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The Rapidmicrobiology Podcast
24 minutes | a month ago
4: Shelf-Life Testing: Opening a Can of Worms - a rapidmicrobiology podcast
The food industry is constantly innovating – we have new protein sources like insects and algae, we have new packaging materials, we have new formulations reducing sugar and salt, other preservatives – how do manufacturers keep their shelf life dates relevant to their product changes? We’ll find out from food safety expert Linda Everis who currently manages the challenge test/shelf life studies at Campden BRI.Timestamps:[1:05] - 'Use-by' or 'Best-before'[4:18] - Challenges with extending shelf-life[7:05] - Determining safe shelf-life[8:26] - Determining quality & open shelf-life[13:11] - Listeria[16:20] - Consequences of a badly-designed challenge test[18:52] - Advanced Microbial Profiling (AMP)[20:51] - Predictive Microbiology
24 minutes | 2 months ago
3: GMP Annex 1: Changes in Microbial Monitoring
In this episode, Anne Klees and Adele Gisselmann (Global Product Managers with Merck KGaA, Darmstadt, Germany) unravel the New GMP Annex I (Draft 2020) and explain what effect its changes and new sections will have on environmental microbial monitoring. Timestamps:[1:20] - Key Changes in Annex I[2:31] - Rapid and Alternative Methods in Annex I[6:10] - Qualification of Recovery Rates for Air Samplers & Culture Media[7:45] - Validating Media for its Neutralization Efficiency[9:05] - Validating Air Samplers [14:40] - New Sections in Annex I (Aseptic Process Simulation/Media-fill etc.) [20:28] - How Merck KGaA, Darmstadt, Germany can help with Regulatory RequirementsSpeakers: Dr Anne-Grit Klees, is a Global Product Manager for Environmental Monitoring at Merck KGaA, Darmstadt, Germany. She is a microbiologist and graduated at Philipps Universität Marburg in 1992. Since then she has been Global Product Manager for Biotest, heipha Dr Müller GmbH and Merck Life Science with strong expertise on environmental monitoring in pharmaceutical industries including ready-to-use culture media for air, surface and personnel monitoring.Adèle Gisselmann is Global Product Manager for Environmental Monitoring at Merck KGaA, Darmstadt, Germany. She has three years of experience in technical support for process solutions at Merck KgaA, Darmstadt, Germany, and a background in the food and beverage industries and microbiology.
29 minutes | 2 months ago
2: Continuous Environmental Monitoring in New Annex I
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. Timestamps:[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 RequirementsSpeakers: Andy Whittard - Managing Director Cherwell Laboratories & Director Pinpoint ScientificAndy 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 ScientificGethin 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.
43 minutes | 2 months ago
1: One Lab’s Experience of Testing for Legionella
In this episode on Legionella testing, we have Ray Petrisek, a principal investigator in the discovery of Legionella in the ‘70s, who gives advice on testing and sampling for Legionella and the limitations and advantages of test kits in today’s market. Timestamps:[4:47] - Legionella discovery in the lab[12:13] - Testing for Legionella in Potable water[13:51] - Sampling: “Look for the biofilm, and you’ll find Legionella”[21:21] - Limitations with plate-based method & PCR[29:54] - Preferred test method; IDEXX Legiolert[35:13] - Ongoing problems with Legionella
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