Single-use filling flexibility, from benchtop to production
Flexicon Liquid Filling’s new peristaltic precision filling with asepticsu single-use technology is said to increase flexibility and performance, while reducing risk and complexity when filling from less than 0.5ml to over 50ml.
Asepticsu is a single-use alternative to traditional hard piped systems with piston pumps that require complex cleaning validation. Flexicon say its technology, supported by a comprehensive validation pack, can save time, effort and cost in validating a new filling process.
The UK-based firm, a division of Watson Marlow Pumps Group, says shorter time to market, validation compliance, and greater profits are the potential rewards for manufacturers, contract fillers, or r&d operators who standardise on this technology.
Single-use technology is one of the biggest growth areas in aseptic processing. Using the gamma-sterilised asepticsu single use fluid path, liquid does not contact any mechanical parts, permanent pipework or the external environment, so there is no risk of cross contamination. As a result, the requirement for cleaning validation is eliminated, offering simple and fast changeover for a variety of fills.
The firm says that the combination of asepticsu and Flexicon peristaltic technology lowers the risk in all high purity, high accuracy filling applications.
Asepticsu is also flexible and ensures that changeover between batches only takes a few minutes. Once the filling process is complete, asepticsu can simply be removed from the filling line. As a result, small batch production becomes easier and more efficient.
At the heart of asepticsu is Accusil platinum-cured silicone tubing. Delivering filling accuracy of ±0.5%, Accusil prevents costly over or underfilling of vaccines, liquids for lyophilisation, diagnostic liquids or biotech products.
Accusil is engineered for post-irradiation dispensing stability and manufactured in Flexicon’s ISO 14644-1 Class 7 cleanroom under tight tolerances. It is also post-cured for lowest extractables and features indelible, laser-etched lot data.
A range of Flexicon asepticsu single-use fluid path options is available. For instance, a range of six tube and bag sizes from 1 to 10 litres, accommodate filling requirements from less than 0.5ml to over 50ml. Various filling nozzle options are also available to fill above or inside the vial, preventing dripping between fills and minimising foaming or splashing.
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