Product shelf-life has always been the priority in the development of packaging materials. For pharmaceutical products, it is a vital feature to protect against biological contamination while maintaining the quality of the product until it reaches the consumer. Thus, the material used for pharmaceutical packaging has to meet requirements such as provide protection against light, heat, and moisture as well as ensure that there is no chemical reaction with the packaged drug.
Furthermore, the materials used in pharmaceutical packaging have to allow for design flexibility and not add extra weight to the packaging, for easy handling and storage.
The use of polymer materials such as thermoplastic elastomers (TPEs) has been an important milestone in the development of pharmaceutical packaging as they render the required properties, such as excellent barrier protection against UV light as well as feature high impact strength and durability.
Meeting these requirements, KRAIBURG TPE, a global TPE manufacturer of a wide range of thermoplastic elastomer products and custom solutions for multiple industries, offers its THERMOLAST® M TPE compounds. This is specially developed for the medical and pharmaceutical industry and assures the specifications required for pharmaceutical packaging. The series meets the medical grade plastics international standards set in the USP Class VI, ISO 10993-4 (haemolysis), ISO 10993-5 (cytotoxicity), ISO 10993-10 (intracutaneous irritations) and ISO 10993-11 (acute system toxicity).
Antimicrobial properties of THERMOLAST® M
Biological contaminants are a major cause of spoilage of pharmaceutical products. The advantage with THERMOLAST® M TPE compounds is that they can be sterilized using methods such as EtO gas, superheated steam (134°C), γ-gamma ray treatment (2 x 35 kGy), β-ray (electron beam) treatment (2 x 35 kGy). Thus, these compounds are suited for applications like seals and valves in bottles for pharmaceutical storage, as well as for closures, septum, caps, infusion caps and ampoules in pharmaceutical packaging. The compounds can also be used in applications related to the process of transfer and filling in pharmaceutical industries.
Material performance for cost
The THERMOLAST® M TPE is developed with optimum productivity and cost-effectiveness in mind. Aside from the materials’ ample range of application possibilities, other features are the cost-effective molding process and short cycle time advantage for injection and two-component injection molding and extrusion processing, which allow manufacturers to boost their productivity. As well, the THERMOLAST® M TPE show excellent adhesion to various polymers such as PP, PE, COC, ABS, PS, PC, PET and PA.
Optimum purity with the Medical Service Package
KRAIBURG TPE provides a Medical Service Package that is orientated to delivering the highest quality standards of its TPE compounds, which are free of intentionally added heavy metals, latex, PVC and phthalates.
As well, the production of the compounds is permanently assigned in a separate processing unit, with the constant manufacturing process recorded in US FDA Drug Master Files (DMF).
Furthermore, the medical service package guarantees a 24-month supply of the compounds, allowing for supply security and long-term use by pharmaceutical packaging processors.