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 sealingSTEP 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 containerSTEP 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 containerADVANTAGES:
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.