BLOW – FILL – SEAL

Technology

PRESENTED BY: SUDHEER NUNNACSO

INTRODUCTION:Blow-fill-seal technology is a manufacturing technique used to produce small, (0.1ml-99ml) and large volume, (100ml 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.

ROMMELAG: We are the master of Blow-fill-seal technology and market leader in making the machines that uses this technology.

Formation of Rommelag, sales company for bottle-pack BFS machines took place in 1964.

Till 2003, our company sold more than 1000 bottle-pack machines with the delivery capacity of 15 billion ampoules, bottles and other containers in total.

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 extrusionStep 2: Container moulding Step 3: Container fillingStep 4: Container sealing

Step 1: Parison ExtrusionFirstly, pharmaceutical plastic resin is vertically heat extruded through a circular throat and forms a tube called Parison.

Step 2: Container MouldingThe extruded tube is then enclosed within a two part mould and then the tube is cut above the mould.

Parison extrusion

Moulding of container

Holding jaws

Holding jaws

Step 3: Container FillingThe 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 SealingThe mandrel is used to fill the container with solution, following filling, mandrels are removed and secondary top mould seals the container.

Filling of container

Sealing of container

Next step: Container DischargeFilled and sealed containers are then conveyed to labelling and packing sections.

Container discharge

Rommelag’s BFS bottle-pack 321 machine.

Produces around 3000 bottles (1000ml) in one hour with six moulds

ADVANTAGES:Produce sterile products.Reduced human intervention.Make it a viable delivery option for injectable products vs traditional glasses.The code numbers and variable data such as batch number and expiry date can be embedded onto the container itself.Cleaning 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 liquidsDifferent types of ointments and gels, liquids for rectal or vaginal applicationsPackaging of certain special food products such as soft drinks or milk productsLarge volume Parenterals (normal saline, dextrose solution etc) and small volume parenterals (eye drops, ear drops and nasal drops).

SUMMARY:Our blow-fill-seal technology is today a widely accepted process in the pharmaceutical industry.The high assurance level in the aseptic filling and the important cost savings are the main reasons for the increasing success.Automation of the infrastructure and installation are becoming of increasing interest for pharmaceutical industry and our company Rommelag is taking these requirements into account and building the machines in a way to comply with Health Authorities regulations.

THANKS FOR Attention