asepticsu Single-Use Fluid Path Technology

Flexicon Liquid Filling, a division of Watson Marlow, introduce asepticsu single-use fluid path technology for precise liquid filling in biopharmaceutical applications.

Single-Use Fluid Path Technology

Watson Marlow Flexicon Liquid Filling have provided peristaltic filling and capping systems to biopharmaceutical researchers for more than 25 years. Flexicon now introduce their new, easily verifiable single-use fluid path technology, asepticsu™ for secure, simple, high accuracy filling of high purity liquid filling. asepticsu single use technology will improve performance and flexibility, whilst simplifying the liquid filling process and reducing associated risks. The system will offer effective filling of values between 0.5ml and 50ml.

Easy Validation

The single-use asepticsu system provides a practical alternative to standard hard piped liquid handling solutions and positive displacement pumps which demand sophisticated cleaning and validation. The new asepticsu solution is supplied with a rigorous validation pack, and can save on validation time and expenses. The system promises reduced development periods, reliable validation compliance and increase profits for contract filling organisations, manufacturers and research and development operators.

Liquid Contamination Risks

Single-use solutions are possibly the fastest growing area in aseptic manufacturing, helping quality engineers to reduce liquid contamination risks. With the gamma-ray treated asepticsu single use fluid path, liquid never comes into contact with permanent pipes, mechanical parts or the environment at large. This eliminates the danger of cross contamination, avoids the demand for repeated cleaning validation and allows fast, straightforward changeover in a range of filling applications. Together, Flexicon's peristaltic pumping and asepticsu technology reduce risks in all high precision, high purity filling operations.

Fast Liquid Changeover

asepticsu enables fast, easy changeover of liquids between one batch and the next. Typically, changeovers can be accomplished in a matter of minutes. After the filling process has been completed, the system can be removed from the filling line. This makes it much simpler and more efficient to manufacture small batches of products. Within the biopharmaceutical industry, there is a trend towards small batch production, so the technology is particularly appropriate for modern aseptic filling operations.

Precise Dosage Filling with asepticsu

The asepticsu is based on Watson Marlow's platinum-cured silicone tubes, Acusil^®, which enables precise dispensing using Flexicon filling solutions. Acusil tubing provides an outstanding filling accuracy of ±0.5 percent and avoids expensive errors in under or overfilling of lyophilisation liquids, vaccines, biotechnological supplies and diagnostic substances where precision is essential to both the producer and the end user.

Accusil is produced in watson Marlow Flexicon's ISO 14644-1 Class 7 cleanroom to precise specifications and is made for high stability in post-irradiation dispensing. The tubing has laser-etched lot data and is post cured to minimise extractables.

A broad selection of esepticsu single-use fluid path solutions are available to assist operators in fulfilling a range of requirements in precise dosage filling applications ranging from pre-clinical trials to full-scale manufacturing. six tube diameters are available with bag sizes from one to ten litres designed to fill doses of under 0.5ml up to more than 50ml. A range of nozzles can be supplied for filling over or inside the vial, eliminating dripping between fills and reducing splashing and foaming.

Clients who are not currently using peristaltic dispensers, but who want to benefit from asepticsu should contact Flexicon Liquid Filling to discuss their needs. Pre-existing filling lines can be adapted or integrated with peristaltic filling systems either in preparation for an audit, or to create a more flexible filling line.