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 problems introduced by Annex 1 for Grade A environments, developed in collaboration with Fresenius Kabi. 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. Our extensive experience with flexible materials, including LDPE, enabled us to create a safe combination with Tyvec 1422A®. Following the update of Annex 1 GMP – Production of Sterile Medicines, we envisaged using these elements to create a coat for operators working in Grade A environments. The Tyvec gown with integrated LDPE helmet and gloves is produced in ISO8 and ISO7 classified areas to be gamma irradiated later.
Elena, can we have a little more detail on the composition of this clothing?
Sure. It is a disposable GMP coat designed to cover the operator’s body, arms, and hands with gloves and a helmet. In this way, we achieve a double objective: to prevent the operators from contaminating themselves in a sterile environment and to protect them from the substances being processed. The device offers comfort and safety as it uses the air (which allows the operator to breathe freely) to automatically adjust the helmet. An adjustable belt allows the operators to hold the clothing tighter to the body and to bind the airflow system to themselves. Finally, a coiled hose connected to the helmet’s hose attachment provides airflow and freedom of movement for several meters.
CSV Containment provides tailor-made solutions for pharmaceutical and fine chemical sectors in terms of containment. For more info: containment@csv-ls.com
