Category: Facility Monitoring

NewsCleanroom sampling points

Cleanroom Contamination Control in a New Pharmaceutical Fill Line: Cleaning and Disinfection (Series Part 3 of 6)

Cleaning and disinfection of a pharmaceutical fill line & surrounding areas is a critical component of cleanroom contamination control. We all think we are familiar with the principles of cleaning protocols, but it is deceptively easy to get this form of control wrong without applying the standards of QbD to…

NewsContinuous Monitoring Concept

How to Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Surrounding Areas (Series Part 2 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 Systemsā€™ Advisory Services Team. Our team has over 70 years of collective experience working in and advising cleanroom users around the world.

NewsStem Cell Therapy Sterility Assurance Guidelines on Good Manufacturing Practice in Advanced Therapy Medicinal Products

Stem Cell Contamination Monitoring to Maintain Quality: (Series Part 4 of 4)

In this four-part blog series, we examine the regulations of stem cell product manufacture, considerations for quality control, and best practices when monitoring total particle and viable contamination.

NewsAirflow Visualization best particle counter ISO cleanroom standards

Electronic Data in Pharmaceutical Manufacturing: Data Integrity (Series Part 1 of 6)

In this six-part blog series, we examine common issues with data transfer, integrity, analysis, reporting and storage that we encounter as cleanroom owners and users every day. Weā€™ll explore how automation and electronic solutions, within the parameters of Regulatory Authorities and cGMP, can help improve efficiency and product quality.

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