Blow fill seal

Blow Fill Seal (BFS) is an advanced manufacturing technology for aseptic primary packaging of pharmaceutical liquids in plastic containers from 0.2ml to 1000ml.
Starting from the polymer granule, containers are formed, filled and sealed in one continuous operation inside one SYFPAC® BFS machine, within seconds and in an aseptic controlled environment.

SYFPAC BFS

The technology

BLOW

Granules are extruded in the form of a hot hollow pipe of molten plastic called “parison”. The mould closes over the parison to form the container and give it the desired shape, either by blowing sterile filtered compressed gas or by applying vacuum on the mould cavities.

FILL

The containers are filled with the pharmaceutical solution under Grade A conditions in a closed system, always protected from the surrounding environment.

SEAL

After filling, the top of the parison gets sealed to close the container. The aseptic containers are now hermetically sealed and are ready to exit the machine for trimming or secondary packaging.

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SYFPAC® – The advantages

SAFE

Blow Filll Seal is intrinsically aseptic as the whole process takes place in a sterile environment inside the machine. It allows particle monitoring inside the parison, thus granting full compliance to EU GMP Annex 1. The vials and bottles delivered may not need terminal sterilization.

FAST AND FLEXIBLE

The full BFS process happens in just a few seconds, making it the perfect choice for mass production of bottles, vials, ampoules or syringes with a wide choice of shape, size and plastic. PP, LDPE or HDPE can be used on the same machine with a simple change of recipe. Modular moulds, easy format changes and preventive maintenance on SYFPAC® machines ensure 24/7 reliable production 365 days/year.

COST-EFFECTIVE

SYFPAC® Blow Fill Seal machines unify three steps which are usually performed separately in pharmaceutical manufacturing, allowing for large savings in procurement, space and equipment. The minimum space of 6m² required for the clean room adds to the fact that plastic scrap is down to 6%, granting further economic benefits.

EASY TO USE

The machine only needs to be fed the plastic granule and the pharmaceutical solution, and it will deliver the aseptic product with a totally automated process where human intervention is not needed. SYFPAC® machines are extremely easy to use thanks to a user-friendly HMI and the automatic performance of CIP&SIP or advanced maintenance tracking.

Applications

SYFPAC® Blow Fill Seal machines are designed for production of Small Volume Parenterals in vials, ampoules and prefilled syringes from 0.2 to 50ml (SYFPAC® DUO), as well as Large Volume Parenterals from 50ml to 1000ml (SYFPAC® LVP).
BFS containers are suitable for many applications: vaccines, eye drops (single use or multidose), IV solutions, injectables, WFI, enemas, biologicals, ophtalmics, disinfectants, chemicals, cosmetics and much more.