To reduce operators’ impact in Grade A areas, CSV Containment has developed a wearable, single-use, contamination reduction device, derived from our experience in the field of flexible isolators.
New Annex 1 also concerns the containment of contamination risks. One of the new guidelines in particular requires that unsealed containers must be maintained in Grade A conditions and normally be separated from operators by physical barrier technologies or any other appropriate measures.
Some of our customers working in the production of sterile lyophilized products for the pharmaceutical industry have been struggling to comply with this new requirement. In particular, they needed to minimize the impact of operators in grade A areas where it is not possible to replace humans with a technological solution.
One possible alternative to barrier technologies may be to robotize operations that require human intervention. However, introducing robots implies a major economic investment, which is not always sustainable, and is an extremely invasive solution. It means forcing significant production shutdowns of critical plants and production areas; rethinking utilities and layouts; disrupting personnel and material flows; preparing specific training; providing special maintenance; narrowing the field of potential suppliers to a few technology players; re-validating all processes and areas; reconditioning the sterility of departments and so on.
A single-use device designed together with the customer.
At the express request of the customer, CSV Containment has proposed and designed a sort of Product Protective Equipment (the opposite of the well-known Personnel Protective Equipment) that complies with Annex 1 requirements. This device ensures that production operators can easily access Grade A areas even though they come from background B.
Operators from Grade B are already dressed for sterile and protected environments, and this makes them protected, but also not exactly agile in their movements. In addition, the environment in which they work requires caution and a certain amount of caution in carrying out production activities. Therefore, CSV Containment has developed this device by involving sterile production operators, testing it under productive conditions, and gathering criticism and suggestions from them. Thus, we have successfully created this device, called B2A XONE, in a useful format, easy to wear on the existing suit, and comfortable to use during movements, especially when loading and unloading large tray dryers.
- Freeze and Tray dryer charging-discharging
- Aseptic Preparation Tank Charging
- Discharging from the sterile side of sterilizing autoclaves and depyrogenating
The B2A XONE consists of a kind of GMP Suit equipped with a transparent helmet made of flexible material with sleeves and gloves.
- Tyvec apron of minimum size 3XL so it can be worn over sterile environment clothing and long enough to protect the operator to below the knees
- Heat-sealed back zipper equipped with a cord to allow the operator to open and close the apron at the back easily
- Tyvec sleeves
- Heat-sealed gloves made of dissipative LDPE or Silver Shield
- Helmet made of transparent and dissipative Film to ensure maximum visibility and lightness for the operator. The helmet is integral to the cover and provides an additional physical barrier between the operator and Grade A.
- The helmet is semi-rigid and self-supporting due to controlled air intake that not only allows the operator to breathe but also provides comfort and room for movement. Air enters the inside of the helmet through calibrated holes in such a way as to inflate the air distribution circuits, allow the operator to breathe, and simultaneously act as pressure vents without which the helmet would explode
- The helmet is equipped with an 8/10mm side quick coupler for connection to the air supply circuit in full autonomy
- A quick-connect belt to be tightened around the waist allows the operator to secure the air hose to which it is connected, preventing it from pulling
The B2A XONE is made of materials in compliance with GMP and EU & US pharmacopoeia requirements. Each item is packaged in double or triple anti-static, gamma-irradiated LDPE bags.
CSV Containment provides tailor-made solutions for pharmaceutical and fine chemical sectors in terms of containment. For more info: firstname.lastname@example.org