With more than 100 years of experience, we have become a global thought leader in the industry with a strong sense of future trends and the ability to set new standards. Please find below a selection of our contributions to the advancement of global health care.

Datwyler introduces the Starter Pack with SCHOTT – a single source solution for drug discovery through drug delivery

To emphasize the goal to be a strong partner to its customers in the development and introduction of new drugs, Datwyler introduced its Starter Pack, which offers comprehensive packaging solutions to ensure drug efficacy, stability, and, ultimately, patient safety in June 2019. Featuring SCHOTT adaptiQ® vials and Datwyler’s Omni Flex stoppers and Prime Caps, the Starter Pack provides its customers with sealing solutions for every stage of drug development – a single source solution to take the drug from discovery to delivery.

“The launch of our Starter Pack once again proves our commitment to strive for a healthier world of tomorrow. The healthcare industry often struggles with the approval of successful new drug registrations due to high costs and start-up difficulties, even though research and development are critical stages in our industry. Therefore, we are very proud to be a strong partner in this process for our customers with our Starter Pack,” explains Massimo Mainetti, Head of Strategic Marketing at Datwyler Sealing Solutions.

Starter Pack: from drug discovery to drug delivery

Datwyler developed the Starter Pack to provide its customers with a range of compatible primary and secondary packaging components to be used in every drug development application. This enables its customers to incorporate high-quality components and commercial packaging solutions into their testing and clinical trial strategy, including diagnostic research, clinical trials, and product launch. After that, the quantities can be ramped up. Datwyler is aware of the challenges that customers are facing in their respective fields. Considering all critical aspects within the product development, Datwyler can help their customers to find the right packaging solution for their needs.

A single source solution: superior packaging components and a full service offering

The Datwyler Starter Pack includes Omni Flex stoppers, Prime Caps, and SCHOTT adaptiQ® vials. All products provided are ready-to-use (RTU) and have been sterilized in accordance with pharmaceutical and regulatory guidelines. All of Datwyler’s vial closure solutions are produced, controlled, and tested under the most stringent conditions in order to guarantee patient safety. Omni Flex is a coating solution that meets the highest demands for highly sensitive, large molecule drugs. Prime Caps are Datwyler’s solution for flawless machineability on high-speed filling lines. The SCHOTT adaptiQ® vials can be processed on a wide range of new and existing fill & finish equipment, allowing the vials to remain nested throughout the fill & finish process, including during lyophilization.

“We are delighted that the Datwyler Starter Pack features SCHOTT adaptiQ® vials. Access to high quality RTU vials and closure systems will enable our customers to accelerate drug development and gain flexibility during development and production. Further, the use of RTU components will enhance patient safety” adds Anil Busimi, SCHOTT, Sr. Global Product Manager, iQ Platform.

The Starter Pack is designed not only to provide the right packaging, but also to support the testing and launch process. For this, the company provides analytical and rubber compounding expertise during product selection and testing. The implementation of these in-house programs presents Datwyler’s customers with a comprehensive solution for parenteral packaging. The service offering includes pharmacopoeia and normative testing, functionality testing, and container closure integrity testing.

Guaranteeing the highest quality standards

Datwyler’s Starter Pack is designed to provide its customers with products that are pre-tested for Container Closure Integrity (CCI). The combination of the Datwyler Omni Flex stopper, Prime Cap, and SCHOTT adaptiQ® glass vial, offers an ideal sealing compatibility, preventing leaks and other seal integrity concerns throughout manufacturing and handling. Using standard CCI testing methods required by pharmaceutical and regulatory authorities, Datwyler can recommend a total packaging solution for storing and administering sensitive drug products.

USP publishes draft general chapters on Extractables and on Drug Product Leachables

As part of its 2010-2015 cycle, USP’s Packaging, Storage, and Distribution Expert Committee in Pharmacopeial Forum 39(5), Sept.-Oct. 2013, has published the first drafts of a number of chapters related to packaging.

Among those are the drafts of chapters that provide general information, namely USP <1663>, ‘Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems’ and USP <1664>, ‘Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems’.

 

Draft USP <1663> on ‘Extractables’ is not prescriptive, but provides an information framework on how to design and execute Controlled Extractables Studies. It describes for example the scientific principles and best practices that apply to extractables studies for packaging components. General concepts and design parameters are discussed with respect to the generation of an extract from the packaging system, component or material. Design parameters include the choice of extraction solvents, techniques and conditions. Processes and analytical methods are subsequently outlined for the discovery, identification and quantitation of extractables.

While draft USP <1664> on ‘Leachables’ is equally non-prescriptive, it too constitutes a framework for the design, justification and execution of leachables studies. Leachables in drug products are of concern not only because they may be harmful to patients if delivered in too high doses, but also because they may compromise drug product stability. The use of safety thresholds as a general concept for leachables assessment is thoroughly discussed, as is the use of analytical thresholds in the characterization of leachables. Consideration is given to the analytical techniques used for leachables characterization and to the validation of quantitative analytical methods. Additional considerations are made related to the use of simulation studies as a link between extractables and leachables studies.

Comments on these draft USP chapters were due by November 30, 2013. Datwyler has naturally committed to submitting a number of comments, particularly with respect to USP <1663> on ‘Extractables’. We will of course keep a close eye on this, and keep you, our customer, up to date on all developments.

 

 

Why halobutyl is used for elastomeric closures in parenteral applications ?

There are several excellent reasons why Datwyler employs bromobutyl and chlorobutyl rubber for elastomeric closures in your parenteral applications.

The principal reason is that halobutyl elastomer - halobutyl being a term that groups bromobutyl and chlorobutyl - has the lowest gas permeability among commonly available elastomers. Datwyler knows that low gas permeability is essential in your parenteral applications, and would like to present you with a few examples.

 

Many active product ingredients are sensitive to oxygen. Ingress of oxygen may lead to degradation reactions in such drugs. Datwyler therefore realizes it is essential that oxygen is eliminated from the packaging of your pharmaceutical products. Halobutyl formulations are best placed to achieve this goal.

 

Lyophilization products are sensitive to water. For this reason they are formulated as lyophilized products, and not as aqueous-based drug formulations. For the same reason, it is essential that the environmental moisture present in gaseous form in air, does not permeate through the primary packaging, and Datwyler is aware of this. For glass, this is obviously no challenge. For rubber, however, this poses a greater problem, since any rubber formulation is characterized by a particular moisture vapour transmission (MVTR). We know that moisture vapour transmission rates are lowest with halobutyl formulations.

 

The same lyophilization products very often are packed under a certain vacuum, primarily to facilitate reconstitution of the drug with a diluent immediately before administration of the drug to the patient. The low pressure in the vial helps in aspirating the diluent into vial, thereby easing reconstitution. We know that it is important that the underpressure initially installed at the time of closing the vial is preserved to the optimum degree over the shelf life of the drug. Any minimal permeation of air through the lyophilization stopper would destroy the vacuum in the vial. The permeability of oxygen and nitrogen (air) are lowest with halobutyl formulations.

The halobutyl elastomer used is not the only factor that determines the gas permeability  properties of a rubber compound. However, although other rubber ingredients play a role in determining these properties, the elastomer is the most prominent factor.

 

Another reason why Datwyler prefers halobutyls when developing your parenteral applications is that they can be crosslinked in the cleanest way. Crosslinking, i.e. vulcanization or curing, is the chemical process that is needed to introduce elasticity in thermoset rubbers such as halobutyls. This chemical process uses a crosslinking system. Crosslinking systems can be simplest and cleanest with halobutyl elastomers, thus ensuring that if they are well balanced, they will contribute minimally to the extractables profile of the resulting rubber used in your application.

 

A third significant reason why Datwyler uses halobutyl elastomers for your parenteral applications is the inherent ageing stability of the polymer with minimal addition of antioxidants. Lower levels of antioxidants again warrant cleaner extractables in the rubber compound.

 

Finally, as part of our drive to ensure that information on rubber compounds is as complete as possible, Datwyler is committed to determining and documenting the oxygen and water vapour transmission rates in those compounds that are used in developing your applications.

Changes in Pharm. Eur. 3.2.9, effective January 1, 2014

Pharm. Eur. 3.2.9 ‘Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders’ is the chapter in Pharm. Eur. that is relevant for physicochemical testing of rubber closures. On 1 January 2014 a number of changes will become effective to Pharm. Eur. 3.2.9.

The most significant changes are in the ‘Identification’ section of Pharm. Eur. 3.2.9:

  1.  ‘Identification Test A’ (stretching by hand) is being removed;
  2. Surface FTIR-ATR replaces pyrolysate IR as infrared identification technique. The only exception will be carbon black-filled rubbers where surface ATR is not effective. For such rubbers FTIR-ATR of the pyrolysate will be used.
  3. A ‘staggered’ set of accuracy limits for the ash test has been introduced. The limit of +/-10 % that has so far been applied has not proved feasible for low ash rubber compounds.

 

In addition to this ‘Water R’ – effectively ‘Purified Water’ – may be used for making Pharm. Eur. 3.2.9 extracts instead of Water-or-Injection.

Other changes are of an editorial or explicatory nature and do not have an impact on the results of testing. Results of Pharm. Eur. 3.2.9 in-process-testing or finished product testing as used by Datwyler therefore will not be affected.

Relevant changes that will be of interest to you, are in respect of Datwyler’s Compound Data Sheets (CDS). We have therefore prepared CDS updates that incorporate these changes where relevant.

 

Datwyler has been working closely together with other experts in realizing these changes – essential to maintaining the high standards inherent in all the products that we develop and produce for you – and we will continue to do so in the future. We will inform you of any further relevant changes as and when they occur.

Please do not hesitate to contact us if you require further information – we look forward to hearing from you.


We constantly identify future trends and ensure that we have the skills, technologies and resources needed to respond to the evolving needs of patients. In doing so, we enable our customers to bring the most advanced and high-in-demand products to the global market.

 

 

 

PRIORITIZING PATIENT SAFETY

Patient safety is one of our biggest priorities. We constantly invest in the most advanced technologies, design and production processes to eliminate patient risks beyond regulatory requirements. Our state-of-the- art manufacturing approach is based on cleanroom facilities, excellent particle level management, and a zero defect policy to ensure the best-in- class solutions for patients worldwide.


SHAPING THE FUTURE OF HEALTH CARE

We constantly strive to deliver excellence, set new industry standards and shape the development of our markets – now and in the future. We are prepared for tomorrow’s needs and expectations, thereby helping our customers to master the challenges of the industry and stay ahead in the age of digital transformation. Our future-oriented innovations aim to improve personal health by advancing new solutions, leveraging new therapies and providing state-of-the-art components for wearable health care devices.


ADVANCING GLOBAL LEADERSHIP

As leading supplier of the industry, we continue to build our global capabilities and presence in key markets around the world. By entering emerging markets, leveraging lean production processes and building on an optimized supply chain, we master the challenges of the global health care industry. In doing so, we ensure efficient market access, maintain a competitive edge and remain a reliable partner – wherever our customers need us.