To provide high quality films to produce flexible primary packaging, medical grade raw materials, perfect knowledge of the manufacturing process and strict quality controls are required.
The production of the polymers used for the composition of Advanced PolyPropylene and PolyEthylene films is carried out according to Polycine’s own formulations. The raw material is first delivered in the form of medical grade granules. Upon receipt, the granules are immediately analyzed to ensure that each batch received, meets the specifications indicated on the attached certificate. This includes identification of the material, the batch number and the supplier’s test results. Once this step is completed and the conformity of the raw material is proven, the material can be released. The PolyPropylene granules are then conveyed via stainless steel piping into the extruder feeding systems of the extruders. The production of the films can then begin.
In a controlled Class 10,000 environment, multilayer PolyPropylene and PolyEthylene films are extruded in a specially developed water-cooling tubular film process. The melt streams coming from the extruders are filtered through screen packs and combined in the die. The extruded tube is then continuously exposed to Class 100 filtered air to ensure very low particle content.
Next comes the cooling phase. Here, the melted raw material is brought into contact with cooled osmosis water. Once the film tube has cooled, it is passed through a flattener and is smoothed. At this stage, the inner surfaces are folded together which provides additional protection against possible contamination. This is a significant advantage for manufacturers of flexible primary packaging. The films are then dried and wound onto the rolls while maintaining a constant tension. This is crucial, consequently preventing the film from shrinking during the final sterilization of the drug. The rolls are then individually wrapped in two successive wrapping films before being prepared for shipment.
To guarantee the highest level of quality expected by our customers, our fully automated production process is monitored online, and follows the Good Manufacturing Practices. All procedures established in the Quality Management System implemented by Polycine are strictly followed. In compliance with the ISO 9001 standard, the QMS also defines all the controls and validations that will be applied during and at the end of the production process, such as visual inspections or physico-chemical controls. Finally, the documentation system guarantees flawless traceability of all manufactured batches, tubes, or films.
Thus, Polycine’s multilayer films are in compliance with the US and European Pharmacopoeia and are registered with the Food and Drug Administration. Flexible packaging manufacturers and laboratories with Form Fill Seal machines have high performance and reliable films at their disposal to guarantee the integrity and purity of the drug until its administration to the patient.