Advanced Cleaning Fluids: Compliant with European Medical Device Regulations for Unmatched Cleaning Performance
The European Medical Device Regulation (MDR) went into effect in May 2021, placing increased pressure on manufacturers to prioritise risk management. One important aspect of this is ensuring that cleaning fluids used in medical device manufacturing are compliant with regulations. NGL, a supplier of cleaning fluids, has taken steps to develop a range of cleaning fluids that are efficient, compliant, and simple to use.
NGL's Kemet range of cleaning fluids is the result of collaboration between various departments, including R&D, production/HSQE, and purchasing. The range was designed to meet the contradictory requirements of efficiency, availability, cost control, and regulatory compliance. NGL's approach includes not only a knowledge of materials but also an anticipation of process and material evolutions, such as additive manufacturing and passivation following laser marking. Collaboration with other players in the production chain allows NGL to develop new solutions.
NGL has implemented ISO 9001, ISO 14001, and ISO 45001 as the basis of their quality management. In addition to these standards, multiple control steps are taken along the production cycle to ensure quality. NGL is also committed to continuous improvement in order to provide even better quality to their customers.
NGL's cleaning fluids are designed to anticipate regulatory changes and facilitate risk assessment. Any substance suspected of presenting a Carcinogenic, Mutagenic or Reprotoxic (CMR) hazard has been excluded from the Kemet range. Additionally, NGL has conducted a screening of the inorganic elements in the range to assist their customers with biocompatibility validation tests, such as ISO 10993-18.
NGL Nordic A/S is a supplier that offers over 300 high-performance cleaning formulations to tackle a wide range of cleaning challenges. Kemet is proud to be a distributor of their products.
Cleaning and Passivation - Surface preparation before anodising and electro-chemical polishing
| 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
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…
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 parts are forged or cast, they typically undergo additional processing such as machining, deburring, polishing, and welding. These steps can result in stubborn contamination, which can be effectively removed by our strong alkalis. Our products, RODACLEAN 2018 and DECOCLEAN 440, are ideal for ultrasonic and spray cleaning as they have high concentrations of potassium and sodium hydroxides that can efficiently eliminate soluble oils, polishing pastes, and various organic residues. Both of these cleaning solutions meet the latest requirements of the medical industry and do not contain any elements that are restricted or banned by REACH, CLP, ROHS, or BPR regulations.
Characterisation of Inorganic Elements
In order to identify the chemical compounds that come into contact with medical devices, it is critical to perform a biocompatibility check. To facilitate this, NGL collaborated with the Albhades laboratory to perform an ICP-EOS analysis, which reveals the presence or absence of inorganic elements in parts per million (PPM) in their medical range. Upon request, we can provide a list of inorganic elements found in our detergents to assist with the characterisation of contaminants in accordance with ISO 10993-18.
Control Your Cleaning Line Parameters with the UPC 3000
UPC 3000 is a device that provides an effective solution for controlling the cleaning parameters of industrial cleaning lines. The device is designed to ensure that the critical cleaning parameters are accurately set to achieve optimal performance of the cleaning process. The main parameters for perfect cleaning include time, temperature, detergent concentration, ultrasonic power, and water quality. By monitoring and controlling these parameters, UPC 3000 helps to maintain the efficiency and effectiveness of the cleaning process.
One of the critical parameters that UPC 3000 monitors is the ultrasonic power, which is measured in Watts/L. The device measures at least five control points to check that the minimum ultrasonic power is above 10 W/L. If the power is too low, it can result in a loss of cleaning efficiency, while too much power can damage the parts' surface. Therefore, UPC 3000 ensures that the ultrasonic power is appropriately set, reducing the risk of attacking the surface of the parts.
UPC 3000 also monitors the temperature of the cleaning line to ensure optimal performance. The device measures the temperature and ensures that it is not too low or too high. If the temperature is too low, the cleaning efficiency can reduce, while too high can cause damage to the parts or mineral precipitation on the substrate. Therefore, UPC 3000 ensures that the right temperature is set, maintaining the optimal performance of the cleaning process.
Another critical parameter that UPC 3000 controls is the detergent concentration, which is essential for achieving effective cleaning. The device measures the detergent concentration and ensures that it is not too low or too strong. If the detergent concentration is too low, the cleaning will be poor, leading to a shorter bath lifetime. On the other hand, if the detergent concentration is too strong, it can result in no improvement in detergency, rinsing problems, and unnecessary over-consumption. Hence, UPC 3000 ensures that the detergent concentration is appropriately set, optimising the cleaning process's effectiveness.
Furthermore, UPC 3000 measures the quality of demineralised water to prevent drying spots. The device measures the water quality down to 0.1 μS and ensures that the conductivity is not too high. If the conductivity is too high, it can result in drying spots. By measuring and controlling the water quality, UPC 3000 helps to maintain the effectiveness and efficiency of the cleaning process.
Pre-Treatment of Process Water
In the process of cleaning medical devices, it is crucial to prevent the growth of bacteria, particularly in sections where microorganisms are difficult to measure and control, such as bends, pipes, and pumps. In the absence of appropriate water treatment, biofilm can develop and spread all the way to the rinse tanks, making pre-treatment of water an essential measure even if water is heated to 70°C and circulated constantly. NGL offers a pre-treatment solution to achieve a quality of purified water in bulk (PBW) of pharmacopoeia level PE7, and it has been successfully implemented by Charles PERY, a manufacturer of medical implants and instruments in France.
To remove various mineral, organic, and bacterial contaminants from drinkable water, NGL supplies equipment for pre-filtration, water softening, reverse osmosis, and dionisation resins. The process is complemented by a UV lamp that removes any "pioneer" bacteria present in the water. The hot water circulation loop at 70°C is piped entirely of 316L steel, seamless, without weldings and stagnant sections, cleaned and passivated according to ASTM G93 standard to pasteurise the water. To ensure that microbiological parameters meet standards at the point of use, the recirculated water is continuously filtered through 0.2μm and endotoxin (0.05μm) filters.
| 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 |
