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Project

Two Pura 2+ Sterility Test Isolators

Year

2020

Location

India

Description

Two Pura 2+ Sterility Test Isolators. Double chamber for continuous batch testing where large numbers of sterility tests need to be performed.

Isolator is pre-loaded with the initial samples and test materials prior to bio-decontamination, after which sterility testing can proceed.

Additional test materials and samples can be introduced and bio-decontaminated via the transfer chamber whilst sterility testing takes place in the main chamber.

The Isolator is designed to offer an internal air cleanliness of Class ISO 5 (4.8) as described in ISO 14644-1.The Telstar range of Sterility Test Isolator is designed to protect product from the process generated and externally generated factors that would compromise its quality.

Scope

  • PURA 2+ ISOLATOR
  • ISO 5 (Grade A) +ve pressure environment
  • ionHP+® Generator
  • Sterility Test Pump Double Filter
  • Telstar Glove Tester
  • Room H2O2 Monitoring
  • Trolley/Racking/Shelving
  • Non-Viable Monitoring
  • Viable Monitoring