TAGS: Medical
KRAIBURG TPE adds new compounds to the THERMOLAST® M series to benefit the primary packaging for solid and liquid drugs, as well as many other products.
Compounds Ideal for Medical Approved Applications
The compounds in this new segment of the THERMOLAST® M series have been specially developed for applications that require basic medical approval and must meet food regulations. In addition, extraction tests in accordance with ISO 8871-1 have been successfully performed; all the raw materials tested are certified under Regulation (EU) No. 10/2011 and US CFR 21 (FDA) standards.
The biocompatibility of the materials series is certified in accordance with ISO 10993-4, -5, -10 and -11, as well as with ISO 8871-1 for parenterals and for devices for pharmaceutical use. The materials also meet the requirements of USP661.1 (plastic materials of construction) as well as of USP661.2 (plastics packaging systems for pharmaceutical use).
Overview of important additional materials properties:
- The translucent TPEs can be colored
- Excellent mechanical properties
- Low compression set
- Sterilizable: Autoclave 121 °C and 134 °C, β/γ radiation 2×35 kGy, EtO
- Free of PVC, silicone and latex
- Free of animal ingredients
Other Important Criterion
Customers will benefit from the unique service package for medical-grade products, which provides advantages in view of the Medical Device Regulation that will be coming into effect from early summer 2021.
- Consistent production procedure; meets all requirements for a full-fledged medical-grade plastic in accordance with the VDI 2017 technical rule
- Guaranteed 24-month supply security
- Purity of the raw materials through commitment by suppliers
- Separate, permanently assigned production units for THERMOLAST® M
“
With many years of experience and the approvals we hold, we are in a good position to compete in the pharmaceutical packaging market. But the human aspect also plays an import part, as customers can rely on our unique medical service package, with consistent materials supply as well as consistent quality and ingredients,” emphasizes Eugen Andert, Product Development Engineer at KRAIBURG TPE.
Source: KRAIBURG TPE