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…

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…

The revision of Annex 1 is requiring a major effort from the life sciences industry; from ‘setting up new processes, to training staff, to managing noncompliance, the industry needs to adapt particularly to new requirements regarding contamination control strategy and the essential elements needed…