Medical products produced in or imported to the US or EU have to comply to the relevant regulations — FDA or the new European Medical Device Regulation (MDR). With the EU regulation in force since end of May 2021, requirements for cleaning and identifying parts for medical products as well as for the qualification, documentation and traceability of the processes have significantly increased.
The spectrum of medical products ranges from simple plasters, syringes and cannulas through surgical instruments, implants and pacemakers right up to large machines such as computer and magnetic resonance tomographs (CT and MRT). Depending on type and intended use, the products must comply to the relevant regulations of the FDA or new European MDR, which became mandatory on 26 May 2021. It has brought about several changes that need to be considered. For example, more products are covered by the regulation, and must be classified in a higher risk category. Furthermore, particulate and filmic contaminations from manufacturing processes must now be considered in addition to bioburden and cytotoxicity values. Traceability and identification requirements have also become stricter.
The comprehensive and globally-available range of certified cleaning solutions from the SBS Ecoclean Group enable these requirements to be met in a robust and reproducible manner. Equipped with software solutions specially developed for medical technology applications and RFID technologies, the cleaning and packaging systems provide optimal conditions for equipment certification and process validation according to IQ, OQ and PQ. The inclusion of Audit-Trail and CFR 21 enable automatic acquisition and storage of process data and ensure that all parts and components processed in the systems can be seamlessly traced and identified.
Cleaning
When components that are manufactured using classic production processes such as achining, forming, extrusion and injection moulding, particulate and/or thin-film residues remain on the surface. These residues are usually removed in a precleaning step. For these tasks, SBS Ecoclean Group supplies modular and customised chamber cleaning systems which use solvents, such as modified alcohols or non-halogenated hydrocarbons, as well as aqueous media (neutral, acidic, alkaline). An intermediate cleaning step that is generally performed after finishing processes such as grinding, blasting or polishing can be done efficiently in an aqueous chamber or in-line immersion cleaning system, for example, the UCMSmartLine.
In today’s human and dental medicine, additively manufactured components play an ever-more important role in individual patient care. Powder residues from parts produced in powder bed-based printing processes must be cleaned off after unpacking. Dry methods such as vacuum technology can be used to do this, which also enable excess powder to be recovered.
Capillary, lumen or pore structures of geometrically complex components manufactured in sintering or 3D printing processes are especially difficult to clean. For these tasks, multistage immersion cleaning systems equipped with multifrequency ultrasound, injection flood washing and/or pulsated pressure cleaning (PPC) coupled with a suitable medium ensure that contaminants and powder residues are reliably removed from the most delicate structures, narrow lumens and complex geometries.
The final cleaning step is usually done in customised in-line immersion cleaning systems, with the appropriate water treatment and cleaning fluid. A passivation step can also be integrated here as necessary.
Packaging process included
Regardless of whether the products need sterile or non-sterile packaging after final cleaning, the Group's turnkey solutions also include suitably-adapted machines and equipment. To make sure that production gets off to a quick start, previously designed and validated packaging materials for medical instruments and implants can be used.
The range of turnkey solutions for the medical industry includes the planning, development and manufacture of cleaning systems, as well as interface coordination and implementation. Local service staff not only trains customer employees to operate and maintain the systems; it provides technical support should any queries arise during their operation and also supplies any necessary spare parts. This guarantees maximum availability of the systems and machines.