Asepsis offers a range of cGMP manufacturing and assembly services for single unit injection kits (SUIK’s) and secondary pharmaceutical finished packaging. Our assembly and packaging areas comprise of three ISO class clean rooms in full compliance with ISO Class 6, 7 and 8, with additional segregated Class 8 climate control (≥10°C) finished storage areas.
SUIK’s have been shown to provide for a higher standard of safety, convenience, and accuracy for parenteral drug administration. SUIK have been used in common practice within the operating theater for decades, however now they are becoming extremely popular in other health care practices.
Asepsis’ patented SUIK’s are uniquely configured to provide either a single dose vial (Safe-T-Dose) or a reduced volume single dose vial (Pedia-Dose); both configurations further prevent infection by restricting the reuse of the vial, while in parallel also reducing environmental discharge impact.
More importantly, both SUIK’s comprise a medication specific calibrated syringe (Safe-T-Syringe), that enables a user to prepare, (reconstitute if required), and administer a medication according to its PI to one or more specific patient characteristics while obviating any calculations or correlation procedures. This patient tailored administration also provides for additional calibration of the syringe indicia, enabling lower incremental dosing indicia of the drug dose(s) and patient characteristic(s). This dose optimization of a patient’s physical characteristics provides higher precision dosing and perhaps patient outcome from this enhanced dose accuracy.
Independent Bain surveys in three countries and GfK usability studies conducted in simulated use physical environments (in adherence to ANSI/AAMI HE75:2009 and ANSI/AAMI/IEC 62366:2007 and FDA Draft Guidance for Industry, Applying Usability and Usability Engineering to Optimize Medical Device Design) concluded 100% of registered nurses preferred our CDD kits and syringes over existing industry practiced technology.