From pre-cleaning to sterile packaging

When cleaning medical technology parts and components of higher classes, especially high standards must be met regarding cleanliness, traceability, process validation, and documentation. (Image source: Shutterstock / 123RF)

The comprehensive range of cleaning systems offers solutions for all tasks along the manufacturing chain. Here is a system for aqueous interim cleaning, for example before coating. (Image source: Philips Medical Systems)

The final or fine cleaning of medical devices is usually carried out in a task-specific batch cleaning system, which can be integrated into or connected to a cleanroom. (Image source: Ecoclean / UCM)

Technology centers equipped with clean rooms and analysis equipment enable the execution and evaluation of cleaning tests under controlled conditions. (Image source: Ecoclean)

The Medical Device Regulation (MDR), which has been in effect since May 26, 2021, significantly increases the requirements for manufacturers of medical technology products. This includes, among other things, cleaning and identification of parts and components, as well as qualification, documentation, and traceability of processes. The SBS Ecoclean Group supports companies with globally available turnkey solutions for cleaning and packaging, as well as local service, to help meet these requirements.

The range of medical technology products extends from simple plasters, syringes, and catheters to surgical instruments, implants, and pacemakers, up to large devices such as computers and MRI scanners (CT and MRI). Depending on the type and intended use, the products are classified into four main classes in the EU (I, IIa, IIb, and III). For safe use, manufacturers have long been required to demonstrate, based on a risk-based approach, that their products do not pose a danger to patients when used properly, which also includes cleanliness. This certification is carried out by "Notified Bodies," except for Class I products that are not sterile, do not have measuring functions, and pose only a low risk. With the new MDR, which has been mandatory since May 26, 2021, various changes in the classification system must be observed. For example, more products fall under the regulation, and products are to be classified into a higher risk class. Furthermore, according to Annex 2 of the MDR, in addition to bioburden and cytotoxicity values, particulate and film contamination from manufacturing processes are now also considered for the first time. Higher requirements have also been introduced regarding traceability and identification. The complete and globally available program of qualified cleaning solutions from the SBS Ecoclean Group enables these requirements to be met in a stable and reproducible manner. The cleaning and packaging systems offer optimal conditions for equipment qualification and process validation in medical technology. Automatic process data collection and storage, as well as audit trails, ensure that all parts and components processed in the systems can be traced and identified without gaps.

Cleaning – a task along the manufacturing chain

Parts produced through traditional manufacturing processes such as machining, forging, extrusion, and injection molding often leave particulate and/or film residues on their surfaces. These residues are usually removed in a pre-cleaning step. For these tasks, the offer includes modular and customer-specific chamber cleaning systems that operate with solvents such as modified alcohols or halogen-free hydrocarbons, as well as aqueous media (neutral, acidic, alkaline). An intermediate cleaning step, often performed after finishing processes like grinding, blasting, or polishing, can be efficiently carried out in an aqueous chamber or batch cleaning system such as the UCMSmartLine.

Additively manufactured components are increasingly important for personalized patient care in human and dental medicine. Parts produced via powder bed-based printing processes need to be depowdered after unpacking. Dry methods such as vacuum technology are available for this purpose. They enable powder recovery.

A challenge for cleaning involves the capillary, lumen, or pore structures of geometrically complex parts produced by sintering or 3D printing processes. Multi-stage immersion cleaning systems equipped with high-frequency ultrasound, injection flood washing, and/or Pulsated Pressure Cleaning (PPC), in combination with a suitable medium, reliably remove contaminants and powder residues from fine structures, narrow lumens, and complex geometries.

Final cleaning is usually performed in task-specific batch cleaning systems with appropriate water treatment and matched media. A passivation step can be integrated as needed. A cleanroom-compatible design of the system or connection to a cleanroom, which is also planned by the SBS Ecoclean Group, can be included in the scope of supply upon request.

Packaging included

Regardless of whether products require sterile or non-sterile packaging after final cleaning, the turnkey solutions of the group also include machines and systems adapted for these tasks. To ensure a quick start to production, validated packaging materials designed for medical instruments and implants can already be used.

Global delivery with local service

The range of turnkey solutions for medical technology includes planning, development, and manufacturing of cleaning systems, including interface coordination and implementation. Customer staff training for operation and maintenance, technical support during operation, and spare parts supply through local service are also provided. This ensures maximum availability of the systems and machines.