Innovative, technologically advanced, constantly growing with a resulting immunity to economic downturns—these attributes describe medical technology, life sciences and the pharmaceutical industry better than almost any other area in plastics processing. Respiratory filters, inhalers, cannulae, multi-directional stopcocks for infusions, transfusion tubing, sterile packaging or blister foils—each product is usually subject to very rigorous medical regulations and requires significant expertise during production. In this area, KraussMaffei has the expertise and years of experience you need in a system partner to meet the demanding requirements for clean production.
Your benefits;
|
 |
Medical technology, the pharmaceutical industry and the life sciences are stable growth sectors for plastics processing. Aging populations, constantly improving hygienic conditions and increasing quality of life in growing regions promise stable growth rates in the coming years. The focus in these areas centers on product cleanliness—particularly in relation to being free of germs or particulates—and article quality. The high specifications require innovative, precise and reliable production technology.
Injection molding machines from KraussMaffei meet these demands—from standard injection molding to automated, complex manufacturing cells using cutting-edge molds to produce top-quality parts—up to cleanroom standards. The CX and EXseries in particular are designed for these applications. When the highest requirements for cleanliness in production or for molded part surfaces are imposed, the CleanForm process developed by KraussMaffei is used.
The starting point for outstanding products for medical technology, pharmaceutical and life science applications is the impeccable quality of the substances and formulations used. This quality must be documented at every stage of the manufacturing and packaging process. Following Good Manufacturing Practice (cGMP) regulations guarantees product quality and supplies the necessary assurance that the product is in compliance with standards imposed by regulatory authorities and dictated by law.
This is why all of KraussMaffei's system solutions include extensive documentation for every qualification step: The customer is supported from design qualification to performance qualification during the creation of verification documents or the customer can receive the required quality certifications along with the system. This provides the transparency required to ensure continuous reproducibility for production down to the strictest tolerances.
KraussMaffei offers special processes and solutions for each different product to create production spaces that meet the requirements for high cleanroom classes up to ISO Class 5 (or Class 100 according to US Fed. Std. 209) and has already successfully implemented many similar projects as the sole machine manufacturer. Our own advanced manufacturing processes based on synchronized assembly enable us to build our machinery to rigorous quality standards and to monitor and document this quality.
Customers benefit most from having a contact partner knowledgeable in both material processing and shaping. Efficient communication can significantly shorten product development cycles. Friction losses in the course of the project are kept to a minimum and you profit from consistent product quality for your entire process chain.
