Covid-19 has brought the need for tomorrow’s way of working crashing down on us today. This “new normal” means that many people will be working remote as frequently as possible. This presents challenges, including how to conduct an audit. Fortunately, there is one solution available today to solve this “new normal” problem when it comes […]
Particle Counter Data Remote Access, 21CFR11 Electronic Signatures…. The new normal is here. Companies want to protect their employees, keep pharmaceutical manufacturing running, while working efficiently and effectively and getting product to market safely and quickly. This presents a wide range of challenges that we did not face at the beginning of 2020. Fortunately, Particle […]
Part 2 of 6 part blog on : Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft The definition for Cleanroom Qualification is “The overall process to assess the level of compliance of a classified cleanroom with its intended use.” That is, classification is a part of qualification. Qualification methodologies […]
Part 1 of 5 part blog on : Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft The latest Annex 1 draft has some new definitions and guidance regarding Cleanroom Classification, Qualification, and Monitoring. Cleanroom Classification Annex 1 provides essentially the same cleanroom classification definition as ISO 14644-1: 2015 which […]
The latest Annex 1 draft offers several updated expectations on cleaning, decontamination and disinfection. Definitions Cleaning (NEW)A process for removing contamination e.g. product residues and disinfectant residues. Decontamination The overall process of removal or reduction of any contaminants (chemical, waste, residue or microorganisms) from an area, object, or person. The method of decontamination (e.g. cleaning, […]
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.
Daniele Pandolfi, Global Product Line Manager, and Frank Panofen, Global Marketing Manager, discuss data management systems and the way they can better improve your process in the digital age.
Upgrading is a streamlined process made easy by the FacilityPro® system’s user requirement specifications (URSs) of data integrity, automation, simplicity, integration, service and support.