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All together now! a case study showing how standardizing pipette quality can offer economic and quality gains.

Large, multi-departmental laboratory organizations find it difficult to effectively allocate quality control responsibility. Although a centralized, top-down approach can simplify regulatory compliance, distributing responsibility for calibration to individual departments has distinct advantages. ARUP Laboratories (Salt Lake City, Utah, USA), a national clinical and anatomic pathology reference laboratory, recently decentralized pipette quality control across its departments to great success. Working closely with Artel (Westbrook, Maine, USA), a provider of liquid handling quality assurance technology, the lab implemented a standardized process for more than 1500 pipettes used in 71 departments. The ARTEL PCS Pipette Calibration System and its associated Artel Pipette Tracker software were used to facilitate this process. ARUP also formed an Artel Users Group, drawing representatives from participating departments to continually ensure that standardized protocols were implemented with input from the entire organization. By implementing rigorous quality standards, ARUP realized significant economic benefits by reducing the number of tests that had to be rerun owing to known or perceived pipetting errors, thus minimizing wasted time and materials.

Need for Quality

Based in the University of Utah Research Park in Salt Lake City, ARUP offers more than 2000 clinical tests and test combinations, ranging from routine screening tests to highly esoteric molecular and genetic assays. As with any medical laboratory, pipetting is a critical component of ARUP's operations. Regular pipette calibration has always been an important part of its quality control system. As many of the tests are extremely sensitive and results often determine patient diagnoses and treatment regimens, accurate and precise pipetting, particularly when working with low volumes, is crucial for the success of the laboratory.

The Drive to Decentralize Calibration

ARUP was an early adopter of the Pipette Calibration System (PCS) in its reagent production lab. As the organization grew, the reagent lab assumed responsibility for calibrating many of the pipettes used organization-wide. The reagent lab, however, often encountered a backlog of pipettes and experienced challenges when handling an uneven workflow. "As most departments specified quarterly calibration intervals, calibration requests would peak and overload the lab at the end of each quarter," said Jeff Howard, ARUP Quality Specialist. Another difficulty with this centralized approach was that, although the reagent lab did the actual calibration, each individual department was responsible for the cleaning, maintenance and calibration frequency of its pipettes, as well as setting pipette-specific tolerance limits.

As ARUP expanded and its pipette population grew, more challenges arose. There were discrepancies in the calibration procedures between different labs. Different tolerances, data requirements, naming conventions and standard operating procedures (SOPs) would often be associated with the same pipette model. Users of a pipette could set their own preferences, potentially leading to the same pipette being entered into the data tracking system two or three times. This duplication led to inefficiencies and hampered ARUP's ability to garner useful data from the pipette tracking system. To remedy these issues, ARUP decided to decentralize the pipette calibration function and install multiple PCS instruments throughout its facility, which allowed each functional department to assume responsibility for the calibration and maintenance of their own pipettes. "Artel's technology was critical in facilitating this changeover," added Howard. "It's enabled us to standardize pipette quality procedures across our entire organization."

[FIGURE 1 OMITTED]

Standardizing Pipette Calibration Protocols

To facilitate and oversee its decentralized approach, ARUP created an Artel Users Group, bringing together quality control staff from across the organization (lab technologists, quality specialists and group managers). The Users Group began by standardizing the calibration methodology, frequency and tolerance limits. For example, a particular pipette with a range of 20-200 [micro]L could have different calibration procedures associated with it based on the department in which it was used. Now, following Users Group standards, the policy is set: the pipette is calibrated quarterly at three volumes (20, 100 and 200 [micro]L) with defined tolerance limits for accuracy and precision. The group also helped to standardize how the data tracking system was used. Artel's Pipette Tracker software schedules calibrations, automates data collection during calibrations and produces the necessary documentation. It also enforces the calibration methodology and tracks who is responsible for calibrating specific pipettes. By standardizing calibration methodologies and procedures for each pipette, the group eliminated duplications and redundancies, reducing the data in the system by two thirds. The group also standardized how the system was used; each pipette now has a defined nomenclature, specific serial number and specified SOP. The group streamlined the entire quality process, making the management of calibration data more efficient. Howard noted: "By implementing standardized policies across the board, we were really able to speed up the entire system, making it more effective and productive in the long term."

[FIGURE 2 OMITTED]

Standardizing Pipetting Technique Training

One advantage of assigning calibration responsibility to the departments that use the pipettes was that it made ARUP more aware of the need to train users in proper pipetting technique. As the PCS provides immediate feedback on pipetting performance, ARUP could observe errors in accuracy and precision based on variability in technique. The organization decided to create a training programme to ensure that all pipette users were proficient in pipetting. To streamline this training process, the Users Group is designing an online tutorial in pipetting technique that will be mandatory for all technical staff. The tutorial combines information from Artel's Pipette Quality Management Certification seminar and the organization's own internal SOPs. ARUP also plans to implement a wet lab training class that will merge elements of Artel's training programme with extant best practices. All incoming technical staff will be required to learn about and practise proper technique and receive hands-on experience using the PCS. "Even for technical staff who don't use pipettes daily, undergoing this training significantly raises their awareness about the relationship between pipetting technique and quality," said Zachary Wilkey, Quality Specialist at ARUP. "That fits with the overall goal of the Artel Users Group to standardize our quality procedures throughout the organization and make quality a priority."

The Benefits of Quality

Rigorous quality procedures are the economic benefit associated with a high degree of accuracy and precision in liquid delivery operations. "The Users Group's emphasis on standardizing quality not only ensures data integrity, it also saves us money in the long term," said Howard. If pipettes are properly calibrated and operators are well trained in proper technique, there are fewer run failures. This minimizes material waste--such as expensive solvents and reagents--and saves time and labour allocated to rerunning tests. "Quality is a goal in its own right," said Howard, "but there is also a strong business case for

maintaining high standards. The Artel Users Group is executing that mission at ARUP." Pharma

RELATED ARTICLE: VISCOSITY: A VALUABLE CONTROL PARAMETER FOR MONITORING THE PROGRESS OF A REACTION

Viscosity, the resistance of a fluid to flow, is one of the great, unsung control parameters in very many processes. As the viscosity of a solution can generally be correlated directly with solute properties such as concentration and relative molar mass, monitoring the viscosity of a mixture of reagents provides an immediate window into the dynamics of the reaction.

Reliable lab- or pilot-scale instrumentation for continuous viscosity monitoring has only recently become a practical proposition. Traditional laboratory methods of viscosity measurement relied on taking samples, which was laborious, time-consuming and prone to error. Now, however, with the availability of research-grade online viscometers, such as the high-performance ReactaVisc RV3 from Hydramotion, it is easy to exploit the benefits of continuous viscosity measurement in the lab, as well as in the process plant.

Tracking polymerization reactions is an important application. Viscosity is highly indicative of the progress of such reactions, which can otherwise be difficult to monitor. As polymerization progresses, the relative molar mass of the polymer chain increases, causing the viscosity to rise. For example, in the course of an oxyalkylation polymerization, the viscosity of the mix builds from less than 1 cP to more than 500 cP as the reaction proceeds.

Conversely, in depolymerization reactions viscosity falls as polymer chain lengths are reduced. In a typical case, where strong acid is used to cleave polyethylene oxide adducts, viscosity falls from approximately 500 cP to 100 cP or less within a few minutes.

In either case, the end-point can be reached quite suddenly, but by continuously monitoring the viscosity of the reaction mixture it is possible to terminate the reaction at just the right moment, thereby avoiding the accumulation of unwanted by-products. This clearly improves quality control, reduces wastage and enhances the efficiency of the process.

For more information

Rob Simpson, Hydramotion Ltd

Tel. +44 1653 600 294

sales@hydramotion.com

www.hydramotion.com

For more information

Paula Puo

ABI Marketing Public Relations

Tel. +1 212 529 4500

ppou@abipr.com
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Title Annotation:ANALYTICAL & LABORATORY TECHNOLOGY
Author:Puo, Paula
Publication:Pharma
Geographic Code:1USA
Date:May 1, 2010
Words:1449
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