Datwyler also offers one of the most extensive product portfolios for vial applications in the present pharmaceutical and biotech markets worldwide.
Quality and safety without compromise
The immediate contact between packaging and drug product makes it clear: meeting the highest standards of quality is mandatory. The product must be pure, free of contamination, and easy to dispense, even after prolonged storage. As a result, all components of the vial system must meet these standards to make the product safe and effective. And that’s where Datwyler comes into play.
At Datwyler, we are playing a key role in providing high-quality sealing solutions, particularly with our highly complex elastomer components coated with our proprietary fluoropolymer spray coating technology. The total fluoropolymer coating provides barrier properties and eliminates the closure as a source of silicone oil-based subvisible particles. Combined with our FM457 compound, this coating solution provides our customers with the most advanced sealing technology for the pharmaceutical and biotech markets.
Datwyler's coated vial stoppers are part of the (smart link: omniflex) stopper platform. OmniFlex® stoppers are coated with Datwyler's proprietary spray coating technology, with 100% coverage of the component. OmniFlex® stoppers are compatible with most standard vials in the market.
That’s what we always deliver: the highest degree of purity and safety. Only in this way can we achieve our goal of patient safety and make ourselves an indispensable partner.
From standardized products to co-engineering
With our products, we not only ensure that our components meet the highest standards, but also that they cover a wide range of potential, individual needs. We support our customers in finding or developing the right packaging solution for their product.
OPTIONS & AVAILABILITIES
Production flexibility – Products can be manufactured in line with our Advanced or FirstLine® production standard
All products are available in ready-for-sterilization (RFS) and ready-to-use (RTU), both in standard bags and Rapid Transfer Port bags. Steam sterilization and gamma irradiation are viable options.
Furthermore, as a reliable partner, we join a co-engineering process when needed and work on a suitable solution for our customers' product development. With extensive industry and material expertise, technical know-how, and a feeling for what drives the market, we are pleased to offer our customers this consultative service. From the beginning of the process, functionality, design, and special requirements are all taken into account.
The results are some of the most complex and unique elastomer compounds and coatings in the industry. And our customers benefit by being able to package and dispense the most sensitive medicines safely and in a protected manner. With this experienced system, we consider all critical aspects for our customers, so that we make the right decision jointly when it comes to primary packaging.
Our high-performance solution:
Aluminum Seals and PrimeCap™
To ensure absolute integrity in any closure system, an adequately crimped aluminum seal or plastic cap is required. Our aluminum seals for vials guarantee the highest degree of reliability.
Datwyler's aluminum seals are controlled and tested under the industry’s most stringent conditions and utilize the best-in-class alloy and plastic polymers. Datwyler's aluminum seals are made in continuously improved manufacturing processes. Our goal with this strategy is to help improve the efficiency and operational excellence of our customers.
For customers looking for flawless machinability on high-speed filling lines, our PrimeCap™ are the optimum solution. Here we offer:
international operations to meet the customers’ global supply needs;
the highest quality alloy available on the market;
availability in 13 and 20mm / five standard aluminum colors;
enhanced machinability;
low bioburden and particulate levels.
For further information about our sealing solutions for Vial applications, why not take a look at our brochure?