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Tailin Sterility Test Isolator HTY Series

Tailin Sterility Test Isolator HTY Series

Tailin Sterility Test Isolator HTY Series

Product catalog summary
Introduction
The Sterility Test Isolator by Zhejiang Tailin Bioengineering Co., Ltd is a cGMP Class A/ISO 5 isolator system designed for quality control operations in sterile environments. It features a robust stainless steel and tempered glass structure, ensuring a dynamic Class A internal environment. The system is equipped with a Siemens PLC for automated control and includes a pressure loss alarm function. It complies with GMP, USP, and EP standards.

Applications
This isolator is suitable for GMP inspections of sterile pharmaceuticals, including sterile preparations and active pharmaceutical ingredients. It supports sterility tests, sampling, weighing, and dispensing, and can be used in environments classified as Class C/D according to EU GMP Annex 1 and PIC/S recommendations.

Features
The HTY series isolators ensure high air quality with features such as:
  • Automatic leak testing system for each chamber.
  • H14 HEPA filters for engineering filtration.
  • Vaporized hydrogen peroxide sterilizers for rapid sterilization.
  • Inflatable seals made of GMP-approved silicone.
  • Real-time monitoring of environmental parameters.
It also includes an integrated automated glove leak testing system compliant with ISO 14644-7.

Data Management
The system complies with 21 CFR Part 11 for electronic records and signatures.

Technical Specifications
  • Power Supply: AC380V/50Hz
  • Cleanliness: GMP Class A
  • Airflow Direction: Laminar flow
  • Bio-decontamination Capacity: ≥106-log
  • Vaporized Hydrogen Peroxide Residual Concentration: <1ppm
  • Max Power: 3000W-4000W
  • Chamber Pressure Range: -80Pa to +80Pa
  • Noise: <75dB(A)
  • Leakage Rate: <0.5% /vol/hour

Optional Accessories
Includes glove integrity tester, air sampler, particle counter, H2O2 concentration sensor, and more.

Validation & Services
Offers DQ/IQ/OQ documents, safety tests, chemical and biological indicators, and training services.

Contact Information
Zhejiang Tailin Bioengineering Co., Ltd, No.2930 Nanhuan Road, Binjiang, Hangzhou, Zhejiang, China. TEL: 0086-571-86589087, EMAIL: [email protected], WEB: www.tailinscitech.com
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Catalog excerpts

Tailin Sterility Test Isolator HTY Series-1

Sterility Test Isolator ZHEJIANG TAILIN BIOENGINEERING CO., LTD

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Tailin Sterility Test Isolator HTY Series-2

Integrated Solution Provider in Life Science Since its establishment in 2002, Tailin has been a leading company in the life science field. Tailin's strength lies in its technological innovation and robust manufacturing capabilities. To provide comprehensive solutions to its customers, Tailin manufactures most of the critical equipments, including sterility test/containment/CGT/radiopharma isolators, Vaporized Hydrogen Peroxide sterilization systems, glove leak testers, sterility test systems, and analytical instruments. Tailin has a team of nearly 1,000 employees, including 200 R&D engineers,...

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Tailin Sterility Test Isolator HTY Series-4

Sterility Test Isolator HTY Series Laminar Flow Introduction The Sterility Test Isolator is a custom-designed cGMP Class A/ISO 5 isolator system, specifically engineered to provide the safest and most ergonomic working conditions for quality control operations. Tailin hard-wall laminar flow sterility test isolator HTY series features a rigid structure made of stainless steel and tempered glass, creating a dynamic Class A internal environment. Operations within the isolator are conducted using gloves, available in two versions: a thick, tear-resistant model and a thin, highly tactile option. The...

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Tailin Sterility Test Isolator HTY Series-5

Sterility Test Isolator Built-in Sterility Test Pump Features Sterile Assurance HTY series isolators ensure the highest air quality within the isolation environment: - Engineering filtration system comprising H14 High-Efficiency Particulate Air (HEPA) filters - The integration of the latest generation of vaporized hydrogen peroxide sterilizers developed by Talin, coupled with precise hydrogen peroxide gas concentration/saturation control technology, which rapidly steriizes the internal environment of the chamber, guaranteeing a sterile environment during sampling processes. - Inflatable seals...

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Tailin Sterility Test Isolator HTY Series-7

Power Supply: AC380V/50HZ Max.Power: 3000W-4000W Cleanliness: GMP Class A Chamber Pressure Range: From -80Pa to +80Pa Airflow Direction: Laminar flow Velocity:0.36~0.54m/s Built-in Sterility Test Pump: 1 or multiple Compressed Air Supply: 0.4MPa-0.6MPa clean and dry Bio-decontamination Capacity: >106-log Noise: <75dB(A) when in pressure hold stage Touch Screen: 12" Tablet PC Leakage Rate: < 0.5% /vol/hour under 2 times working pressure test Vaporized Hydrogen Peroxide Residual Concentration: < 1 ppm cabin Illumination: 500 lux, LED light source Half-Suit Integrity Tester Glove Integrity Tester...

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Tailin Sterility Test Isolator HTY Series-8

'VVfff.fJV Zhejiang Tailin Bioengineering Co., Ltd No.2930 Nanhuan Road, Binjiang, Hangzhou, Zhejiang, China. E-MAIL: [email protected] WEB: www.tailinscitech.com OO @Tailin [0j @Tailin_official @TAIUN All Copyright Reserved By Tailin Version: 20241121-01

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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.