ICSE news: Clariant Masterbatches launches new pharma brand
Clariant Masterbatches has a new brand aimed at helping manufacturers manage change control
Clariant, a global provider of colour and surface engineered materials, unveiled its new brand of masterbatches and compounds for pharmaceutical and medical applications at ICSE 2010 in Paris.
As concerns about falsified ingredients and undesirable impurities appearing in products grow among regulators, even the suppliers of colours and additives for pharmaceutical packaging are feeling the heat.
As a result, Clarient has launched a new, sector-dedicated brand that reflects Clariant’s commitment to help the need for reliability and consistency in materials used for pharmaceutical packaging and medical devices.
Change of processes, suppliers or ingredients needs careful consideration in the pharma sector and may lead to a requirement for new validation studies and documentation to ensure the change complies with the current Drug Master Files.
The Mevopur brand ensures that controlled, compliant and consistent products deliver colour and functionality and help to minimise the risks and costs of non-compliance.
The new brand will be produced at Clariant’s three centres of competence dedicated to the production of specialty formulated masterbatches and compounds for medical and pharmaceutical applications.
The company is expecting to achieve full ISO 13485:2003 accreditation, having already gained accreditation for two out of the three sites. Located in the US, Europe and Asia, they offer manufacturing-line segregation to reduce risk of cross contamination between products.
Consistency and reliability of formulations and procedures is assured through alignment with the globally harmonized quality management system.
