Gerresheimer’s Indian plants produce glass vials, ampoules, and bottles that are specially designed for storage of high quality drugs. These are all examples of primary packaging, which means they come into direct contact with their contents.
Image: Gerresheimer manufactures pharmaglass in accordance with globally recognized standards in India. Photo: courtesy of Gerresheimer AG.
For pharmaceutical applications, therefore they must be manufactured in line with the stringent requirements of the relevant pharmacopeias. After all, the packaging must allow drugs to be stored safely until their use. Gerresheimer is to present its glass packaging solutions at booth D6 at the InnoPack Pharma Confex at Sahara Star Hotel in Mumbai on May 21 and 22.
Gerresheimer has two plants at its site in the Indian city of Kosamba: The recently constructed Gerresheimer plant manufactures vials and ampoules for the pharmaceutical industry using tubular glass, while Neutral Glass makes moulded glass products for pharmaceutical applications and only very recently put a new high-performance furnace into operation.
“The upgraded technological features of our new furnace for type I glass has significantly enhanced our quality levels to meet growing demands of pharmaceuticals worldwide” says Khasim Saheb, Managing Director for Primary Packaging Glass in India and SEA.
“Most importantly, he explains, the glass is considerably more homogeneous, thanks to an improved electrical boosting control during conditioning and processing. The state-of-the-art furnace has higher pull rate, he adds. Along with the construction and technological upgradation on the new furnace, a clean room inspection area was also added at the cold end, also installed on-line camera inspection systems to guarantee a comprehensive examination of the finished products before “safe packing”.
The new plant is certified in accordance with GMP ISO 15378 standards.
Neutral Glass is set up to produce different types of glass at the same time. Here, for example, Gerresheimer manufactures clear and amber glass infusion and injection bottles from type I borosilicate glass. The company also produces type III glass containers for a large number of drugs. The production line at this factory is certified in accordance with DMF (Drug Master File) type III requirements.
“Our new plant in Kosamba produces ampoules and vials made from borosilicate glass to the same high quality standards as apply in Europe or the Americas,” says Sachin Sule, Sales Director for Primary Packaging Glass in India who will be on hand at Innopack Pharma Confex in Mumbai to advise customers and other interested visitors looking for a suitable solution for their drug. “All of our production and inspection processes are internationally standardized and certified.” The new plant is certified in accordance with the following standards: ISO 9001:2015, US DMF Type III, Health Canada (DMF), and ISO 15378. Gx Rhoc, the camera inspection system developed by Gerresheimer, ensures exceptional dimensional quality for vials. Several HD cameras detect every flaw.
Vials are amongst the world’s most popular pharmaceutical packaging solutions and Gerresheimer produces versions in clear and amber glass that can hold between 1 and 50 ml. The range of tubular glass vials on offer in Asia includes clear and amber glass type I. All manner of different shapes are available, either with or without blowback and compliant with either international standards or the customer’s own specifications.
Gerresheimer’s wide range of high-quality pharmaceutical ampoules made from pharmaceutical glass type I includes ampoules made from clear and amber glass that can hold between 1 and 30 ml. Among these products are straight-stem, funnel-type, and closed ampoules that comply with the relevant ISO standards (types B, C, and D) with various break systems such as OPC (one point cut), CBR (color break ring), and score ring. Customer-specific requirements can also be implemented alongside the major ISO standards.
Gerresheimer’s full global range encompasses all classes of glass used for pharmaceuticals – types II and III sodium silicate glass as well as type I borosilicate glass. This enables the company to supply the perfect glass packaging to suit drugs of any shape or size. Its extensive glass range means that appropriate packaging solutions can be found for even the most sensitive pharmaceuticals. With its Duma and Triveni brands, Gerresheimer also offers plastic containers in line with international requirements.
Source: Company Press Release