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Gx® InnoSafe: Optimal for pharmaceutical companies and healthcare professionals

With Gx® InnoSafeTM, Gerresheimer now offers a syringe with an integrated and passive safety system that prevents unintentional needle stick injuries, excludes the possibility of accidental reuse and takes the needs of pharmaceutical companies and health care professionals equally into account.

Gerresheimer presents at CPhI Worldwide in Frankfurt (Germany) an integrated and passive safety system for the prevention of unintentional needlestick injuries

Duesseldorf/Wackersdorf/Frankfurt, September 14, 2017. With their exposed cannulas, used syringes are an omnipresent source of danger in doctor’s surgeries, 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 healthcare professionals. With Gx® InnoSafeTM, Gerresheimer now offers a syringe with an integrated and passive safety system that prevents unintentional needle stick injuries, excludes the possibility of accidental reuse and takes the needs of pharmaceutical companies and health care professionals equally into account.

One careless movement is enough for healthcare professionals 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 already 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 thereby activated automatically and requires no further handling steps by the end user. This thus involves a so-called passive needle protection system. Also of advantage to the pharmaceutical companies is the processing of the Gx InnoSafe syringes, which can take place on existing filling lines in the nested state without significant changes. An additional assembly 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.
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.

 

The user wants to have a safety system which remains the injection process unchanged, ensures an intuitive and ergonomical handling and does not require any additional operating steps for securing the cannula prior to disposal. The Gx InnoSafe safety system is installed like a standard needle shield in the clean room on Gx RTF glass syringes in the context of the manufacturing process. The syringe body is completely visible in order to be able to optimally see and check the presence of the active agent, its purity and the administering. The injection itself is administered as usual. Following the removal of the ergonomic sealing cap with integrated flexible needle shield, the syringe is positioned at the injection point, the cannula inserted into the tissue and the active ingredient injected like with a conventional syringe. An accidental triggering of the safety system is prevented, as the mechanism isn’t preloaded prior to the injection. The system is first activated with the piercing 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 reuse of the syringes is excluded.

For the pharmaceutical company, Gx InnoSafe offers advantages for the filling process of ready-to-fill syringes. The safety system is installed fully automatically like a standard needle shield in the clean room onto Gx RTF glass syringes and checked to 100 percent by visual inspection for potential needle piercing and safety system position. The syringes are then packaged, sealed and sterilized with ethylene oxide gas including the safety system in a 100 hole tray (nest) and in a tub. They can be processed on existing filling lines without additional preparation and assembly steps. The design of the safety mechanism ensures that unintended activation while filling, packaging, and transport is avoided. The flexible needle shield is available in all customary available elastomers for pharmaceutical applications. With the introduction of the new product line Gx InnoSafe is available for the 1.0 ml long RTF glass syringe with a ½“ 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.

Gx® and RTF® are registered trademarks of the Gerresheimer Group. InnoSafe is a pending trademark of the Gerresheimer Group.

About Gerresheimer

Gerresheimer is a globally leading partner of the pharmaceuticals and healthcare industry. With special products of glass and plastic, the company contributes to health and well-being. Gerresheimer is represented worldwide and, with around 10,000 employees, produces there where its customers and markets are. With works in Europe, North and South America, and Asia, Gerresheimer generates sales of around 1.4 billion Euro. The broad range of the offering encompasses pharmaceutical packaging, as well as products for the simple and secure administering of medication: insulin pens, inhalers, prefillable syringes, injection vials, ampoules, flasks, and vessels for liquid and solid medication with sealing and safety systems, as well as packages for the cosmetics industry.

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