Operational qualification is important for most life science laboratories, especially those in the clinical and pharmaceutical markets, as it is used to prove that equipment performs within specifications and complies with regulations. Third-party validation of equipment performance also strengthens data integrity and facilitates compliance. Because liquid handling is a core component in laboratory processes, qualification of liquid handling devices is especially critical for data integrity. For these reasons, many Beckman Coulter customers opt into the company’s Field Service Operational Qualification program, including users of the Biomek® FXP, Biomek® NXP and Biomek® 3000 Laboratory Automation Workstations (liquid handling devices designed for drug discovery laboratories) and VidieraTM NsP (Nucleic Sample Preparation device geared for hospital and reference laboratories).
The purpose of Beckman Coulter’s on-site Operational Qualification level 3 (OQ3) program is to determine whether equipment is performing within manufacturer’s specifications, which are typically tighter than regulations require. OQ3 is the highest level of instrument qualification that Beckman Coulter offers.
In the OQ3 program, Beckman Coulter previously employed a photometric method to verify automated liquid handler performance, as determined per instrument for both ends of the volume spectrum. However, this technology only provided precision data. While it was useful to know that the instrument was performing consistently (i.e. precisely), there was no proof to confirm that the instrument was dispensing accurately.
In addition, this technology was problematic at low temperatures. If the bead-based solution froze, in transit for example, the beads would be physically altered after thawing, and this rendered the solution useless. Service technicians also had to manually record the results, lengthening the amount of time spent at customer facilities and increasing the propensity for error and doubt. All of these issues coupled with growing customer demand for data about the accuracy of their instruments led Beckman Coulter to source a new technology for its Operational Qualification program.
To satisfy customer demands for accuracy and precision data, and to provide stronger assurance of the integrity of results produced by its equipment, Beckman Coulter upgraded its Field Service Operational Qualification level 3 (OQ3) with the Artel MVS® Multichannel Verification System.
Based on proprietary Ratiometric Photometry, the MVS employs a dual-dye, dual-wavelength absorbance method for rapid, accurate and precise measurement of small target volumes. The MVS can also determine the volume delivered from each tip of the device being tested, and can interact with the complete range of Beckman Coulter’s automated liquid delivery devices, from 1-channel through 384-channel instruments.
With the MVS, Beckman Coulter’s OQ3 provides more information to customers for a full assessment of liquid delivery device performance, facilitating assay validation and method transfer. In addition, the automated documentation feature eliminates the time-consuming and error-prone step of manually recording results. The MVS measurement results are also traceable to international standards, allowing comparability of all Beckman Coulter devices regardless of model, location, or number of dispensing channels.
Since the implementation of the MVS, Beckman Coulter has seen an increase in positive feedback and the number of laboratories enrolled in the optional Operational Qualification Program. As Beckman Coulter continues its phased rollout of the new MVS-based Field Service Operational Qualification program and specifies accuracy requirements in the SOPs for a growing number of instruments, the demand for its services continues to expand. Because service representatives can more efficiently complete service visits and more accurately diagnose and solve issues, Beckman Coulter can meet this need and enhance customer satisfaction in its instrumentation.