Sterility Testing

Sterility testing is a test required by authorities to confirm sterile products do not contain microorganisms that might affect product integrity and ultimately consumers.

The presence of microorganisms in a product can pose serious risks to patients and consumers, including infections and other adverse reactions. Sterility testing helps to minimize these risks by verifying the absence of viable microorganisms, including bacteria and fungi.

Mérieux NutriSciences AQ offers a comprehensive range of microbiology services compliant with GMP & TGA requirements for pharmaceutical, medical and manufacturing products (sterile and non-sterile).

What is the purpose of a Sterility Test?

To determine whether a pharmaceutical product, medical device, or any other healthcare product is free from viable microorganisms. It is a critical quality control measure used to ensure the safety and efficacy of these products.

Sterility testing is a crucial microbiological requirement within Good Manufacturing Practices (GMP) standards and TGA. It serves to verify that products claimed to be sterile, such as medical devices, pharmaceuticals, formulations, and tissue materials, are devoid of viable microorganisms prior to their release and eventual administration to patients. The precision of sterility testing methods is of utmost significance due to the critical nature of ensuring the absence of viable microorganisms in these products

(TGA Guidelines for Sterility Testing of Therapeutic Goods – 2006)

Sterility is defined as the absence of viable microorganisms, but achieving absolute sterility often requires harsh conditions that may be unsuitable for active ingredients. Therefore, when it comes to medicinal products, the definition of sterility must be based on practical considerations.

In pharmaceutical practice, a container is considered sterile if the probability of contamination with replicating microorganisms is less than one in a million. Since it is impractical to open and test every single container of a biological medicinal product, a representative number of samples from the batch, taken at various times during the filling process, are used to monitor sterility.

This means that if there are only a few non-sterile containers in a large batch of identical containers, the likelihood of detecting a non-sterile container is relatively low.

Our Sterility Testing Methods

• Membrane Filtration Method (USP <71>): This widely accepted method involves passing a known volume of the product through a sterile membrane filter. The filter is then placed on appropriate growth media to cultivate any microorganisms present. Our membrane filtration method ensures accurate quantification of microorganisms, making it suitable for various liquid and aqueous products.
• Direct Inoculation Method (USP <71>): Ideal for solid and semi-solid products, this method involves directly inoculating the product onto appropriate growth media. It allows for the detection of microorganisms that may be present in products that cannot be easily filtered.

Method Reference:

• United States Pharmacopeia (USP): Our methods are in accordance with USP Chapter <71> Sterility Test, which provides guidance on sterility testing procedures, acceptance criteria, and validation.
• British Pharmacopoeia (Ph. Eur.): We follow the principles outlined in….BP… Chapter 2.6.1 Sterility, details the requirements for sterility testing and the methods to be employed.
• ISO 11737: We comply with ISO 11737 standards for validation and routine control of sterilization processes to ensure accurate and consistent results.

What microorganisms can we test?

Sterility testing uses methods with broad sensitivity, incubation of samples in growth media promotes growth across a wide range of microorganisms.

In which sectors is this test required?

• Pharmaceutical Industry
• Medical Devices and Manufacturing
• Compounding Pharmacy

We partner with manufacturers to support them in validating the safety of their products. Contact us to find out what testing solutions are right for you.