Blow Fill and Seal technology is mainly used for pharmaceutical solutions. The examples of pharmaceutical solutions that can be packaged are injectable solutions, antibiotics, ophthalmological drops, suspensions, infusion solutions, solutions for dialysis, solutions for irrigation and solutions for hemofiltration. Besides this main field of application, this technology has been used also for packaging of fresh fruit juice, non aerated drinks, milk and various cosmetic products including creams.
The process begins with the Extrusion of plastic granules in the form of a hot hollow pipe of molten plastic called a parison.
The following step is the Blow moulding of the container from the plastic granule. The parison is closed between the mould, and the container gets formed either by blowing sterile compressed air or by vacuum or by using vacuum as well as blowing. The container assumes the shape of the cavity in the mould. The container thus produced is open from the top and in its top part, the plastic is still hot and in molten state until the subsequent steps of filling and container sealing.
The subsequent step is Filling of the formed container from the top, which is still open (and still in a “hot molten” state). Filling nozzles enter from the top of container and filling is done. Filling nozzles are specially designed and constructed to facilitate automatic cleaning and automatic sterilization. Additional functions of filling nozzles are to blow the bottles and also to provide an exhaust path for air in the container. The filling process can be carried out under a shower of sterile filtered air to avoid contamination during filling. The blower on the sterile air shower can have variable pressure which can be made to change automatically so as to maintain constant air pressure under various situations. The sterile air shower is validated at certain air pressure, and an automatic device can maintain the same pressure by automatically modulating the speed of the blower.
The next step is Sealing the top of the container, which is still open and in a hot molten state. The top gets pressed between head moulds and as a consequence, the top part of the container gets formed, sealed and at the same time, gets cooled. The result is a hermetically sealed container.
The final steps are for De-flashing to remove the flash or scrap, trimming the containers and delivering the containers outside the machine. The whole process of extrusion, blowing, filling, sealing and removing scrap takes between 10 to 18 seconds depending upon the type and size of the container. The advantage of the Blow-Fill-Seal process is derived mainly from the fact that container is formed, quickly filled and sealed under protected environment automatically without human intervention.
Provision for Automatic CIP, SIP and facility for testing filter integrity in situ
The SYFPAC® is designed to carry out automatic cleaning in place (CIP) for removing traces of earlier product before filling another solution. Crucial parameters for cleaning in place are pressure, temperature and number of cleaning cycles, and these parameters can be set after suitable validation study. Similarly, SYFPAC® has also the facility to carry out automatic sterilization in place (SIP) to sterilize complete filling path, complete path of sterile air for parison, and path of air for blowing and buffer tank including filters. There is also the facility to automatically dry the filters and maintain the sterilestatus of the machine by pressurising the whole circuit using sterile compressed air. Additionally, integrity of the filter can be tested in place by attaching external integrity testing equipment.