We at Datwyler enable our customers to cater to global markets with the most advanced and in-demand products. We offer a range of services designed to promote product safety and efficacy, secure a safe and fast regulatory approval, and ensure a path towards future growth. Our service fields provide comprehensive solutions for primary and secondary packaging needs.
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.
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 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
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
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 Nelson Labs, 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.
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.
For each new custom design, we develop the product drawing, calculate the total surface, and produce a product rendering. We also determine the product volume and a realistic rendering of the final design.
Once the desired product has been rendered, we use 3D software to ensure that each product is rendered per the customers' requirements and is practical to real-world production.
Customized Engineering Activities
In every co-engineering process, the customers decide which services we shall perform. At the end of the process, our customers receive a reproducible safe, and effective product to be integrated into their packaging solutions.
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 mechanical analysis facilitates the systematic optimization of single parts or entire assemblies to provide best product performance.
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.