INTRODUCTION: *Blow-fill-seal technology is a manufacturing technique used to produce small, (0.1m|-99ml) and large volume, (100m! and above) liquid filled containers. *Blow-fill-seal is a specialised packaging technology using in-line forming and sealing a polymeric material to a container of choice.HISTORY AND TODAY: *Blow-fill-seal technology was originally developed in Europe in 1930s. *It was introduced for the first time in USA in 1960s by our company Rommelag. *But over the last 20 years, it has become more prevalent technique in pharmaceutical companies. *It is now widely accepted and considered as superior form of aseptic processing by many pharmaceutical companies and approved by various medicine regulatory agencies like United States Food and Drug Administration.CONCEPT AND WORKING: * The basic concept is formation, filling and sealing of plastic container in aseptic environment. *The BFS cycle can be divided into following main steps:- Step 1: Parison extrusion Step 2: Container moulding Step 3: Container filling Step 4: Container sealingSTEP 1: PARISON EXTRUSION Firstly, pharmaceutical plastic resin is vertically heat extruded through a circular throat and forms a tube called Parison. Holding —— ~—— — Parison extrusion STEP 2: CONTAINER MOULDING The extruded tube is then enclosed within a two part mould and then the tube is cut above the mould. Holding = 0. Moulding of containerSTEP 8: CONTAINER FILLING The mould is transferred to sterile filling zone where filling needles called mandrels are lowered and used to inflate the flat to form container within the mold. STEP 4: CONTAINER SEALING The mandrel is used to fill the container with solution, following filling, mandrels are removed and secondary top mould seals the container. oak ~~ ° = s Filling of container Sealing of containerADVANTAGES: Produce sterile products. Reduced human intervention. Make it a viable delivery option for injectable products vs traditional glasses. oThe code numbers and variable data such as batch number and expiry date can be embedded onto the container itself. OCleaning and sterilization of prefabricated containers and closures is not required. No need to purchase and stock a range of prefabricated containers and their closures.APPLICATIONS: *Respiratory preparations, *Oral solutions, disinfectant liquids *Different types of ointments and gels, liquids for rectal or vaginal applications *Packaging of certain special food products such as soft drinks or milk products *Large volume Parenterals (normal saline, dextrose solution etc) and small volume parenterals (eye drops, ear drops and nasal drops).References € S$ Sinclair and A Tallentire, “Predictive Sterility Assurance for Aseptic Processing”, Sterilization of Medical Products, (R F Morrissey, ed.), VI, 1993, Polysclence Publications, Montreal, pp. 97-114. € § Sinclair and A Tallentire, "Performance of Blow-Fill-Seal Equipment under Controlled Airborne Microbial Challenges”, J. Paren. Sci. Technol., 49 (6) 1995, pp. 294-299, ABradley, S P Probert, C § Sinclair, and A Tallentire, “Airborne Microbial Challenges of Blow/Fill/Seal Equipment”, J. Paren. Sci. Technol., 45 (4) 1991, pp. 187-192. P Poisson, “Non-Viable Particle Management During B/F/S Manufacturing Operations", BFS News, Autumn Edition, 1999, pp. 12-16. P Poisson, C Reed and C Sinclair, “Challenge Testing of the KleenKut Parison Cutoff Mechanism’, Joint Presentation, BFS User's Group Annual General Meeting, Switzerland, 14 June 2001.