The Process

Quality Assurance of parenterals is paramount for the success of a batch, the company and its reputation. Simple, reliable and repeatable process steps form the basis of design of Klenzaids Sterility testing isolator system. Klenzaids containment and barrier technology teams have workflowed & developed an isolator with an inbuilt KlenzVap VHP biodecon system that generates an ideal environment for sterility testing.

The Product

  • Environment: Grade-A UDAF
  • Product includes:
  • Transfer isolator segment TI for product and implements transfer
  • Sterility testing isolator STI segment for conducting sterility tests
  • Inbuilt KlenzVap Biodecontamination system
  • Alternative fogging systems also available (for select applications/cycle times)
  • In-room design for ease of installation and engineering management
  • Catalytic conversion for maximum personnel safety and faster cycle times
  • Environmental Monitoring
  • Full documentation for cGMP compliance and qualifications
  • KontrolKlenz automation with batch recording and trending
    Value adds:
  • CE, UL marking as specified
  • Cycle Development and Cycle Validation (CD/CV) in collaboration with Valicare®
  • Potent Containment option with BIBO filtration to building exhaust
  • Turnkey sterility testing laboratory projects by Klenzaids Design & Build group
  • Microbial Limit Testing MLT work benches
  • Training modules for QA teams
  • Online automation support
  • Re-qualifications support
  • Annual maintenance

The Video

The Segments

Various custom configurations are possible ranging from 3 or 4 gloved sterility testing segments, to halfsuit versions for scale of operation. Klenzaids recommends this design as due to ergonomics, ease of install, qualification & re-qualification and after numerous interaction with global quality assurance experts like Valicare®.

Get in touch

O +91 22 6115 6215
E info@klenzaids.com

Klenzaids Contamination
Controls Pvt. Ltd.

A-21, M.I.D.C Industrial Area,
Street # 3, Andheri East.
Mumbai - 400 093, India.
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