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Automation in Regulated Labs

Automation in Regulated Labs

When deciding whether automation will benefit your lab operations, there are several things to consider

Gina Hagler

Most labs are subject to guidelines and requirements of one sort or another, including ISO standards for non-regulated labs. Because many organizations issue regulations and oversee compliance in regulated labs, different types of labs have requirements that vary in the particulars, if not the intent. Nonclinical laboratories are subject to Good Laboratory Practice under Part 58 of Title 21 of the Code of Federal Regulations. The Centers for Medicare & Medicaid Services regulate all non-research testing performed on humans in the US through the Clinical Laboratory Improvement Amendments. Contract research organizations (CROs) require strict adherence to regulations because they not only take on the regulatory responsibilities of their sponsors but are subject to comprehensive audits by not only their sponsors, but the FDA and other regulatory bodies as well.

The automation of repetitive or highly-specialized work may be a way to remain in compliance while improving efficiency, and even the bottom line. Still, when deciding whether automation will benefit your lab operations, there are several things to consider:

1. Which processes in your lab would you automate?

In general, it makes sense to automate the work that is most repetitive and routine. Because of that, pipetting systems make a good starting point. Electronic pipettes produce accurate results with less reliance on individual technique, while multichannel pipettes make it possible to transfer samples to plates in less time reliably. The more high-tech version of electronic pipettes is an automated liquid handling mechanism that can be configured as an automated pipette with a robotic arm with a small footprint. For some systems, the arms are available from a variety of manufacturers. With others, the arm is part of the system, but the consumables can be purchased from any manufacturer.

Processes that are time consuming and demand precision, even if performed less often, are another good choice for automation. DNA sequencing is one such process. The available automation options cover the most basic to more complex operations. For large laboratories, the use of such automation may make even more sense. For complicated, interrelated processes with many discrete steps, automation through the use of robots can be used to create an elaborate system. In this system, materials pass from station to station for tasks that are performed by the robotic arms as instructed through the operating software. In such systems, when a task is completed, the resulting materials are conveyed along a track to the next station. The entire operation can be done without physical interaction by lab personnel once the process begins.

2. Is the equipment you want in compliance?

It’s easy to get caught up in the possibilities of automation, especially with so many choices promising so much in the way of efficiency and accuracy. Identifying the automated product or process and checking to see if the equipment states that it is in compliance with your regulations is an important reality check that will narrow your plan to one that’s feasible. If you are purchasing the equipment from a party other than the original vendor, or if there is a question of the equipment being in compliance, performing a validity check will be necessary. This check can be performed in advance of purchase and to your specifications. If, ultimately, the equipment you’d like is not in compliance, alternatives may exist.

3. How will you adapt to the changes that the use of automation will create in the current operating environment?

Looking ahead and preparing your team in advance for the changes that come with automation will go a long way to a smooth transition. Discuss the parts of existing processes that will be impacted. Decide on the reports that will be needed to keep any multi-step processes on track. If the person directing the process on an automated part of the system will not be in the same location as the equipment, determine the plan for interacting with that person. Taking the time to get feedback about which processes to automate, where to place the equipment, and potential pitfalls envisioned by the people in your lab will help you to bring automation into the lab as a positive development.

4. What costs and benefits are associated with this automation?

The cost of automation is more than just the cost of the equipment. There will likely be training, maintenance, and materials specific to the equipment. It may be necessary to make a change to the current configuration of the lab and you may need to install new ductwork, piping, electric feeds, or other dedicated fixtures. Placement of the equipment in a location that does not disrupt the workflow, but instead enhances it, may also require some creative thinking and adjustments. The goal is to reap the benefits of automation through greater ease for maintaining compliance, greater efficiency in the work performed, a reduced margin of error, and savings in morale or dollars.

5. Will the benefits outweigh the costs over the life of the project or the equipment?

Meeting the operating budget is essential, but the cost/benefit consideration is about more than the cost of the automated equipment. How well will this new equipment interface with your existing equipment? If there will be a work-around by IT to “make the system work,” you’ll need to add that to the cost. You will also need to consider the life of the technology (automation) and that piece of equipment. Is this the newest technology on the market? Will equipment from the generation before meet your needs? What’s on the horizon? Could you purchase used equipment? Depending upon what you learn, it may make it easier to decide if now is the time to act.

Once you are certain the equipment has a useful life and price point that is realistic, it’s time to consider whether this expenditure will compromise your ability to meet necessary outlays such as payroll and fund expenses for materials and other projects. A machine may be perfect for the automation you have in mind, and it may not cost “that much” relative to other options. However, unless there is a tangible benefit from that purchase during the life of the project it is intended for, there is no reason to make the expenditure. You could see how this purchase would play against other purchases or savings that result from the purchase, perhaps in a different area, to determine if the purchase as part of a larger automation package results in a significant benefit.

Automation holds great promise for those required to remain in compliance with a set of regulations. The judicious use of automation can also free personnel to work on more intricate aspects of a project, attracting and retaining talented people in the process. It can improve results while reducing or eliminating some categories of error. Automation can also reduce costs, freeing funds for additional equipment and training that will help the lab remain in compliance.