Service and Support
Comprehensive support services
Datwyler’s highly experienced personnel are renowned for their extensive product knowledge. However, in addition to comprehensive documentation and product support, Datwyler also offers a range of customized laboratory testing services focusing on the (physico-)chemical, functional and (micro)biological properties of any given compound.
Learn more about our services on :
- Extractables & Leachables
- Chemical and Functional testing
- Labscale Prototyping
EXTRACTABLES & LEACHABLES
Full support for your regulatory requirements.
Datwyler has all bases covered when it comes to extractables and leachables. Our comprehensive E&L programmes are designed to address every facet of your compliance risk.
Strict regulatory requirements
Primary packaging materials are subject to very strict regulations these days. Drug manufacturers, for instance, are responsible for identifying and quantifying potential extractables and leachables and to evaluate any associated toxicity. Datwyler can help you manage your compliance risk from set-up to final assay.
Datwyler maintains standard extractables reports for most of its compounds, identifying specific extractables relevant to the elastomeric material composition itself but also materials used during processing. These reports are available for five model solvents (water of pH=3, 7 and 11, isopropanol and hexane) based on tests conducted under extreme conditions. Standard extractables reports are available on request for most of the rubber formulation.
Datwyler can also perform customized extractables or leachables studies in accordance with user-specific requirements. Here, too, our approach includes the entire trajectory from test design to results interpretation. We have a close working relationship with Toxikon, guaranteeing unparalleled expertise and state-of-the-art analytical techniques. Datwyler can also provide a full toxicological assessment evaluating the toxicity of any and all identified and quantified leachables.
CHEMICAL AND FUNCTIONAL TESTING
Fully equipped, staffed and certified testing facilities
Datwyler has all the resources in place – from state-of-the-art laboratories to highly routined technicians – to perform comprehensive (physico-)chemical and functional testing. our rubber closures for primary parenteral packaging applications are routinely tested in accordance with iso 8871, with pharmacopoeia and with other applicable standards.
In addition to routine batch release testing, we are also well versed in setting up customized testing regimes for a variety of other applications.
Preventing microbial contamination
Bioburden and endotoxin testing is critical to RFS and RTU configurations. Datwyler employs the most up-to-date techniques to test for the presence of bioburden. The quantity of viable microorganisms and of endotoxins present on rubber stoppers, for instance, is assessed using methods according to ISO 8871-4.
Microbial contamination can be tested batch-to-batch. The results are included on the certificate of analysis for each subject batch.
Minimizing development costs at the prototype stage
Datwyler can help you manage the development costs of your project by fine-tuning your prototype design prior to upscaling and, importantly, prior to investments in industrial-scale tooling equipment.
Datwyler avails of a fully independent pilot plant equipped with a wide range of presses and other machinery. as it runs entirely separately from our regular production lines, it has the necessary independence to run smaller-scale development trials, experiments and trial runs.
Helping to pave the way !
We take pride in servicing you to the best of our abilities within the shortest lead times.
Helping you to pave the way with authorities is just 1 example. With our easy on-line LOA request form we aim to speed up and facilitate your process with the authorities.
Find more information on our
- DMF files
- Letters of Authorization
- LOA request form
- USP <1>
Comprehensive Drug Master Files
The following Drug Master Files have been filed with the FDA and Canadian Health Authorities:
FDA Type III
- describes the formulation of the standard compounds produced in Alken, Belgium; Pregnana, Italy; Pennsauken, USA; and Montegaldella, Italy
- describes the different coating types
- describes the validated washing processes (ISAF, OMNI, FLNC and FLCO)
FDA Type V
- describes the RTU gamma sterilization process for rubber products
The DMF file describes the formulation of the standard compounds produced in Alken, Belgium; Pregnana, Italy; Pennsauken, USA; and Montegaldella, Italy as well as the different coating types.
LETTERS OF AUTHORIZATION
Submission of drug applications
All standard Datwyler rubber compounds are registered in a type III Drug Master File (DMF) in the United States and in Canada.
To facilitate the submission of drug applications, Datwyler can provide letters of authorization for these confidential files, free of charge.
STANDARD QUALITY CERTIFICATES
PRESENTATIONS & PUBLICATIONS
Whitepaper : Enabling Device Innovation through Component Satisfaction
Lyophilized Biologics and Vaccines
Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics.
- Technical Documentation family of Omniflex coatings
- Description of washing cycles