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.
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
Final Reports
Upon completion of test, a final report will be issued and all records and raw data will be held for five years.
Key Differences Between USP 1115, USP 1116 and USP 1211
Learn about USP regulations regarding non-sterile and aseptic processes, and sterility assurance and how these relate to regulatory testing requirements.
Microbial Aerosol Challenge Testing vs. Bioburden Testing
Learn the differences between microbial aerosol challenge testing and bioburden testing for combination products as well as parenteral products.
Why Are Bacterial Spores Hard To Sterilize?
Learn about sterilizing bacterial spores, why they are hard to kill, and how to create sterilization processes to fully sterilize your medical devices.