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Microbiological Services | Testing Services | Sterility

Sterility testing USP <71> - In order to cite USP <71> as the test method, you must submit a copy of a formulation sheet and sufficient sample material to perform method suitability testing the next time you submit a product for sterility testing. In addition, you must verify each time that you submit articles for sterility testing that the number of articles submitted is consistent with the requirements of Chapter <71> of the U.S. Pharmacopeia. Details follow.

  1. A formulation sheet with a unique identifying number (that you generate) must be submitted for each unique preparation. ARL will be able to definitively show that method suitability data is traceable to the earlier unique formulation if the previously submitted formula identification number is provided. Failure to provide a number for the formulation will result in a requirement for additional sample(s) to be provided for method suitability testing, and your facility may experience delays in reporting of results. The first time sterility testing is performed on that particular formulation, you need to send approximately 6 times your normal sample amount (not to exceed 200mL). Please identify on the submission form what articles are for method suitability testing and which articles are for testing.  
  2. Additionally, if you confirm that the number of articles submitted for testing is in compliance with USP <71>, the report on those articles will cite USP <71>. Please reference USP <71> for the correct number of articles to submit for testing. Remember to submit an additional sample if you have also requested fungal or chemical testing.

Sterility testing MBI-144 - This is an internal ARL method that will be cited in the event that you do not provide the proper number of articles per USP <71> or method suitability cannot be traced to your specific formulation. This method does not comply with USP <71>.

Sterility testing is performed in a certified, environmentally controlled suite that is managed in accordance with current aseptic processing guidelines.

Negative controls are used daily and positive controls are used during the initial testing of samples when method suitability testing is performed.

We examine each sterility test for growth at intervals during the incubation and at its conclusion. If a test shows no evidence of microbial growth in either media over the incubation period, then it complies with the test for sterility.

A preliminary sterility report is available after 72 hours of incubation.

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ISO 17025:2005 Laboratory Accreditation
ARL is accredited to the ISO 17025:2005 standard as applicable to our scope of accreditation that outlines general requirements for the competence of testing and calibration laboratories.

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