MEDICAL | INNOVATION
Right: Aptar Pharma, the manufacturer of spraying and dosing systems for medical applications, has used Thermolast M from Kraiburg TPE for its Ophthalmic Squeeze Dispenser
the US and Asia. Americhem says that its engineered materials for medical device manufacturing are developed in collabo- ration with customers to address func- tional and aesthetic needs while meeting all biocompatibility require- ments. These materials are available as pre-coloured or custom coloured thermoplastic resin compounds, and have short lead times. Clariant has completed the testing of
Below: PolyOne has expanded its line of OnColor HC Plus colourants and OnCap HC Plus additives for healthcare applications
ingredients in its Mevopur and Remafin- EP product ranges in order to bring them into full compliance with USP 661.1 — a new standard for pharmaceu- tical packaging and drug delivery devices which takes effect in May 2020, when it will impact all current and future drugs on the US market. Clariant says that it is completing the testing process now to help customers “future-proof” packaging launched in the interim and, in addition, to offer data to support the ICH-Q3D guidelines for risk assessment of elemental impurities in drugs. “The ICH-Q3D guideline strengthens the risk assessment process by evaluating not only the pharmaceuticals themselves, but also the packag- ing to ensure it is not the source of elemental impurities in drugs,” says Steve Duckworth, Global Head of Healthcare Polymer Solutions. “As part of Clariant’s commitment to the continued availability of ‘controlled, consistent, and compliant’ packag- ing ingredients through our Mevopur and Remafin- EP product ranges, we initiated the required testing in 2017 and completed it early this year.” Kraiburg TPE has developed Thermolast M elastomer compounds for use in direct contact with blood and medication. These materials can be
coloured in conformity with medical compliance requirements and open up new potential fields of applications, says the company. TPE compounds of the Thermolast M portfolio can be used for medical and pharmaceutical applications, such as primary medical packaging, hospital care applications and resealing membranes. The company adds that medical and pharmaceutical products must fulfil uncompromising requirements for safety, quality and reliability. Thermolast M compounds have passed standard biocompatibility certifications. These portfolio materials are certified according to DIN ISO 10993-5 (cytotoxicity), -10 (intracutaneous irritation), -11 (acute system toxicity), USP Class VI (chapter 88), and DIN ISO 10993-4 (hemolysis).
These certifications enable processing of the compounds for use in direct contact with medication and blood. In addition, a drug master file (DMF) for the materials is on file with the US Food and Drug Administration (FDA). Aptar Pharma, the manufacturer of spraying and dosing systems for medical applications, has used Thermolast M for its Ophthalmic Squeeze Dispens- er, which is the only repeated-use dosing system so far approved by the FDA for liquid medications that do not contain preservatives. The design contains no metal parts in the drug flux and is therefore also suitable for very sensitive formula- tions. The purely mechanical functioning principle of the seal membrane and spring unit eliminates the possibility of microbiological contamination of the liquid. PolyOne has expanded its line of OnColor HC Plus colourants and OnCap HC Plus additives for healthcare applications. These colourants and additives are pre-certified to meet USP Class VI or ISO 10993 biocompatibility testing for global healthcare applications, such as medical devices, pharmaceutical, and health and wellness products. The company says that these formulations will allow customers to have more resin choices and performance options for a greater range of applications, especially those that require biocom- patible solutions. Functional performance additives that are now tested and certified for biocompatibility include antimicrobials, surface energy modifiers, content protection additives, laser-marking, and dimen- sional and physical property modifiers. Expanded resin families able to incorporate biocompatible
28 INJECTION WORLD | September 2018
www.injectionworld.com
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