Blow fill seal technology

1. Blow Fill Seal Technology

2. Content..
✓Introduction
✓Concept
✓Working
✓Requirement
✓Advantages
✓Application
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3. Introduction
✓Blow-Fill-Seal technology refers to the manufacturing
technique used to produce small, (0.1mL) and large volume,
(500mL +) liquid filled containers.
✓Blow-fill-seal is a specialized packaging technology using
in-line forming and sealing of a polymeric material to a
container of choice.
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4. History
✓Blow-Fill-Seal technology was originally developed in
Europe in the 1930s.
✓It was introduced in the United States in the 1960s.
✓But over the last 20 years it has become more
prevalent within the pharmaceutical industry.
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5. Today
✓It is now widely considered to be the superior form of
aseptic processing by various medicine regulatory agencies.
✓U.S. Food and Drug Administration (FDA) in the packaging
of pharmaceutical and healthcare products.
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6. Concept
✓The basic concept of blow fill seal (BFS) is that a
container is formed, filled, and sealed in a continuous
process without or less human intervention, in a sterile
enclosed area inside a machine.
✓Thus this technology can be used to Aseptically
Manufacture sterile pharmaceutical liquid dosage forms.
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7. How it works?
✓The BFS cycle can be divided into the following main
steps –
✓ Step 1: Parison Extrusion
✓ Step 2: Container molding
✓ Step 3 : Container Filling
✓ Step 4: Container Sealing
✓ Step 5: Container Discharge
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8. Step 1: Parison Extrusion
✓Firstly pharmaceutical plastic resin is vertically heat
extruded through a circular throat, to form a tube called
the Parison.
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9. Step 1: Parison Extrusion
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Fig. Parison Tube

10. Step 2: Container molding
✓This extruded tube is then enclosed within a two-part
mould, and the tube is cut above the mould.
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11. Step 3 :Container Filling
✓The mould is transferred to the filling zone, or sterile filling
space where filling needle mandrels are lowered and used to
inflate the plastic to form the container within the mould.
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12. Step 4: Container Sealing
✓The mandrel is used to fill the container with liquid,
following filling, the mandrels are remove and a secondary
top mould seals the container.
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13. Step 5: Container Discharge
✓Finally, the filled container is discharge from mould.
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14. BFS Cycle
✓All actions take place inside a sterile chamber inside the
machine. The product is then discharged to a non-sterile
area for labelling, packaging and distribution.
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15. Material use for container
✓Polyethylene
✓Polypropylene
✓Polyvinyl chloride
✓Polyester
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16. Requirement for process
✓Sterile-air is used.
✓BFS machinery and its surrounding barriers should be
designed to prevent the potential for extraneous
contamination.
✓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.
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17. Requirement for process
✓HEPA-filtered or sterile air provided 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.
✓Only person who have been qualified and appropriately
gowned should enter the classified environment
surrounding the BFS machinery.
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18. Advantages
✓This manufacturing technology includes economies in
container closure processing. Reduced human intervention.
✓Often used for filling and packaging ophthalmic.
✓The same advantages that Blow/Fill/Seal brings to these
products quality/sterility assurance, processing efficiencies,
flexibility in container design.
✓Make it a viable delivery option for injectable products Vs
traditional glass or plastic vials.
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19. Applications
✓Injectable products
✓Respiratory Products
✓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).
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