A New Approach to Active Air Sampling, Meeting the Proposed Changes to Annex 1 Regarding Viable “Monitoring”

Time: 3:10 pm - 3:30 pm

Date: 30 April 2019

30-april-2019 15:10 30-april-2019 15:30 Europe/London A New Approach to Active Air Sampling, Meeting the Proposed Changes to Annex 1 Regarding Viable “Monitoring”

Within the proposed changes to Annex 1 of the GMP Guide, Section 9.27 specifically refers to Viable “Monitoring” throughout the sterile production period for the first time. A typical Environmental Monitoring plan, includes active air sampling and settle plates. In the talk we will discuss the options to progress from interval sampling by active air… Read more »

Making Pharmaceuticals

Synopsis

Within the proposed changes to Annex 1 of the GMP Guide, Section 9.27 specifically refers to Viable “Monitoring” throughout the sterile production period for the first time. A typical Environmental Monitoring plan, includes active air sampling and settle plates. In the talk we will discuss the options to progress from interval sampling by active air samplers, to monitoring, employing real time microbial instruments and / or by alternative classical agar based sampling procedures.

Speakers

  • John Cobb Microbiology Manager - PMT (GB) Limited

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