Blow
Fill Seal
Introduction Blow Fill Seal (BFS)
technology is an effective method of filling liquid pharmaceutical
products. It involves the formation of the final container, filling
and hermetically sealing in an uninterrupted sequence of operations.
BFS is particularly suited to the aseptic manufacture of multiple
pack or single dose units.
For aseptic manufacture, the liquid product
pipe-lines, buffer tank, filter housings and other product contact
parts are sterilised in-situ using clean steam (Steam in Place). Approach
Along with the thermometric testing required for the steam in
place process, we are also able to test the filling room background
environmental conditions, the supply filter integrities, discharge
velocities, room pressure differentials, air change rates and
particle counts.
Our testing is comprehensive and designed to
satisfy the requirements of US (FDA), UK (MHRA) and European
regulatory authorities.
Detailed validation reports are compiled
that contain all of the real-time data generated as well
as a concise summary, with a clear conclusion and details of
any recommendations, as appropriate.
Experience
PEV staff are experienced in the validation of
the SIP procedure on BFS machines. We are aware of the potential
difficulties associated with sterilising multiple pathways
(sometimes alternately on early models), filters, air shower
etc.
We can provide operational resource and assistance
with the generation of User Requirement Specifications (URS),
through Factory Acceptance Testing (FAT) to Site Acceptance
Tests (SAT) and Installation Qualification (IQ), Operational
Qualification (OQ) and Performance Qualification (PQ) protocols.
|