Technology for disposable manufacturing optimises biopharmaceutical drug production by eliminating the need for autoclaving or steam sterilising equipment in final fill and finish operations
Millipore will soon deliver a new disposable filling technology for production of sterile products.
Customers are looking for a simplified process, searching for ways to improve process economics and efficiency by reducing set-up time, avoiding cleaning, and reducing validation efforts without losing the cleanliness or decreasing the sterility assurance level.
A new enabling technology for disposable manufacturing optimises biopharmaceutical drug production by eliminating the need for autoclaving or steam sterilising equipment in final fill and finish operations.
This completely disposable system for manufacturing of sterile products is being developed by Millipore and performances have been already tested in a real industrial environment at Pharmacia.
The gamma pre-sterilised flow paths, product reservoir, filling needles and connectology achieve the highest level of safety in the final fill environment by elimination of aseptic assembly of pumps, tubing and filling needles as found in conventional filling environments.
The integral assembly ensures product sterility, personnel safety and allows fast installation within five to ten minutes.
The system creates a completely disposable contact surface for the product that eliminates the need for conventional equipment cleaning. Acerta operates on a volumetric fill technique where the product is dispensed by gravimetric force versus the use of a pump.
Pump shear is eliminated and there is no chance for particulate introduction from pump wear.
The Acerta disposable filling system is intended for use with final sterile injectables and diagnostics across a full range of filling capacities in biotechnology and classical pharmaceutical manufacturing.
The complete containment of the drug makes it especially suited for cytotoxic or biohazardous fills.
Reduced validation efforts, as well as the pure scalability promotes faster development from research and development to production scale.
At the end of this year (2003), two systems will be launched: a single-head and a four-head.
Both Acerta systems can be integrated into existing filling lines.
Beyond the obvious advantages of time savings and enhanced product sterility, the key benefits of Acerta disposable filling system are personnel safety, pure scalability, adaptability and improved process economics.
