FDA and EU GMP Annex 1 Differences of Cleanroom Specification. Is it Not Time to Eliminate Them?

FDA and EU GMP Annex 1 Differences of Cleanroom Specification. Is it Not Time to Eliminate Them?

04/02/2019, 11:30 AM - 12:15 PM

Javits Conventions Center - Stage 2, Booth 1577, Exhibit Hall
Language:
English
This presentation highlights several bullet points: - 5.0 μm particles and a general comparison of EU and FDA approaches to cleanroom specification/testing; criticism of Annex 1 and proposals to improve; - requirements for terminal sterilization and aseptic processes; - difference between cleanroom testing at start-up and routine monitoring; General requirement for testing to be more wide, than monitoring and Annex 1 confusion; - multi cascade enter procedure to zones CNC-D-C-B; useless of unnecessary complications and experience form other industries; - confusion with 4.8 ISO class in Annex 1 and nature of cleanroom classification in ISO 14644-1 standard; - doors interlocking in air-locks; danger for safety if to make this condition mandatory; - biocontamination in air; what do we really measure? Benefit of Rapid microbiological control and problem with relevant GMP issues; - others.

Contributors

  • ALEKSANDR FEDOTOV

    Speaker

    Dr.

    Clean Technologies

Type of Session

  1. Type of Session
    Session

Categories

  1. Track
    Optimizing Facilities through Innovation & Technologies

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