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 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 facility to automatically dry the filters and maintain the sterile status of the machine by pressurising the whole circuit using sterile compressed air. Additionally integrity of filter can be tested in situ by attaching an external integrity testing equipment.
Aseptic packaging process
As the container is made, filled and sealed within a single machine and the process is protected using sterile air shower and additionally, all process medium (solution, air etc.) are sterile filtered, the chance of contamination is very remote. Adding the fact that during the whole cycle, open container remains exposed to the clean room air for less than 1.5 seconds, the Blow-Fill-Seal technology becomes process of choice where contamination of particle matter and microbial contamination is a prime concern.
Flexibility in choice of packaging material
Primary Packaging (or the container) protects pharmaceutical ingredients from environmental contaminants, micro-organisms as well as particulate material. The container also protects active ingredient and/or excipient from getting out due to diffusion and thus providing stability to the product. It can also protects 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 in to 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 packagingof pharmaceutical product.
Several leading manufacturer today produce Polypropylene as well as Polyethylene approved for making containers for intravenous and injectable.
Although the final package is sterile after BFS process, GMP of some countries and U.S.A Pharmacopoeia and European Pharmacopoeia still impose terminal sterilization for products which can sustain steam sterilization. In fact, the European Medicinal product Evaluation Agency -EMEA) goes to extent of recommending the manufacturers to search 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 capability to process and make containers out of wide range of material (low density polyethylene, high density polyethylene, polypropylene) is preferred in a pharmaceutical industry.
This allows pharmaceutical company to choose different materials for different applications and situations.
Versatile design of SYFPAC® machine allows the use of wide range of polymers without changing the mould. Following types of polymers can be processed on SYFPAC®:
- Extrusion blow moulding grade LOW DENSITY POLYETHYLENE (LDPE)
- Extrusion blow moulding grade HIGH DENSITY POLYETHYLENE (HDPE)
- Extrusion blow moulding grade POLYPROPYLENE (PP)
The flexibility of choosing packaging material from a wide range of plastics increases the possibility of finding most suitable material which is compatible and provides higher stability for the product being packaged. Special attachment on the extruder can allow mixing of measured quantity of colorant or special purpose additive in extruder along with plastic granule prior to the extrusion for producing coloured container or containers with special properties like ultra violet light barrier etc.
Special protective atmosphere and purging of inert gases
In order to prevent the product from oxidation, the space above liquid level in the container can be purged with inert gases (Nitrogen, Carbon dioxide).
Type of Containers which can be made on the machine
The process is versatile and so wide variety of containers of different sizes can be made on the machine. The size may range from 0.2 ml to 13 litres. For convenience the sizes of containers are classified in the following three categories:
The containers can assume wide variety of shape and they could be very rigid or quiet flexible as to render the container squeezable. The liquid is usually dispensed from the top of the container, and to facilitate dispensing, top of the container can have different shape and can have even thread to fix connector or a cap.
