Sterility Testing is an essential requirement for quality control of sterile pharmaceutical products, medical devices, and injectable water. According to the United States Pharmacopeia, the USP <71> Sterility Tests are necessary in both sterilization validation and batch release of sterile products on a regular basis. We at Chromak Research ensure trustworthy and regulatory compliant sterility testing by employing validated methods and controlled environments.

What is Sterility Testing?

Sterility testing is a microbiology test that confirms that a product is free of live contaminating microorganisms. Sterility testing is a required test for any product that is marketed as sterile for the safety of the patient and regulatory requirements with international regulatory bodies like the FDA.

Sterility testing is most important for:

  • Injectable pharmaceuticals

  • IV solutions

  • Ophthalmic products

  • Implantable devices

  • Sterile water and other sterile drug products

Sterility Testing according to USP <71>

Chromak Research adheres strictly to the specifications of USP <71> Sterility Tests, in which two validated tests for the determination of sterility are described:

Membrane Filtration Method

This is the method of choice for filterable water-based products and is a popular one with the pharmaceutical industry. It entails passing the product through a sterile membrane and subsequent incubation in growth media to detect microbial contamination.

Direct Inoculation Method

It is best used in products that cannot be filtered well as it inoculates the product directly into sterile media and monitors for microbial growth during the period of incubation.

Controlled Laboratory Environment

To prevent environmental contamination while testing, all sterility procedures are carried out in ISO 5 laminar flow hoods within ISO 7 classified clean rooms. This helps to maintain test result integrity and adherence to GMP (Good Manufacturing Practices) regulations.

Growth Promotion Testing & Method Suitability

Prior to the conduct of sterility testing, Chromak Research conducts Growth Promotion Testing (GPT) to ensure that the media used is effective in supporting the growth of the six microorganisms that are part of USP <71>:

  • Staphylococcus aureus

  • Pseudomonas aeruginosa

  • Bacillus subtilis

  • Candida albicans

  • Aspergillus brasiliensis

  • Clostridium sporogenes

We also conduct Method Suitability Testing for every product formula to ensure that the chosen method of sterility test would not repress microbial growth. This maintains accuracy and reproducibility of results for every type of product.

Why Chromak Research for Sterility Testing?

Testing is done as per USP <71> and relevant GMP guidelines.

Our microbiologists are trained in aseptic technique and method validation protocols.

We offer both membrane filtration and direct inoculation based on product requirements.

Testing is done within certified cleanrooms to offer zero background contamination.

Quick turnaround with thorough reporting for product launch and regulatory audits.

Industries We Serve

Our sterility testing services benefit several industries, including:

  • Pharmaceuticals

  • Biotechnology

  • Medical Devices

  • Compounding Pharmacies

Contact Us

Maintain the highest safety and quality standards in your sterile products with Chromak Research’s USP <71> Sterility Testing Services. Call us today to find out more about our microbiological testing or to schedule a consultation.