If this is your company, CONTACT US to activate Packbase™ software to build your portal.

    Clariant Healthcare Packaging announces compliance with new USP desiccant rules

    • Clariant
    • Information on USP compliance available at INTERPHEX 2016
    • Clariant assists USP in development of new standards
    • Guidelines govern quality, efficacy of drop-in desiccant products

    The US Pharmcopeia and The National Formulary (USP-NF is a compendium of pharmacopeial standards for chemical and biological drug substances, dosage forms, compounded preparations, excipients, medical devices, and dietary supplements. Chapter is dedicated to “Auxiliary Packaging Components” and until now has mainly addressed requirements for pharmaceutical packaging coil. Previous guidance for desiccant quality were only covered in other chapters within the USP-NF as they applied to pharmaceutical ingredients and usually was not applicable to packaging applications.

    Thus, the USP decided to develop a new “Desiccants” section within USP and invited Clariant (and others) to provide input. After a lengthy process, a draft chapter was published in November 2015 and becomes official on May 1, 2016 in the latest issuance of the USP-NF (USP 39–NF 34 2016).

    “The new guidelines will only have meaning and industry support if it is based on real data,” explains Desmond G. Hunt, M.S., Ph.D., Sr. Scientific Liaison, USP, Rockville, Maryland. “Clariant was a major contributor to the effort, providing materials for testing and answering key questions along the way. They helped make development of the new Chapter section extremely easy.”

    The new desiccant section officially sets forth specific quality standards for desiccants used in pharmaceutical packaging, and includes sub-sections on desiccant substance appearance, identification, inorganic impurities, specific test methods, and moisture adsorption capacity. It covers the major desiccant materials used in pharmaceutical packaging including silica gel and molecular sieve.

    USP’s drug standards are enforceable in the United States by the Food and Drug Administration (FDA) and are also used in more than 140 countries. The standards leave it up to pharmaceutical packager to determine how best to demonstrate compliance, but generally that involves testing and obtaining certificates of compliance from their suppliers.

    “We have been working internally and with our suppliers to ensure that we are prepared to help our customers understand and comply with the new standards,” explains Frédéric Gaire, Global Head of Quality, Clariant Healthcare Packaging. “Verification and testing has been completed by a 3rd party laboratory to certify that our standard silica gel and molecular sieve desiccants are compliant.”

    Accordingly, Statements of Compliance will be made available to customers certifying that its standard desiccants meet applicable requirements of USP , and Clariant will now begin an ongoing process to ensure the compliance is maintained.

    See also

    Clariant additives enabling recyclability of plastics waste while sustaining valuable properties

    Clariant additives enabling recyclability of plastics waste while sustaining valuable properties

    Through a “Symphony of Collaboration” with partners along the full plastics value chain, Clariant is taking proactive steps in addressing the problem of plastic pollution with new solutions for diverse industry sectors, from packaging – the main use of plastics – to textile floorings and consumer electronics. Newly-developed AddWorks PKG 906 Circle for polyolefin films is a prime example of enabling plastic packaging producers to achieve some of their critical sustainability and business goals.

    Clariant unveils controlled-atmosphere packaging solutions

    Clariant unveils controlled-atmosphere packaging solutions

    Clariant, a world leader in specialty chemicals, will present new products that help control moisture and prevent degradation of packaged pharmaceuticals at CPhI Middle East & Africa 2018. Clariant Healthcare Packaging is exhibiting its full range of desiccant canisters and packets, tubes and desiccant stoppers, oxygen scavengers, Advanced Desiccant Polymer (ADP®) and humidity stabilizers at Stand C25 at the trade show being held at the National Exhibition Center in Abu Dhabi, UAE, 3 - 5 September 2018.

    Clariant introduces Humitector Type 2 non-reversible humidity indicator cards for SMD dry packing

    Clariant introduces Humitector Type 2 non-reversible humidity indicator cards for SMD dry packing

    Clariant, a world leader in specialty chemicals, and its Cargo & Device Protection unit, the originator of the color change humidity indicator card, introduce an industry-first innovation to better ensure that the integrity of dry packing that protects moisture-sensitive devices has not been compromised by high humidity at any time during shipment or storage. The new Humitector Type 2 Non-Reversible Humidity Indicator Cards are low-halogen and free of cobalt dichloride, a substance of concern to the European Chemical Bureau.

    Clariant liquid colors, additives for silicones featured at Medical, Pharmaceutical Trade Shows

    Clariant liquid colors, additives for silicones featured at Medical, Pharmaceutical Trade Shows

    Clariant, a world leader in specialty chemicals, is continuing the global rollout of its MEVOPUR®-LQ family of color and additive liquid masterbatches by featuring products for silicone elastomers at two important trade fairs: Pharmapack Europe 2017 in Paris (February 1-3) where Clariant is exhibiting on stand C35/C37, and MD&M West 2017 (booth #2450), which is being held in Anaheim, CA, February 7 - 9.

    Clariant and Shinkong collaborate further to promote non-halogenated flame retardants for broader applications

    Clariant and Shinkong collaborate further to promote non-halogenated flame retardants for broader applications

    Clariant, a world leader in specialty chemicals, will broaden its collaboration with Engineering Plastics division of Shinkong Synthetic Fibers Corp. to promote Clariant's non-halogenated flame retardants to a host of applications in China. Shinkong Engineering Plastics belongs to Taiwan’s top 3 enterprise, Shinkong Group. As a leading supplier of plastics, it serves various industries including electronics, home appliances and automotive etc. Its halogen-free compounds based on Clariant's flame retardants are experiencing rising demand as more and more OEM manufacturers in the electronics and electrical appliances industry eliminate components with bromine and PVC from their products because of tightening environmental regulations.

    Clariant introduces new liquid colors, additives for medical devices, pharmaceutical packaging

    Clariant introduces new liquid colors, additives for medical devices, pharmaceutical packaging

    Clariant, a world leader in specialty chemicals, is introducing MEVOPUR®-LQ, a family of color and additive solutions that combines the benefits of the MEVOPUR ‘Controlled, Consistent and Compliant’ formulation and manufacturing approach with Clariant’s Hi Former® liquid-vehicle technology. The new products made their debut at CPhI / Innopak Europe, the global pharmaceutical event that took place in Barcelona.

    Clariant and SICPA launch PLASTIWARD robust in-product protection solution for plastic medical devices

    Clariant and SICPA launch PLASTIWARD robust in-product protection solution for plastic medical devices

    Clariant, a world leader in specialty chemicals, has joined forces with SICPA SA, a trusted provider of global security solutions, to launch PLASTIWARD, a robust integrated protection for plastic pharmaceutical packaging or medical devices. Both companies are at the Clariant booth (Hall 2, Booth 2K60) at the CPhI in Barcelona, from 4-6 October 2016, to share with interested companies and journalists the benefits of PLASTIWARD and how it protects pharmaceutical brands and their patients.

    • Elias Bittan
    • Product Info
    • English
    • Created 26 Apr 2016
    • Modified 14 Oct 2016
    • Hits 647