In light of the new version of Annex 1, which came into force in August 2023, many pharmaceutical manufacturers are facing the question whether they must invest in new equipment. However, in many cases upgrades are a good alternative, as the Danish company AJ Vaccines showed. Together with this cust…

A fundamental consideration in Annex 1 is the risk posed by people and the necessity to exclude people from Grade A environments. Any personnel interaction with Grade A poses a risk. The primary means to address this is trough the use of separative devices – isolators and forms of RABS.

Once again, we…

“For disinfection to be effective, prior cleaning to remove surface contamination should be performed. Cleaning programmes should effectively remove disinfectant residues. More than one type of disinfecting agent should be employed to ensure that where they have different modes of action, their co…

The highest risk within a cleanroom is personnel. Despite this, the new Annex 1 seems to give not enough attention to such an extremely delicate operation as gloved hand disinfection. Human error, its imponderability, and especially the absence of traceability make this a high-risk operation. What i…

Buy a new machine or upgrade the existing equipment? In light of Annex 1, pharmaceutical manufacturers are facing this perennial question now more than ever. The Danish pharmaceutical company AJ Vaccines and its long-term partner Syntegon showed that upgrades can also yield great results. They moder…

Das perfekte Nebelfluid gibt es nach wie vor nicht. Pharmaunternehmen, die  Strömungsvisualisierungen in kritischen Reinraumbereichen durchführen bzw. durchführen lassen, finden in diesem Whitepaper fundierte Informationen, um das für den konkreten Anwendungsfall geeignete Nebelfluid auszuwähl…

Im August 2022 erschien der neue und vollständig überarbeitete Annex 1 zum GMP-Leitfaden der EU mit vielen neuen Anforderungen an Luftströmungen und Strömungsvisualisierung. Diese werden im vorliegenden Whitepaper einzeln erörtert.

Der Anhang 1 zum GMP-Leitfaden1 (nachfolgend als neuer Annex 1 bezeichnet…

Let's talk about a challenging topic for the pharmaceutical industry, the transfer of materials in a contamination controlled area with Dr.Tim Sandle.

Dr. Tim Sandle is a pharmaceutical microbiologist, science writer and journalist. He is a chartered biologist and holds a first-class honours degree i…

Cherwell, specialists in cleanroom microbiology solutions for the pharmaceutical, healthcare and related industries, has published the findings of an investigative study suggesting that prepared media plate choice can affect the accuracy of microbial air sampling. This is a significant finding as fo…

Im August 2022 veröffentlichte die europäische Kommission den überarbeiteten Annex 1 „Manufacture of Sterile Medicinal Products“ der „Volume 4 EU Guidelines for Good Manufacturing Practice für Medicinal Products for Human and Veterinary Use“. Dieser enthält unter anderem Änderungen und…