Combining creativity with regulatory compliance

The global market for masterbatch has seen dramatic increase over the years. By 2018, this market is expected to reach $10.5 billion, according to a report by Global Industry Analysts, Inc., (GIA). As material of choice to put colours to plastics, masterbatches find applications in almost all areas of plastic processing. Rapid industrial growth and the significant rise in the production of plastic products and components have given impetus to the sector.

Masterbatch manufacturers have adopted strategies to bring about product differentiation to gain competitive edge in the market. Key innovations which have benefited the market over the past few years include properties such as anti-shrinkage, flame retardant for PP pipes and PC sheets, anti-fog for food packaging, anti-microbial, and masterbatches for biopolymer and biodegradable resins, according to the GIA report.

Pharmaceutical packaging demand

New masterbatches were developed and launched in time for the Pharmapack Europe 2014 in Paris. These materials are aimed at supporting pharmaceutical products production and provide added safety and convenience. Clariant demonstated the concept of combining creativity with regulatory compliance through its display of extrusion blow moulded (EBM) pharmaceutical bottles featuring trend-inspired colours of ColorForward developed by Clariant’s ColorWorks design centres. Each year, the ColorForward tool is published; a dedicated colour forecasting guide in the plastics industry that appeals to people’s emotions and psychology. Using pre-evaluated raw materials for these masterbatches used to create these colours demonstrates how regulatory concerns do not have to be a barrier to developing attractive colours for pharmaceutical packaging.

Clariant, launched its MEVOPUR. range of masterbatch and compounds for healthcare applications in 2010. The products under this portfolio were developed and developed and produced at three ISO 13485 certified and dedicated production facilities located in USA, Europe and Asia to ensure ‘Controlled, Consistent and Compliant’ innovations for the industry.

The company has embarked on developing new additive masterbatches under this range and these attracted high interest because Clariant had pre-tested the raw materials for the masterbatches using the extraction and biological evaluation protocols of US Pharmacopeia (USP) 23 parts 87 and 88. However initial feedback raised the question of whether the substances were also listed European Pharmacopeia chapter 3.1.3 (EP 3.1.3). Clariant has reacted to this feedback and recently completed a test programme on raw materials of its masterbatches, and is now offering products that use raw materials that have been pre-evaluated to both the above USP and EP standards.

Addressing health standards

EP 3.1.3 (Polyolefin Materials for Pharmaceutical Packaging) is a reference for the industry, but has limitations in that, apart from a few substances such as antioxidants, there are few substances that might offer opportunities for development of the plastics materials used for pharmaceutical packaging. To list a new substance in EP is not a viable route, but the guidelines open an alternative for packaging specifiers, based on the information that Clariant can provide.

In addition, existing polyolefin bottles often use white masterbatch containing titanium dioxide (TiO2). Since TiO2 has its own monograph in EP, this reason is often used to demonstrate ‘compliance’ to EP. This is highly theoretical in many cases, because the TiO2 in the EP monograph is a high purity anatase form used in tableting of drugs, and is quite different from the coated rutile grades used in plastics.

These coatings are often proprietary to the TiO2 pigment supplier and can change between grades and suppliers. Apart from the weak link to the requirements of the EP, these difference produce interesting discussion points for ‘change control’ and potential differences in leachables testing.

Clariant has addressed both these concerns by recently concluding independent test programme on a range of raw materials and included the extraction testing of EP3.1.3, which added to data already generated from the extraction and biological evaluation in USP 23 parts 87 and 88, an evaluation that often forms the base information demanded for packaging materials used for parenteral, ocular and nasal drugs, and is an indication of potential for leachables. The raw materials evaluated included a global platform of, polymers, selected grades of titanium dioxide and a several substances such as nucleants, clarifiers, lubricants, and laser marking additives. “The successful conclusion of this test programme removes a barrier to use new innovations that could improve performance and/or productivity,” stated Roland Maartensson, European Head of Segment Medical and Pharmaceutical at Clariant Masterbatches.

Using this knowledge, Clariant has created a new ’EP’ range of polyethylene (PE) and polypropylene (PP)-based white masterbatches, where the raw materials have been tested using the EP 3.1.3 standard, rather than relying on the theoretical compliance previously described. The new white ‘EP range’ consists of four low and high density PE grades and one PP grade and are offered with supporting documentation to EP3.1.3, USP23 parts 87 and 88, a Drug Master File (DMF) and a Change Control Agreement.