Form

Please download and fill out a Test Request Form for each sample/test submitted. Identify each submission clearly and completely. Please be specific with the description, Lot Number, PO etc. and specify the test desired. Please indicate the Test Code Number on the form also. This will greatly reduce turnaround time necessary to generate an accurate, final report.

Final Reports

Upon completion of test, a final report will be issued and all records and raw data will be held for five years.

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