PALL Newform Medical Grade LDPE Bag

PALL Newform Medical Grade LDPE Bag

Description | Applications | Benefits | Medical Compliance | Features | Fact Sheets | Purchase Information

Description

In the biopharmaceutical and medical industries, visible and sub visible contaminants from packaging materials will not only reduce process efficiency by generating unacceptable waste percentages, but they can also constitute real chemical and biological hazards when delivering a parenteral drug to a patient.

Low particle level should be guaranteed by the product supplier. In addition, product integrity must be 100% guaranteed by the packaging itself. PALL LifeSciences has developed medical grade low-density polyethylene (LDPE) bags for packaging and gamma irradiation of powders, products and components.

Applications

For packaging and/or Gamma sterilization of:

  • Stoppers, caps and closures.
  • Vials and containers.
  • API, medical powders, buffers, media.
  • Filters. Medical devices.
  • Cleanroom garments.
  • Syringe components.

Benefits

  • Low visible and subvisible contaminants level.
  • Low bioburden and endotoxin level.
  • Low leachables and extractables level.
  • Certified cleanliness level.
  • Improved process efficiency.
  • Gamma sterilisable up to 50kGy.
  • Pre-sterilized bags available upon request (gamma irradiated at 25 kGy certified).

Medical Compliance

  • Quality approved by key market players.
  • Cleanliness level 100 according to IEST-STD-CC1246D standard.
  • LDPE film is compliant to:
  • FDA Title 21 Code of Federal Regulation 177.1520 ‘Olefin polymers’.
  • EU Directive 10/2011 relating to plastic materials and articles intended to come into contact with foodstuffs and its amendments.
  • USP <88>, biological reactivity test in vivo, class VI. USP <87>, biological reactivity test in vitro. USP <661>, physicochemical test – plastics.
  • EP monograph 3.1.3, Polyolefins.
  • EP monograph 3.1.4, Polyethylene without additives for containers for parenteral and ophthalmic preparation.
  • EP monograph 3.2.2, plastic containers and closures for pharmaceutical use. LDPE film is Animal Derived Component Free (ADCF).

Features

  • In-house extrusion of LDPE film using certified and virgin resin without any additives.
  • Blown-film extrusion of LDPE film, conversion and packaging in certified ISO Class 5 cleanrooms.
  • Flexibility in customizing sizes, thicknesses and shapes (bags, tubing, sheets, film).
  • Dye-penetration test (methylene blue) to show packaging integrity.
  • Certified working in conformity with the European current Good Manufacturing Practices (cGMP).
  • Notification of Change policy prior to change on resin composition, manufacturing process or regulatory status.
  • Material Drug Master File on resin registered with US FDA.
  • Customized sizes are available upon request.
  • All bags are labeled and double packed per 100 pieces and delivered with a Certificate of Conformity (CoC).
  • Standard thickness: 100 μm. Other thickness available upon request.
  • Can be delivered gamma-irradiated upon request and delivered with a certificate of sterilization.
  • Width equals opening of bag.
  • Certificate of Analysis available on request.

Fact Sheets

Download

Purchase information

Available upon request