Gx InnoSafe: customized syringe safety for manufacturers and users

Gerresheimer will present an integrated system for prevention of needlestick injuries at CPhI Worldwide.

With their exposed cannulas, used syringes are an omnipresent source of danger in medical practices, labs, or hospitals. Existing needle protection systems reduce the risk of injury for the user, but require additional effort for filling on the part of the pharmaceutical companies and with respect to the use of the syringe by medical personnel. With Gx InnoSafe, Gerresheimer introduces a syringe with an integrated safety system for the avoidance of needlestick injuries that fulfils the current requirements of the pharmaceuticals industry and of users equally.

One careless movement is enough for medical specialists to injure themselves on unprotected, used syringe cannulas or come into contact with aggressive active ingredients. In the most adverse case, this can result in serious infections. There is also a danger that used syringes may accidentally be used a second time. Gx InnoSafe provides reliable protection against needlestick injuries and eliminates the possibility of reuse. In contrast with many existing solutions, the needle protection mechanism is activated automatically and requires no additional actions. This involves a passive needle protection system. Also of advantage to the pharmacists is the processing of the Gx InnoSafe syringes, which can take place on existing lines in the nested state without significant changes. An additional installation step of a safety system, as is usual on the market, is dispensed with.

The syringes, including the safety system, are packed in perforated trays and tubs and then sterilized with ethylene oxide gas. They can be processed on existing filling lines without additional preparation and assembly steps.

Users want a safety system that leaves the familiar injection procedure unchanged, is intuitive and can be operated ergonomically, and which requires no additional manual activation to secure the cannula prior to disposal. The Gx InnoSafe  safety system is installed like a standard seal in the clean room on Gx RTF glass syringes as part of the manufacturing process. The syringe body itself remains completely visible, so that the presence, filling level, and state of the active ingredient, as well as the injection procedure can be inspected without obstacles.

The injection itself is administered as usual. Following the removal of the ergonomically optimized sealing cap with the integrated flexible needle shield, the syringe is positioned at the injection point, the cannula inserted into the tissue to be administered and the active ingredient injected as with a conventional syringe. An accidental triggering of the safety system isn't possible, as the mechanism is completely relaxed prior to the injection. The system is first activated with the pricking of the cannula and then automatically ensures when removing the syringe from the injection point that the safety mechanism is permanently locked. In this way, the cannula is reliably covered and renewed use of the syringes is impossible.
For the pharmaceuticals company, Gx InnoSafe offers advantages for the filling process of ready-to-fill syringes. The safety system is positioned fully automatically in the RTF process and visually inspected with an X-ray check for correct positioning.  They can be processed on existing filling lines without additional preparation and assembly steps. Here too, the design of the safety mechanism ensures that unintended activation while filling, packaging, and transport is avoided. With the introduction of the new product line, Gx InnoSafe  is available for the 1.0 ml long RTF glass syringe with a half inch cannula. Additional syringe variants will follow.
From October 24 to 26, Gerresheimer will be at CPhI Worldwide in Frankfurt, Germany in hall 4.2 at booth D02.