Archived On Demand Webinars
Monitoring of nonviable and viable particles in a cleanroom is critical to meet regulatory requirements. An environmental monitoring system effectively collects, manages and reports on data from both types of sensors.
Best known methods to minimize external contamination in the sample are presented to support data optimization. Customers are encouraged to incorporate these concepts in their own process development.
When designing a process, product quality is an important measure of success. To ensure product quality, it is imperative that the environment is monitored for contamination.
Control of the environment in which pharmaceutical products are manufactured is a key element of Good Manufacturing Practices (GMP). Monitoring of particles & microorganisms in manufacturing cleanrooms, Restricted-Access Barrier Systems (RABS), and isolators consists of clearly defined components.
Download this webinar to get a first look and review of the Annex 1 draft, released for comments. Our experts will be providing their comments and will want to hear your thoughts on this new version.
Microbiologists have long recognized there are significant numbers of microorganisms in the environment that cannot be cultured successfully with conventional methods. A wide range of nonsporulating gram-negative and gram-positive bacteria can exist in the Viable But Non Culturable state.
Today, both the MHRA and FDA are highly focused on data integrity and currently discourage methods by which data is recorded manually.
ISO 21501-4 has two main goals; to improve instrument-to-instrument data correlation and count accuracy, and to enhance compliance with ISO 14644.