Assured global source of additive and color masterbatches and compounds formulated to be entirely free of animal-derived
Supports regulatory approvals through pre-evaluation of masterbatch raw materials against international standards including ISO 10993-5, -10, -11, -18; USP parts 87 and 88; and EP3.1.3.
Dedicated ISO 13485 production facilities in the USA, Europe,and Asia help ensure back-up supply and change control
Muttenz, February 10, 2015 – Clariant, a world leader in specialty chemicals, announces the global availability of a new line of ‘animal-free’ MEVOPUR® standard masterbatches and compounds. The development offers the makers of pharmaceutical packaging and medical devices a consistent and traceable supply of products that are compliant with global standards and support a wide range of
product design, marketing, and manufacturing needs. The new products are being featured on Stand 430/431 at the Pharmapack Europe 2015 trade show being held in Paris, France, February 11 – 12, 2015 as well as featured at Booth 2242 at the MD&M West trade show being held in Anaheim, Calif.,USA,February 10 – 12, 2015.
Manufactured to meet the needs of the medical and pharmaceutical market, these products are not only free of animal-derived ingredients but they are also free of phthalates and heavy-metal pigments. The new line of standard MEVOPUR color masterbatches includes 17 polyolefin (PP and PE) colors. ‘Standard’ means that the color formulations – and standard regulatory declarations -have already been developed and some colors are available off-the-shelf for faster , faster approvals, and faster market introduction.
The MEVOPUR brand is Clariant’s commitment to change-control and back-up-supply practices tailored to the needs of medical and pharmaceutical companies. Three ISO 13485 certified production facilities located in the USA, Europe, and Asia – all dedicated to the pharmaceutical and medical device segment – ensure raw-material traceability and change control. Also, because product compliance depends on every ingredient, the raw materials for every MEVOPUR product are chemically characterized and batch tested versus a ‘finger-print’ to verify their consistency before they enter production.
The new ‘animal free’ products, the latest additions to the MEVOPUR line, are a key part of the continued response by Clariant to the evolving demands of masterbatch and compound users in the pharma and medical device industries, where products come into contact with medication and body tissues.
According to Steve Duckworth, Head of the Clariant Medical & Pharmaceutical Masterbatches segment, concern about the use of animal-derived ingredients in polymers first emerged after the outbreak of ‘mad cow disease’ or BSE (Bovine Spongiform Encephalopathy). BSE is one of a class of animal diseases known as Transmissible Spongiform Encephalopathy, or TSE, caused by tiny particles, or prions, in tallow and other animal by-products that are the basis for a number of
polymer ingredients. Concern grew when scientists found that similar prions can cause a rare neurological disease in humans called variant Creutzfeldt-Jacob Disease (vCJD). To meet these concerns Clariant joined the polymer industry in developing and introducing products based on certified ‘BSE-TSE free’ raw material ingredients.
“However,” Duckworth explains, “we soon realized that some users wanted a greater margin of safety and Clariant launched an effort to produce additives and masterbatches that were entirely free of any animal-derived ingredients. For Clariant, the challenge was two-fold: not only was it necessary to develop ‘animal-free’ additives and colorants, we also had to source ‘animal-free’ polymers that make up the balance of its masterbatch and compound . It is relatively easy to find polymers that meet requirements for being ‘BSE-TSE free’. However, because many of the substances typically used in the polymer production process have historically been derived from animal sources, it can be especially difficult to find polymers that are actually ‘animal-free’.”
Despite the challenges, Clariant has successfully built this ‘animal-free’ supply chain, ensuring makers of pharma packaging and medical devices of a consistent and traceable supply for their global operations. Like all MEVOPUR products, the new ’animal-free’ masterbatches and compounds use ingredients that have been pre-evaluated against international standards including ISO 10993, parts 5, 10, 11, and 18; United States Pharmacopoeia (USP) parts 87 and 88; and also, in specific cases, EU Pharmacopoeia 3.1.3. They support a wide range of product design, marketing,and manufacturing requirements around the world under the banner “Controlled, Consistent,Compliant.”
“It is not easy to make available ‘animal-free’ MEVOPUR masterbatches and compounds with this rigorous level of consistency, compliance, and traceability. But at Clariant, we believe that this support is essential to enable customers to respond to ever increasing regulatory needs and create new, more attractive, and better functioning medical devices and packaging,” Duckworth concludes.