Sterility Testing Labs

Besides being a required part of sterilization validation for medical devices and parenteral products, sterility testing is an important step in the quality control process. If contaminated medical devices or parenteral products are sold, the consequences are serious — and may even lead to fatalities. For this reason, all medical devices and injectable drugs must pass sterility testing before being released for purchase.

At EMSL, we’re proud to partner with medical device manufacturers and pharmaceutical companies across the U.S. to ensure product safety, sterility and compliance. For expert quality assurance and control, contact EMSL laboratories today for sterility testing.

EMSL’s Sterility Testing Methods

Sterility testing requires an exceptionally high level of control for the analyst, the environment and lab practices. To conduct the test accurately, lab personnel must be experienced and highly trained and working in a highly controlled, sterile laboratory. Because of these rigorous requirements, only a few independent labs offer sterility testing — and at EMSL, we’re proud to be a leader in this field.

Specific sterility test procedures include direct immersion or transfer, filtration or product flush (the choice of which are product dependent). In addition to these specialized methods, sterility testing involves many special considerations, including:

  • Environment. Tests can be performed in an ISO Class 5 Cleanroom or in an ISO Class 5 isolator, but because sterility testing must be done in an environment that is equal to or better than the manufacturing environment, most tests are now being conducted in specially designed isolators.
  • Pre-tests. The sterility test method requires special validation pre-tests to ensure accurate results. Therefore, it is strongly recommended that you supply EMSL with pre-test samples before actual testing proceeds.

Sample batch quantities for particular product types are specified in the ISO 11137/11135 and USP <71> standards, most of which are harmonized with the EP/JP guidelines. The ISO method is a modified USP <71> method and recommends that the sterility test be validated by using known sterile products. The use of these test methodologies are legal requirements worldwide.

Ensure Quality Control with Help from EMSL

To ensure your products are safe, sterile and compliant, you need a trusted partner to deliver accurate results and quick turnaround. At EMSL, we’re proud to be an industry leader among independent analytical labs offering sterility testing. For the best in quality assurance and control, contact EMSL today to learn more about our sterility testing services.


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