The new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.

Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.

The Growth Promotion Test (GPT) evaluates whether the culture media is suitable for use in environmental monitoring sampling. Explore recommendations to follow to ensure a successful GPT.

Learn how modern advancements can improve the efficiency of microbial air sampling while minimizing the chances of false positives in cleanrooms.

Explore key guidelines for preserving the purity and quality of compressed gas, with an emphasis on contaminants, monitoring, and preventive maintenance practices.

Learn about compressed gas systems and why effectively identifying and managing the risks associated with these systems is critical for maintaining product quality and ensuring compliance with GMP.

Learn about active air sampling and the characteristics of various microbiological sampling methods that are designed to optimize collection efficiency.

Explore test results demonstrating the suitability of a robust microbial sampler for environments where frequent exposure to harsh cleaning and sterilization methods, like VHP in isolators, is routine.

Examine how one environmental monitoring system provided seamless and continuous cleanroom monitoring and control during the major global IT outages due to the CrowdStrike incident.

Here, PMS Senior GMP Scientist, Mark Hallworth answers questions that arose while presenting on EU GMP Guidelines for Environmental Monitoring. Explore his answers to gain insights into these guidelines.

There are several factors associated with active environmental microbial monitoring. Watch to learn how the EU GMP Annex 1 compliance focuses on microbial monitoring in cleanrooms.

Industry expert Mark Hallworth guides viewers through the latest ISO document (ISO 14644), exploring the reasons behind the decisions made by the team during its development.

Airflow visualization techniques like Smoke Studies and CFD analyses are crucial for contamination control, aiding cleanroom qualification, environmental monitoring, and optimizing contamination control strategies under Annex 1.

Discover how a Quality by Design approach can streamline the development of new sterile product filling lines, featuring a real-life example illustrating its effectiveness.

Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.

Review the standards and regulations promoting a cohesive environmental program, and explore manual compounding in laminar flow hoods, through to filling lines, in both open and closed systems.

Gain insight into the standard for microbiological monitoring and control, ISO/EN 17141, and how it harmonizes with ISO 14698 parts one and two.

Review the latest revisions to the USP<1788>, which has expanded to support a holistic view of finished product contaminants, how they should be investigated,  and added flow imaging technologies.

In this webinar we review how to be compliant with the most recent particle counter calibration requirements, particle counter terminology, and how a particle counter works in theory.

Learn how the BioCapt® Single Use microbial impactor for cleanroom monitoring satisfies the requirements of the new EU GMP Annex 1 and is an efficient device under stress conditions.

Modern pharmaceutical manufacturers are already generating and managing big data from environmental monitoring; the next step is to create actionable insights and ensure 21CFR11 compliance. This webinar discusses data collection, 21CFR11 data management and the generation of actionable insights.

The New Annex 1 has some critical changes that are important to understand and start applying. While the drafts cover many areas of environmental monitoring in-depth, this webinar by Particle Measuring Systems (PMS) experts focuses on the Viable/Microbial Air Monitoring aspects.

Sometimes we focus on data while forgetting how poor practices, bad decisions, incorrect definitions, and lack of evaluations effect the outcome. In this webinar, we analyze how to go from “data” to “data quality” to improve your overall contamination control strategy.

Settle plates are a non-validatable method as it is simply based on the physical principle of the downfall of a particle on a surface. We discuss the using active air sampling versus passive air settle plate monitoring in routine environmental monitoring.

Defining a Contamination Control Strategy (CCS) is unique for each process and requires an intimate understanding of both the process and how to implement an effective strategy.