As the container is made, filled, and sealed within a single machine and the process is protected using a sterile air shower and additionally, all process media (solution, air etc.) are sterile filtered, the chance of contamination is very remote. Adding to the fact that during the whole cycle, open containers remain exposed to the cleanroom air for less than 1.5 seconds, the Blow-Fill-Seal technology becomes the process of choice where contamination of particle matter and microbial contamination is a primary concern.
Primary Packaging (or the container) protects pharmaceutical ingredients from environmental contaminants, micro-organisms, as well as the particulate material. The container also protects active ingredients and/or excipients from getting out due to diffusion and thus providing stability to the product. It can also protect the content from light and can act as a barrier to protect the content from environmental gases.
Another aspect to be kept in consideration is that the additives in the plastic container can leach into the solution.
Pharmacopoeia has set limits on the content of the additives in plastic containers for drug products. It has also specified the types of additives which are not allowed in plastic material destined for making primary containers for packaging pharmaceutical products. Several leading manufacturers today produce Polypropylene, as well as Polyethylene, approved for making containers for intravenous and injectable applications.
Although the final package is sterile after the BFS process, Good Manufacturing Practice (GMP) in some countries and Pharmacopoeia in the United States and European Union still impose terminal sterilization for products that can sustain steam sterilization. In fact, the European Medicinal product Evaluation Agency (EMEA) goes to extent of recommending that manufacturers should search for suitable packaging material which allows terminal sterilization at preferred temperatures within a limited time frame.
Due to the above considerations, a BFS machine, which has the capability to process and make containers out of a wide range of materials (low density polyethylene, high-density polyethylene, polypropylene), is preferred in the pharmaceutical industry.
This allows a pharmaceutical company to choose different materials for different applications and situations.
The versatile design of SYFPAC® allows the use of a wide range of polymers without changing the mold.
The following types of polymers can be processed on SYFPAC®:
• extrusion blow molding grade LOW DENSITY POLYETHYLENE (LDPE).
• extrusion blow molding grade HIGH DENSITY POLYETHYLENE (HDPE).
• extrusion blow molding grade POLYPROPYLENE (PP).
The flexibility of choosing packaging material from a wide range of plastics increases the possibility of finding the most suitable material which is compatible and provides higher stability for the product being packaged. Special attachments on the extruder can allow the mixing of a measured quantity of colorant or a special purpose additive in the extruder along with plastic granules prior to the extrusion for producing colored containers or containers with special properties, such as ultraviolet light barrier, etc.
To learn more about Breveti Angela’s Blow-Fill-Seal technologies please watch the recording of our recent presentation embedded below, or reach out by filling out this form.