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Form Fill Seal Machine

1. Form fill seal (FFS) machines automate the process of preparing sterile products like IV bottles by forming, filling, and sealing containers sequentially in a closed sterile chamber. 2. This reduces contamination risks compared to manual processes. FFS also increases production volumes at low operational costs while ensuring sterility. 3. Key steps include pre-sterilizing the machine, producing items in an aseptic chamber through forming, filling, and sealing individual containers, and post-production cleaning of the machine.

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3K views12 pages

Form Fill Seal Machine

1. Form fill seal (FFS) machines automate the process of preparing sterile products like IV bottles by forming, filling, and sealing containers sequentially in a closed sterile chamber. 2. This reduces contamination risks compared to manual processes. FFS also increases production volumes at low operational costs while ensuring sterility. 3. Key steps include pre-sterilizing the machine, producing items in an aseptic chamber through forming, filling, and sealing individual containers, and post-production cleaning of the machine.

Uploaded by

info tamil
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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FORM FILL SEAL

MACHINE
DONE BY
MUKILAN RS URK17FP090
TAMIL SELVAN A URK17FP094
INTRODUCTION:

It is an automated computer operated technology, to prepare sterile


products like I.V. infusion bottles. In this process all steps are performed
sequentially, consistently and automatically in a closed sterile chamber of machine
such as:
1.    Form: Formation  of container
2.    Fill: Filling of container with content
3.    Seal: Sealing of container
Reason behind FFS:
The reason behind FFS technology is to reduce the contamination by
forming the container, filling the content and sealing in a closed sterile chamber of a
machine. There is no personnel intervention to reduce the chances of contamination
during the manufacturing of sterile products. Again it gives more production in very
low operational cost with high assurance of sterility.

Processing of FFS:
It involves 3 actions:
1.    Pre-sterilization of machine
2.    Production in aseptic chamber
3.    Post-production cleaning

 
Pre-sterilization of machine:
Pre-sterilization of  machine is carried out in 2 different phases:
 
Programmed in sequence:
The first is steam sterilization phase consisting of a water steam
sterilization cycle at a minimum temperature of 121°C, which will take less than 60
minutes for product tank, filling unit, product pipelines and filling nozzles.
 
H2O2 sterilization cycle:
It takes approximately one hour and 40 minutes and it consists in
spraying machine tunnel, forming plugs, bell and counter mould, sterilization
baths and sterile air pipelines with hydrogen peroxide fog followed by a drying
phase obtained through mechanical dryers and sterile hot air.
Consequently machine is ready for aseptic packaging for
continuous production up to 48 hours before machine will be cleaned in place.
Machine sterile conditions are permanently controlled and maintained during the
packaging phase by overpressure of sterile air in the feeding tank and all along the
closed aseptic tunnel where the filling nozzles are placed.
 Production in aseptic chamber:
This is the heart of  FFS technology, which involves 3 working steps:
a.    Formation of container
b.    Filling of container with content
c.    Sealing of container.

a.Formation of container:
In this process polypropylene granules are heated at 200 ± 30ºC to
form parison. The parison reaches the mould forming the container by the pressure
350 Bar of a sterile compressed air and temperature 170 - 230ºC. Here two halves of
the mould closed around the parison to seal the base. Simultaneously the top of the
parison is cut free by hot knife edges.
b. Filling of container with content:
Bulk solution prepared under aseptic condition is delivered to the
machine through a bacteria retaining filter, before entering in container. Fill nozzle
fills the liquid in to container with a metered volume of solution, displacing the
sterile air. The pipe, filter housing and machine parts that are coming in contact
with the product are steam sterilized. Again system uses nylon filter media to
remove colloidal silica, pyrogens, mycoplasma, viruses and other contaminants.

c. Sealing of container:
After filling the container the filling unit is raised above and the
containers are sealed automatically. Then the mould is opened.
It takes 10-15 seconds to produce one container.
Post-production cleaning:
After completion of the process the machine is cleaned at the place, means
the concept of Clean In Place (CIP). In this step machine is cleaned at the place
where it is installed and should not be transferred to clean room or anywhere else.
Again it includes once circulation system and recirculation system. In once
circulation system the washed liquid is directly withdrawn from the machine and
thrown off. While in case of recirculation system the washed liquid is again re-used
to clean the machine and gets re circulateds. The machine may be steam sterilized
finally.
FFS machine should be surrounded by class 1,00,000 area. Container
formation, filling and sealing process is done in class 100 area within the machine.
System should be validated by media fill runs before starting the commercial
production.
This is a fully automated computer controlled technology which allows filling
and packing of  up to 40,000 I.V. bottles per day. N2 purging is available to machine.
Sterilization is achieved through an automatic microprocessor controlled circulating
Advantages of FFS technology:
1.    Entire operation takes place in aseptic chamber.
2.    It reduces personnel contamination.
3.    A very low manual labor is required for the operation.
4.    It gives high production efficiency means about 40,000 I.V.
bottles are prepared per day.
5.    It is cost effective technology for production of I.V. fluid bottles.
6.    Single machine operates all processes such as formation of
container, filling and sealing.
Types of form fill Seal machine:
1. Horizontal Form Fill Seal Machine
2. Vertical Form Fill Seal Machine
Horizontal Form Fill Seal Machine
Vertical Form Fill Seal Machine

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