Clariant supports color creativity in pharmaceutical packaging

Controlled, Consistent, Compliant…and creative
Pre-tested colorants help to reduce customers' development times and costs
Address industry concerns regarding change minimization and adulterated drugs

Muttenz, March 13, 2012 - Color can boost the on- and off-the-shelf appeal of packaged medicines. Clariant is offering a globally-available MEVOPUR® standard color range of pre-tested ISO10933/USP 23 Part 87 and 88 colorants for pharmaceutical packaging. The range’s new MEVOPUR colors for TOPAS® cyclic olefin (COC) polymers from Topas Advanced made their European debut at Pharmapack 2012 in Paris.

Clariant’s pre-evaluated MEVOPUR colorants help to reduce customers’ development times and costs, and minimize risk of change during the product life-cycle. Masterbatches and compounds utilizing these colorants help to address the industry concern regarding drug adulteration caused by leaching of substances from the plastics packaging. By providing documentation on testing of ingredients using USP 23 parts 87, 88 and ISO10093 test protocol Clariant supports converters and pharmaceutical companies to establish a basis for a clear extractable profile and simulation of potential leachables.

“Within the pharmaceutical packaging sector there has been increased awareness of, and much discussion of extractables and leachables from plastics and how changes in the materials may often result in unintended contamination of the drug,” comments Steve Duckworth Clariant’s Head of Global Segment Medical & Pharmaceutical. “By offering a pre-evaluated range of colorants, we give our customers the confidence and ability to explore exciting new color options for their packaging, knowing that the risks and the costs of a failure in late stage development or product-life cycle are reduced.”

Clariant’s MEVOPUR standard colorants are based on biologically-evaluated ingredients using the test protocols of USP 23 parts 87, 88 for Class VI devices or ISO10993 parts 4, 5, 10, 11 and 18. “The USP 23 part 87 and 88 is one of the long established industry protocols for evaluation of extractables for higher risk drug / packaging interactions particularly in ocular, nasal and parenteral drugs” explains Duckworth. “The pharmaceutical packaging industry has a limitation that many polymers, pigments and additives do not have any status in regulations such as European Pharmacopeia, so having this type of data helps our customers to have confidence to move forward with their approval processes.”

In line with Clariant’s “Controlled, Consistent, Compliant” approach for its medical and pharmaceutical customers, the colorants are manufactured at its three ISO 13485:2003 registered dedicated medical and pharmaceutical centers of competence based in the USA, Europe and Asia. The standard colors are available on short lead-times with supporting documentation to accelerate the development and approval process. Production from the same raw materials at all three sites supports customers’ global production and back-up requirements, and helps to speed up development by eliminating the need for expensive and time consuming revalidation.

The MEVOPUR ISO10933 /USP color range introduced in 2011 with up to 17 colors for widely used polyethylene and polypropylene materials has been further extended into newer materials of interest to packaging development engineers. Responding to the interest in glass-like polymers, the range was expanded to include the transparent polyester co-polymer Tritan™ for Eastman Chemical Company, and new colors for TOPAS cyclic olefin (COC) from Topas Advanced. The TOPAS polymers offer glass-like clarity, temperature and chemical resistance whilst providing the safety aspects of a tough polymer. The MEVOPUR colorants complement these properties by offering colors to differentiate the product or to block UV, thereby helping to protect UV sensitive pharmaceutical products.