1. BLOW – FILL –
SEAL
TEchnOLOgy
PRESENTED BY:
SUDHEER
NUNNA
2. 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.
3. 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.
4. 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.
5. 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
6. STEp 1: pARISOn Holding
jaws
ExTRUSIOn
Firstly, pharmaceutical plastic resin
is vertically heat extruded through
a circular throat and forms a tube
called Parison.
Parison extrusion
Holding
jaws
STEp 2: cOnTAInER
MOULDIng
The extruded tube is then enclosed
within a two part mould and then
the tube is cut above the mould.
Moulding of container
7. STEp 3: 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
Filling of container
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. Sealing of container
8. nExT STEp: cOnTAInER
DISchARgE
Filled 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
9. 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.
10. 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).
11. 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.
