PreVAS single-use products by Bosch have set the standard and represent the future of dosing system technology. PreVAS was the first completely pre-Validated, pre-Assembled and pre-Sterilized single-use filling system available for the clinical production and commercial manufacturing of pharmaceuticals. With the unveiling of the next generation of single-use needles, PreVAS continues to lead in the field of final fill technology.
PreVAS Single-Use Fill Needles
PreVAS needles offer a solution to the woes of traditional, reusable filling needles. Reusable needles require lengthy and expensive validation cleaning processes and can often become damaged during operation or during decontamination. Additionally, when reusing filling needles, users always run the risk of devastating cross-contamination. PreVAS single-use needles solve these problems. They are constructed of passivated 316L hypodermic/fractional tubing and overmolded with medical grade, ADCF, Class VI polycarbonate. They are clean room injection molded and cleaned with a validated process, including 100% straightness testing, prior to packaging on ISO 5 (Class 100) clean benches within an ISO 7 (Class 10,000) environment. PreVAS single-use needles can be autoclaved or gamma irradiated as part of a complete single-use filling assembly. By simply using new needles for each batch, you can be assured that your needles are clean, sterile and straight.
Expanding the Portfolio
Two new needle designs are making their debut. The 1.6 mm shorter molding needle more than doubles the tip length of the standard 1.6 mm needle. A longer tip length allows for filling in taller, higher-necked vessels like cartridges and ampoules. The innovative single-use basket needles, initially available in 2.5 and 3.4 mm inner diameter sizes, split the filling stream and direct the flow towards the walls of the container. This feature reduces splashing and turbulence to enable accurate filling of vials and ampoules at high speed.
- Direct replacement for standard “TL-style” needles
- Needle holders, with a snap-fit design for clean installation, are available as an upgrade for all types/brands of liquid fillers
- Reduced risk of cross-contamination and improperly cleaned parts
- Reduced validation burden and costs
- Increased rigidity over standard SS needles
- 100% straightness tested
- Increased productivity and safety
- More filling applications than ever before
Author: Dr. Laura Moody
Laura holds a Ph.D. in cellular and molecular biology. She is Bosch Packaging Technology’s product manager for single use systems.