Nipro PharmaPackaging and medmix Drug Delivery (Haselmeier) announce the successful compatibility testing of PiccoJect™ with Nipro’s D2F™ pre-fillable syringes.
In April 2023, a test program was performed to assess the compatibility of Nipro’s D2F™ pre-fillable syringes (“PFS”) with the PiccoJect 100 autoinjector from medmix. The test results confirm full compatibility of Nipro’s PFS with PiccoJect 100.
The compatibility in terms of fit, performance, and safety were proven between PiccoJect 100 and Nipro’s PFS (D2F syringes, 1 ml long, staked-needle with RNS). The syringes were subjected to different characterization tests to determine relevant force values and robustness limits. The capability of PiccoJect 100 to meet required dose accuracy and injection time performance was confirmed with fill volume and fluid viscosity at the specification limits.
"I am pleased to share the positive outcome of the compatibility testing of the Nipro syringes in our PiccoJect 100. As an ISO 11040 compliant syringe, we expected everything to work without issue and it is always nice to have proof with real data." said Chris Muenzer, Vice President Innovation and Development at Haselmeier. "Further tests with other syringes are in process and we look forward to sharing more data in the future."
PiccoJect is a disposable, highly compact, customizable, and fully featured two-step autoinjector designed for subcutaneous delivery of pharmaceuticals and biologics.
Some facts and figures about PiccoJect:
- Low part count of only eight components
- Committed to sustainability: Material with sustainable feedstocks and regional supply chain
- Patient-centric design with an ergonomic shape, a large wrap-around drug window and a status indicator that provides clear binary feedback
- A full-service platform including combination product development, design verification, final assembly, secondary packaging, labeling, and serialization
- Developed for a standard 1 ml long or 2.25 ml pre-filled glass or plastic syringes
- Fill volumes from 0.2 ml to 2.0 ml
- Viscosity up to 20 cP
Nipro´s D2F pre-fillable syringes in eNhance quality are designed to meet the rigorous requirements of sophisticated drug products. They offer excellent compatibility between the drug and container, smooth integration into auto-injection devices (AID), optimized processability to minimize drug loss, and are accompanied by an extended data package for quick acceptance of goods.
During manufacturing, Nipro pays special attention to multiple syringe parameters regarding the integration into auto-injection devices:
- Controlled rigid needle shield (RNS) concentricity and barrel bowing for optimal assembly and safe AID usage
- Precise syringe dimensions for exact fitting into AID
- Low break-loose force, consistent plunger gliding force for complete dose delivery, and optimal injection time
- Reduced RNS pull-off force supports reliable use of cap removers
- Strong flange supports safe operation of injection mechanisms
About medmix
medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer, and industrial end-markets. Our customers benefit from a dedication to innovation and technological advancement that has resulted in over 900 active patents. Our 14 production sites worldwide together with our highly motivated and experienced team of nearly 2,100 employees provide our customers with uncompromising quality, proximity, and agility. medmix is headquartered in Baar, Switzerland. Our shares are traded on the SIX Swiss Exchange (SIX: MEDX). www.medmix.swiss
