Fast, Accurate Sterility Testing

Industry regulations and current Good Manufacturing Practices (cGMP) require sterility testing on any product intended to be sterile, such as medical devices, injectables, cosmetics, ophthalmic solutions and more. Sterility testing is critical to your product-development process to ensure products are free of viable microorganisms and safe for customers or patients.

Why Choose Certified Group for Sterility Testing?

You need a laboratory partner that can provide accurate results while delivering fast turnaround times. What’s more, you need a partner who can help disentangle complex regulations and provide guidance specific to your industry so you can maintain compliance. We have the expertise to help.


Sterility testing performed under aseptic conditions in an ISO-certified class-5 environment


Testing done in accordance with the appropriate standards (USP <71>, 21 CFR 211) for maximum quality & accuracy


Continual quality-assurance monitoring throughout testing increases accuracy


Our commitment to quality and accuracy provides fast turnaround times (TAT) and peace of mind that you’re releasing safe, high-quality products into commerce


Service tailored to the material & products you’re testing


Expertise to help understand complex regulations so you can remain compliant

ISO-Certified Sterility Lab Testing Services

Inaccurate test results can put your customers at risk, damage your reputation and waste money. We test in an ISO-certified class-5 environment while using processes that strictly adhere to USP 71, 21 CFR 211 and other appropriate standards, depending on the material being tested. Our quality-control process helps us provide accurate results.


Our ISO-certified class-5 testing environment is isolated in a separate building to help ensure aseptic conditions for increased accuracy


We continually update our processes to increase automation, accuracy, and speed


Our microbiologists triple gown and perform all procedures and testing in HEPA-filtered rooms for the most accurate results


Our microbiologists participate in routine requalification to ensure we are in line with stringent ISO and FDA protocols


We perform suitability testing to determine how best to test your products for sterility

Sterility Testing Methods

There are two primary ways to perform sterility testing: the membrane filtration method and direct inoculation. We use the proper methodology based on your products and the appropriate compendia.

Our Processes Help Speed Turnaround Times (TAT)

We continually work to automate our sterility testing process to remove variability and the potential for contamination, which not only increases accuracy but helps speed turnaround times.

We Answer the Phone When You Call

We understand that your business must act in compliance with regulations. But industry regulations change often and quickly get confusing. That’s why we take our customer service as seriously as our microbiological tests. We help you understand what tests you need and how to interpret the results.


Personalized attention and service


Guidance on the right tests for your products and materials


Expertise to understand regulations and directions for remaining compliant


Constant communication throughout the process

Whether you produce pharmaceuticals, medical devices, cosmetics or more, we can help you get the sterility testing you need to ensure you’re releasing safe products into commerce as quickly as possible.

Sterility Testing FAQs

What is USP 71 sterility testing?

The USP 71 sterility test is applied to substances, preparations, or articles that are required to be sterile according to the Pharmacopoeia.

What are the different methods for sterility testing?

The two different methods for sterility testing are Direct Plating and Membrane Filtration.

What is suitability testing and why is it needed?

Suitability testing is performed to ensure that the method being performed is suitable for the sample. It is needed for every new sample, new formulation, or any variation in the technique.

What is the turnaround time (TAT) for sterility testing?

The TAT for the testing with suitability is 3-4 weeks due to the 14-day incubation period.

Sterility Testing Blogs by Our Experts

3 Tips For 503B Sterile Compounding Facilities When Choosing a Lab Partner

503B sterile compounding pharmacies are ultimately responsible for their products, even when they outsource quality and sterility testing.

Here’s how to ensure your testing partner uses adequate laboratory controls so you can remain compliant and produce safe, high-quality products.

USP 797 Sterile Compounding: What You Need to Know About Sterility Testing

Sterility testing and assurance are critical regulatory compliance requirements for 503B facilities that perform sterile compounding according to USP <797>.

Subject to section 503B under the Federal Food, Drug, and Cosmetic (FD&C) Act, 503B facilities manufacture bulk pharmaceuticals or their components for further processing. Compounded drug products provide life-saving alternatives for patients unable to take FDA-approved drugs.

Contact us today to find out how we can help you.