Annex 1 is a regulation that outlines manufacturing requirements for sterile drugs made in and imported to the EU. In August 2022, a new revision of the EU GMP Annex 1 regulatory standard for sterile drug products was released, replacing the most recent draft from 2020 and the existing revision from 2008. Contamination control is vital in pharmaceutical manufacturing, and the requirements for environmental monitoring remain essentially the same in this revision; changes in the recent revision of Annex 1 highlight strategic control through further alignment with existing regulations from other organizations, the concept of a contamination control strategy (CCS), the separation and expanded guidance on Cleanroom Classification and Cleanroom Monitoring, and the definition of Quality Risk Management (QRM) as a central principle to defining processes, operations, and limits.
DataPhysics Instruments has developed a new, 
written by Albrecht Truter
courtesty of
DVS Resolution is a dual vapor gravimetric analyzer, with key feature, is the combined ability to Question: “What is the need of taking a non-viable particle count after a power shut down for an hour. Our Class C area is stabilizing
after 30 minutes of a power cut?”
There are several reasons for deploying your Non-Viable Environmental Monitoring Program following a power outage,
but primarily it is to ensure that the HVAC has been restored and is now operating optimally – this is the 30-minute
stabilization that you witness in your Grade C areas. Grade C areas have a relatively high air exchange rate
(nominally, 20 air volumes per hour) so stabilization will occur rapidly in the unmanned state.
Online Workshop: Advanced Methods for Determining Physicochemical Properties of Solid State Materials
- Details
- Created: Monday, 25 April 2022 14:51
courtesy of Surface Measurment Systems
Join us for this workshop organized with the CARPOR platform of the University of Liège to explore pharmaceuticals
and inorganic materials using vapor sorption techniques.
The Data Quality Concept – A New Challenge for Quality Experts
- Details
- Created: Monday, 11 April 2022 09:09
courtesy of Particle Measuring Systems
The role of quality systems in pharmaceutical organizations has grown faster than any other function during the last 15 years. During this period, a small group dedicated to traditional Compliance grew and expanded to include Quality Experts in areas such as validation, product release, operations, sterility assurance, and other specialized functions.
Creating a deeper quality connection between manufacturing and engineering has always been the aim of that growth. Little by little, quality became fundamental to every step of the pharmaceutical manufacturing process: changing from a silo concept to a more fluid one. Now, a new challenge is approaching. The fourth industrial revolution (Pharma 4.0™) is the beginning of the “Smart Facility” era, where digitalization and automation will combine to reach very complex applications and life cycles. In this brand-new framework, Quality Experts will face the challenge of rethinking their roles and redesigning the Quality Systems of their pharmaceutical companies to be based on the concepts of Data Quality.
Just Added – Educational Podcasts from PMS
- Details
- Created: Monday, 11 April 2022 08:01
courtesy of Particle Measuring Systems
What’s new and interesting in the world of environmental monitoring? The 5 most recent podcasts from PMS are listed here. See below for the complete library of archived episodes. Here is the link
How structured surfaces can influence the dewetting behaviour of water droplets during icing and melting cycles
- Details
- Created: Monday, 28 February 2022 14:40
courtesy of Dataphysics
In January 2022, authors Lizhong Wang et al. published an article in Nature Communications with the title Spontaneous dewetting transitions of droplets during icing and melting cycle
. In it, they describe how the structure of a surface can influence the behaviour of a droplet during freezing and melting.
A case study of 4 hours active sampling using the Biocapt Single use - by Particle Measuring Systems
- Details
- Created: Tuesday, 04 January 2022 15:58
courtesy of Particle Measuring Systems
Extended active microbial sampling is allways of interest due to the possibility
to decrease the number of samples that has to be processed as well as potential
cost savings. Particle Measuring Systems recently released a nice case study
that proves that 4 hours of active sampling is possible.