Gerresheimer is presenting new products such as the Gx InnoSafe, the metal-free RTF syringe, and RTF vials at the CPhI China trade fair in Shanghai from June 20 to 22, 2018 (SNIEC, booth N5P21). Inhalers and injection pens will also be on show, along with glass vials, ampoules, and cartridges as well as plastic medicine containers. Many of these products aremanufactured at Gerresheimer’s own plants in China and India.
“To make sure our customers at CPhI China have all the informationthey need, we are showcasing our highlights from CPhI Worldwide andPharmapack Europe,” says David Tsoe, Sales Director PrimaryPackaging Glass by Gerresheimer Shuangfeng.
An Asian debut at CPhI China for the Gx InnoSafe
With the Gx InnoSafe, Gerresheimer offers a syringe with an integrated passive safety system that avoids inadvertent needlestick injuries and prevents the syringe from being reused. It is designed withpharmaceutical companies’ production processes in mind as well asbeing optimized for simple and intuitive use by medical professionals.
Metal-free 1 ml long Luerlock Gx RTF syringe
By developing an innovative, patent-pending manufacturing technology, Gerresheimer has succeeded in readying its metal-free 1 ml long Luerlock Gx RTF syringe for series production. Traces of tungsten or other metals occasionally remain in the drilled hole when the cone of a syringe is moulded, which can cause problems when the syringes are used. There is therefore a need for pre-fillable syringe systems that ideally eliminate the risk of metal contaminants, particularly for drugs based on bioengineered active substances.
Two manufacturers – one packaging
Gerresheimer’s two areas of expertise – the moulding of vials made from tubular glass and the ready-to-fill process for pre-fillable syringes – are combined with recognized Ompi EZ-Fill packaging technology for the new Gx RTF vials. The result is vials that are washed, packed in trays or in nests and tubs, and sterilized before being delivered to pharmaceutical customers. This enables our customers to start filling them straight away without the need for any intermediate process steps.
TE ring – firmly attached to type A and B drop bottles
The US Food and Drug Administration (FDA) stipulates that the TE ring must be firmly attached to the bottle to protect the original contents. Gerresheimer manufactures both type A and type B drop bottles in accordance with this new standard.
Gerresheimer in China and India – glass and plastic primary packaging for drugs
Gerresheimer’s Shuangfeng site in China manufactures vials, ampoules,cartridges, and other specialty products made from clear and amber glass. In India, the company produces vials and ampoules for local and international customers across three sites. The Neutral Glass plant in Kosamba makes pharmaceutical primary packaging from moulded glass, while the Gerresheimer Kosamba factory next door produces vials and ampoules from tubular glass. The Triveni Polymers plant in Kundli makes plastic containers bearing the Triveni Round and Square brand name.
Manufacturing medical systems made from plastic in China itself
Gerresheimer’s production site in Dongguan City near Hong Kong offers the full range of injection moulding techniques under ISO class 8 clean room conditions as well as assembly, product finishing, and packaging.Project management, the validation of customers’ tools, and a toolmaintenance and repair service complement the offering. 4,200 m2 ofthe site’s 10,700 m2 is given over to production, including 600 m2 ofclean room in accordance with ISO class 8 (100,000) and 1,100 m2 of other clean room space.
Gerresheimer Medical Plastic Systems Dongguan Co. is an FDA- inspected Medical Device Manufacturer. During the Pre-Approval Inspection (PAI), the management system was audited along with the entire product manufacturing process, from incoming goods to outgoing goods.
Gerresheimer’s factories in Asia, Europe, and the Americas work closely together as part of a global network. They apply current good manufacturing practice (CGMP) principles rigorously and are certified to ISO 9001. Some of them own ISO 15378 as a bare minimum. All Gerresheimer products comply with the relevant pharmacopeias (Ph. Eur., USP, and JP). Gerresheimer is a leading global partner to the pharma and healthcare industry. With specialty glass and plastic products, the Company contributes to health and well-being. Gerresheimer operates worldwide and its approximately 10,000 employees manufacture products in local markets, close to its customers. With our plants in Europe, North America, South America, and Asia, we generate revenues of approximately EUR 1.4 billion. The comprehensive product portfolio includes pharmaceutical packaging and products for the safe, simple administration of medicines: Insulin pens, inhalers, prefillable syringes, injection vials, ampoules, bottles, and containers for liquid and solid medicines with closure and safety systems as well as packaging for the cosmetics industry.