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AM Instruments Srl

Pharmaclean® Tyvek® - PET/PP Bags & Reels

Pharmaclean® Tyvek® - PET/PP Bags & Reels

AM Instruments Srl
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Description

Pharmaclean® bags and reels in Tyvek® 1073B and PET/PP for the autoclaving of components and tools are manufactured and packaged in our Grade C Operational cleanroom. Tyvek® and PET/PP are biodecontaminated with the exclusive Safe4Clean® system which guarantees a significant reduction of viable and non-viable particles. The strength and breathability qualities of Tyvek® 1073B combined with the transparency of PET/PP allow the preservation of the sterilised content while maintaining its total visibility.

GMP QUALITY

  • Industry 4.0 production machine with integrated Safe4Clean® material biodecontamination system
  • great peelability, very low particle release
  • raw material and finished product analysis
  • availability for production site audit

EFFICACY

  • high efficacy antimicrobial barrier
  • excellent resistance to sterilisation cycles, rips and drillings
  • thumb notch opening and chevron welding
  • 5-year shelf-life

FLEXIBILITY

  • possibility to make drill to hang bag inside isolators
  • dedicated before- and after-sales assistance

More from us

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Pharmaclean® Tyvek® Covers & Bags

Pharmaclean® is the AM Instruments production department in cleanroom dedicated to an innovative line of products for the packaging and the protection of sterility, specifically designed to meet our customers’ needs in terms of effectiveness, safety and compliance with regulatory requirements.

Production in Grade C Operational, Grade A/B RABS

Pharmaclean® responds to the specific needs of the life sciences industry, producing customised protection, packaging and sterilisation systems. Each customer request is discussed with the support of our QA, defining the operational flows and any verification and release test, to offer a GMP-compliant service that satisfies customers’ specific requests.

FEATURES

  • standard and custom shapes and sizes
  • tear and perforation resistant
  • easy to apply and remove
  • low particulate release
  • excellent microbiological barrier
  • uniform vapour penetration across the surface

Zherox® line for Biodecontamination with HPE Technology

Zherox® is a complete line for biodecontamination with the innovative HPE (Electromagnetized Hydrogen Peroxide) technology.

Mobile (cloud and stand alone system), portable and fixed systems.

A <8% hydrogen peroxide solution is diffused through a nozzle, creating a mist of micro-droplets which are ionised when they pass through a high-voltage electromagnetic field. The resulting solution has a high concentration of hydroxyl radicals and ROS (reactive oxygen species) which are able to cause damage to microorganisms by the oxidation of proteins, carbohydrates and fats. The electromagnetic field generates an electrostatic charge in the mist which thereby acts as a gas due to the mutually repulsive action of positive charges. The result is a high rate of solution dispersal able to cover 100% of the area to be treated. The resulting products, oxygen and water, leave no residue on surfaces.

EFFECTIVENESS

The biodecontamination effectiveness of the solution and its improved distribution are guaranteed by the action of a source of ionising energy consisting of an electromagnetic field able to increase the oxidising efficiency of the solution by 50%.

OPTIMISED DIFFUSION

Optimised distribution of the solution in the space. The positively charged micro-droplets repel one another, dispersing the solution as if it were a gas. It is not necessary to use ventilators to optimise diffusion.

SPEED

The system is capable of sanitising up to 300 cubic metres with a single unit. In larger areas it is possible to use several units Zherox® Cloud Based System at the same time, interconnected by Wi-Fi and managed as a single system, permitting optimised dispersal of the mist and reducing cycle times. No ambient conditioning of the premises is necessary.

MATERIAL COMPATIBILITY AND SAFETY

Maximum material compatibility: the solution used has a concentration 4 times lower (<8%) than VHP systems (35%) and has no hazard rating, is not explosive and is not flammable or corrosive.

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