The spectrum of medical technology products is extremely diverse and presents specific requirements for component cleaning and packaging. Particulate and filmic contaminants from manufacturing processes must be reliably removed. Additionally, compliance with regulatory requirements from MDR or FDA regarding product identification as well as the qualification of equipment, documentation, and traceability of components and processes must be ensured. These high demands can only be met with cleaning processes and equipment optimally adapted to the tasks along the entire production chain, fulfilling requirements in a process-safe and economical manner.
The production of medical technology products such as instruments, implants for human and dental medicine, disposable items (e.g., syringes, cannulas, tubes, and valves), as well as devices for diagnostics and therapy occurs using various technologies and typically in several manufacturing steps. During these manufacturing processes, such as machining or additive manufacturing, material residues (particles) and operational and auxiliary materials, such as coolants, drawing and forming oils, and release agents, inevitably remain on the surface. These contaminants can hinder the processability and quality of subsequent processes and pose a risk to patients or impair the proper functioning of devices. An example is the production of a knee implant, which must be free of manufacturing media, particles, and germs before packaging.
The blank produced in a casting process or additively manufactured is machined, polished, possibly coated, cleaned, and packaged. Each of these processing steps presents individual requirements for the surface. This results in different tasks for component cleaning.
Defining the requirements
When selecting the technically and economically suitable solution for each cleaning step, the following questions play a role: Which part needs to be cleaned in what quantity? What cleanliness specifications must be achieved? What cleaning method and chemistry are suitable for this? What environmental regulations, standards, and laws need to be considered? What steps must be taken to meet all criteria?
Are intermediate steps to be added? Does the logistical process fit? What role do employees play in the cleaning process? What budget is available for the acquisition? What are the ongoing operating costs, e.g., for new media, disposal, energy, and maintenance? Based on this, it can be determined how many and which cleaning steps with which method are necessary, which medium is most suitable, and which drying technology should be used.
As an experienced complete 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. Furthermore, the portfolio includes turnkey solutions, including cleanroom and packaging systems.
Typical cleaning steps along the production chain
Both for additively manufactured components and after machining, a pre-cleaning is required. Its goal is to prepare the workpieces for the subsequent process by removing adhering powder (depowdering) or particles and processing media. This step usually takes place in single-chamber systems, which, depending on the processing medium used, are operated with solvents, e.g., hydrocarbons or modified alcohols, or a tailored water-based cleaner.
Intermediate cleaning steps are used, among other things, to remove polishing pastes and residues from grinding processes, for example, after vibratory finishing. They are carried out in a single-chamber cleaning system like the EcoCwave or a multi-stage ultrasonic multi-bath immersion system like the modular UCMSmartLine with an aqueous cleaning medium, depending on the cleanliness requirements.
The state of the art for cleaning before coating as well as for final cleaning and passivation are multi-stage ultrasonic multi-bath immersion systems with appropriate water treatment. For example, the UCMPerformanceLine can be easily adapted to the respective task by modules with integrated electrical and control technology for the process steps of cleaning and rinsing with variable ultrasonic equipment for mono, twin, and multi-frequency, drying with vacuum, warm 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 round cycle solution UCMIndexLine for small precision parts or the UCMSprayLine GMP, which meets high cGMP quality requirements.
The effectiveness of the cleaning medium is enhanced by various application-specific process technologies, such as spray, high-pressure, immersion, ultrasonic, and plasma cleaning, steam degreasing, injection flood washing, Pulsated Pressure Cleaning (PPC), or Ultrasound Plus, thereby reducing the cleaning time by up to 50%.
By integrating a low-pressure plasma process as a final step of a solvent or aqueous batch cleaning, the component surface can be effectively and efficiently prepared for subsequent coating. The pressure change process PPC is particularly used in intermediate and final cleaning processes of components with narrow cavities, fine capillaries, and porous surfaces. It allows contaminants to be reliably and quickly removed from these hard-to-reach areas.
Monitoring validated process parameters
Whether in a chamber or ultrasonic multi-bath immersion system, the cleaning of medical technology products often relies on validated process parameters, the compliance of which must be monitored and documented. These include, among others, ultrasonic frequency and power. This is enabled by the Acoustic Performance Measurement (APM) systems from Ecoclean up to an ultrasonic frequency of 2,000 kHz inline and reproducibly.
The monitoring is carried out with a capacitor or laser acoustic microphone, which is aligned to the surfaces of the ultrasonic-equipped cleaning and rinsing tanks of a multi-bath immersion system. The measurements are thus carried out without motion and contact, ensuring the reproducibility of the results. Furthermore, with APM technology, it is possible to detect ultrasonic frequency and sound pressure through 'walls'. Therefore, it can also be used in closed cleaning and rinsing tanks as well as chamber cleaning systems. Analysis, evaluation, and storage of the captured data are performed by the software of the measuring system.
Complete with cleanroom, packaging, and sterilization
In addition to final cleaning, since the introduction of the MDR, packaging of various medical technology products has also become a critical component of the product. The turnkey solutions of the corporate group include appropriate cleanroom, packaging, and sterilization solutions. Pre-validated packaging is already available for certain products. Software solutions and RFID technologies specifically developed for medical technology applications, as well as audit trails according to CFR 21, ensure that all regulatory requirements are met and that seamless automatic data collection and traceability are guaranteed. The experts also provide support in qualification (IQ; OQ; PQ) and risk analysis.
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