PAPER: Annex 1 2022 Frequently Asked Questions
Particle Measuring Systems (PMS) recently hosted a webinar about the new Annex 1 2022 Revision. This easy-to-read compendium for quick…
PAPER: Condensation Particle Counter and Manifold FAQ
Commonly asked questions are combined with questions submitted during and after the webinar on the NanoAir® and ParticleSeeker® instruments in this document. The questions are answered below by product experts.
PAPER: Airflow Visualization Studies – The Impact of Annex 1 (2022) on Sterility Assuarance
Understanding critical air patterns and their impacts is paramount to controlling an environment and is a crucial activity in adhering to the relevant regulations. Scientific demonstration is the basis of pharmaceutical GMP regulatory compliance, and the best way to demonstrate air patterns is through airflow visualization studies (also known as smoke studies). If unidirectional airflow (UDAF) is used as a tool for mitigating the risk of contamination, a company must demonstrate its effectiveness through such studies.
PAPER: Contamination Control Strategies for Innovation and Regulatory Compliance
PAPER: Environmental Monitoring in ATMP Facilities
PAPER: The Continuous Monitoring Concept for Pharmaceutical Manufacturing
PAPER: Real-Time Aerosol Particle Monitoring Inside of Semiconductor Process Tools Using the Airnet® II
PAPER: Validation and Qualification Approach Outlined in New Annex 1 Revision
PAPER: Characterization of Critical Factors Affecting the Stabilization Time of Particle Measurements in Ultra-Pure Water Systems
PAPER: Adding Point-Specific Concentration Data into FacilityNet via OPC in a AirSentry® II AMC Monitoring System
