In recent years, KRAIBURG TPE specialists have built up a wide range of medical TPE products and established them on the market under our brand name THERMOLAST® M. The range includes products in various degrees of hardness that can be sterilized using all common processes such as autoclaving, gassing with ethylene oxide (EtO), gamma or electron irradiation. In addition to compounds with increased slip stick properties KRAIBURG TPE offers grades with optimized adhesion to technical thermoplastics such as polyesters and polyamides. There are also translucent and highly transparent THERMOLAST® M compounds for treatment-critical visual inspections in medical applications as well as compounds with resealing properties.
Whether medical packaging, pharmaceutical products for various applications or medical equipment and devices: Thermoplastic elastomers that are brought onto the market for medical products must meet both the specific requirements of the manufacturing companies and the detailed legal requirements that apply to products from the medical environment.
TPE for medical applications
The market for medical devices has always been one of the most demanding and strictly regulated segments of the industry. The high degree of responsibility that the manufacturing companies assume here regarding the use of their end product by the respective users also involves their raw material suppliers. This makes it even more important to establish supply chains that combine long-term reliability with a binding promise of quality.
Medical TPEs must meet the specific requirements of the manufacturing companies as well as the detailed legal requirements for products in the medical environment. At the same time, the cross-industry fulfillment of all requirements for the development of high-performance compounds is crucial. Whether medical packaging, pharmaceutical products for various applications or medical equipment and devices: the specific compounding of the raw materials, which must be performed with regard to the targeted fields of application and environments, is guaranteed by the expertise and decades of experience of the TPE developers and application engineers. Even with highly complex requirements, suppliers must be able to offer solutions that can meet specific customer needs within the framework of legal regulations and specifications.
Consistency and conformity
The high risk factors in the various application areas of medical products generally remain with the manufacturing companies. This makes it all the more important that they can rely one hundred percent on the raw material products and processes of their suppliers. This means that the compounds must not only be generated from the exact same mixing ratio of the base materials, but should also be manufactured under the same process conditions.
With KRAIBURG TPE's THERMOLAST® M products, the company meet all these requirements. In addition, it offers customers medically compliant thermoplastic elastomers:
• Durability and flexibility
• Excellent resealing properties
• Injection molding and extruding possible
• Adhesion to polyolefins (PP, PE, COC, COP) and technical thermoplastics such as ABS, PC, PET-G as well as polyamides by means of multi-component injection molding
• Low-friction and highly elastic
• Excellent compression set characteristics
• High transparency and precoloring option
Long-term availability
If change notifications are required due to formulation adjustments, the continued availability of raw materials, at least in the medium term, is vital for manufacturers of medical products. Changes to the raw material base generally entail test procedures lasting several years in order to ensure the safe use of new or alternative raw materials. The base requirement should therefore be an at least two years' availability guarantee for the TPE supplied after the release of the change notification. In addition, upon announced forecast agreement, product quantities should be held in stock to an extent that extends the deadline by the period agreed with the customer as part of a “last call”.
The THERMOLAST® M portfolio is also listed in FDA Drug Master Files (DMF) in order to document the formulations in accordance with a mandatory change control system. In accordance with the VDI 2017, KRAIBURG TPE also guarantees that the manufacturing processes are included in the change management system and that the original formulation of such a compound will be available for at least 24 months in parallel with the new grade following any notification of change or discontinuation.
Traceability
The third pillar on which the specific suitability of TPE for medical products rests is the traceability of all manufacturing processes. This ensures that raw material suppliers can quickly provide their customers with an inventory in the event of irregularities or hazard reports. Ideally, this traceability should be continuous, i.e. it should also include the services and products of the company's own suppliers!
Author:
Oliver Kluge, Market Segment Manager Medical Applications | EMEA
