Continuous Environmental Monitoring in New Annex I

Episode 2,   Jan 13, 2021, 11:18 AM

In this episode, Andy Whittard (Managing Director at Cherwell Laboratories) and Gethin Jones (Managing Director at Pinpoint Scientific) lend their expertise to environmental monitoring in pharmaceutical manufacturing, focusing on the changes to continuous monitoring in the proposed Annex I. 

[0:45] - Differences Between Air monitoring & Air sampling
[4:53] - Difficulties in Setting up New System + Case Examples
[9:28] - Importance of High-Collection Efficiency
[11:20] - D50 Explained
[12:29] - Sieve vs Slit-to-Agar Samplers
[14:55] - Continuous Monitoring for Viables in New Annex I
[19:30] - Minimizing Contamination Risk
[21:52] - Adoption of Rapid Methods vs Reconfiguration of Existing Ones
[25:20] - Data Integrity Requirements

Andy Whittard - Managing Director Cherwell Laboratories & Director Pinpoint Scientific

Andy has been MD at Cherwell for 15 years. This family-owned business celebrates 50 years in business this year. Cherwell focuses on delivering cleanroom microbiology solutions to its customers in pharma and associated industries across the UK and Europe, through its own range of prepared microbiological media products and distribution of air sampling and monitoring equipment.

Gethin Jones - Managing Director Pinpoint Scientific
Gethin is founder and MD of Pinpoint Scientific, which was formed in 2011.  Before setting up the company, Gethin was R&D manager for a global biotech company and could see that the market products were not addressing the changing regulations in the pharma industry. 

Gethin saw an opportunity to develop a range of Annex 1 compliant Microbial Air Monitors, and that is exactly where we are today.  Pinpoint Scientific has developed a core monitoring technology platform based on well-established and trusted methods that can be packaged into a range of instrument formats to suit isolators and portable general monitoring applications. Gethin is an electronics & mechanical engineer by training with 30 years experience in biotech product design.