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Microbiological Testing

ISO 11737-1

Bioburden Testing

The term "Bioburden" is used to describe the population of viable microorganisms present in a product and/or sterile barrier system.

ISO 11737-2

Sterility Testing

A sterile medical device is a device that has been freed from viable microorganisms.


Physical and Chemical Testing

ASTM F1929-15

Package Leakage Testing

Package leakage testing is performed to detect a leak equal to or greater than a channel formed by a 50 µm (0.002 in.) wire.

ASTM F1980-16

Accelerated Aging Test

Accelerated aging tests are performed to develop accelerated aging protocols for the rapid determination of the effects caused by the passage of time.

ISO 2271

Detergent Residue Test

The detergent residue test is performed by manual or mechanical methods for the determination of anionic active matter in detergents.

ASTM F2459-18

Extractable Residue Test

The extractable residue test is performed for the quantitative assessment of the amount of residue obtained from metallic medical components.

Shelf Life Testing

Real Time Aging Test

Stability programs for medical devices, cosmetics, supplements, drugs and related products evaluate the effect of temperature and humidity on the product.

Microbiological Testing

Microbiological tests are generally applied to cosmetic products, pharmaceuticals and biocidal products. Test applications are performed to determine whether various parameters are suitable for health based on ISO 17025 conditions. Microbiological testing processes focus primarily on determining whether the products cause microbiological, allergic or chemical irritation on humans.

It is important for both human health and animal health that products are clean in microbiological terms. The products offered to the user must conform to necessary regulations before release. Tests on medical products provide accurate evidence for maintaining patient safety.

Depending on the type of medical device to be verified, appropriate test methods should be determined. We fulfill our duties in Microbiological Test laboratories, evaluating and reporting the bioburden or sterility levels according to required specifications. We evaluate tests with full accuracy to help deliver sterile medical products smoothly, ensuring proper protection from contamination during sterilization processes. We conduct Sterility, as well as Stability, Accelerated Aging, Shelf Life, Package Seal Strength Determination, and Package Leakage analyses at our accredited laboratory.

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