Materials

KRAIBURG TPE offers innovation and superior support

for medical and pharmaceutical TPE applications

 

Aditya Purandare Managing Director Kraiburg TPE Pvt. Ltd

About KRAIBURG TPE Founded in 2001, KRAIBURG TPE is a global manufacturer of custom thermoplastic elastomers offering a wide product portfolio for applications in the automotive, industrial and consumer goods industries, including the strictly regulated medical sector. With production sites in Germany, the USA and Malaysia, KRAIBURG TPE, as a competence leader offers global customer orientation, customized product solutions and reliable service. Minimizing risk in medical and pharma material selection When selecting any materials for medical device and pharma packaging applications, the primary focus should be on the choosing the right materials to accomplish the application requirement, complemented by reducing the risk to a minimal. Risk mitigation is a crucial aspect in KRAIBURG TPE’s thermoplastic elastomers, in addition to offering many advantages over traditional soft materials such as PVC and silicone rubbers. KRAIBURG TPE’s material solutions for the medical device and pharmaceutical market are marketed under the THERMOLAST® M and THERMOLAST® H brand names.

THERMOLAST® M – comply with high medical standards

THERMOLAST® M TPEs comply with VDI-2017 which includes change management control, full material traceability, and a dedicated production line and quality control system for manufacturing medical TPEs.

Additionally, these products meet ISO 10993-5 standards and representative compound tests for ISO 10993-4, -6, -10 and -11, USP 87/88, USP Class VI, in addition to having Drug Master File listing. That’s not all - THERMOLAST® M TPEs carry a 24-month supply guarantee (in the event of any forced change in raw material specifications or even changes in customer’s product design) to ensure a continued supply of the approved TPE product, should a new end product approval be necessary. All THERMOLAST® M TPEs are produced at our manufacturing facility in Germany.

THERMOLAST® H for medical device and pharma packaging applications

THERMOLAST® H TPEs focuses on the healthcare as well as medical device and pharmaceutical packaging applications in the Asia-Pacific region. Most of these TPEs are tested as per ISO 10993-5 and GB/T 16886.5 and comply to the EU No 10/2011, US FDA CFR21 and GB4806.6. These TPEs are produced on a designated production line at our manufacturing facility in Malaysia using controlled GMP procedures. This line of medical grade TPEs caters primarily to the APAC market requirements.

All KRAIBURG TPE medical TPE series are sterilizable via autoclave/steam, EtO or gamma radiation. The choice of sterilization depends on the part numbers produced, the intended device use, and access to the sterilization equipment. Besides this, our medical TPEs are resistant to most cleaning and disinfecting liquids that contain typical chemicals such as hydrogen peroxide, ethanol, chlorinated solutions and sodium hydroxide, and others.