Gerresheimer is presenting new products such as the Gx InnoSafe, the metal-free ready-to-fill (RTF) syringe, and RTF vials at the CPhI China trade fair in Shanghai.
Taking place from 20 June to 22 June at the Shanghai New International Expo Centre (SNIEC) in booth N5P21, the company will show inhalers and injection pens, along with glass vials, ampoules, and cartridges, as well as plastic medicine containers. Many of these products are manufactured at Gerresheimer’s plants in China and India.
Sales director of primary packaging glass at Gerresheimer Shuangfeng David Tsoe said: “To make sure our customers at CPhI China have all the information they need, we are showcasing our highlights from CPhI Worldwide and Pharmapack Europe.”
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 with pharmaceutical companies’ production processes in mind, and is optimised for simple and intuitive use by medical professionals.
Metal-free 1ml long Luerlock Gx RTF syringe
By developing an innovative, patent-pending manufacturing technology, Gerresheimer has succeeded in readying its metal-free 1ml 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 recognised 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 sterilised 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 speciality 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 cleanroom conditions as well as assembly, product finishing, and packaging.
Project management, the validation of customers’ tools, and a tool maintenance and repair service complement the offering. Around 4,200m² of the site’s 10,700m² is given over to production, including 600m² of cleanroom in accordance with ISO class 8 (100,000) and 1,100m² of other cleanroom 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.
Global ties
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, including the European Pharmacopoeia (Ph Eur), the US pharmacopoeia (USP), and the Japanese pharmacopoeia (JP).