Polypropylene films for Bioprocess containers & Single-use technology
Single-use systems for biopharmaceutical manufacturing processes are in ever-increasing demand. They are cost effective as they do not require cleaning procedures, are easily used and simple to implement. The 2D pillow bags and 3D process bags make production much more agile, and from a quality point of view, eliminate cross-contamination during production changes.
However, biopharmaceutical drugs are extremely sensitive products. Unlike chemical drugs, biological products (e.g., vaccines, cell cultures) are manufactured from living cells. As they cannot withstand the heat of terminal sterilization, they require containers that meet very high-quality standards. One other specification is that they must be strong enough to ensure excellent resistance, as the volume of this type of container can reach several thousand liters.
Polycine’s multilayer polyolefin films are qualified according to strict quality standards to meet all requirements of the biopharmaceutical industry. They are manufactured in an ISO7 controlled atmosphere environment, which guarantees a low level of particles. As interactions between the container and the content can alter the integrity of the products, Polycine has conducted studies of extractables and leachables, which confirm the inertness of the raw material. Another advantage is that Advanced PolyEthlyene (APE) films have a high resistance to allow the design of process bags and bioprocess containers in volume ranges up to 1000 to 2000 liters.
Fully traceable, each batch is supplied with the corresponding certificates of analysis. The co-extruded films of the APE range with high purity and medical quality are thus perfectly adapted to the manufacturing of bio-containers for the biopharmaceutical industry.
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