Medical technology specialist Gerresheimer is pleased to announce that it is extending its services portfolio...
Gerresheimer has announced it will be attending the Pharma Expo Dhaka trade fair in Bangladesh, focusing on pharmaceutical primary packaging made from glass.
The show will take place from 8 February to 10 February.
Gerresheimer owns two plants at its Kosamba site in India, the Neutral Glass facility and the new Gerresheimer Pharmaceutical Packaging Mumbai factory.
Neutral Glass manufactures moulded glass products for the pharmaceutical industry. The plant will soon receive a new high-performance furnace for making type I glass. Gerresheimer’s recently constructed plant manufactures vials and ampoules using tubular glass. It will shortly be awarded ISO 15378 certification.
Director of sales Saibal Sengupta said: “Our new plant in Kosamba produces ampoules and vials made from borosilicate glass to the same high standards as apply in Europe or the Americas. All of our production and inspection processes are standardized and certified worldwide. In February, we will receive ISO 15378 certification.”
Sengupta will be on hand at Pharma Expo Dhaka in booth 123 to advise customers and other interested visitors looking for a suitable solution for their drugs.
The new plant is already certified in accordance with the ISO 9001:2015, US DMF Type III, and Health Canada (DMF) standards. Phase I for certification in accordance with the ISO standard 15378 has been completed, and the final audit will be carried out by the end of January, meaning that the plant’s certification will run from February.
ISO 15378 applies to primary packaging that comes into direct contact with medication. The standard covers all materials commonly used to make primary packaging such as glass, rubber, aluminum, and plastic. ISO 15378 gives all contract manufacturers and all manufacturers that package such materials themselves an opportunity to secure a high good manufacturing practice (GMP) standard and gain international acceptance at an early stage. Suppliers of primary packaging for pharmaceutical products benefit from the fact that the standard incorporates all the relevant GMP requirements and facilitates compliance with international, European, and national law.
Gx vials made from glass
Vials are amongst the world’s most popular pharmaceutical packaging solutions and Gerresheimer produces versions in clear and amber glass that can hold between 1ml and 50ml.
The range of tubular glass vials on offer in Asia includes clear and amber glass types I and II. 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 offers a wide range of high-quality pharmaceutical ampoules made from pharmaceutical glass type I. The standard portfolio includes ampoules made from clear and amber glass that can hold between 1ml and 30ml.
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 one point cut (OPC), colour break ring (CBR) and score ring. Customer-specific requirements can also be implemented alongside the customary ISO standards.
State-of-the-art camera inspection systems
Gx® Rhoc, the camera inspection system developed by Gerresheimer, ensures exceptional dimensional quality for vials. Several high-definition (HD) cameras detect every flaw.
Rebuilding the furnace for type I glass at Neutral Glass
Head of sales and marketing for Moulded Glass Sachin Sule said: “Constructing a new furnace for type I glass will significantly enhance our quality.”
In India, 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 medications. The production line at this factory is certified in accordance with drug master file (DMF) type III requirements.
Gerresheimer’s complete 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.
Gerresheimer offers a portfolio of glass pharmaceutical bottles extending from the smallest glass cartridges made from tubular glass up to large acid-resistant chemicals bottles.
Gerresheimer employs cutting-edge techniques and monitoring technology from the development stage right through to production and packing for delivery. With bases in the Americas, Asia, and Europe, Gerresheimer specialises in manufacturing primary packaging for pharmaceuticals in line with the relevant pharmacopeias. All of its factories are currently certified to standards including ISO 9001.
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