Product Details

Medicinal LDPE Films

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.

Medicinal LDPE films/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