Medical and pharmaceutical products must fulfill uncompromising requirements for safety, quality and reliability. THERMOLAST M compounds from KRAIBURG TPE 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 medications and blood. In addition, a drug master file (DMF) for the materials is on file with the US Food and Drug Administration (FDA). KRAIBURG TPE is therefore committed to consistent adherence to the specified formulation and manufacturing process. Any necessary changes are announced and implemented in accordance with a defined change control process. After announcement of a change, KRAIBURG TPE guarantees delivery for a period of 24 months and also has the purity of the raw materials guaranteed by its suppliers.
Compounds for medical technology or medical applications are manufactured at KRAIBURG TPE only on special equipment reserved for these products. The company offers its customers in the medical and pharmaceutical sector an extensive service package that ensures maximum control with respect to quality, safety and reliability. THERMOLAST M compounds can conform to cleanroom processing standards and can be sterilized using standard techniques such as gamma or beta radiation, ethylene oxide or steam.
KRAIBURG TPE will present these medical conforming materials together with the Medical Service Package at the Pharmapack in Paris at booth #D66.
Purity, tolerance, quality, continuous availability and safety of the materials used are top priorities in medical technology and are subject to stringent regulations. These are the principles Aptar Pharma also focuses on. For decades the company has been setting standards for spraying and dosing systems for medical applications including nasal spray pumps, inhalers, drop dispensers and injectors. To further optimize their Ophthalmic Squeeze Dispenser, the manufacturer sought a thermoplastic processable material that allows direct contact with medications. KRAIBURG TPE supported Aptar Pharma in choosing the material through to series production with a comprehensive medical technology service package. The result is a new component manufactured from a new THERMOLAST M material developed by KRAIBURG TPE for the medical and pharmaceutical market.
For all materials from the THERMOLAST M portfolio KRAIBURG TPE guarantees product reliability and safety within the scope of its Medical Service Package. In addition to this quality assurance, the change control process for medical and pharmaceutical technology at KRAIBURG TPE enables the company to guarantee the consistency and availability of the formulation for two years.
The Ophthalmic Squeeze Dispenser from Aptar Pharma is the only repeated-use dosing system thus far approved by the FDA for liquid medications that do not contain preservatives. The design contains no metal parts whatsoever in the drug flux and is therefore also suitable for very sensitive formulations. The purely mechanical functioning principle of the seal membrane and spring unit eliminates the possibility of microbiological contamination of the liquid.
Source KRAIBURG TPE