BFS (BLOW FILL SEAL)

                                  

Blow-fill-seal (BFS) Technology

 
BFS is an automated aseptic filling process in which containers are formed, filled and sealed in a continuous operation. BFS systems can reduce the risk of product contamination by reducing operator interventions. The systems are typically used for filling sterile ophthalmic and respiratory care products.

 
Blow fill seal technology is now widely considered to be superior form of aseptic processing by various medicine regulatory authorities including FDA.This type of system combines the blow molding of container with the filling of product and a sealing operation in one piece of equipment.From microbiological point of view,the sequence of forming the container,filling with sterile product and formation and application of the seal are achieved aseptically in an uninterrupted operation with minimal exposure of the environment.This systems have been in existence over 30 years and have demonstrated the capacity of achieving contamination rates below 0.1%.Blow Fill Seal equipment restricts employee contact with the product.

 
The process is multi stepped-in which,first pharmaceutical grade plastic resin is being heated and extruded under pressure through a circular throat,to form a hanging tube called the parison.The mold that forms the body of the container is in two halves.The lower halt closes to seal the bottom of the open parrison.Filling needles draw the stipulated volume of sterile product in to the container and after withdrawal of the needles the upper part of the mold closes to form the upper part of the container.All the actions takes place in a sterile chamber inside the machine.The forming,filling and sealing steps are thus carried out in one unit operation,taking just 10-12 seconds.Throughout this process sterile air is used.
 

BFS machinery and its surrounding barriers should be designed to prevent the potential for extraneous contamination. The classified environment surrounding BFS machinery should generally meet Class 100,000 (ISO 8), or better, standards, depending on the design of the BFS machinery and the surrounding room. HEPA-filtered or sterile air provided by membrane filters should be used during the steps when sterile products or materials are exposed (e.g., parison formation, container molding or filling steps). Air in the critical area should meet Class 100 (ISO 5) microbiological standards during operations. A well-designed BFS system should also normally achieve Class 100 (ISO 5) airborne particle levels. Only personnel who have been qualified and appropriately gowned should enter the classified environment surrounding the BFS machinery.

 

BFS technology reduces personnel intervention making it a more robust method for the aseptic preparation of sterile pharmaceuticals. By its nature,the BFS process offers high levels of quality assurance. By integrating container manufacture with product filling,BFS removes a major step from the production process,together with its associated risks.