Published 10/15/2021

Navigating Medical Cleaning Regulations

Medical product cleaning and packaging solutions enable new regulations from the FDA and MDR to be met in a robust and reproducible manner.

Edited by: Chris Pasion

Managing Editor, Modern Machine Shop | Production Machining

The SBS EcoClean Group (Southfield, Mich.) supplies companies with turnkey solutions and local services for the cleaning and packaging of medical products. These products range from simple plasters, syringes and cannulas to surgical instruments, implants and pacemakers, as well as large machines such as computer and magnetic resonance tomographs (CT and MRT).

With the European Medical Device Regulation (MDR) in force since the end of May 2021, as well as changing FDA requirements, regulations for cleaning and identifying parts for medical products — including new requirements for the qualification, documentation and traceability of the processes — have significantly increased. Under the new regulations, more products are covered and classified in a higher risk category. Particulate and filmic contaminations from manufacturing processes, as well as bioburden and cytotoxicity values, must now be considered. EcoClean says its range of certified cleaning solutions enable these requirements to be met in a robust and reproducible manner.

EcoClean’s cleaning and packaging systems are equipped with software solutions specially developed for medical technology applications and radio-frequency identification (RFID) technologies. This enables them to provide optimal conditions for equipment certification and process validation according to installation, operation and performance qualifications (IQ, OQ and PQ). According to the company, the inclusion of Audit-Trail and Code of Federal Regulations (CFR) 21 enables automatic acquisition and storage of process data and ensures that all parts and components processed in the systems can be seamlessly traced and identified.

Cleaning

New MDR and FDA regulations have to be met for cleaning medical components and products, including requirements for cleanliness, traceability, process validation and documentation. Photo Credit: Shutterstock / 123RF

A pre-cleaning step is necessary for particulates and thin-film residues that remain on the surfaces of components that are manufactured using machining, forming, extrusion and injection molding. For these tasks, EcoClean supplies modular and customized 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 usually performed after finishing processes can be carried out in an aqueous chamber or in-line immersion cleaning system — for example, the UCMSmartLine.

EcoClean says that 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 off after unpacking. Dry methods such as vacuum technology can be used to do this, which also enable excess powder to be recovered.

The EcoCWave, a system for aqueous intermediate cleaning. Photo Credit: Philips Medical Systems

In addition, capillary, lumen or pore structures of geometrically complex components manufactured in sintering or 3D printing processes are especially difficult to clean. For these tasks, multi-stage immersion cleaning systems equipped with multi-frequency ultrasound, injection flood washing and/or pulsated pressure cleaning (PPC) are used, coupled with a suitable medium. According to EcoClean, this ensures that contaminants and powder residues are reliably removed from the most delicate structures, narrow lumens and complex geometries.

The final or ultra-fine cleaning of medical technology products usually takes place in a task-specific immersion cleaning system that can be integrated or connected to a cleanroom. Photo Credit: EcoClean / UCM

The final cleaning step is usually carried out in customized in-line immersion cleaning systems, with the appropriate water treatment and cleaning fluid. A passivation step can also be integrated here as necessary. A cleanroom-compatible design of the system or connection to a cleanroom, which is also planned by the EcoClean Group, is a further service that is available on request.

Packaging

Regardless of whether the products need sterile or non-sterile packaging after final cleaning, EcoClean’s solutions include suitably-adapted machines and equipment. EcoClean says that previously designed and validated packaging materials for medical instruments and implants can be used to ensure that production gets off to a quick start.

Global delivery and local service

EcoClean’s solutions for the medical industry include the planning, development and manufacture of cleaning systems, as well as interface coordination and implementation. When installing the equipment, local service staff trains customer employees to operate and maintain the systems, provides technical support during operation and also supplies any necessary spare parts. EcoClean claims that this guarantees maximum availability of the systems and machines.