- Gerresheimer’s new plant in Kosamba to receive ISO 15378 certification for the production of vials and ampoules
- New furnace to make type I glass at Neutral Glass
ISO 15378 certification for the new plant in Kosamba
“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,” says Saibal Sengupta, Director Sales, who 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 drug.
The new plant is already certified in accordance with the following standards: ISO 9001:2015, US DMF Type III, and Health Canada (DMF). Phase I for certification in accordance with the ISO standard 15378 has been completed. 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 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 1 and 50 ml. 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 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 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 HD cameras detect every flaw.
Rebuilding the furnace for type I glass at Neutral Glass
“Constructing a new furnace for type I glass will significantly enhance our quality,” says Sachin Sule, Head of Sales & Marketing for Moulded Glass. In India, 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 medications. The production line at this factory is certified in accordance with DMF (Drug Master File) 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 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 specializes in manufacturing primary packaging for pharmaceuticals in line with the relevant pharmacopeias. All of its factories are currently certified to standards including ISO 9001.