Medical Device Sterility Testing

Protheragen-ING Lab offers comprehensive sterility testing services for the medical device industry, designed to meet regulatory requirements and provide you with reliable results. With state-of-the-art technology and an experienced team of professionals, we are committed to helping you maintain the highest standards of safety and quality for your medical devices.

Why do medical devices need sterility testing?

Sterility testing plays a critical role in the development, manufacture, and release of medical devices. The presence of microorganisms in medical devices can pose serious risks to patients, leading to infections, complications, and even death. Sterility testing is necessary to ensure that medical devices are free of live microorganisms, thereby minimizing the potential for infection and ensuring patient safety. Compliance with various international standards and guidelines is a fundamental regulatory requirement.

Our sterility testing methods for medical devices

We use validated sterility testing methods to assess the effectiveness of the sterilization process and to confirm the absence of viable microorganisms in medical devices.

We typically perform direct transfer sterility testing on medical devices. Sterility testing of medical devices is typically performed using a culture medium called soy casein digestion medium (SCDM). The device to be tested is in direct contact with the test medium throughout the incubation period, during which time any microorganisms in or on the device will grow and proliferate. The amount of sample required depends on the test method chosen, but all methods require fourteen days of incubation. The sample fails the sterility test if the medium becomes cloudy after fourteen days.

Additionally, product rinse sterility testing is preferred for products with hollow tubing (e.g., infusion and infusion assemblies) in which the fluid passages are labeled as sterile. The inner lumen of the product is flushed with rinse solution, and the eluate is membrane filtered and placed in a suitable medium for incubation.

Testing standard

At Protheragen-ING Lab, we strictly adhere to internationally recognized testing standards to ensure the highest level of accuracy and compliance. Our sterility testing procedures comply with the following standards:

• ISO 11737-2:2009 - Sterilization of medical devices.
• United States Pharmacopoeia <71>: Sterility Testing.
• European Pharmacopoeia <2.6.1>: Sterility.

By following these standards, we ensure that our testing protocols are robust, consistent, and meet the regulatory requirements of various global markets.

Our service advantages

• Expertise and Experience.
• State-of-the-Art Facilities.
• Compliance with Regulatory Standards
• Customized Testing Solutions.
• Timely and Reliable Results.
• Quality Assurance.
• Confidentiality and Data Security.

Contact us today to learn more about our sterility testing services and how we can assist you in meeting your regulatory obligations and ensuring patient safety.