The range of medical technology products is extremely diverse and places specific demands on parts cleaning and packaging. For example, particulate and filmic contamination must be reliably removed from manufacturing processes. In addition, there is compliance with the regulatory requirements from the MDR and FDA with regard to product identification and the qualification of systems, documentation and traceability of components and processes. These stringent requirements can only be met with cleaning processes and systems that are optimally adapted to the task at hand along the entire production chain in a reliable and cost-effective manner.
The manufacture of medical technology products such as instruments, implants for human medicine and dentistry, disposable items (e.g. syringes, cannulas, tubes and valves) and devices for diagnostics and therapy is carried out using different technologies and usually in several production steps. Manufacturing processes such as machining or additive manufacturing inevitably leave material residues (particles) as well as operating and auxiliary materials, such as cooling lubricants, drawing and forming oils and release agents, on the surface. These impurities can hinder the feasibility and quality of subsequent processes, pose a risk to patients or impair the proper functioning of devices. One example is the manufacture of a knee implant, which must be free of production media, particles and germs before packaging. The blank produced using a casting process or additive manufacturing is machined, polished, possibly coated, finally cleaned and packaged. Each of these processing steps places individual requirements on the surface. This results in different tasks for parts cleaning.
Define the requirements
The following questions play a role in the selection of the technically and economically suitable solution for the respective cleaning step: Which part needs to be cleaned and in what quantity? What cleanliness specifications must be achieved? Which cleaning process and chemicals are suitable? Which environmental regulations, standards and laws need to be taken into account? What steps must be taken to fulfill all criteria? Are there any intermediate steps that need to be included? Does the logistical process fit? What role do employees play in the cleaning process? What budget is available for the purchase? How high are the ongoing operating costs, e.g. for new media, disposal, energy and maintenance? On this basis, it is possible to determine how many and which cleaning steps are required with which process, which medium is most suitable and which drying technology should be used.
As an experienced full-service provider of future-oriented and globally available solutions for industrial component cleaning, surface treatment and automation, Ecoclean and UCM cover the entire spectrum of cleaning processes used in medical technology. The portfolio also includes turnkey solutions including cleanroom and packaging systems.
Typical cleaning steps along the production chain
Pre-cleaning is required both for additively manufactured components and after machining. The aim is to prepare the workpieces for the subsequent process by removing adhering powder (depowdering) or particles and processing medium. This step is usually carried out in single-chamber systems which, depending on the processing medium used, are operated with solvents, e.g. hydrocarbons or modified alcohol, or a coordinated water-based cleaner.
Intermediate cleaning steps are used to remove polishing pastes and residues from grinding processes, for example after mass finishing. Depending on the cleanliness requirements, they are carried out in a single-chamber cleaning system such as the EcoCwave or a multi-stage ultrasonic multi-bath immersion system such as the modular UCMSmartLine with an aqueous cleaning medium.
The state of the art for cleaning before coating as well as final cleaning and passivation are multi-stage ultrasonic multi-bath immersion systems with corresponding water treatment. For example, the UCMPerformanceLine can be easily adapted to the respective task using modules with integrated electrical and control technology for the cleaning and rinsing process steps with variable ultrasonic equipment for mono-, twin- and multi-frequency, drying with vacuum, hot air and infrared drying, loading and unloading as well as a flexible transport system. In addition, various systems are available for these tasks, such as the UCMIndexLine rotary indexing solution for small precision parts or the UCMSprayLine GMP, which meets high cGMP quality requirements.
The effect of the cleaning medium is enhanced by various application-specific process technologies, for example for spray, high-pressure, immersion, ultrasonic and plasma cleaning, steam degreasing, injection flood washing, pulsed pressure cleaning (PPC) or ultrasonic plus, thereby reducing the cleaning time by up to 50 %.
By integrating a low-pressure plasma process as the final step in a solvent or aqueous batch cleaning process, the component surface can be effectively and efficiently prepared for subsequent coating, among other things. The PPC pressure change process is used in particular for intermediate and final cleaning processes of components with narrow cavities, fine capillaries and porous surfaces. It enables contaminants to be removed reliably and quickly even from these hard-to-reach areas.
Monitoring of validated process parameters
Whether in a chamber or ultrasonic multi-bath immersion system, the cleaning of medical technology products is often based on validated process parameters, compliance with which must be monitored and documented. These include the ultrasonic frequency and power. The Acoustic Performance Measurement (APM) systems from Ecoclean make this possible inline and reproducibly up to an ultrasonic frequency of 2,000 kHz. Monitoring is carried out using a condenser or laser acoustic microphone, which is aligned with the surfaces of the ultrasonically equipped cleaning and rinsing tanks of a multi-bath immersion system. The measurements are thus carried out without movement or contact, ensuring the reproducibility of the results. In addition, APM technology makes it possible to detect ultrasonic frequency and sound pressure through “walls”. It can therefore also be used in closed cleaning and rinsing tanks as well as chamber cleaning systems. Analysis, evaluation and storage of the recorded data are carried out by the measuring system software.
Complete with clean room, packaging and sterilization
In addition to final cleaning, the packaging of various medical technology products has also been a critical component of the product since the introduction of the MDR. The Group’s turnkey solutions include appropriate cleanroom, packaging and sterilization solutions. Pre-validated packaging is already available for certain products. Software solutions and RFID technologies specially developed for medical technology applications and audit trails in accordance with CFR 21 also ensure that all regulatory requirements are met and that seamless automatic production data acquisition and traceability are guaranteed. The experts also offer support with qualification (IQ;QQ;PQ) and risk analysis.
Contact: Ecoclean GmbH, Fabio Cordaro, Global Business Development Manager CLP, 52156 Monschau, Germany, fabio.cordaro@ecoclean-group.net, www.ecoclean-group.net
Author, Doris Schulz
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