Newform™ LDPE cleanroom bags
Low-density-polyethylene (LDPE) cleanroom bags for packaging and gamma irradiation.
Newform™ LDPE cleanroom bags
Low-density-polyethylene (LDPE) cleanroom bags for packaging and gamma irradiation.
Variant
概述
Newform medical grade LDPE bags are a range of medical-grade, low-density-polyethylene (LDPE) bags for use in biopharmaceutical applications.
In the biopharmaceutical and medical industries, visible and subvisible contaminants from packaging materials not only reduce process efficiency by generating unacceptable waste percentages, but they can also constitute real chemical and biological hazards when delivering parenteral drugs to patients. Low particle levels should be guaranteed by the product supplier, and product integrity must be 100% guaranteed by the packaging itself.
Newform Bags are medical-grade, low-density-polyethylene (LDPE) bags, ideal for packaging and gamma irradiation of powders, products and components.
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
cGMP focused manufacturing
Material Drug Master File on resin is registered with FDA
Benefits
Low visible and subvisible contaminant level
Low bioburden and endotoxin level
Low leachables and extractables level
Certified cleanliness
Improved process efficiency
Gamma sterilizable up to 50 kGy
Pre-sterilized bags available upon request (gamma irradiated at 25 kGy, certified)
Quality
Cleanliness level 100 according to IEST-STD-CC1246D standard
LDPE film is Animal-Derived-Component-Free (ADCF)
Compliant to:
FDA Title 21 CFR 177.1520 ‘Olefin Polymers’
EU Commission Directive 10/2011 (food contact approval)
USP<87> Biological Reactivity test in vitro
USP <88> Biological Reactivity test in vivo, class VI
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’
Applications
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
