Pre-Cleaning to Sterile Packaging

From Pre-Cleaning to Sterile Packaging Turn-key cleaning solutions compliant with MDR and FDA requirements for the medical industry Medical devices manufactured or imported in the United States or EU must comply with the relevant regulations - FDA (Food and Drug Administration) or the new European Medical Device Regulation (MDR). Since the end of May 2021, when the EU regulation came into force, requirements regarding the cleaning and identification of parts for medical devices, as well as process qualification, documentation and traceability, have increased significantly. SBS Ecoclean Group provides turn-key solutions for the cleaning and packaging of medical devices and local services, helping companies worldwide to meet these requirements. [caption id="attachment_132221" align="aligncenter"] Final or ultra-precision cleaning of medical technology products is typically performed in custom-designed immersion cleaning systems that can be integrated into or connected to a clean room. Ecoclean / UCM Copyright: Ecoclean GmbH Publisher: Ecoclean GmbH[/caption] The range of medical devices spans from simple bandages, syringes and cannulas to surgical instruments, implants and pacemakers, as well as large machines such as computed tomography and magnetic resonance imaging systems (CT and MRI). Depending on their type and intended use, products must comply with the relevant FDA regulations or the new European Medical Device Regulation (MDR), which became mandatory on 26 May 2021. This brings with it many changes that need to be considered. For example, more products fall within the scope of the regulation and must be classified in a higher risk category. Additionally, in addition to bioburden and cytotoxicity values, particle and film contamination resulting from manufacturing processes must now be taken into account. Traceability and identification requirements have also become stricter. SBS Ecoclean Group's comprehensive and globally available range of certified cleaning solutions ensures that these requirements are met soundly and repeatedly. Cleaning and packaging systems equipped with software solutions specially developed for medical technology applications and RFID technologies provide the most suitable conditions for equipment certification according to IQ, OQ and PQ and process validation. The inclusion of Audit-Trail and CFR 21 enables automatic collection and storage of process data and ensures seamless traceability and identification of all parts and components processed in the systems. [caption id="attachment_132226" align="aligncenter"] When cleaning medical components and products, high requirements must be met, especially for cleaning, traceability, process validation and documentation according to FDA regulations or the new MDR.
Source: Shutterstock / 123RF Copyright: Ecoclean GmbH Publisher: Ecoclean GmbH[/caption]

Cleaning - One of the Tasks in the Production Chain

When it comes to components manufactured using classical production processes such as machining, forming, extrusion and injection molding, particles and/or fine film residues remain on the surface. These residues are typically removed in a pre-cleaning step. For these tasks, SBS Ecoclean Group provides modular and customized tank cleaning systems using solvents such as modified alcohols or non-halogenated hydrocarbons, as well as aqueous environments (neutral, acidic, alkaline). An intermediate cleaning step, typically performed after finishing operations such as grinding, blasting or polishing, can be efficiently carried out in an aqueous tank or inline immersion cleaning system such as UCMSmartLine. Today, in human and dental medicine, additively manufactured components play an increasingly important role in individual patient care. Powder residues from parts produced in powder bed-based printing processes must be cleaned after removal from the packaging. Dry methods such as vacuum technology can be used for this, which also allows for the recovery of excess powder. Cleaning the capillary, lumen or pore structures of geometrically complex components produced in sintering or 3D printing processes is particularly challenging. For these tasks, multi-stage immersion cleaning systems equipped with multi-frequency ultrasound, jet washing and/or pulsed pressure cleaning (PPC), combined with an appropriate medium, ensure that contaminants and powder residues are reliably removed from the most delicate structures such as narrow lumens and complex geometries. The final cleaning step is typically performed in customized inline immersion cleaning systems with appropriate water treatment and cleaning fluid. If required, a passivation step can also be integrated here. Again, planning by SBS Ecoclean Group companies and design of the system compatible with clean rooms or connection to a clean room is another service offered on request.

Packaging Process Included

Regardless of whether products require sterile or non-sterile packaging after final cleaning, Ecoclean Group's turn-key solutions also include appropriately adapted machinery and equipment. Pre-designed and approved packaging materials for medical devices and implants can be used to ensure rapid start of production.

Local Service With Global Delivery

The range of turn-key solutions for the medical industry includes the planning, development and manufacturing of cleaning systems, as well as interface coordination and implementation. Local service personnel not only train customer employees to operate and maintain the systems; they provide technical support with any issues that may arise during operations and also supply the necessary spare parts. This guarantees maximum availability of systems and machinery. Source