Form Fill Seal Technology: A Brief Review

 

Mr. Bhushan P. Gayakwad*, Dr. Shashikant D. Barhate, Mr. Mayur S. Jain

Shri. Sureshadada Jain Institutes of Pharmaceutical Education and Research, Jamner, Maharashtra (India)

*Corresponding Author E-mail: bhushangayakwad5@gmail.com

 

ABSTRACT:

Form fill seal (FFS) technology is an automated computer operated technology, to prepare sterile products. Mostly it is applicable for I.V. infusion bottles. In this process all steps such as formation of container, filling of container with content and sealing of container are performed sequentially, consistently and automatically in a closed sterile chamber of machine. This technology reduces the contamination rate below 0.1%. The reason behind FFS technology is to reduce the contamination during production in a closed sterile chamber of a machine. Thus there should be 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.

 

KEY WORDS: Sterile, Moulds, Parison, Class 100 Area, I.V. Bottles.

 

 


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[1]

 

This technology is being used since 30 years and reported to achieve contamination rate below 0.1%. This technique is more popular in U.S. and U.K.

 

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[2]

 

1. 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 121C, 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 (blowers and diffusers) 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 (depending on the product to be packaged) 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.

 

2. 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 30C to form parison (a tube like structure). The parison reaches the mould forming the container by the pressure 350 Bar of a sterile compressed air and temperature 170 - 230C. 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 (mandrel) 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.

 

Fig: Form Fill Seal Technology

 

It takes 10-15 seconds to produce one container.

 

3. 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 recirculateds. The machine may be steam sterilized finally.[3]

 

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 water shower. The pressure and temperature link controls the whole process.

 

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.[4]

CONCLUSION:

The present review elaborates the entire operation of form fill seal technology. It is an automated computer operated technology, to prepare sterile products. Mostly it is applicable for I.V. infusion bottles. In this process all steps such as formation of container, filling of container with content and sealing of container are performed sequentially, consistently and automatically in a closed sterile chamber of machine. This technology achieves contamination rate below 0.1%. The reason behind FFS technology is to reduce the contamination during production in a closed sterile chamber of a machine. Thus there should be 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.

 

ACKNOWLEDGEMENT:

The authors would like to thanks Shri. Sureshadada Jain Institutes of Pharmaceutical Education and Research Center, Jamner Maharashtra (India)for supporting for the fulfillment of this work.

 

CONFLICT OF INTEREST:

Declared none.

 

REFERENCES:

1.     http://www.pharmaguideline.com/2013/12/blow-fill-seal-bfs-and-form-fill-seal-ffs-in-sterile-production.html

2.     http://www.ppma.co.uk/form-fill-seal.htm

3.     http://www.reiser.com/pdf/RepakBrochure.pdf

4.     http://www.sacmi.com/System/00/02/17/21769/ed_itIT/FFS%20Form%20-%20Fill%20-%20Seal%20machine_2013_09_72dpi.pdf

 

 

 

 

 

Received on 19.09.2017 Accepted on 26.10.2017

Asian Pharma Press All Right Reserved

Asian J. Pharm. Res. 2017; 7(4): 244-246.

DOI: 10.5958/2231-5691.2017.00038.7