Sterility Test Isolator

Sterility Test Isolator
Product Description

1. Built-in Vaporized Hydrogen Peroxide (VHPS) generator for bio-decontamination which can reach 6-log Sterility Assurance Level

2. The VHPS residual concentration is less than 1ppm after aeration

3. leakage rate is less than 0.5% /vol/hour under 2 times working pressure test

4. Pressure is adjustable within -80pa~80pa

5. 12.1” IPC with NetSCADA

6. Built-in Sterility Test Pump

7. Comply with 21 CFR Part 11 electronic records and signature requirements;

8. GMP, USP, EP compliance

9. Interlock, alarms record and audit trails

10. Noise: ≤65dB(A) when in pressure hold stage

11. Compressed air supply: 0.4MPa~0.6MPa clean and dry

12. Power Supply: 380±38V,50±5Hz,25A ( HTY-1800G4/HTY-1800AG4)

Tailin Bioengineering

  • CN
  • 2017
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Machinery and Equipment Supplier/Manufacturer
Primary activities
Biopharmaceutical
Specifications
  • Details
    TAILIN sterility test isolators are designed to allow operators to perform sterility testing in an aseptic environment providing assurance of process integrity.
  • Selling Points
    Quality Service
  • Supplied from
    China

Tailin Bioengineering

  • CN
  • 2017
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Machinery and Equipment Supplier/Manufacturer
Primary activities
Biopharmaceutical

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