ADVANCED ASEPTIC PROCESS
Some of the most relevant features of the Blow Fill Seal technology are what makes it the best choice for the manufacturing of sterile pharmaceutical products.
BFS machines can operate inside a class C clean room environment, as the aseptic condition of the process is guaranteed by the grade A sterile air shower during the filling and sealing steps. To ensure a contamination free product, it handles the process media through pre-sterilized pipes, valves and absolute filters. For more details on clean room classification, see EU GMP or FDA guidelines
SCADA, HMI AND CONTROL SYSTEM
The BFS system is designed to capture, record and monitor all changes made to the machine operation parameters. If requested, such recording and storage could be FDA 21 CFR part 11 compliant. The system also stores all alarm conditions generated during all phases of machine operation; it automatically performs CIP & SIP, drying, filter integrity tests; it provides information regarding preventive maintenance activities in advance and keeps their record.
CIP & SIP
The entire aseptic circuit, which includes all the parts that come in contact with sterile formulation, sterile air, steam and the parison, needs to be subject to CIP (Cleaning In Place) and SIP (Sterilization in Place, or Steaming In Place). Once the parameters are set, CIP and SIP processes are automatically performed in the machine as a standard procedure with no need of further human intervention.
Temperature of the liquid while filling should be typically between 4°C to 30°C. Modified systems can be developed to handle liquids at higher or lower temperature. This is particularly relevant for biologicals and vaccines, where temperature should be carefully monitored throughout the entire packaging process.
OUTPUT AND CYCLE TIME
The output of a BFS machine depends mainly on the container volume and design. Generally speaking, production of Large Volumes can reach 22 million units per year, while Small Volumes 150 million units per year. Cycle time depends on the characteristics of the product that is being filled, and is usually around 10 seconds for aqueous solutions having density and viscosity similar to water.
Blow Fill Seal containers are produced under aseptic conditions. However, Good Manufacturing Practice (GMP) in some countries and Pharmacopoeia in the United States and Europe still impose terminal sterilization for products which can sustain steam sterilization. BFS bottles and ampoules have an optimal resistance to terminal sterilization by steam or other methods (typically 121°C for PP), as well as an excellent stability of product and shelf-life.