Conventional approaches to contamination control are changing. They are being driven by the need to anticipate contamination events, rather than simply react to them, and new regulations are supporting this shift in thinking. 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. This blog series goes into depth on both topics.
Consideration and Steps for Building a Contamination Control Strategy (CCS) – Series Part 1 of 4
Conventional approaches to contamination control are changing. They are being driven by the need to anticipate contamination events, rather than simply react to them, and new regulations are supporting this shift in thinking. 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. This blog series will go into depth on both topics.
How to Achieve Quality by Design (QbD) in a new Pharmaceutical Fill Line: Intro and Regulatory (Series Part 1 of 6)
In this blog series we will examine what a new fill line looks like with and without QbD implemented at the design phase. We will study each critical area of the fill line and the activities necessary to effectively bring the control features into effect. These examples come from real-world applications experienced by the Particle Measuring Systems’ Advisory Services Team. Our team has over 70 years of collective experience working in and advising cleanroom users around the world.
パーティクルカウンターの基礎知識と活用法を解説しました
株式会社R&D支援センター様主催のセミナーにおいて、気中および液中パーティクルカウンターの動作原理、使用方法、ISO 21501-4の要求事項などを解説しました。パーティクルカウンターの利用は、クリーンルームや超 […]
セミナーを開催しました
2019年6月7日㈮、梅雨入りした東京において、無菌医薬品の製造・品質保証にたずさわるお客様を対象にセミナーを開催しました。
