Healthcare Polymer Solutions (Mevopur)
Modification of polymers for healthcare applications
Trusted color and performance. Clariant Masterbatches has over 10 years experience in this segment. However in 2008 after discussions with customers we started to develop a new approach to the medical and pharmaceutical sectors based on controlling and minimizing risk.
To help customers manage their risk potential, dedicated facilities and systems govern the production of Clariant’s medical color and performance masterbatches and compounds. These ISO13485 certified production sites offer full manufacturing line segregation to reduce risk of cross contamination between products, giving customers peace of mind regarding material purity.
The result of this work is captured under the service and product brand MEVOPUR®
- Controlled, Consistent, Compliant.
- Three ISO13485 certified centers of competence in USA, Europe, Asia.
- Extensive experience in developing coloration and functional formulations to meet the regulatory requirements of these markets, such as USP, EuP, and DMF.
- Clariant’s innovative color and performance materials for medical and pharmaceutical applications help customers respond quickly to rapidly changing preferences and demands. They meet the latest industry trends for surface functionality and aesthetics still taking into account safety and regulatory compliance.
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MEVOPUR® Masterbatches & Compounds
Medical Masterbatches and Compounds for Medical and Pharmaceutical Applications
Our expertise and market understanding is based on numerous years of working in these highly-demanding sectors. The result: an ever-expanding portfolio of color and functional additive compounds and masterbatches, compatible with all thermoplastic processes utilized by the industry, which combines creativity with production efficiency for our customers.
To meet preferred manufacturing processes, color is provided as color concentrate masterbatches for dilution into another polymer or as small and large lot pre-color compounds. Functional additives such as nucleants, clarifiers, lubricants, anti-microbial etc follow the same approach or can be added in combination with color as a ‘combi’ solution. The effects are not only visual. Functional additives are being introduced to improve productivity.
Our product solutions cover the wide range of polymers and thermoplastic elastomers (TPEs) used in the medical and pharmaceutical sectors. These include PE, PP, COC cyclic olefins, ABS, SAN, polyester copolymers, PC/ABS, PC, PA6, 66 and 12, high performance polymers, and elastomers such as EVA. SEBS, TPU, Hytrel® PEBA, and now, newly added, Liquid Silicone Rubbers.
Controlled, Consistent, Compliant, and Creative
When it comes to boosting the functionality, or providing color to help to the safe identification, or help create brand appeal of medical and pharmaceutical applications, Clariant is at the cutting-edge of industry creativity.
Safe Identification Color helps provide reliable identification
When it comes to safe identification of a medical device or the correct dose of a pharmaceutical, color helps to provide quick and reliable method of coding your device or pharmaceutical packaging.
The materials used, including any colorants and additives, are often required to comply to regulatory standards such as USP parts 87 and 88 or ISO10993 particularly if in contact with liquid pharmaceuticals or body fluids. Regulatory bodies are increasingly aware of the impact of changes in materials during the development and life time of the product.
Clariant, has developed a ‘USP / ISO Range of Standard Colors’ based on pre-tested ingredients. This helps reduce development time and costs of matching special colors, and the possibility of additional regulatory evaluation. For more information on our standard color range please download our color chart at the bottom of the page.
To assist in FDA submissions for devices and pharmaceutical packaging, such as PMA or 510(k) Clariant is including this standard range in a MAF Type III reference MAF-1833 covering the 3 designated ISO13485 sites. For a copy of Clariant MAF refer to the list of documents at the bottom of the page.
Color helps create brand appeal for customers
Product differentiation for your device or pharmaceutical packaging through the use of vibrant colors. To enhance our normal color matching process, Clariant’s specialist design team based at ColorWorks™ Design Centers at seven strategic locations around the world works closely with customers from the early design stage to choose compliant but inspirational colors for the relevant.
No time? Project too small? To help reduce development time Clariant has developed a range of standard colors based on pre-tested ingredients. This ‘USP / ISO Range of Standard Colors’ avoids development time and costs of matching special colors, and the possibility of additional regulatory evaluation.
To assist in FDA submissions for devices and pharmaceutical packaging, such as PMA or 510(k) Clariant is including this standard range in a MAF Type III reference MAF-1833 covering the 3 designated ISO13485 sites. For a copy of Clariant MAF please refer to the document list at the bottom of the page.But differentiation is not just about creativity in color design, it is also adding new functionality and about productivity in manufacturing. During 2011, Clariant is introducing a range additives products based on evaluating raw materials to the same USP / ISO test protocols as the standard color range.
Visualization of Surgical Devices
Custom radiopaque compounds
Visualisation of devices in surgical procedures is vital for the success of the operation. Materials are modified to make them radiopaque and therefore visible using techniques such as X-ray fluoroscopes. There are a number of design issues that Clariant formulation know-how can solve.
- Thin wall sections require higher density fillers to be radiopaque. Clariant offers a range compounds with different filler options e.g. barium sulphate, tungsten, Bismuth subcarbonate;
- Complex multi-wall extrusion processes used in catheters require excellent surface finish. Clariant’s dispersion and processing know-how helps to achieve high quality surfaces. Lubricants can be included to further enhance extrusion and surface finish.
- Several different types of resins are used including PP, TPU, PEBA. Clariant offers radiopaque compounds in a wide range of resins where ingredients have been pre-tested to USP parts 87 and 88 for Class VI devices and /or ISO10993.
- Colors? Clariant provides the radiopaque compounds in a range of colors using the standard USP /ISO range or custom color to your requirements.
Additives bring functional performance
Surface engineering advantages that help to improve the ease of use and reliability of devices. For example:
- Activation of the polymer for laser marking providing ink or solvent residue-free identification eg. for the purpose of Unique Device Identification (UDI);
- Fluorine-free lubrication systems lowers friction between parts reducing force to rotate, slide and actuate helping the reliability of metered dose devices;
- Permanent antistatic agents help to ensure smooth delivery of powdered drugs;
- Addition of anti-microbial additives;
PLASTIWARD™ is a new unique end-to end in-plastic security system co-developed with SICPA SA, a leading provider of secured identification, traceability, and authentication solutions and services. The exclusive and proprietary taggant technology can be added by Clariant under ISO13485 GMP conditions to virtually any polymer, combined with MEVOPUR or REMAFIN-EP in a color concentrate or compound. Combined with SICPA’s detection and monitoring platform, the result is a robust end-to-end system thereby contributing to your brand-protection strategy.
Design for Manufacturing
Controlled, Consistent, Compliant, and Productive
Manufacturing in the medical and pharmaceutical sector has similar pressures to others; productivity and consistent quality. Manufacturing engineers continuously search for new ways to reduce manufacturing costs and improve the product during the development and life cycle of the product. :
Using a wealth of experience gained in other sectors Clariant is introducing a standard range of functional additives to compliment the Standard USP Color Range, Device and pharmaceutical packaging converters can take advantage of a new range of sector-dedicated MEVOPUR® additives to boost their productivity and cost-efficiency, with the assurance of regulatory compliant ingredients.
For example MEVOPUR® nucleating masterbatch uses latest generation technology and potential to reduce in cycle times in PP-Homopolymers and improvements to morphology and mechanical properties.
In addition international companies often experience difficulties with obtaining materials when establishing production in another continent. Local regulations such as REACH may prevent use of certain raw materials. This is why new products in the MEVOPUR® range are developed using a controlled global raw material palette and are available from our ISO13485 certified sites in Lewiston USA, Mälmo Europe, and Singapore Asia Pacific. Our USP/ISO Range of Standard Colors (color chart can be downloaded at the bottom of the page) is available from all 3 sites using same formula and same raw materials supplier.
Medical Manufacturing Sites
ISO13485 Certified Sites - Medical Centers of Competence
Global consistency - Consistent performance, be it product or service-related, is a key priority at Clariant. Our customers can be confident that no matter what the application or location, they will receive the right materials and support to meet their exact specification or challenge.Strict controls ensure the consistency and reliability of formulations and procedures around the world. Clariant implements a quality management system in line with the global harmonized standard ISO 13485 across all three plants.
To facilitate our manufacturing processes, different levels of segregation of lines are available at these facilities. Selection is based on detailed customer discussions on the product requirements and an ISO13485 based process for risk assessment of the final application.
Change-control processes reduce the potential for product alterations, allowing customers to focus on the marketing of their product with the assurance of consistent quality and regulatory compliance in mind. Change-control refers to Standard Operating Procedure (SOP) under Clariant’s global quality system.
It is possible to enter into individual change-control agreements covering aspects of our processes. Please contact us using the contact box at the bottom of the page for further discussion.
Regulatory & Material Characterization
USP <87>,<88> VI & ISO10993
Characterization of our raw materials and/or final masterbatches and compounds through careful selection, pre-testing and evaluation gives customers a clear picture of their material of choice.
Ingredients for specific masterbatches and compounds have been evaluated and characterized under ISO10993 parts 5, 10, 11, 18 and / or United States Pharmacopeia (USP) parts 87,88 (Biological Reactivity tests for Class VI devices). More details and test certificates are available on request. You can download the Clariant Evaluation Protocol at the bottom of the page.
However, because of the wide variety of medical device applications, sterilization regimes, etc, it is the responsibility of the device manufacturer to perform further appropriate tests for compliance with all requirements for the intended end-use application.
Specifically for MEVOPUR and REMAFIN-EP grades targeted at pharmaceutical packaging applications we also offer in addition regulatory declarations used in this sector namely USP <661.1> and European Pharmacopeia monograph 3.1 based on real test data.
To help reduce development time, Clariant has developed a ‘USP / ISO Range of Standard Colors’ based on pre-tested ingredients. This avoids development time and costs of matching special colors, and the possibility of additional regulatory evaluation. Also this standard range is covered by our Change Control commitment and Risk Assessment processes.
Currently these are available in polyolefin, polyester copolymer (Tritan™) PEBA (polyether block amide elastomer), polycarbonate carriers, and will be expanded to other polymer groups and a range of additives.
Newly added is the MEVOPUR-LQ range of liquid carriers combining the expertise of Clariant’s HiFormer® liquid-vehicle technology with translucent packaging (eg. PET amber) and now Liquid Silicone Rubbers (LSR) .
For more information, please download a color chart at the bottom of the page.
To assist in FDA submissions for devices and pharmaceutical packaging, such as PMA or 510(k) Clariant is including this standard range in a MAF Type III reference MAF-1833 covering the 3 designated ISO13485 sites. For a copy of Clariant MAF please refer to the links at the bottom of the page.
As part of ISO13485 quality standard, Clariant has a risk assessment process, and a clear medical policy. To read more about our medical policy please refer to the following tab.
Clariant Medical Policy
Clariant products have not been designed for nor are they promoted or intended for use in:
(a) medical devices categorized by either the United States Food and Drug Administration or the International Standards Organization (ISO) as an “implant” device; or “Permanent” as defined under US Pharmacopoeia (USP) or ISO standards; or
(b) active implantable medical devices as defined in EU Directive 90/385/EEC as amended; or
(c) medical devices for “Long Term” use as defined in EU Directive 93/42/EEC as amended
Without limiting the generality of this statement, Clariant products shall not be used in any medical device application intended for:
(1) exposure to human tissue or body fluids for 30 days or greater;
(2) “plastic” (cosmetic or reconstructive) surgery use;
(3) reproductive implants or any birth control device; or
(4) any critical component in a permanently (greater than 30 days) implanted medical device that supports or sustains human life.
It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device, including the suitability of all raw materials and components used for its manufacture, with all applicable laws and regulations.
CLARIANT MAKES NO REPRESENTATION, PROMISE, OR EXPRESS OR IMPLIED WARRANTY CONCERNING THE SUITABILITY OR LAWFULNESS OF CLARIANT’S PRODUCTS FOR USE IN ANY MEDICAL DEVICE UNLESS EXPRESSLY STATED IN A WRITTEN AGREEMENT SIGNED BY A DULY AUTHORIZED CLARIANT REPRESENTATIVE.
Version January 18, 2010
Risk Reduction for Customers
Controlled - to help customers manage their risk potential, dedicated facilities and systems govern the production of Clariant’s medical color and performance masterbatches and compounds. During 2010 each of the 3 medical Centers of Competence gained external certification to ISO13485.
Our ‘open to audit’ policy and controlled operations help meet FDA and other regulatory guidelines regarding fully traceable production. We strive constantly to improve our practices and reporting systems by working closely with partners in the supply chain.
Consistent - Consistent performance, be it product or service-related, is a key priority at Clariant. Our customers can be confident that no matter what the application or location, they will receive the right materials and support to meet their exact specification or challenge. Consistency across the three COC production centers allows Clariant to deliver same product formulations to customers with operations in several continents.
Compliant - Clariant is proud to develop material formulations that can help customers more easily comply with local regulatory requirements. Documentation supporting relevant product safety and compliance data is available to all customers, further encouraging transparency between Clariant and its customers.
Characterization of our raw materials and/or final masterbatches and compounds through careful selection, pre-testing and evaluation gives customers a clear picture of their material of choice. Our range of products includes those whose ingredients meet the requirements for biological reactivity under ISO 10933-1 and United States Pharmacopeia (USP) parts 87,88 (class VI devices) and /or USP <661.1> and European Pharmacopeia 3.1.
Fight the Fake - Counterfeit devices and medicines are growing at an increasing rate, and undermines the mission of medical device and pharmaceuticals companies to deliver safe access to treatments. Clariant and SICPA SA have jointly developed PLASTIWARDTM, a complete in-plastic solution that effectively protects from counterfeiting and dilution, while enabling pharma and medical devices companies to guarantee supply chain integrity with low impact on productivity and operations. Our joint expertise in the management of security and polymer solutions allows us to be an ideal partner to design, deploy and monitor a tailor-made approach to answer your needs in terms of security and compliance.
Our mission is to help you fulfill your promise of access to safe medicines to millions of patients and consumers around the world.
Clariant Healthcare Packaging specializes in active materials, functional design and innovative plastic processing. With this expertise, we create and manufacture controlled atmosphere packaging, effectively combining sorbents with innovative features.
Protecting pharmaceuticals, nutraceuticals, diagnostics and medical devices has been Clariant Healthcare Packaging’s core business for many years. Whether the need is for a pharmaceutical desiccant or full container closure systems, Clariant can design an application-specific packaging solution to meet market and regulatory requirements.
Because we serve healthcare markets we know how to work within stringent industry standards. We are dedicated to a culture of excellence and continuous improvement, and we employ cutting-edge material engineering, product design, molding technologies and production methods. Working with our teams of six-sigma black belts and green belts, we are constantly improving our production processes to meet or exceed customers' needs.
To learn more please visit our Healthcare Packaging page.