Datasheets

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’