(depending on the container size and machine type utilized).
The two primary BFS machine types are shuttling and
rotary. A shuttling machine forms the container, cuts it from
the extruded plastic and then shuttles the container to the
filling system. Rotary technology forms, fills and seals the
containers in a continuous process where the filling system
is directly integrated with the plastic extrusion system.
The key to Blow/Fill/Seal’s success is that it is a highly automated system that reduces the main contamination source
– it’s people – by minimizing outside interventions. BFS is operated in controlled environments where the open container time
is minimal, reducing the opportunity for contamination. The
critical area is relatively small compared to other advanced
aseptic techniques (e.g. fillers in Isolators or closed RABS).
The point of fill as with all aseptic filling is very import-
ant. The current standard in Blow/Fill/Seal is to clean and
steam all wetted parts, the air shower, and the point of fill.
The sterile pathway, the air shower and point of fill are
sealed, cleaned and steam sterilized prior to use. The clean
in place (CIP) and steam in place (SIP) systems are
fully automated and do not require outside
systems to complete their function, no man-
ual actions are required. After sterilization the
system continuously monitors the aseptically
filtered air shower that protects the point of
fill through over-pressurization.
With properly maintained and operated sys-
tems  the technology provides a container
that does not have the particle contamination
that is inherent to preformed containers. Since the
containers are not formed and transported to the
filling place the need to decontaminate BFS con-
tainers is eliminated. The BFS extrusion system kills
spores and the plastic encapsulates any endotoxin
found on the supplied plastic resin.[ 2] BFS contain-
ers do not need to be washed because the particles
found in preformed containers do not have a mech-
anism to be introduced to the BFS container. Tests
have shown that particles present in the environment
do not find their way into a BFS container during the
filling process [ 3] [ 4].
Acurrent challenge today is to produce an aseptic liquid product with the highest aseptic assur- ance level possible. A primary package is the final step in an aseptic product’s manufacture.
This final step provides the product with a hermetically
sealed environment, shelf stability and protection from the
Blow/Fill/Seal (BFS) is an Advanced Aseptic process that performs the primary packaging for a wide product variety: nebulized inhalation drugs, ophthalmic OTC products and drugs,
and small volume injectable products. BFS is an automated
process where plastic resin is extruded and formed into a container. The container is
then filled and hermetically sealed. The entire
process is performed
in a controlled environment and completed
within 4 to 15 seconds
■ By Tim Kram, Rommelag
Using Blow/Fill/Sea/ technology to ensure the highest aseptic assurance
level possible for liquid products
Blow/Fill/Seal machines can perform the primary packaging for wide variety of
products including nebulized inhalation drugs, ophthalmic OTC products and drugs,
and small volume injectable products.
Aseptic Primary Packaging