Cleaning Fluids that comply with European Medical Device Regulations

In May 2021, the European Medical Device Regulation comes into force and puts detergent suppliers at the heart of manufacturers' risk management.

  • Can NGL provide the technical data required in validation processes?
  • Are NGL detergents compliant with current regulations?
  • Is the quality of detergents maintained over time?

The Kemet range is designed to be efficient, simple and compliant. The simplification of this range was made possible by the implication and coordination of all departments: R&D, production/HSQE, purchasing. Informed about the new challenges the medical industry faces, they managed to condense contradictory requirements: efficiency, availability, cost control, regulatory compliance.

In addition to regulations and standards, NGL's approach includes knowlege of materials but also anticipation of process and material evolutions, such as additive manufacturing, or passivation following laser marking. Extending our collaboration to other players in the production chain (equipment manufacturers, consultants, laboratories, manufacturers of consumables, etc.) allows us to develop new solutions.

ISO 9001, ISO 14001 and ISO 45001 are the basis of our quality management, in addition to multiple control steps all along the production cycle. Finally, NGL is commtitted to continuous improvement in order to bring ever better quality to its customers.

Kemet are a distributor of NGL Nordic A/S with more than 300 high performance formulations providing a solution to most cleaning challenges.

Regulation

Our new references have been designed with carefully selected elements to anticipate regulatory changes and facilitate risk assessment. Any substance suspected of presenting a CMR hazard has been excluded. In addition, NGL has carried out a screening of the inorganic elements in this new range, to assist our customers with their biocompatibility validation tests, ISO 10993-18 in particular.

Cleaning and Passivation - Surface preparation before anodising and electro-chemical polishing

Compatibility

  • Stainless steel:
    • Austenitic
    • Martensitic
    • Precipitation Hardening
  • Titanium:
    • T40, Ti-6Al-4V
    • Chromium - Cobalt
    • Ceramics
    • Aluminium
    • Polymers

Devices

  • Implants:
    • Orthopaedics
    • Dental
    • tents
  • Surgical instruments:
    • Ancillary
    • Needles, staples
    • Blades, drills, saws, etc…
    • Catheters

Applications

  • Interoperation cleaning:
    • Cutting oil, neat or soluble
    • Abrasives : blasting, polishing compounds
  • Finishing:
    • Tumbling, emery
    • Iron oxide (passivation)
    • Dust, fingerprints, etc…

European Medical Device Regulation 2021

PRODUCTS FUNCTIONS APPLICATIONS PH
RUBIFIN N°4 Vacuum cleaning Oil removal solv.
RODACLEAN 2018 Ultrasonic cleaning Interoperation 12.6
DECOCLEAN 440 Spray cleaning Interoperation 13.7
GALVEX 20.01 Ultrasonic cleaning Interoperation and finishing 8.9
DECOSPRAY TM Spray cleaning Interoperation 9.6
DECOMET Soaking Passivation 2.4

Range compatible with validation standards

  • Cleaning:
    • ISO 19227 - 2018 (UE)
    • ASTM 3127 - 2016 (USA)
  • Characterization of inorganics:
    • ISO 10993 - 18
  • Passivation:
    • ASTM A967M - 17

Regulatory compliance

REACH N°1907/2006 CLP 1272/2008 DM 2017/745 2011/65/UE BIOCIDE 528/2010/UE
Candidates subst. to SVHC Authorised subst. (annex XIV) Restricted subst. (annex XVII) CMR Cat. 1A/1B Cat. 2 Severe endocrine disruptors Phtalates, latex, nanomaterials Subst. of animal origin ROHS BPR
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Strong Alkalis – Cleaning

After forging or casting, parts undergo several additional processing steps: machining, deburring, polishing, welding, etc... These can leave stubborn contamination, for which our strong alkalis are perfectly suited: RODACLEAN 2018 - For ultrasonic cleaning. Due to its high concentration of potassium and sodium hydroxides, Rodaclean 2018 efficiently removes soluble oils and polishing pastes, as well as most types of organic residues. DECOCLEAN 440 - The particular chemistry of this detergent makes it a very versatile product, suitable for the removal of neat oil in ultrasonic or spray cleaners (the machine must be equipped with an oil separator), but also polishing paste or various organic residues. Both references comply with the medical sector's latest requirements and do not contain elements banned or restricted by the following regulations (REACH, CLP, ROHS, BPR).

Characterisation of Inorganic Elements

For the biocompatibility check, the identification of chemical compounds that come into contact with Medical Device is critical. In collaboration with the Albhades laboratory (www. albhades.com), NGL has carried out a "screening" of its medical range, by ICP-EOS analysis, which reveals the absence or presence of inorganic elements in PPM. Upon request, the list of inorganic elements in these detergents can be provided to facilitate the characterisation of the contaminants (ISO 10993-18).

UPC 3000, Control the Parameters of Your Cleaning Line

The main parameters for perfect cleaning are: time, temperature, detergent concentration of adequate chemistry, ultrasonic power and water quality. The UPC 3000 ensures on a daily basis that your equipment is properly set up:

  • Measurement of ultrasonic power in Watts/L
    • Measure 5 control points to check that minimum ultrasonic power is above 10 W/L.
    • Power too low = loss of cleaning efficiency.
    • Too much power = risk of attacking the surface of the parts.
  • Temperature measurement
    • Too low = loss of cleaning efficiency.
    • Too high = damage to the parts or mineral precipitation on the substrate.
    • The right T (temperature) ensures optimal performance of your process.
  • Detergent concentration measurement
    • Too low = poor cleaning, shorter bath lifetime.
    • Too strong = no improvement in detergency, rinsing problems and unnecessary over-consumption.
  • Measuring the quality of demineralised water (down to 0.1 μS)
    • Conductivity too high = risk of drying spots

Pre-Treatment of Process Water

In a Medical Device cleaning process, avoiding bacterial growth, especially in demineralised water rinses, is a challenge. Water flows through sections which can be difficult to reach (bends, pipes, pumps) where the presence of micro-organisms is hard to measure and control. Without specific water treatment, biofilm can develop and proliferate all the way to the rinse tanks. Prevention, through appropriate pre-treatment of the water, is thus essential, even if water is heated to 70° and constantly circulated. Such a pre-treatment solution, supplied by NGL, has been successfully implemented for the final rinse of medical devices prior to entry into the cleanroom at Charles PERY, a manufacturer of medical implants and instruments in France. To achieve a quality of purified water in bulk (PBW) of pharmacopoeia level PE7 (see panel), NGL supplies equipment to filter and remove the various mineral, organic and bacterial contaminants found in drinkable water.

RO/EDI/UF

  • Pre-filtration on sediment filters.
  • Water softening.
  • Reverse osmosis to remove most organic matter, colloids, suspended particles and minerals.
  • Dionisation resins to remove dissolved mineral residues.
  • UV lamp to remove any "pioneer" bacteria present in the water.
  • Hot water circulation loop at 70°, piping made entirely of 316L steel, seamless, without weldings and stagnant sections, cleaned and passivated (ASTM G93 standard) to pasteurise the water.
  • Continuous filtration of recirculated water through 0.2μm and endotoxin (0.05μm) filters to ensure microbiological parameters concentration meets standards at point of use.
Water in bulk (PBW) PE 7
Production mode All techniques are allowed
Supply water Water intended for human consumption according to Directive 98/83/CE
Aspect Clear and colourless liquid
Total organic carbon ≤ 0,5 mg/L
Bacterial endotoxins < 0,25 UI/mL
Conductivity at 20°C ≤ 4,3 μS/cm
Conductivity at 25°C ≤ 5,1 μS/cm
nO3- ≤ 0,2 ppm
nO2- n/A
Heavy metals ≤ 0,1 ppm
Counting of microbiological germs ≤ 100 UFC/mL

Pre Treatment of Process Water

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