European Annex 1 encourages companies to develop a “Total Contamination Control Strategy” (TCCS). TCCS starts with proper determination of Maximum Safe Carryover (MSC), calculated based on health-based exposure limits (HBELs), a routine cleaning program to evaluate effectiveness of the steps used, followed by microbial Environmental Monitoring, Water and Utilities Monitoring, HVAC filter qualifications, Media Fills,…
Novatek will be leading workshops and exhibiting at this year's A3P workshops solely dedicated to the Cleaning Validation process. Full details on the workshop (to be provided in French and English) can be found here: https://www.a3p.org/a3p-validation-nettoyage-2022-lille
Sterility Assurance University is the industry’s most focused event dedicated to microbiology, contamination control strategy (CCS), and sterility assurance across the product lifecycle. This two-day summit brings together leading experts from pharma, biopharma, and device organizations to share actionable insights on Annex 1 implementation, environmental monitoring, aseptic processing, and cleaning validation — including lifecycle development,…
PDA Southeast Chapter presents the 2025 Vendor Showcase: Pharma on the Right Track – a vendor show designed to connect the region with product and service providers who can help drive the momentum in pharmaceutical manufacturing and biotechnology. Catch all of your key service provides in one incredible station! More than 40 top-tier, Life Science vendors have pulled into…
Since 2012, aseptikon has been an integral part of the German conference landscape with its conferences on aseptic production, microbiology, hygiene and other current topics on quality assurance and quality control. Lectures face-to-face, direct discussions with speakers and colleagues, exchanges of opinions during the breaks and during the evening together. Be sure to find our…
Regulatory agencies are requiring stricter standards for environmental monitoring systems, facility cleaning and disinfectant qualification, aseptic cleanroom operations, filtration, sterilization, and aseptic process simulation (or media fill). This two-day summit features comprehensive coverage of best practices in barrier, containment, and aseptic manufacturing and processing technologies.
Novatek International is excited to partner with Particle Measuring Systems for a webinar that dives deep into how environmental monitoring in pharmaceutical manufacturing is being transformed. Join us on October 14, 2025 for “Discover the Future of Automated Environmental Monitoring in Pharma.” What we’ll cover: 💠How to design automated, paperless workflows that reduce human…