Gerresheimer's product range includes vials for conventionally manufactured pharmaceutical drugs as well as for biotechnologically produced and other specialty pharmaceutics. In order to meet the different requirements of the applications
The vaccines under development to protect against Covid-19 are, like many other drugs, filled in so-called injection or vials made of type 1 borosilicate glass, also known as vials.
The large worldwide demand for vials is met by the Gerresheimer Group’s plants in Europe, America and Asia, where they are manufactured to high quality standards for customers in the pharmaceutical industry. The Company has already received initial orders for vials for drugs and vaccines against Covid-19.
“Our injection vials, manufactured according to ISO standard, have been successfully used by our customers for decades and have proven themselves in the use with vaccines. Thanks to the continuous development of our portfolio, we are now able to produce a portfolio of injection vials that is geared to the increased needs of our customers. The keyword patient safety is at the heart of all our developments,” says Hans-Ulrich Pieper, Senior Director Sales Pharma Parenteral Solutions Europe & MENA, who is responsible for tubular glass products (Tubular Glass Converting).
Gerresheimer’s product range includes vials for conventionally manufactured pharmaceutical drugs as well as for biotechnologically produced and other specialty pharmaceutics. In order to meet the different requirements of the applications, Gerresheimer produces not only standard vials but also a corresponding range of different qualities of injection vials, also known as vials.
All Gx Vials (Standard, Pharma-Plus, Gx Elite and RTF) are manufactured and inspected using the latest technology and image processing techniques. The quality level of the agreed specification is decisive. Gerresheimer can use its camera systems for a wide range of parameters with or without restricted tolerances and for differently agreed quality levels, also known as AQLs (Acceptable Quality Levels).
In addition to glass ampoules, injection or piercing vials are the standard for the primary packaging of parenterally administered drugs and vaccines. They are the classic packaging material for numerous vaccines and medicines. Gerresheimer produces the vials in all sizes in accordance with international standards and the requirements of pharmacopoeias.
Pharma Plus injection bottles are designed to exceed the pharmaceutical industry’s requirements for critical dimensions and cosmetic quality. The Pharma Plus Type I injection vials have a high standard that is critical to meet customer requirements. The vials are manufactured using state-of-the-art technology and are inspected during production using image processing technology.
A Gx Elite Vial is a flawless container (cosmetic defects less than 100 microns) with two to three times the strength, a high process capability (Cpk) for critical features and improved delamination resistance. Gx Elite is a product development that exceeds all known market requirements for a Type I borosilicate injection vial. These vials increase patient safety while reducing the total cost of ownership (TCO).
The Gx RTF injection vials are made of borosilicate glass type I and meet all current requirements of the applicable ISO standards and pharmacopoeias (USP and Ph. Eur.) They are formed according to cGMP, washed in a clean room, packed in trays or nest and tub and sterilized. Gerresheimer offers its own packaging configurations, but also the well-known Ompi EZ-fill packaging format. This means that the vials are ready for the subsequent process steps in filling. The advantages are obvious: sterile delivery, a simplified filling and finishing process, the highest quality standards, flexibility through different packaging configurations and a wide range of filling and sealing technologies. All of these factors together ensure an improvement in overall manufacturing costs throughout the product life cycle.
All tubular glass plants producing vials work with standardized control, inspection and packaging technologies. These are mainly the Gx G3 and Gx RHOC technologies. The inspection systems are in-house developments and part of a tightly meshed inspection system that ensures the highest precision and quality assurance according to the most modern standards. For example, the Gx G3 inspection system uses state-of-the-art HD cameras to ensure reliable detection of cosmetic defects. The intelligent software detects and classifies the defects in fractions of a second. Gx RHOC ensures dimensional quality with high-resolution matrix cameras and a hyper-centric ID camera.
The Gerresheimer Vial portfolio leaves no customer wishes unfulfilled because it can be tailor-made. All vial qualities are suitable as packaging material for numerous vaccines and have proven this many times over. The future vaccines for protection against Covid-19 will be equally patient-safe.
Source: Company Press Release