Sterility Testing

Sterility testing is a critical quality control measure used to confirm that pharmaceutical products, including drugs, biologics, and medical devices, are free from viable contaminating microorganisms. This process is essential for products that are intended to be sterile, such as injectables, ophthalmic solutions, and certain biopharmaceuticals.

At Protheragen-ING Lab, we offer comprehensive sterility testing services to ensure the safety, purity and efficacy of your medicines to meet the highest industry standards.

Our sterility testing capabilities

• Sterility testing for injectable products, ophthalmic solutions, and other sterile pharmaceutical preparations.
• Compliance with international regulatory standards (EP, USP, JP).
• Utilization of both direct inoculation and membrane filtration methods.
• Comprehensive microbial identification and characterization services.
• Experienced team of microbiologists and QC specialists.
• Dedicated sterile testing facility with controlled environmental conditions.
• Rapid turnaround times and reliable results.

Our sterility testing methods

We offer a full suite of sterility testing services using state-of-the-art technology and methodologies to ensure reliable and accurate results.

Membrane Filtration Method

1. Ideal for aqueous, oil-based, and soluble solid products.
2. Utilizes membrane filters to capture any potential contaminants.
3. Filters are incubated in growth media to detect microbial presence.

Direct Inoculation Method

1. Suitable for products that cannot be filtered.
2. Test samples are directly inoculated into growth media.
3. Monitored for microbial growth over a specified incubation period.

Isolator Technology

1. Advanced aseptic processing environment.
2. Minimizes the risk of false positives due to contamination.
3. Ensures a high degree of sterility assurance.

Standards and regulations

Our sterility testing procedures are conducted in strict compliance with the following reference standards:

• EP 2.6.1

The EP 2.6.1 standard outlines the test for sterility, which is designed to detect the presence of viable microorganisms in pharmaceutical preparations, raw materials, or medical devices that are required to be sterile.

Our laboratory follows the guidelines set forth in this standard, utilizing both direct inoculation and membrane filtration methods to evaluate the sterility of your samples.

• USP <71>

The USP <71> Sterility Tests chapter provides the official procedures for determining the sterility of pharmaceutical articles.

We adhere to the test methods described in this compendium, including the use of fluid thioglycollate medium and soybean-casein digest medium to cultivate potential microbial contaminants.

• JP 4.06

The JP 4.06 Sterility Test is the standard for evaluating the sterility of pharmaceutical products in Japan. Our laboratory is equipped to perform this test, which involves the inoculation of test samples into fluid thioglycollate medium and soybean-casein digest medium, followed by incubation and examination for microbial growth.

Contact us today to discuss your specific requirements and learn how we can support your quality assurance needs.