PRODUCTS

In the biopharmaceutical and medical industries, visible and subvisible 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. ATMI LifeSciences has developed medical grade low density polyethylene (LDPE) bags for packaging and gamma irradiation of powders, products and components.

• 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

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

For packaging and/or Gamma sterilization of:

• Stoppers,caps and closures
• Vials and containers
• API, medical powders, buffers, media
• Filters
• Medical devices
• Clean room garments
• Syringe components
• Organs

Downloads

• Data Sheet