Unisex medical coat

disposable

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.