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
  • Microbiology
  • 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.

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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.

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MICROBIOLOGY

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.

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LABSCALE PROTOTYPING

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.

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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>

DMF

Comprehensive Drug Master Files

The following Drug Master Files have been filed with the FDA and Canadian Health Authorities:

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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.

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PROCESS FLOWS

STANDARD QUALITY CERTIFICATES

PRESENTATIONS & PUBLICATIONS

Whitepaper: Pharmaceutical Manufacturing and Packing Sourcer

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.

Buy eBook on Springer.com

TREATMENTS

  • Technical Documentation family of Omniflex coatings
  • Description of washing cycles

Aluminium - Technical Information