Validatable Cleaning Solutions for Medical Technology
MDR‑ and FDA‑compliant systems for reproducible, audit‑ready processes – from pre‑cleaning to final cleaning with passivation.
As a leading manufacturer of systems for industrial parts cleaning, we provide tailored solutions for the medical technology sector that meet the highest regulatory and process‑specific requirements. Our cleaning systems support you in reliably complying with MDR and FDA quality requirements – from pre‑cleaning and intermediate cleaning through to final cleaning including passivation.
Why Ecoclean?
As a partner to the medical technology industry, Ecoclean combines regulatory confidence with in‑depth process engineering expertise. We support our customers in optimizing existing processes or developing new processes for evolving requirements. From process development (Pre‑PQ) through IQ and OQ to PQ and global after‑sales service, we accompany our customers throughout the entire lifecycle.
Regulatory Compliance – From Design to Audit
Ecoclean develops cleaning systems for medical technology applications with transparent and fully traceable documentation to support validation, qualification and audits. This includes MDR‑ and FDA‑compliant system concepts, IQ/OQ/PQ documentation, EN 10204 Type 2.1 certificates for media‑contacting components, as well as calibratable sensors in accordance with international standards. End‑to‑end traceability of components, software and process data ensures audit readiness; optional support is available for Design Qualification (DQ) and during system ramp‑up.
The complete process chain from a single source
Whether it’s pre-cleaning, final cleaning, or passivation—we combine the right technology with a stable, validatable process. This allows you to achieve reproducible results even with complex geometries and tight tolerances.
Pre-cleaning after CNC machining
Single-chamber cleaning systems using aqueous and solvent-based solutions reliably clean medical components after CNC machining—even in capillaries, blind holes, and complex geometries, thanks to vacuum technology.
Intermediate Cleaning After Grinding and Polishing
Single-chamber aqueous and ultrasonic immersion cleaning systems ensure the cleanest medical components after grinding, polishing, and mechanical processing—even for capillaries and blind holes, thanks to vacuum technology.
Final Cleaning / Passivation After Final Inspection
Ultrasonic batch immersion systems with PPC vacuum-pressure technology ensure the highest level of cleanliness during the final cleaning and passivation of medical implants—in compliance with FDA and MDR regulations.
Cleanroom Transfer and Packaging
Comprehensive cleanroom and packaging solutions enable the safe transfer and validated packaging of medical implants and instruments.
Typical Applications
Implants, surgical instruments, endoscopy components, 3D-printed components.
From Concept to a Validated Process
- Support from the very beginning
From the early concept phase through to a qualified and validated cleaning system - Systematic MedTech engineering
Optimal alignment of cleaning technology, process control, and documentation - Validatable cleaning processes
Compliance with all relevant MDR and FDA requirements - Reliable ramp‑up & stable series production
Reproducible processes for dependable manufacturing
Process and Technology Consulting
- Regulatory focus on MedTech
Consistent alignment with the regulatory requirements of the medical technology industry - Selection & design of the optimal cleaning technology
Precisely tailored to the component, cleanliness requirements, and operating environment - Scale‑up & industrialization
Support from prototype parts through to series production - Support with validation & audit preparation
Hands‑on, structured and audit‑ready - Training & best‑practice concepts
For production and quality assurance
Testing and Validation – Under Real‑World Conditions
- Production‑like test environments worldwide
Cleaning systems in series‑production layouts as well as cleanroom environments at our competence centers - Joint process development
Development, testing and verification of MedTech cleaning processes together with you - 1:1 transferability to series production
Processes tested under realistic conditions and directly scalable - Holistic testing approach
From feasibility studies and validation trials through to complete documentation
Global Locations & Test Centers
- Worldwide support for MedTech projects
Fast response times and local availability - MedTech test centers in Europe & the USA
Specifically designed for regulated medical technology applications - Enpak Technology Center, Warsaw (Indiana, USA)
Center of excellence for cleaning and packaging - Cleanroom‑connected test centers
Locations in Dettingen and Monschau - Contract cleaning options
Support extending beyond testing - Regional points of contact
Close, personal on‑site project support
Certified Analytics for Reliable Evidence
To reliably verify your cleaning results, we work with certified partner laboratories. Upon request, you receive test reports that fully meet regulatory requirements and provide solid, audit‑ready evidence.
Analytical Services:
- Particle analysis (size, quantity, distribution)
- Film‑type contaminants (organic / chemical residues)
- Biological contamination (bioburden)
- Endotoxins
- Validation‑supporting analyses in accordance with defined specifications
Maximum System Availability – Worldwide
We ensure process stability throughout the entire system lifecycle. With global service teams, a reliable spare parts supply, and planned service concepts, your system remains ready for operation, compliant, and continuously validatable at all times.
Service Portfolio:
- Worldwide maintenance contracts with SLAs
- Spare parts supply and remote support
- Regular sensor calibration as a certified service provider
- Acoustic Performance Management (APM) for objectively measurable process monitoring
- Lab‑on‑a‑Chip (LOC) for rapid pre‑analyses to support quality assurance
- Disinfection & hygiene concepts
- Training & consulting for operation and quality assurance
- Retrofits & upgrades for new specifications
Ready for validatable cleaning in medical technology?
We show you the fastest path to audit‑ready, reproducible results – precisely tailored to your components and specifications.
