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X-ONEPONCHO disposable protection from grade B to A

X-ONEPONCHO disposable protection from grade B to A

X-ONEPONCHO disposable protection from grade B to A

Product catalog summary
Overview: The X-ONEPONCHO Grade A Disposable Protection is designed to comply with updated Annex 1 GMP for sterile medicine production. It serves to prevent contamination in sterile environments and protect operators from exposure to processed substances.
Design and Features: The X-ONEPONCHO is a disposable protective overdress covering the operator's body, arms, and hands, with integrated gloves and a helmet. It is made from Tyvek® 1422A and LDPE materials, ensuring comfort and safety. The poncho is gamma-irradiated and packaged in a triple LDPE bag.
Usage Procedure: Operators can easily wear the X-ONEPONCHO without contacting its outer surface. The process involves inserting hands, donning the helmet, and unrolling the gown to cover the body up to the ankles.
Technical Specifications: The helmet is self-supporting with calibrated holes for sterile air, ensuring correct vision, breathing, and movement agility. The poncho includes LDPE gloves and a polyurethane piping system for air conveyance. A flexible polyurethane coil allows movement up to 7 meters, with a suggested airflow of 1.5 Bar - 80 L/min.
Compliance and Materials: The materials used do not contain asbestos, latex, phthalates, nitrosamines, metal impurities, PVC, or animal-origin raw materials. The LDPE material complies with EU regulations regarding BSE/TSE.
Company Information: CSV Life Science Group provides integrated solutions for the pharmaceutical market, including containment systems for high potent API design. The group consists of several branches, including CSV Containment, which specializes in containment systems.
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Catalog excerpts

X-ONEPONCHO disposable protection from grade B to A-1

Grade A Disposable Protection

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X-ONEPONCHO disposable protection from grade B to A-2

The X-ONEPONCHO 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-ONEPONCHO 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-ONEPONCHO allows the operator to wear it easily without contact with its outer surface.The...

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X-ONEPONCHO disposable protection from grade B to A-3

1 N.1 White Tyvek® 1422A PONCHO 2 N.1 Helmet in trasparent antistatic LDPE 3 N.2 Gloves in trasparent antistatic LDPE 4 N.2 Opaque white PP 90° curves 5 N.1 T-union in matt white PP N.2 Barb in opaque white PP 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 selfsupporting thanks to calibrated holes that feed sterile filtered air to assure: • Correct vision • Correct breathing thanks to air injection The poncho sleeves end in two LDPE gloves (3), also heat-sealed. A transparent polyurethane...

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X-ONEPONCHO disposable protection from grade B to A-4

(f/cs^Containment DESTINATION PHARMA •••••• CSV Containment is the branch of the Group with strong expertise in containment systems for high potent API design, construction and integration. The company can satisfy to the most demanding requirements thanks to its deep knowledge of the processes. CSV life Science Group is a group of companies providing the pharmaceutical market with integrated solutions. Its final purpose is to successfully complete a project in all its phases: from strategic decisions to engineering activities definition, from process development and containment strategy up to...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.