Quick Detail
Base Material: High-purity pharmaceutical-grade LDPE (Low-Density Polyethylene)
Core Advantages: Pre-sterilized (EO/Gamma), contaminant-free, excellent flexibility
Compliance: GMP, ISO FDA certified
Target Application: Transfer of APIs, pharmaceutical excipients, and bulk drug substances
Sterility Level: validated sterilization process
Custom Options: Thickness (0.03mm-0.2mm), width (100mm-1200mm), roll length
Safety Traits: No plasticizers, low extractables, biocompatible, non-toxic
Production Standard: Class C+A clean room manufacturing
Description
For the transfer of APIs (Active Pharmaceutical Ingredients) and pharmaceutical excipients, maintaining sterility and preventing cross-contamination is non-negotiable—yet traditional non-sterile films or low-quality LDPE materials often fail to meet these critical demands, leading to batch rejection, regulatory penalties, and compromised drug safety.
Our Sterile Pharmaceutical LDPE Film is specifically developed to solve these pain points, tailored for the safe transfer of high-value APIs and excipients. Produced entirely in a Class C+A clean room, the film undergoes a validated sterilization process ( Gamma ray) to achieve a sterility assurance level , eliminating pre-transfer contamination risks for your pharmaceutical supply chain.
Crafted from high-purity pharmaceutical-grade LDPE resin, the film is free of plasticizers, heavy metals, and harmful additives. Its low extractable profile ensures no chemical leaching into the transferred materials, preserving the purity and efficacy of APIs and excipients. With excellent flexibility and tear resistance, it adapts to various transfer equipment (e.g., transfer hoses, funnels, and containers) while maintaining structural integrity, preventing spills and cross-contamination during handling.
The film’s smooth surface minimizes material adhesion, reducing product waste and ensuring maximum yield of valuable pharmaceutical substances. Whether for in-plant transfer, between production stages, or bulk shipment of APIs/excipients, this sterile LDPE film delivers reliable performance, regulatory compliance, and peace of mind for your critical pharmaceutical processes.