Medical technology

Medical technology

Cleanliness as a safety-critical quality factor

Reproducible component cleaning – reliable and documentable

Industrial cleaning systems for medical technology

In the medical technology, component cleaning is a safety-critical process. Residues from manufacturing and machining can impair the functionality of medical devices, disrupt downstream processes, or create regulatory risks. At the same time, requirements for process stability, validation, and documentation are increasing due to the Medical Device Regulation (MDR), Food and Drug Administration (FDA) requirements, ISO 13485, and customer-specific cleanliness specifications. Industrial parts cleaning is therefore not a supporting step, but an integral part of quality-assured medical device manufacturing.

BvL Oberflächentechnik GmbH develops cleaning systems that meet these requirements and can be reliably integrated into defined production environments.
 

Benefits for medical device manufacturers and suppliers

Process-reliable part cleaning creates measurable value throughout the entire product lifecycle. It reduces product risk, stabilizes manufacturing processes, and supports compliance with regulatory requirements. For production managers, quality managers, and engineers, this means:

  • reproducible cleanliness at a defined level
  • a reliable basis for downstream processes such as coating, assembly, or packaging
  • audit-proof documentation and traceability
  • less defective units and rework rates

Cleanliness thus becomes a controllable quality parameter.

Industrial cleaning systems for medical technology

Requirements for component cleanliness in medical technology

Medical devices are subject to particularly stringent requirements regarding particulate and filmic cleanliness. Contaminants from machining, forming, additive manufacturing, or surface finishing must be reliably removed, including from hard-to-reach areas. In addition, organic residues, bioburden, cytotoxicity, and endotoxin levels of components are critical factors.

Beyond the cleaning result itself, regulatory aspects are a key focus. Cleaning processes must be designed to be reproducible, qualified, and validatable. Relevant process parameters such as time, temperature, media quality, pressure, or drying must be monitored and documented per batch or component, depending on the application. Only in this way can internal quality requirements, customer specifications, and normative and legal frameworks be reliably met.

Typical devices, materials, and geometries

Materials processed include stainless steel alloys, titanium, cobalt, plastics, and ceramics. Different materials and complex geometries require application-specific cleaning concepts tailored to the component, type of contamination, and required cleanliness level.

Industrial part cleaning in medical technology covers a wide range of applications, including:

Implants for orthopedics and dental technology
Surgical instruments and surgical trays
Precision components for endoscopy, diagnostics, and medical devices
Assemblies with narrow lumens, capillaries, blind holes, or undercuts

Our solution:

Flexibly Configurable Precision Cleaning Systems

BvL develops modular cleaning systems specifically designed to meet the requirements of demanding industries, including applications in medical technology. The solutions range from pre-cleaning and intermediate cleaning to final cleaning prior to sensitive downstream processes.

Possible processes

Vacuum impulse technology (VIT)
Deep cleaning using implosion power: innovative pressurechange process for improved media exchange and enhanced contaminant removal. Ideal for components with complex geometries, narrow channels, and blind holes. The VIT process can be integrated into any Niagara series system and, in the future, also into the Atlantic immersion cleaning system

Ultrasonic cleaning
e.g., 40, 80, and 132 kHz, multi-frequency systems, ultrasonic generators with sweep function for delicate geometries.

Spray/flood cleaning
Powerful all-round cleaning through special nozzle frames and flooding of the cleaning chamber (continuous partial flooding, full/vacuum flooding, recirculating flooding)

Immersion cleaning
Perfectly coordinated combination of different cleaning processes in a multi-stage system. The treatment processes and number of tanks can be individually adapted.

Drying
Vacuum drying, recirculating air and hot air drying with HEPA filter, air blow-off, infrared drying – used alternatively or in combination.

Our systems:

Configurable to your needs – perfectly matched to your component and your process

NiagaraUp:

NiagaraUp: NiagaraUp:

Basket cleaning system with Vacuum Impulse Technology (VIT)

The NiagaraUP combines a compact design with high process depth for top-level cleanliness.. All process steps are carried out in a single chamber saving space.

The system design prevents recontamination and cross-contamination. Amoung other things through, electropolished surfaces and a rounded chamber design, as well as special processes such as chamber cleaning with UPW (ultrapure water), rapid complete draining, etc.


Process
The key feature here is Vacuum Impulse Technology (VIT), which reliably removes residues even in capillaries, boreholes, and cavities. In addition, spray and flood cleaning (stepless partial flooding, full/vacuum and recirculating flooding) as well as HEPA-filtered hot air and vacuum drying extend the process into a complete solution for high purity requirements. All processes are individually configurable.

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Atlantic:

Atlantic: Atlantic:

Atlantic immersion cleaning system

The Atlantic multi-chamber immersion system is an optimal inline solution for the highest cleanliness requirements with high throughputs.

Components are immersed by means of an automated portaltransfer system into sequentially arranged tanks with differenttreatment stages. The number of tanks can vary.

Process
Immersion cleaning, phosphating, spraying, injection cleaning, ultrasonic cleaning (optional), rinsing, passivation, and optional drying are available. This wide range allows precise configuration of the cleaning process.

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Shared strengths:
  • Modularity: multiple tanks and chambers possible
  • Freely configurable program sequence: The order, number, and combination of all cleaning steps can be selected completely individually.
  • Seamless traceability of process parameters: documentable,audit- and validation-capable.
  • Reliable integration into production processes and cleanrooms.
  • Use of DI and ultrapure water (UPW) with low conductivity and TOC values.
  • Drying options: HEPA-filtered recirculating air and hot air drying, infrared and vacuum drying.
  • System quality (made in Germany), high-quality and durable materials, electropolished surfaces, stainless steel in V4A quality
  • Usable as a pre-washer and final washer
Get in touch with us!

We will find the optimal solution for your application!

Would you like to have components tested, request a quote, or learn more about our Atlantic series?

Contact us now without obligation or book a consultation.

We would be happy to advise you personally on cleaning solutions for your applications.