Mycoplasma Test for Human Vaccines and Biologicals Compliance with 21 CFR 610.30

M-800 Procedural Summary

The purpose of Bionique’s M-800 Mycoplasma Test is to detect the presence of agar cultivable and non-cultivable mycoplasma species in viral vaccines produced in cell substrates and similar products. The test is also recommended for virus seed stocks, master / working cell banks, cells substrates, and other biological products produced in cell culture. (GMP service)

Bionique’s M-800 Mycoplasma Test was designed in accordance with the requirements of Chapter 21 of the Code of Federal Regulations (CFR), Subpart D Mycoplasma, 610.30 Test for Mycoplasma (21 CFR 610.30). Bionique enhances the compendial direct culture-based method by incorporating the indicator culture procedure to promote the detection of potentially non-cultivable or fastidious strains of mycoplasma.


Sample Preparation:

Under 21 CFR 610.30, for virus vaccines produced from in vitro living cell cultures, each virus harvest pool and control fluid pool (when control cells are used) must be tested for mycoplasma prior to clarification or filtration in the case of live virus vaccines and prior to inactivation in the case of inactivated virus vaccines. For other types of samples, the control fluid may represent a carrier or dilution fluid used to process the test article submitted to Bionique. The client is responsible for determining the appropriate material to test along with the test article.

A minimum of 10 mL sample aliquots of both the product and control fluid should be frozen in a 15 mL sterile polypropylene centrifuge tube or a sterile 20 mL Nalgene PETG screw cap bottle. Sample aliquots greater than 10 mL should be submitted in a sterile 50 mL polypropylene centrifuge tube or a sterile 40 mL Nalgene PETG screw cap bottle.

The client is responsible for maintaining a reserve sample of the test article sent to Bionique for mycoplasma testing per 21 CFR Subpart 1 – Laboratory Controls, Section 211.170-Reserve Samples.

Shipping Instructions:

Per 21 CFR 610.30, samples shall be stored either (1) between 2-8 °C for no longer than 24 hours; or (2) at -20°C or lower if stored for longer than 24 hours. Bionique requires that samples for the M-800 Mycoplasma Test be shipped and received frozen with dry ice remaining upon receipt at our facility. Place the sample vessels inside a plastic bag with crush proof packaging in an appropriate container. The frozen samples should be shipped overnight in an insulated container with sufficient dry ice to keep frozen for a minimum period of 48 hours. Samples must arrive under the conditions as stipulated in 21 CFR 610.30.


Please view our general sample submission instructions page for details on how to submit your sample(s) online.

Download Sample Submission Forms
GMP Service
Total Testing Time: 28 days
Sample Requirements: Minimum Test Volume = 12 mL Test Article and 12 mL of Control Fluid

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Bionique has optimized the MycoSEQ Real-Time PCR Detection Assay for mycoplasma testing.

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