The enclosure’s integral filter systems support processing under cleanroom conditions.

Lake Region Medical GmbH needed a cleaning process that causes no damage to the product while meeting stringent specifications on the removal of particulate, film-type, and microbiological contaminants.

Ultrasonic Cleaning Machines (UCM AG) of Switzerland responded with an ultrasonic fine-cleaning system that provides reliable cleaning of more than 1 million stainless steel turned parts and tubes per day, six days a week – with products being discharged directly into a good manufacturing process (GMP) Class D cleanroom.

Outsourcing cleaning

In 2013, a Lake Region Medical customer from the pharmaceutical/med-tech sector needed to expand cleaning capacity for stainless-steel turned parts and tubes. The company decided to outsource this operation to Lake Region Medical. Under the contract, the equipment required for this process had to achieve given levels of cleanliness – with limits on particulate, film-type, and antimicrobial contaminants – while also ensuring that the parts would emerge from the cleaning process undamaged. An additional challenge resided in the product geometry. The turned parts – measuring up to 10.0mm in diameter – have very fine drilled holes. The tube parts are up to 60.0mm long, with internal diameters of only 0.4mm, and must be consistently and reliably cleaned inside.

Performance, process, validation

To address the client’s requirements, Lake Region Medical invested in an ultrasonic fine cleaning system made by UCM AG, a member of the Dürr Ecoclean Group. The choice relied heavily on the supplier’s expertise in designing cleaning systems for medical technology applications. The cleaning system developed for Lake Medical Region provided the exacting cleanliness and throughput specifications and met the customer’s expectations regarding process stability and batch documentation.

“In generating the extensive and detailed documents needed to qualify and validate the system, UCM gave us tremendous support and achieved compatibility with existing installations,” notes Klaus Wisnewski, development engineer at Lake Region Medical.

High process reliability

The cleaning system has 13 stations designed for the individual process steps: loading, cleaning, and rinsing with ultrasound; hot air and vacuum drying with infrared support; and unloading. Cleaning and rinsing steps are performed with demineralized water – so a demineralized water treatment system adapted for this purpose was included in the system’s design. To accommodate cleanroom conditions, the system is fully enclosed and equipped with appropriate filtration systems and pressure monitoring.

Products are manually placed in special drums or baskets which are then automatically fed to the system. Parts are then cleaned in bulk or arranged in part carriers, depending on the type.

The cleaning system has 13 stations. All process sequences, parameters, and equipment functions are continuously monitored, logged, and documented.

“For part-specific cleaning, we defined various cleaning processes and stored them in the system’s controller,” Wisnewski notes.

Programs and part and batch information are entered from a bar code which also records the part container type and number. All program sequences, process parameters, and equipment functions are automatically monitored, including: condition of cleaning and rinsing fluids, automatic input of cleaning agent, individual timer settings, temperatures, ultrasound frequencies, and power. Upon completion of each batch, the process is analyzed with assessment of the cleaned parts via a process data tracking function. Additionally, data for each batch are recorded and archived in a document to ensure product traceability.

Upon program selection, the cleaning process executes automatically. Cleaning and rinsing fluids enter the tanks from below, move upwards, and exit by overflow on all sides. This four-sided overflow feature developed by UCM removes foreign matter from the product and immediately discharges it from each tank, avoiding re-contamination during parts unloading. This fluid management also prevents the formation of dirt pockets in the tanks and provides uniform treatment of bulk products.

Adding to the reliability and safety of the cleaning process are the medicinal tanks and the system’s special piping designed to combat germ formation. All process areas are automatically sanitized and disinfected at regular intervals by a program developed specifically for this purpose.

After drying, parts are conveyed into a GMP Class D cleanroom via an automatic airlock. Inside the cleanroom they are unloaded and packed, and a conveyor system returns the empty part containers and conveying racks to the loading end.

“The equipment is in operation around the clock, six days a week. We clean more than 1 million parts per day, and the result meets our exacting demands,” Wisnewski says.

Lake Region Medical officials have already ordered a second system of identical design from UCM.

UCM AG

www.ucm-ag.com

Dürr Ecoclean Group

www.durr-ecoclean.com

IMTS 2016 Booth #NC-276

Lake Region Medical GmbH

www.lakeregionmedical.com