Many manufacturers of medical devices ask themselves: How can a validated cleaning and packaging process be established without having to invest directly in their own cleaning facilities? This was precisely the challenge faced by the medical device company LiNA Medical.
This is because medical devices place the highest demands on cleanliness, documentation, and process reliability. At the same time, new products often need to be brought to series production within a short timeframe.
Working together with LiNA Medical, Ecoclean developed, verified, and successfully qualified a fully validated cleaning and packaging process for catheters within just six months of the initial meeting.
Validated Contract Cleaning as a Strategic Alternative
With its validated contract cleaning service, Ecoclean provides medical device manufacturers with access to qualified cleaning and packaging processes without requiring them to invest in their own facilities.
Typical use cases include:
- Product launches and pilot runs
- Bridging delivery times for new equipment
- Temporary capacity expansions
- New products for which a suitable cleaning process must first be developed
If a validated process already exists, it can be adopted. For new applications, however, Ecoclean develops and verifies the process in collaboration with the customer, in accordance with regulatory requirements.
Ideal infrastructure for demanding MedTech applications
The Ecoclean Test Center in Monschau offers various cleaning systems for testing and process development. These include the UCMPerformanceLine, which is directly connected to an ISO Class 7 cleanroom. This allows cleaned components to be packaged under controlled conditions immediately after cleaning. As a result, customers can realistically simulate their future production environment right here.
Working Together Toward a Validated Process
Following the initial meeting in December 2025, component data and process requirements were first analyzed. Based on this, Ecoclean developed two possible cleaning processes for cleaning the catheters. Both combined multi-stage cleaning technologies, including ultrasound and PPC (Pulsed Pressure Cleaning) technology, to reliably clean even hard-to-reach internal areas of the catheters.
This prototype workpiece holder was used for preliminary testing.
This was followed by the first series of trials, after which the microbiological contamination and particle cleanliness were analyzed. In addition, the biocompatibility of the workpieces was verified. All results met the specified requirements. Of the two different process proposals, one was selected as the process to be validated.
Ecoclean then developed the product-specific workpiece holder concept for subsequent contract cleaning or potential serial production cleaning with 50 catheters per batch.
This workpiece holder concept was developed by Ecoclean.
After the concept was approved, a further final series of tests was conducted to validate the process under “production conditions” .
It was agreed beforehand that the effectiveness of the water treatment would be verified by taking water samples and having an external, accredited laboratory analyze them for endotoxins and microorganisms. Once validation has been completed, the sensor system of the facility’s own system (TOC – Total Organic Carbon – and conductivity, which detects dissolved ionic contamination that could otherwise leave residues on components) is considered sufficient evidence.
Of course, even after these “validation tests,” all catheters were again subjected to the various analyses.
Good to know: The correct concentration of the cleaning agents can, by the way, be monitored and documented using the Lab-on-a-Chip (LoC) developed by Ecoclean itself!
The final catheter holder can carry 50 catheters.
Transparency and Full Traceability
Each cleaning batch — understood as a set of cleaning holders — is documented by a batch protocol automatically generated by the system. This includes, among other things:
- Process times
- Temperatures
- Conductivity
- Ultrasonic parameters
- Functional verification reports for ultrasonic and pump systems
This ensures complete process documentation and traceability, down to each individual cleaning holder.
In addition, Ecoclean has the option of consulting certified and accredited partners for the selection of cleaning chemicals or the performance of analyses.
The Result
By the end of June 2026, both Ecoclean’s supplier qualification and the validation of the cleaning and packaging process had been successfully completed.
For LiNA Medical, this means:
- A qualified and approved cleaning partner
- Validated cleaning and packaging process
- Documented traceability of every batch
- Rapid scaling of production without the need for in-house capital investment
- High process reliability for sophisticated medical devices
Partnership for Success
The time from initial contact to successful process validation and supplier approval took just six months. This was made possible by close collaboration among all parties involved, as well as Ecoclean’s combination of process expertise, medical technology experience, cleanroom infrastructure, and validation-ready documentation.
For medical device manufacturers, Ecoclean thus offers far more than just contract cleaning: a qualified partner for the development, validation, and implementation of regulatory-compliant cleaning processes.
Are you planning product launches and looking for a partner to bridge the lead time for new equipment? Or do you need a temporary capacity expansion or a suitable cleaning process?
Talk to our MedTech experts about your requirements: sales.monschau(at)ecoclean-group.net
