Medical Product Analysis

BIOBURDEN (BIOLOGICAL LOAD QUANTITY TEST), BIOBURDEN (BIOLOGICAL LOAD QUANTITY TEST) VALIDATION:

It is performed to detect the biological bacterial load on your products.

Analysis Method: - ISO 11737-1 / Analysis Time: 7 Days

Analyzes: - Aerobic mesophilic bacteria

- Anaerobic mesophilic bacteria

- Mold-yeast

STERILITY TEST:

It is performed to determine the sterility control of your products.

Analysis Method: - ISO 11737-2 / Analysis Time: 14 Days

Analyzes: - Aerobic mesophilic bacteria

- Negative Control

- Positive Control

ETHYLENE OXIDE RESIDENCE TEST:

After sterilization of your products with ethylene oxide
Is performed.

Analysis Method: - ISO 10993-7 / Analysis Time: 3 Days

Analyzes: - Ethylene oxide (EtO)

- Ethylene hydrochloride (EtCH)

- Ethylene glycol (EtG)

STABILITY TEST AND SEALING TEST:

To determine if your products remain stable for the specified real-time shelf life
Is performed. At the end of the test, a tightness test is carried out on the product packaging.

Analysis Method:

Stability Test: ASTM F 1980

Tightness Test: ASTM F 1929

Analysis Time: Stability Test: Time varies depending on test temperature

Tightness Test: 2 days

CLEANING VALIDATION TESTS (OIL-GREASE REMAIN AND DETERGENT REMAIN TEST):

The cleaning validation of your products is carried out to determine whether it is done correctly.

Analysis Method: Oil-Grease Test: SM 5520 B

Detergent Residue Test: ISO 2271

Analysis Time: 3 days

CLEAN ROOM MICROBIOLOGICAL TESTS

Cleanroom microbiological tests are carried out in accordance with the ISO 14698 standard of clean rooms where your products are manufactured.
microbiological controls.

Air Microbiological Count Test (Aerobic Mesophilic Bacteria and Mold-Yeast)

Personnel Handheld Biocontamination Test

Surface-Equipment-Textile Biocontamination Test

Analysis Time: 7 days
Air Particle Count: It is carried out in order to measure the air particle level in the clean room according to ISO 14644-1 standards.
Analysis Time: 1-2 days
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