For those in the medical industry, there is a wealth of choice when it comes to cleaning options and technologies. In our opinion, water-based precision rotation cleaning is one of, if not the strongest choice if you’re looking to boost the efficiency of your operations.
What kind of cleaning occurs in the medical industry?
Before we explain why water-based precision rotation cleaning is great for the medical industry, let’s define what cleaning occurs and why it needs to happen.
Generally speaking, medical cleaning has two parts:
Step 1 – interprocess cleaning during the manufacturing process.
This cleaning happens between machining applications. After every step in the manufacturing process, a clean will occur; this removes the possibility of contamination and means parts are clean the whole way through.
Step 2 – final cleaning.
Final cleaning – will often, not always – be coupled with passivation (making surfaces inert); this is commonly acid-based to seal the surface of the medical part. The parts are then packed and sent off the sterilisation – once sterile, they can be used in a medical environment.
Why are these steps so critical?
As you can imagine, cleanliness is more than dirty or clean if you’re in the medical environment.
Medical implants, for instance, need to be away from environments that encourage the growth of pathogens. Manufacturers are always concerned about bacteria and their customers’ requirements.
“Our goal is to create safe and high-quality products. On our way to this point, we need surfaces absolutely free from stains between the production steps and after production stops.”
Markus Lutter, Head of Workshop and Production at surgical instrument manufacturer Gebrüder Zepf Medizintechnik GmbH & Co. KG
At a more technical level, it is imperative that manufacturers are always able to carry out tests in advance with subsequent analytical procedures, such as cytotoxicity, endotoxin, bioburden, TOC, THC or tests for particulate contamination by means of an optical particle counter (OPC). In accordance with USP 788 or microscopic evaluation in accordance with ISO 16232 / or USP 788, in order to prove the theory in practice and at the same time confirm the process.
So, why do medical manufacturers choose water-based precision rotation cleaning?
Broadly, there are four key strengths to water-based precision rotation for medical manufacturers:
- Raw cleaning power and speed
- Repeatability and documentation
- Compact solutions
Let’s explore each in more detail.
Cleaning power and speed
Cleaning power is essential for medical industry professionals. Much like aerospace parts, medical components need to meet high levels of compliance. Tobias Zepf, also from Gebrüder Zepf Medizintechnik, explains that “there are demands for cleanliness that did not exist in the past”.
Spray-flood cleaning machines, such as the superb MAFAC JAVA, are simply more powerful than their in-line ultrasonic counterparts. While ultrasonic cleaners are great for penetrating beyond visible surfaces, spray-flood cleaning machines provide strong liquid and detergent movement. And, because the parts are fixtures, held and rotated, the cleaning and rinsing processes are fast. This ensures excellent cleaning results, quickly.
Precision rotation cleaning machines use one wash chamber to house the entire process, meaning thorough cleans typically take 10 to 20 minutes. A comparable ultrasonic line would be slower than a rotation machine.
Compared to conventional cleaning processes, this technology offers the ability to apply different mechanical effects on the surface of components, such as:
- VAP (Vacuum Activated Purification)
- Multiple intermediate rinses
- Water treatment
- Water discarding
These processes result in almost endless process combinations (depending on the component geometry and cleanliness requirements), and improved cleanliness compared with historical methods.
Repeatability and documentation
As we mentioned earlier, the safety of medical instruments is paramount. During the manufacturing process, there must be proof of monitoring and control.
As medical instrument manufacturer MBengineering explains, precision rotation machines use “validated processes and permit a variety of applications”, meaning there can be documentation of the individual process parameters in manufacturing and reprocessing.
The automated and self-contained nature of spray-flood cleaning machines means increased repeatability compared to multiple basket systems or manual processes.
“It was important for us that all processes are compactly combined in one machine and run reliably. We can accommodate the entire cleaning process in the production run in a space-saving manner and react flexibly to changes.” Tobias Zepf, Gebrüder Zepf Medizintechnik
Compared to other options like a solvent cleaning machine formulated for specific alcohols, precision rotation cleaning machines offer greater cleaning flexibility. Every parameter can be chosen, including detergent.
Medical manufacturers can adapt to different component materials, geometries or component types, meaning they are prepared for any future changes to their processes.
For Thomas Gutman, Head of Customer Support at MAFAC, precision cleaning with rotation “offers a wealth of parameters with which the cleaning process can be individually adjusted to any requirement in a process-safe manner”.
With spray-flood machines, all processes are combined compactly into a single machine. This means:
- Fewer tanks
- Space savings
- Energy savings
Compared to ultrasonic systems that feature several individual tanks in a row, spray-flood machines offer a much smaller footprint.
How can MAFAC and Turbex help the medical industry?
A trusted partner
For those producing medical parts, a reliable partner who understands validation processes is a must.
MAFAC has a long track record in aqueous parts cleaning and considerable experience in both cleaning technologies, and the documentation of necessary process parameters.
While MAFAC offers a range of machines and options, each individual customer is offered personalised support and advice. It is just as crucial for MAFAC that customers reach a flawless, repeatable and reliable cleaning process.
If you’re interested in levelling up your medical manufacturing processes, speak to our expert team today about MAFAC spray-flood machines.
Turbex is the sole UK supplier of Mafac machines in the UK and Ireland.