Unisex protective coveralls

sterileair-fedwhite

Annex 1 has introduced more strict safety standards, since its last revision. Elena Lovazzano, Process QA Specialist at CSV Containment, explained a possible solution to the updates introduced by Annex 1 for Grade A environments, developed in collaboration with a client. The product is intended to reduce the risk of contamination from direct operator contact. Elena, how did you create this disposable anti-contamination device in response to annex 1? At CSV Containment we are used to working step by step with the customer to meet their needs best. But this time we went one step further, and together with the customer we developed a tailor-made solution, a product that is both original and open to the entire pharmaceutical market that produces in sterile environments. Our client need was to further reduce the exposure of products to potential contamination by operators. However, the valuable human presence can sometimes pose a risk to the product being handled in a sterile environment. This is why, in recent years, robotics has been used in the pharmaceutical world for some delicate process steps. While robots are a guarantee of safety, they are also an inflexible, bulky, and certainly expensive solution. Not to mention the fact that no automation can fully replace the human ability to deal with unforeseen events or situations that require unconventional procedures. Does your solution guarantee a high level of safety, according Annex 1 regulations? Is there no risk of particles being released from the materials that make up the worn device? We performed several laboratory tests to identify the materials with the lowest particle release.