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PharmaPure AS™ Anti-Static LDPE

PharmaPure AS™ Anti-Static LDPE

Product catalog summary
Overview: PharmaPure AS is an anti-static LDPE film designed for the handling and storage of pharmaceutical products, including APIs, media buffers, and excipients. It offers anti-static performance without relying on chemical additives, thus eliminating the risk of contamination from additive leaching.
Key Features and Compliance:
  • Complies with European Pharmacopoeia 3.1.4 for polyethylene without additives for parenteral and ophthalmic preparations.
  • Meets US Pharmacopoeia standards, including physicochemical and in vivo biological reactivity tests for Class VI requirements.
  • Adheres to FDA regulations under 21 CFR 177.1520 for olefin polymers.
  • Exhibits anti-static dissipative properties with an average surface resistivity of 10⁹ Ω sqm.
Product Range:
  • Continuous/Endless Liner Packs: Standard with PharmaPure AS, simplifying liner pack changes to under 15 seconds for a single operator.
  • Flexible Chargebags: Available in various sizes with Tri-Clamp connections, customizable from 0.5 to 60 liters.
  • Ezi-Flow High Containment Chargebags: Designed for high containment charging of materials, tested to <1µg/m³ based on SMEPAC guidelines.
  • Tailgate Bags and Sample Pouches: Additional packaging solutions offered.
Contact Information: For more details, contact [email protected] or call +44 1623 888 000.
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Catalog excerpts

PharmaPure AS™ Anti-Static LDPE-1

Anti-Static LDPE Additive Free Anti-Static Performance No Product Contact PharmaPure AS is an Anti-Static LDPE film suitable for the handling & storage of most Pharmaceuitcal Products, including API’s, Media Buffers & Excipients. PharmaPure AS has an antistatic performance that DOES NOT rely on chemical additives, completely eliminating the risk of migration & product contamination due to additive leaching. A unique production process uses digital print technology to apply a lacquered grid matrix on the outer surface of the film. The inner, product contact area, is completely additive free. Material Key Feature/Compliance. European Pharmacopoeia 3.1.4 Polyethylene without additives for containers for preparations for parenteral use and for opthalmic preparations. (EP 9.2th Edition 2017) US Pharmacopoeia Passed the relevant physicochemical tests according to USP <661> and in vivo biological reactivity tests required for the USP <88> Class VI requirements. It also complies with the Plastic Class VI 70° Celsius - 24 Hour Requirements. Code of Federal Regulations - FDA Paragraph 21 CFR 177.1520 (olefin polymers) (c) 3.2a Anti-Static Dissipative Properties Achieves an average surface resisitivity of 10 ⁹ Ω sqm World Class Industrial Packaging Solutions PharmaPure AS™ Product Range Continuous/Endless Liner Packs Ezi-Dock continuous liner packs are manufactured with PharmaPure AS™ as standard. Ezi-Flow Safe Change Continuous Liner A New product to simplify the tricky operation of removing & replacing a continuous liner pack. No more flexible canister bands + grooved O Ring swap overs. Changeover takes less than 15 seconds - Single Operator. Tested to <1µg/m³ (Task Duration), based on SMEPAC guidelines Flexible Chargebags A wide range of Chargebags with 2/4/6/8inch Tri-Clamp Connections (BS4825-3) - 0.5 Litre - 60 Litre (Custom Sizes Available) Ezi-Flow High Containment Chargebags High Containment Charging of materials <1µg/m³ (Task Duration), based on SMEPAC guidelines Tailgate Bags + Sample Pouches For further info contact [email protected] or Telephone +4

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