Packaging whose primary component consists of a vial or bottle plus an elastomeric closure has long been used as a solution for packaging drugs. Elastomeric closures can be provided with or without a fluoropolymer barrier coating. No such system, however, can guarantee container/closure integrity without the addition of an adequately crimped aluminium or aluminium/plastic cap.

Of the many ways used to dispense parenteral drugs to a patient, vial systems, prefilled syringes and cartridges are currently the most preferred solutions.

Packaging whose primary component consists of a vial or bottle plus an elastomeric closure has long been used as a solution for packaging drugs. Elastomeric closures can be provided with or without a fluoropolymer barrier coating. No such system, however, can guarantee container/closure integrity without the addition of an adequately crimped aluminium or aluminium/plastic cap.

Of ever increasing importance are prefillable syringe and cartridge systems. Elastomeric plunger stoppers, needle shields and tip caps are there to seal your prefilled syringe systems.

Plungers and rubber lined aluminium seals (‘combiseals’) ensure that your cartridges are provided with system integrity.

DRUG DELIVERY SYSTEMS IN VARIOUS APPLICATIONS

HEPARINS

Taking convenience to a whole new dimension.

In terms of volume alone, heparins are among the most commonly used intravenous pharmaceuticals for surgical applications.
Guaranteeing you top-quality packaging solutions that meet all your requirements is therefore essential.

Maximum stability and compatibility

As a common anticoagulant, heparins not only play a vital role during surgery but also in both pre- and post-operative therapies. As with other parenteral drug solutions, heparins call for maximum stability and compatibility when it comes to packaging components.
 

Safe, efficient operation

While conventional glass ampoules used to be commonplace, they fall short on practicality. Heparins are therefore typically supplied in small vials or prefillable glass syringes. Datwyler can furnish you with a wide range of high-quality vial stoppers for multi-dose, neck-finish vials. Combining robust mechanical properties with excellent chemical characteristics, Datwyler’s engineered chlorobutyl and bromobutyl compounds guarantee you maximum convenience and compatibility, even for your multiple piercing applications.

Ready-To-Use solutions

Datwyler also develops advanced solutions for prefilled syringes including needle shields and plunger stoppers specifically to match your requirements. 0.5 and 1ml long syringes are usually supplied with a staked needle protected by a needle shield such as the V6524. Made from an advanced compound, Datwyler needle shields combine optimized permeability with the highest standards in compatibility and chemical stability. Our standard plunger stoppers – such as the V9315 and V9283 – also guarantee you optimum levels of PBSI (plunger barrel seal integrity) and functionality.

Contact us for more details and find out how Datwyler can develop the perfect solution for your application

DIABETES CARE

Components for diabetes care developed specifically for your needs.

As the diabetes epidemic continues to grow, the demand for efficient, convenient and reliable drug delivery systems is also on the rise.
Datwyler has invested heavily in the development of innovative closure systems for prefilled insulin cartridges, which specifically address the requirements of our customers, and meet the strictest of industry standards.

Advanced compounds

Datwyler offers you a range of pre-filled, multi-dose cartridge components that are both standard and able to be custom-made to your specific requirements. Our range of rubber plungers are made from the most advanced compounds, and are guaranteed to meet the often conflicting requirements you face for product stability, ease-of-use, dose accuracy, closure integrity and extended shelf life. Datwyler plungers guarantee you seal integrity while exhibiting superior gliding behaviour that ensure your drug is dispensed accurately, even for the minutest of displacements.

 

Fusing performance and compatibility

At the other end of the cartridge, the aluminium/rubber combiseal must also meet a complex set of requirements. In addition to ensuring the lowest possible extractables and leachables profile, the combiseal must be capable of resealing after multiple punctures. To meet these divergent challenges of mechanical performance and chemical stability, Datwyler has developed a revolutionary bilayer laminate seal featuring a chemically inert contact face for optimum compatibility and a polyisoprene layer. The latter protects the integrity and sterility of your product after every puncture, while limiting the release of rubber fragments, even after multiple punctures.

To meet these divergent challenges of mechanical performance and chemical stability, Datwyler has developed a revolutionary bilayer laminate seal featuring a chemically inert contact face for optimum compatibility and a polyisoprene layer. The latter protects the integrity and sterility of your product after every puncture, while limiting the release of rubber fragments, even after multiple punctures.

 

Expert advice

Our expert account managers are ready to assist you in every respect in selecting the components and compounds most suitable for your specific application. For your specialist formulations, your account manager will also work closely with Datwyler’s research & development department to ensure that customized solutions are developed that meet your specific requirements.

Contact us for more details and find out how we can provide the optimum solution for your application

GENERICS

Working hard to deliver your packaging solutions.

Generic small molecules today form a considerable part of the injectable drugs market.

Whether it is for vial or syringe administration, Datwyler is committed to developing the best possible packaging solutions for your generic drug applications. These components are manufactured using standardized production methods to the highest quality standards in many Datwyler plants all over the world. These components are partially based on the universal compounds that you will no doubt know us for, and have been regularly used as original applications before becoming the more generic forms that you know today.

These components, however, are also based on newer high-performance low extractable compounds which Datwyler has been committed to developing for its customers for some time. Many of these particular applications offer distinct advantages.

Finally, if the highest compatibility requirements are foremost on your decision agenda, Datwyler can provide you with a complementary range of coated closures.

 

A trusted partner

Datwyler is committed to supporting you in delivering follow-on generic small molecule drugs to the marketplace.  Our technical and quality teams are committed to working together with you to deliver packaging solutions that meet your specific needs.  Where you have needs that are still unmet, make Datwyler your partner of choice in innovation and delivery.

Contact us for more details and find out how we can provide the optimum solution for your application

ANTIBIOTICS

Your Safe and Reliable Packaging Solutions for Antibiotics.

Datwyler understands that the high sensitivity of antibiotic powders demands packaging systems that guarantee the highest levels of stability and compatibility.

The Right Component

Selecting the right rubber closure components for your application is critical to preserving the quality and safety of your drug right up to the moment of use. The right component will keep the interaction between the container and the drug to an absolute minimum. For instance, in the case of highly sensitive cephalosporin powders we know that choosing the right component to protect your drug is critical to achieving the best compatibility.
 

Optimum Compatibility

Datwyler’s exceptionally clean compounds and coated products guarantee optimum levels of stability and compatibility to protect your drug throughout its lifecycle. Together with you, our specialist staff will complete a compound recommendation questionnaire to help you select the right compound for your application.

Custom solutions

Datwyler will provide you with an experienced team of technical, research, quality, tooling and laboratory personnel dedicated to developing specialized closure solutions to match your specific requirements. We also provide a wide range of vial seals offering you optimum convenience, protection, and - most importantly - safety for your patients.

Contact us to find out more about our precision solutions for storing antibiotics

VACCINES

A Proven Track Record in Vaccine Packaging.

Given the wide variety of prophylactic and therapeutic vaccine formats currently available, Datwyler is presented with a real challenge in developing safe, reliable and stable packaging solutions that meet all the requirements of your applications.

Multiple Delivery Formats

From classic liquid vials to lyophilized powders and ready-to-inject, prefilled syringes, Datwyler has a proven track record in producing chemically stable, low permeable and narrow tolerance packaging components ensuring fast production and secure storage, and guaranteeing you safe and efficient administration.
 

Diverse Product Range

13 mm serum and lyo stoppers with corresponding aluminium caps together with plungers, tip caps and needle shields for prefilled syringes are all included in the product range available to you.

Secure Supply Chain

With a range of back-up systems in place, Datwyler can guarantee you maximum security and reliability throughout the supply chain, combined with extensive scientific support for your product development process. Optional procedures such as camera inspections offer you an even higher degree of confidence while a wide range of RTU (ready-to-use) components provide the added advantage of shortening your supply chain.

Contact us to discover the full range of vaccine packaging components

BIOLOGICS

Committed to helping the biotechnology industry save lives.

Datwyler fully understands the specific needs of its customers in biotechnology, and has the resources, expertise and processes on hand to develop specialized solutions that match your requirements. We consistently meet the highest standards for quality, reliability and efficiency, allowing you to focus on what matters most: saving lives.

The highest quality standards

Complex, high-value drug formulations demand the most advanced packaging components. Datwyler offers you a range of speciality closure solutions designed to assist you in accelerating and streamlining your drug development process. Our customers recognise our worldwide reputation for quality and reliability, and our investment in continuous improvement in the development and delivery of your solutions is ongoing. Our new, state-of-the-art FirstLine™ facility, for example, incorporates validated camera inspection capabilities, meeting the rigorous quality requirements of six sigma systems that you expect from us.

 

Unparalleled purity

Datwyler protects the quality and safety of your product via a range of ptfe-like coated products offering the lowest possible levels of extractables and leachables. The inherent lubricity of these Omniflex components eliminates the need for siliconization, making our Omniflex3G stoppers and OmniflexCP plungers ideal for protein-based drugs and the other sensitive products that you use.

The extraordinary purity of these revolutionary components effectively eliminates the risk of incompatibility issues, thereby significantly accelerating the time-to-market of your drug formulations.

 

Tailor-made solutions

Datwyler offers a range of customized systems that meet the specific requirements of biotechnology companies. Our ready-for-sterilization (RFS) and ready-to-use (RTU) components maximize both safety and production efficiency in your facilities, thus drastically reducing the resources that you might otherwise invest in inspection, testing and validation.

Contact us for more details and find out how Datwyler’s proven expertise can add value to your operations

BIOSIMILARS / BIOBETTERS

Datwyler – the industry leader in quality and cleanliness for your biologic applications.

Follow-on biologics are poised to make biologic drugs more available and affordable to patients who need them.  At Datwyler we understand your drive to deliver these medications to the marketplace in a timely manner and our technical experts are ready to support you in achieving this goal.  We also recognize that while speed to market is key, you cannot afford to compromise on quality for follow-on biologics.  We understand that biologic drugs - whether innovative, biosimilar, or biobetter - demand the highest technical demands for primary packaging, making Datwyler the ideal partner for your biologic packaging needs.

The industry leader in quality and cleanliness

Datwyler is the industry leader in the manufacturing of elastomeric closures with the highest quality and cleanliness.  Starting with our base rubber formulations with the lowest extractables profiles, these compounds can then be coated with our Omniflex barrier technology which also eliminates plungers as a source of silicone-oil-based subvisible particles.  Our state-of-the-art FirstLine™ manufacturing facility, which offers 100% camera inspection, ensures the lowest levels of particulates and endotoxin/ bioburden load.

 

Combining compatibility, stability and function

Omniflex Coated Plungers are the leading solution to silicone-oil induced aggregation of sensitive proteins.  Migration of silicone oil from the plunger face plays a significant if not dominant role in the total silicone oil migration into the drug formulation.

Our Omniflex coating technology gives you the added advantage of eliminating the need for plunger siliconization while still maintaining the lubricious function.  The barrier properties of the fluoropolymer coating help to ensure that your formulation remains stable during transport and storage.

 

A trusted partner

Datwyler is committed to supporting you in delivering follow-on biologic drugs to the marketplace.  Our experienced technical and quality teams are dedicated to working together with you to develop and deliver packaging solutions that match your specific requirements.  Where you have needs that are still unmet, make Datwyler your partner of choice in innovation and delivery.

Contact us for more details and find out how we can provide the optimum solution for your application

DENTAL CARE

Meeting the Challenge of Dental Care

The complex mix of drugs often delivered in a single dose during dental surgery requires the highest standards when it comes to compatibility and reliability.
Datwyler is your development partner committed to supporting you in this challenge in every respect.

A complex mix

As is the case with many other drugs, local anaesthetics often contain a combination of multiple active ingredients and excipients. You will no doubt have found that the elastomeric closures that the resultant complex matrix requires reduce interaction with the matrix to an absolute minimum.

 

Giving you the right solution

Enter Datwyler with a comprehensive range of components for all your dental applications. In addition to combiseals that can be used in your prefilled glass cartridges, we can also produce elastomeric plungers for dental syringes specially designed according to your requirements and standards.

The advantage to you of choosing Datwyler products

Datwyler employs the most advanced elastomeric formulations with all the essential physical, chemical and mechanical properties that ensure your anaesthetics are administered safely and easily with a very low E&L profile. The hardness of these components also guarantees you maximum PBSI (plunger barrel seal integrity). In short, when you choose Datwyler you are assured of maximum protection of your product’s integrity, and optimum functionality for the user.

Contact us for a comprehensive overview of our packaging solutions for dental care.

CATHETER FLUSH

 Your high-performance catheter flush syringe

Prefilled saline or heparin-filled catheter flush syringes have been a fast-growing application on your market in recent years. Crucially, if the contents of these syringes is not intended for injection, the application exerts tremendous strain on the rubber plunger in the syringe, adversely affecting chemical cleanliness but more significantly, physical performance.

For these reasons, Datwyler is the ideal choice as your partner of excellence in this field. We are committed to working together with you in developing a robust rubber material that matches your needs, as well as in perfecting the plunger’s multitude of physical attributes.  Once its other essential components have been refined, you have at the end of this process a high-performance catheter flush syringe to meet the most stringent of your requirements.

Contact us for more details and find out how we can provide the optimum solution for your application.