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Sterility Testing Services

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Introduction to Sterility Testing Services

Sterility testing is critical to ensure that all pharmaceutical products, medical equipment, and other critical materials are devoid of harmful microorganisms. This test is essential for industries such as pharmaceutical, biotechnology, and healthcare sectors where the safety and quality of the products are paramount. Sterility testing services thus protect product integrity and consumer safety by ensuring that pharmaceuticals, biologics, and medical devices meet strict regulatory standards before they can be released for use in healthcare or other sterile environments.

What is sterility testing?

Sterility testing is a process used to detect the presence of viable microorganisms, such as bacteria, fungi, and yeast, in products that are intended to be sterile. In other words, it is designed to check whether products that are considered to be sterile contain microorganisms that could raise significant safety and efficacy concerns. Products tested under this method include pharmaceuticals, biologics, medical devices, and tissue grafts among others. Sterility testing is important for most products that come into direct contact with the human body and used in environments where sterility is of paramount importance, such as surgical areas and implantation procedures.

The two main methods of sterility testing include membrane filtration and direct inoculation. The choice of sterility testing methods used is based on the nature of the sample, regulatory requirements, and the type of product under test.

Our sterility testing services

At MIS, sterility testing services can be customized for various industries and products. Whether you are developing new pharmaceuticals, biologics, medical devices, or other sterile products, our testing solutions ensure that your products meet regulatory requirements and are safe for end users.

Sterility testing methods offered at MIS include direct inoculation method and the membrane filtration method. Our experts can guide you in choosing the best method that suits your product type and specific regulatory needs. Our microbiologists have extensive experience and skills in handling complex testing requirements along with a commitment to deliver accurate results within a short turnaround time.

Some of the frequently used standards for sterility testing at MIS include:

USP 71: Standard guidelines for Sterility testing of pharmaceutical products

USP 61: Microbial enumeration tests for non-sterile products such as cosmetics, pharmaceuticals and personal care products. 

Industries we serve

Sterility testing is an important requirement for many industries, each with its own specific regulations and standards. At MIS, we carry out sterility testing for the following industries:

  • Pharmaceuticals and biotechnology

For drugs, biologics, and vaccines, sterility testing is of prime importance because it ensures that these formulations are sterile and safe for use. Final products as well as raw materials must be checked for sterility.

  • Medical instruments

Medical devices that come in direct contact with the body must be tested for their sterility. These devices include but are not limited to catheters, implants, and surgical instruments.

  • Cosmetics and personal care products

Sterility testing ensures that personal care products such as eye drops, lotions, creams meet extremely high standards of safety for consumer use.

Compliance and standards

Our sterility testing services adhere to international guidelines and standards thus ensuring that your product is safe for market entry in any country.  We adhere to established standards such as:

  • European Pharmacopoeia (EP)
  • United States Pharmacopeia (USP)
  • International Organization for Standardization (ISO)
  • International Council for Harmonisation (ICH) Guidelines

These standards ensure that the sterility tests are performed in accordance with global regulatory expectations, therefore giving your products safety and efficacy validation. Compliance with these standards also ensures acceptance of your products in various international markets.

Why choose us?

Choosing the right partner for sterility testing is very critical in ensuring the safety and quality of your products. Our sterility testing services give you several benefits:

  • Experienced team 

Our scientists and microbiologists are highly experienced in sterility testing and are keen on providing reliable results for a wide range of products.

  • State-of-the-art facilities

Our company employs the latest equipment and updated standard test methodologies to ensure precision and compliance with industry standards.

  • Timely results

We understand the importance of achieving timely results for developing a product or releasing it within set timelines while maintaining all the precision required. Therefore, MIS experts strive to provide accurate results with short turnaround times.

  • Integrated solutions 

Our services are not limited to sterility testing. We offer a diverse range of complementary microbiological testing services to provide our customers with the ability to fulfill all of their testing requirements with one provider.

Conclusion

Sterility testing is a vital aspect of various industries where ensuring the safety and efficacy of sterile products is of utmost importance. Our wide scope of service offers customized solutions for pharmaceutical, and medical device manufacturers, and more. With our state-of-the-art facilities, experienced team, and commitment to regulatory compliance, we provide sterility testing services you can rely on.

For professional sterility testing services, Microbe Investigations Switzerland is here to assist you. Reach out to our specialists today to discover how we can support you in ensuring the sterility of your products and adhering to industry regulations.

FAQs on sterility testing services

Sterility testing is the process of determining whether a product is free of harmful microorganisms. Sterility testing services include testing products that are intended to be sterile such as pharmaceuticals and biologics, medical devices, tissues, and other related products.

Sterility testing guarantees that the products are free from the presence of harmful microorganisms that could cause infections, illness, or other health complications. This test is very crucial where the product comes into direct contact with the sterile areas of the body, for instance, surgical implants or injectables.

The membrane filtration method involves filtering the sample through a fine, porous membrane to trap microorganisms that might be present. The membrane is then incubated in a growth medium to determine the growth of any microorganism, which indicates contamination.

In direct inoculation, the sample is introduced directly to a growth medium. The medium is then incubated and checked for the growth of microbes. If microbial growth is observed, the product is considered as “not sterile”.

Positive controls ensure that the testing conditions support the growth of microorganisms. Negative controls check if the test is not affected by external contamination. 

The sterility of a sample is confirmed through a thorough series of tests, which involve both positive and negative controls, and adherence to standardized protocols as specified by regulatory guidelines. Proper documentation and validation are required to ensure that the sterility testing meets all the necessary requirements.

Get your product tested now

✓  Completed test order form (TOS)
✓  Customization and Assistance to determine the right test for your project
✓  FAST TRACK Program with less Turnaround Time

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