X-One Poncho

The X-ONE PONCHO Grade A Disposable Protection has been designed to comply with the updated Annex 1 GMP: Production of Sterile Medicines. It is a disposable GMP protective overdress designed to cover the operator's body, arms, and hands with gloves and a helmet.

X-ONE PONCHO achieves a dual objective: to prevent contamination of sterile environments by operators and to ensure that operators are not exposed to the substances being processed.

The device offers comfort and safety for any type of operation. X-ONE PONCHO allows the operator to wear it easily without contact with its outer surface. The operator must first insert both hands, then put on the helmet, and finally, without contaminating the outer surface thanks to the gloves, can unroll the gown covering the body up to the ankles.

Like all our flexible products, it is produced in ISO 8 and ISO 7
classified areas. X-ONE PONCHO comes in a triple LDPE bag closed by heat-sealing. The product is gamma-irradiated.

The PONCHO (1), heat-sealed to the helmet and made of Tyvek® 1422A, covers the operator up to the ankles.

The helmet (2) made of LDPE is designed to be self-supporting thanks to calibrated holes that feed sterile filtered air to assure:

• Correct vision.
• Correct breathing thanks to air injection.
• Agility in movements.
• No contamination of products.

The PONCHO sleeves end in two LDPE gloves (3), also heat-sealed. A transparent polyurethane piping system (7) and opaque white polypropylene fittings (4) (5) (6), placed on X-ONE PONCHOs' helmet, serve for conveying sterile filtered air necessary for breathing and support of the structure.

A very flexible polyurethane coil (9), connected via a quick coupling to the ventilation circuit, quarantees freedom of movement thanks to its extension up to 7 meters. Suggested air flow: 1,5 Bar - 80 L/min.

A silicone belt (8) secures the reaction circuit and the spiral to the X-ONE PONCHO. This avoids damaging the coat, ensuring that the feed air escapes from the bottom. The belt is adjustable with two stainless steel snap hooks to be inserted into the multiple holes.

X-ONE PONCHO compliance-The LDPE material of X-ONE PONCHO complies with:

• Reg. 1069/2009/EC and 142/2011/EC as well as the 'Explanatory Note EMEA/410/01, rev. 3' about BSE/TSE
• EU Guideline EMA/CHMP/ICH/353369/2013)

Materials do not contain:
• Asbestos
• Latex
• Phthalates
• Nitrosamines
• Metal impurities
• PVC
• Raw materials of animal origins.