The PLÜMAT Blow Fill Seal technology BFS involves the combination of PLÜMAT bottle filling technology based on over 30 years of experience with the market-established one and two stage stretch blow moulding technology, as well as extrusion blow moulding technology for the making, filling and sealing of flexible or rigid PP infusion bottles in one production line.
The integration of the technologies primarily involves, alongside the combination of filling and Blow molding machines in a production line, the pharmaceutical industry conformant designing of the entire machine process in accordance with the applicable cGMP and FDA rules. Consequently, the system as a whole fulfils the requirements of future-orientated pharmaceutical production plants.
A 2-stage Stretch Blow Fill Seal machine can produce up to 10,000 infusion bottles per hour, where, due to the separate injection and stretch blow molding processes, there is, in principle, no upper output limit. Bottle formats vary from 50 ml to 1,000 ml.
► Separate, dedicated bottle manufacturing process for
optimised high quality bottles
► In the 2-stage stretch blow molding process, the
separation of "injection molding" and "stretch blow
molding" permits high outputs and flexibility.
► Manufacture of empty bottles in the dry area of the
production line
► Separation of the cGMP relevant parts using partitions
from the rest of the system
► Sealing using welded on caps, crimped caps or screw
caps
► CIP/SIP (125°C) sterilisable filling system
(Mass flow rate • Pressure/time • Turbine •
Magnetic-inductive • Piston • Peristaltic pumps)
► Protection of the open containers through use of
sterile air cowls or LF areas to prevent contamination
► IQ/OQ documentation