服务
德特威勒医药包装为
您提供一站式服务
德特威勒助力客户面向全球市场，提供最先进、最受欢迎的产品。
我们提供多项服务，旨在提升产品安全性与有效性，确保快速、安全的法规审批，并为未来增长奠定基础。我们的服务涵盖初级和二级包装的全面解决方案，为客户提供一站式支持。
StarterPack™
The StarterPack™ is the ideal service to tackle small quantity component needs. It includes OmniFlex® Stoppers, PrimeCap™, and SCHOTT adaptiQ® vials.
Packaging & sterilization
We have applied our expertise in ready-for-sterilization (RFS) solutions to a platform of ready-to-use (RTU) components. Our solutions optimize process efficiency as well as cost management and ensure a secure and reliable delivery.
Our service offering.
With our service offering, we at Datwyler intend to provide our customers with state-of-the-art solutions and testing strategies. In addition to the supply of primary packaging, our team of experts assists with lab testing, custom product design, simulations / Finite Element Analysis (FEA), business continuity plans or a combination of several of these services.
Lab testing
Lab testing to assure conformance with regulatory and industry requirements.
With more than four decades of experience as a market leader in parenteral packaging, Datwyler understands the ever-changing requirements posed by the pharmaceutical industry and its regulatory bodies. To assure that the company’s products meet those requirements prior to being distributed, Datwyler has assembled a series of tests to provide its customers with a comprehensive product analysis.
Datwyler’s lab service begins with assisting in compound selection through questionnaires to specify the requirements for the customer’s ideal product. Thanks to extensive product knowledge and experience, Datwyler’s R&D team is able to recommend the ideal compound solution aligned with the indicated requirements.
Pharmacopoeia and normative testing
- Customized E.P.3.2.9 / USP<381> chemical testing
- Customized E.P.3.2.9 / USP<381> functional testing for injection stoppers
- Normal and customized functional testing for infusion stoppers as per ISO8536-2
- ICP – Elemental impurities as per ICH Q3D
Functionality testing
- Fitting test, part 1: insertion force on vial
- Fitting test, part 2: popping up / off test
- RSF – Residual Seal Force
- Gliding profile testing for prefilled syringes and cartridges
Container Closure Integrity testing
- PBSI – Plunger Barrel Seal Integrity test as per ISO 7886-1
- PBSI – Plunger Barrel Seal Integrity test using He-leak testing
- CCSI – Container Closure Seal Integrity test using laser-based headspace analyzer
- CCSI – Container Closure Seal Integrity test using He-leak testing
Other standard industry testing
- Silicone oil determination using DCM / FTIR
- Extractables and leachables services
- Moisture percentage of products
- And others
Extractables & Leachables Testing
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
Comprehensive reports
Customized testing
Custom product design
Custom product design to make
individual ideas become reality.
At Datwyler, we provide our customers with the opportunity to develop custom
sealing solutions for their drug product platform. In a “co-engineering” process, we
work with and alongside our customers to incorporate our unique process
knowledge into the design of their products from the very beginning of the
development process.
The co-engineering process
incorporates three main phases.
Product Design
Product Analysis
Customized Engineering Activities
Simulations
Finite Element Analysis to eliminate
possible issues at an early
stage in product development.
We increasingly employ numerical simulation techniques to ensure the best product functionality as well as efficient
and reliable production processes at the core of our customer applications. We use Finite Element Analysis (FEA) to
fully comprehend the functionality of new elastomer components before real prototypes exist. FEA permits the
assessment of a wide variety of engineering problems ranging from structural mechanical analyses to mold flow
investigations and facilitates the examination of parameters such as deformation, reaction forces, contact pressure,
material stress, filling behavior, and temperature. Our customers benefit from an accelerated development cycle as
well as superior product quality.
Industry-leading simulation
capabilities in four areas.
At Datwyler, we offer industry-leading simulation capabilities, which serve as the basis for the best product performance and reliable serial production:
Testing & Modeling
For most accurate simulation results, we have established rigorous testing and modeling procedures, which allow the comprehensive characterization of the material behavior.
Computer Aided Design (CAD)
Product design and mold layout are developed and edited on a powerful CAD platform which supports fully parametrized 3D models.
Structural Mechanics
Structural mechanical analysis facilitates the systematic optimization of single parts or entire assemblies to provide best product performance.
Mold Flow
Mold flow analysis enables the examination and optimization of mold layout and process parameters to ultimately guarantee a reliable and cost-effective serial production.
Business continuity plans
Business continuity plans minimizing the risks for our customers.
At Datwyler, we take every measure to ensure our customers have access to their products, and we have a plan in place to mitigate supply risks. Our risk mitigation strategies consider disaster risks, product discontinuity, as well as regional supply constraints. By analyzing each of these areas in conjunction with our customers’ supply needs, we are able to develop a joint business continuity plan to assure security of supply of our customers’ products.
Resources
