Surgical instruments, implants and accessory medical devices are already subject to stringent hygiene requirements during their manufacture.
The most exacting quality standards, complex quality documentation and traceability of all production batches, significant product liability risks and long-term responsibility for products used in the medical field: all of these are key quality management issues in the field of medical technology, as both the negative impact of faults in medical devices and the costs incurred as a result are considerable. Better to be safe than sorry: insist on 100% reliable production quality. At every single stage of production, this protects against the far-reaching consequences of product liability.
Process water – an important link in the quality chain.
In order to guarantee that products are free from stains as required, demineralised water is needed for rinsing during the relevant stages of cleaning. This purified water must also demonstrate low organic contamination (TOC) as well as minimum levels of bacteria and endotoxins. Water is thus a relevant contributory factor in the quality chain, as optimum water quality in each case is crucial at every stage of processing: from interim cleaning through to final cleaning to remove any deposits. For this reason, conductance, pH levels, TOC levels, endogenous substances, pyrogens, bacteria, germs and endotoxins have now become important parameters in responsible quality management in the field of medical technology.
AQUAmeditech – the new generation of process water treatment systems from EnviroFALK for medical technology.
So that the right water quality is always used in all stages of processing, EnviroFALK provides modular treatment systems that meet all requirements at all locations involved in the production process:
In order to achieve the required quality, reverse osmosis systems and mixed-bed ion exchangers or EDI technology are generally used to remove salts from the feed water, while UV light and ultrafiltration ensure low germ and endotoxin contamination.
During each stage of the process, computer-based documentation systems record and document the data relevant for quality.
AQUAmeditech systems are tailored to meet the specific requirements of medical technology: PP or PVDF pipework that supports strong water currents and that is welded using IR techniques prevents contamination. Our storage tanks are manufactured from stainless steel and can be emptied entirely. Furthermore, the special resin pool used in the ion exchangers and adapted according to the industrial application in question ensures the pureness of quality required in medical technology. The resins used in the ion exchangers are also disinfected and vacuum-packed.
In collaboration with you, our application consultants will discuss and plan the technical combination that best suits your application requirements, ensuring optimum quality for your products.
AQUAmeditec from EnviroFALK ensures the right water quality at all stages of production. For impeccable product quality.
AQUAmeditec from EnviroFALK stands for unrivalled process water technology. Now also with 0 % financing.
Consistently high-quality water at Brehm Chirurgie-Mechanik thanks to EDI
More efficient DI water production for implant manufacturer
The Peter Brehm Chirurgie-Mechanik e. K. company in southern Germany produces implants and instruments for artificial joints made from cutting-edge material. Until recently, DI water had been supplied by a mixed-bed ion exchange unit. Each cartridge replacement required subsequent water quality analyses. The new EDI (electrodeionization) cell, installed downstream of a reverse osmosis unit, is now constantly regenerated on site and continuously supplies DI water with a stable conductivity value of 0.06 µS/cm. The microbial load is below 20 cfu/ml and endotoxins are below 0.01 EU/ml. "The intermittent water consumption was the real challenge" says Dr. Rolf Schreinert of EnviroFALK. "We thus decided to produce only small amounts of DI water that are then stocked in almost sterile atmosphere and treated with UV radiation. This is how larger amounts of high-quality DI water can be drawn any time." In order to minimize contamination by colony-forming units (CFU) and endotoxins, the DI water is recirculated permanently, passing an ultrafiltration unit with hollow-fibre membrane modules and a cut-off of 30 kDalton. The DI water is needed for final cleaning of implants made of cobalt-chrome, titanium, polyether and PEK. Inside a tunnel washer – before packing and gamma-radiation – all impurities stemming from production are removed. The washing process comprises an alkaline as well as an acid cleaning step and several rinsing steps. The final fine rinsing process with DI water produces ultra-clean surfaces.
External tests of the implants that Brehm Chirurgie-Mechanik has had carried out in parallel with to the DI water analyses have confirmed the constantly high quality of the water.