Flexible film manufacturer Solo Containment has developed an isolator half-suit that it claims is more pharmaceutically compliant than current PVC half-suit designs.
Because many pharmaceutical companies prefer not to use PVC due to the hazards associated with phthalate release, the company’s engineers realised that there was a need for a half-suit manufactured from a Food Approved polyester-polyurethane.
Polyurethane film has excellent mechanical properties and is free of phthalate, making it suitable for contact with pharmaceutical products. Unlike conventional PVC, polyurethane will not work-harden, providing a lighter more flexible half-suit enclosure that greatly reduces operator fatigue.
To further help user comfort, Solo’s new half-suit is provided with a knitted fabric lining to ease entry and exit; the suit is also fully ventilated with cooling channels at the helmet and arm regions.
For added operator safety in pharmaceutical applications a suit-mounted canister H14 HEPA filter may be specified as an inline filter for the air supply system to the suit.
The half-suit is available with either an interchangeable standard half-suit helmet or a permanently attached lightweight helmet, in addition to a range of glove and cuff systems.
ATEX compliance for pharmaceutical manufacturing applications was a key consideration in the development of the Solo half-suit, resulting in a product fabricated from a high spec antistatic polyurethane film. (1 x 1010 Ω)
The half-suit features anti-static gloves mounted on a conductive HDPE push-push safe change glove cuff system that meet the pressure decay requirements for Nitrogen inerted isolation systems.
Solo’s polyurethane formulation has been trialled by a partner NHS hospital and is resistant to common hospital disinfecting and biocidal agents.
Several key pharmaceutical clients are also using the half-suit in manufacturing operations and feedback shows that the new design is a major step forward, the firm says.
