CSV Containment’s upgrade to meet new Annex 1 requirements is a sterile disposable protection in Tyvek® and LDPE.
X-ONE PONCHO is the sterile disposable protection made in collaboration with Fresenius Kabi iPSUM S.r.l. ready to enter the Grade A zones. Shortly after the changes introduced with the most recent revision of Annex 1, CSV’s team of containment experts worked on a flexible solution, in every sense. As always, the blue division of CSV Life Science Group works closely with its customers to create tailor-made solutions. However, this is one of those cases where customisation can work for everyone.
Tested and modified according to direct field feedback provided by Fresenius Kabi Ipsum S.r.l. operators, the over-dressing coat is universal, disposable, lightweight and easy to use.
Minimal impact.
It is now a well-established imperative to have minimal impact on an environment, to affect production times and costs as little as possible, to be more sustainable. Working in sterile environments without running the risk of even the slightest contamination of the environment is an objective that, even following the upgrades brought about by Annex1, we are trying to work towards with more solutions. There are alternatives that do not involve a human presence, that increase tremendously costs by having no margin for error because they rely, for example, on robotics. They have no impact in terms of contamination, but they are energy-intensive and remove the man’s presence from delicate processes in which, however, the human capacity for reaction and judgement can make a difference.
The Tyvek® 1422A.
Therefore, the X-ONE PONCHO had to be designed and manufactured with high quality materials known in the market. Dupont’s Tyvek® 1422A was chosen for the textile component of the disposable protection. The consistency of Tyvek® makes the coveralls lightweight, which can also reduce the amount of energy needed to transport them compared to products made from heavier materials. Its superior tear resistance means less waste as it is less likely to need to be replaced during use. Finally, Tyvek® is manufactured without the use of plasticisers or chemicals that are restricted by European directives. The combination, by ultrasonic welding, with antistatic LDPE gloves and helmet, makes it possible to complete the protection with light, transparent materials from highly qualified suppliers and in compliance with the pharmacopoeia.
CSV Containment - X-ONEPONCHO BROCHURE A4
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A clear vision.
From the outset, CSV Containment had a clear vision: to provide the customer with a product that was easy to use, did not rely on batteries, as in the case of PAPR devices, and 
was able to provide the operator with a wide field of vision. One of the difficulties often encountered with wearable devices is that they have a limited field of view and a significant weight to support. In the case of the X-ONE PONCHO, the self-supporting structure of the LDPE helmet gives the product lightness and solidity, thanks to the air supply that is seamlessly connected to the existing systems. A lightweight tubular structure (already assembled in the irradiated gamma triple-bag kit containing the X-ONE PONCHO) carries the air from the top to the bottom of the protection and is connected, at the level of the silicone strap, to a spiral tube that extends up to 7 metres. The gamma irradiated tube, made of PU, is connected to the filtered air systems and allows the operator to breathe and move freely and support the helmet.
CSV Containment provides tailor-made solutions for pharmaceutical and fine chemical sectors in terms of containment. For more info: containment@csv-ls.com
