Sterilization validation test
We offer comprehensive services in the field of microbiology. With our many years of experience and capabilities, we can provide you with complete solutions, from the development and validation of specific test methods to production monitoring and final testing of your products.
We advise you on all aspects of sterilization safety, microbiological quality of your products, environmental hygiene and validation activities, test methods, production monitoring, and final product testing.
There are three common ways to sterilize medical device:
ISO 17665 Moist heat sterilization validation
ISO 11135 Ethylene oxide sterilization validation
ISO 11137 Radiation sterilization validation
Manufacturers must evaluate the testing required for packaging materials based on the sterilization process used.
Microbiological testing
ISO 11737-1
Bioburden test/recovery rate
Assessment of the number of bacteria present on the product prior to sterilization. Estimate the distribution and number of microorganisms on the sample.
To detect these, the sample is dissolved in a suitable test solution, or the microorganisms are washed away and then cultured.
BI
Biological Indicator Sterility Testing
During sterilization, biological indicator reagents are used for specific sterilization methods to determine whether the sterilization process is complete, as an indicator of the effectiveness of the sterilization process.
ISO 11737-2
Sterility test/ Bacteriostasis/ Fungistasis test
Assessment of the impact of product packaging sealing and effective barrier properties after sterilization to provide requirements for sterile packaging of medical devices before use.
ISO14644
Clean room standards
Inspection methods in work environments, such as airborne particle measurements, airborne microbial counts or surface contact inspections.
We perform the complete procedure including sampling at your site.
Central Office：+886-2-2995-6899
FAX：+886-2-2278-2859
Phone：+886-921290329
E-mail : info@medserv-biotech.com
Taiwan Company
1, No. 145, Zhongshan Rd, Xinying District, Tainan City, 730
Taiwan Officea
a, No. 172, Section 2, Guangfu Rd, Sanchong District, New Taipei City, 241
Malaysia Office
Lot 4-1B, Lukas Ark Digital Mall, Lengkok Nipah, Taman Lip Sin 11900 Bayan Lepas, Penang Malaysia