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Sterilization Monitoring and Validation

Sterilization Monitoring and Validation

Sterilization Monitoring and Validation

Product catalog summary
Overview: Zhejiang Tailin Bioengineering Co., Ltd offers a wide range of biological indicators for various sterilization processes, including steam, hydrogen peroxide, dry heat, ethylene oxide, and ozone. These indicators are designed to assess the effectiveness of sterilization and comply with international standards like ISO 11138 and FDA 510k.
Types of Biological Indicators: The company provides different types of biological indicators such as self-contained indicators, spore suspensions, and carrier-type indicators, suitable for diverse sterilization methods and industries, including pharmaceuticals and medical devices.
Applications: These indicators are utilized in pharmaceutical companies, medical device industries, CDC, and biosafety laboratories to verify the performance of sterilization equipment and processes.
Product Features: Tailin's products boast patented designs that ensure effective medium evaporation control, high resistance to sterilization temperatures, and ease of use. They deliver accurate results within 48 hours and are packaged to prevent contamination.
Regulations and Standards: The biological indicators adhere to ISO 11138, GB18281, GMP, PDA TR51, FDA 510k, and various pharmacopoeias (USP, EP, ChP). The spores are traceable, and test reports include critical data like spore concentration and D-value.
Technical Specifications: Detailed specifications are provided for various biological indicators, including species, population, storage conditions, shelf life, and packaging. Technical parameters for sterilization equipment, such as temperature range, pressure, and sterilization curve, are also outlined.
Additional Products: Tailin also offers chemical indicators that change color to indicate sterilization effectiveness, used alongside biological indicators for comprehensive monitoring.
Conclusion: Tailin's solutions for sterilization monitoring and validation are designed to meet stringent industry requirements, ensuring reliable and accurate monitoring of sterilization processes.
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Catalog excerpts

Sterilization Monitoring and Validation-1

Sterilization Monitoring and Validation Zhejiang Tailin Scitech Co., Ltd Fully owned subsidiary of Zhejiang Tailin Bioengineering Co., Ltd No.2930 Nanhuan Road, Binjiang, Hangzhou, Zhejiang, China. TEL: 0086-571-86589087 E-MAIL: [email protected] @Tailin All Copyright Reserved By Tailin ZHEJIANG TAILIN BIOENGINEERING CO.

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Sterilization Monitoring and Validation-2

Sterilization Monitoring and Validation Sterilization Monitoring and Validation Self-Contained BIs for Autoclave Steam Patented design structure, efective control of medium evaporation during cultivation, compliance with GMP requirements. The medium is resistant to sterilization up to 134 °C. Types of Biological Indicators movable plug 专利设计 Patent cap dialysis paper ampoule spores carrier Biological indicators are the ideal process indicators that directly monitor the lethality of a given sterilization process. Tailin's biological indicators meet the requirements of ISO 11138, GB18281, GMP, PDA...

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Sterilization Monitoring and Validation-3

Biological Indicators I Biological Indicators for Vaporized Hydrogen Peroxide I Biological Indicators for Autoclave Steam They are used to confirm the performance of steam sterilization equipment, develop and establish steam sterilization processes, and re-validation of the steam sterilization equipment. They are suitable for pharmaceutical enterprises, medical device industries, CDC, biosafety laboratories and other fields. + Self-contained Bis with a patented structure, less than 10% evaporates of incubation + Color-changing medium, 48h for accurate results + Medical packaging dialysis paper...

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Sterilization Monitoring and Validation-4

I Biological Indicators for Ethylene Oxide They are used to monitor EO sterilization effectiveness, and re-validation of the EO sterilization equipment, which are widely used in pharmaceuticals, medical device industries and other fields. + Self-contained Bls with a patented structure, less than 10% evaporates of incubation + Color-changing medium, 48h for accurate results + Medical packaging dialysis paper aviod external contamination and allows EO penetration + Selected carriers for easy microbial elution and count They are used to confirm the performance of dry heat sterilization equipment,...

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Sterilization Monitoring and Validation-5

Chemical Indicators Cls are mainly used to monitor various sterilization processes and confirm that the sterilization conditions meet the requirements through color changes. Cls have special sensitivity to specific environmental factors (e.g., temperature, humidity chemicals, etc.). Cls will change color according to these factors to assist in determining the effectiveness of the sterilization. Tailin's Cls for monitoring the sterilization of steam, hydrogen peroxide and ethylene oxide meet the requirements of GB 18282.1/ISO 11140 and other relevant standards. Used together with Bls to ensure...

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Sterilization Monitoring and Validation-6

Sterilization Monitoring and Validation iBIER-EOlOO Ethylene Oxide Sterilization BIER i BIER-VH100Vaporized Hydrogen Peroxide Sterilization BIER + Intelligent operation; one-click automatic, sterilization, and exhaust + Data authority, traceability, and real-time observation to verify or determine the sterilization situation + Safe and reliable; door opening protection, automatic pressure relief, temperature grading, negative pressure airtightness test procedures, multi-level management authority settings + Flexible adjustments to customize the program, one-click generation of the test report...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.