Find below the replies to the most frequently asked questions about the Blow Fill Seal technology and our SYFPAC machines.
CIP & SIP
The entire aseptic circuit of a SYFPAC machine, 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.
CLEAN ROOM
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.
CONTAINER DESIGN
The standard SYFPAC® design can be customized with a wide choice of optional items and functions. Custom-tailored shapes for the containers include the possibility to adjust the head shape to the product application. For vials and ampoules that means different types of luer connection, screw heads, or twist off openings. For bottles, a brilliant example is our Eco-head design, which brings an eco-friendly and economic solution to large volume parenterals packaging by eliminating the need of secondary capping.
CONTAINER STERILIZATION
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.
CUSTOM MOULDS
Our shuttle-type machines are equipped with modular moulds that are exclusively produced at our factory. Each mould is uniquely designed on the specific requests of the final product, to allow the best flexibility in shape, size and embossing of variable information. Moulds can have up to 50 cavities and allow production of different volumes by simple changes of inserts. We carefully select the materials to build the mould based on the polymers, products and chemicals that come in contact with it.
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.
PARISON THICKNESS CONTROL
Thanks to its special engineering, SYFPAC® can control the wall thickness of the parison and allows to manufacture containers from very rigid to lightweight, self-collapsible to the extent of imitating flexible bags. This particular feature significantly reduces plastic consumption up to 30% compared to traditional machines.
POLYMERS
The unique design of SYFPAC® allows the use of different types of polymer with no change of mould nor complex operations. On the same mould and the same machine you can use different plastic materials like PP, PE or HDPE. To change polymer, you will only need to set the new recipe, with no need to dismantle the mould nor change any spare parts. The choice of the resin depends on factors as bottle design, product stability and end-user requirements. These materials are compatible with several pharmaceutical substances in accordance with US, EU and other pharmacopoeias, and are easily available on all markets.
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.
SOLUTION TEMPERATURE
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.
STANDARD TO FULL OPTIONAL
Each SYFPAC® machine is uniquely built with top quality components, with standard features always implemented by specific requests to meet the customer’s needs. To mention only a few examples: possibility of black and white separation, addition of inert gas, recirculation loop for suspensions, modification for temperature sensitive formulations, inserts to emboss variable information.
