Using a customised X-tra-Line cleaning system, Elma’s modular cleaning solution delivers cleaning results with <10 CFU.
Rainer Johe (Somi Medical) was looking for a solution to his cleaning needs. “We clean, assemble, sterilise and package a wide variety of medical devices on a daily basis,” he says.
“Due to the different and very complex geometries of the implants and instruments, we were looking for a cleaning system that is as flexible as possible.” Johe also adds that cleaning results must be “with <10 CFU (bioburden).”
Elma’s ultrasonic system not only fulfilled these strict cleanliness thresholds, but it also fitted seamlessly into Somi Medical’s existing manufacturing process. This was, as Johe explained, to ensure “continuous and high throughput of goods.”
How did Elma solve the problem?
Elma provided a closed X-tra-Line ultrasonic cleaning system to Somi Medical. This machine cleans, rinses and dries medical implants and instruments across six stations.
This solution is also automated: loading and unloading belts worked in unison with a transportation robot to ensure a seamless flow of goods through the system and the production process. The processes and transport sequence is also freely programmable depending on the cleaning task; this allows the system to work with a range of geometries.
How does the solution work?
With an integrated lifting and rotation system, baskets can be swivelled, lifted, lowered and rotated horizontally depending on the part’s geometry. This means that even the most minute blind holes, bores and undercuts can be targeted and cleaned effectively.
What’s more, the efficiency of the solution results in fewer media carry-over in subsequent baths, saving resources, water and energy.
Rinsing and drying:
Somi Medical cleans using Highly Purified Water (HPW) combined with Elma’s alkaline cleaner Medtech Clean A25 (medical class 1). Drying is completed without residue through hot air and vacuums.
Finally, the instruments are transported under laminar flow units for a final HPW rinse before being placed in the cleanroom – packaging and completion of the parts can then be carried out.
Quality assurance and support:
Elma’s system is fitted with AuditTrail software (FDA CFR 21 Part 11) to ensure a validated process; trained and licensed Somi Medical staff can then access process data directly.
RFID readers recognise each batch’s order data before the cleaning process. Elma data logger software then ensures that all data per batch and process is logged accurately. After the cleaning process has been completed, this data is made available for quality assurance.
This system is professionally maintained through Elma’s After Sales Service; spare parts packages are also provided. Elma’s factory can provide certification of the ultrasonic cleaning system. Regular system maintenance also offers the opportunity for the requalification of the machine’s ultrasonic performance.
To meet the requirements and applications specified by Somi Medical, the X-tra-Line ultraosnic cleaning system was assembled from Elma’s modular construction system. This includes the following features:
- Transportation of goods (including loading and unloading buffers)
- Automatic filling and refilling process chambers
- Feeding and re-dosing cleaner (through conductivity in the ultrasonic bath)
The individuality and high availability of the equipment ensure the X-tra-Line system stands out amongst the competition.
Turbex are the sole representative for sales & service of Elma products in the UK and Ireland.