Key Considerations in Laboratory Design: An Analytical Approach

Key Considerations in Laboratory Design: An Analytical Approach
by Randall Smith and Richard Crowley

Thereare several integrated factors that affect the quality of the analytical testingprocess for food and dietary supplement products and ingredients. From ascientific perspective, the expertise of the laboratory staff and quality of theinstrumentation are certainly of primary importance. From a regulatoryviewpoint, adherence to mandates such as Good Laboratory Practices (GLPs) arekey to compliance and the acceptability of the data.We also must not forgetmanagement expectations for a return on investment and customer demands thatplace a premium on efficiency and quick turnaround times without compromisingthe accuracy and integrity of the data. Although tools such as electronic delivery of data areinvaluable in attaining these goals, what is sometimes overlooked is that all ofthese factors are significantly impacted by the physical design of thelaboratory and the processes it promotes. Regardless of whether you aredesigning a new laboratory or modifying an existing facility, the interaction ofall these factors and their impact on what is critical to success must beconsidered.

Starting from Scratch

With purpose-built laboratory space you have the luxury ofstarting with a blank slate and can take full advantage of engineering the spaceto achieve the ideal relationships between staff, equipment and space. Thisexercise starts with the development of a high-level sample flow process map(Figure 1), identifying the primary steps in the testing pathway of a typicalsample. Staff input is an invaluable factor in laboratory design. Althoughstandard operating procedures (SOPs) define the testing process, the nuancesused by experienced scientists and technicians to facilitate accurate andefficient assays should be captured and taken into consideration in the planningprocess. Another valuable exercise is the use of time of motion studies to helpdetermine the distance traveled by analysts as a sample progresses through thetesting process. This will allow an evaluation of the needed coordinationbetween functional areas (e.g., sample preparation, vitamin chemistry) and theirlocations potential effect on the efficiency and accuracy of the testingprocess. With this information in hand, a basic concept of the floordesign based on the actual sample flow and data collection procedures can bedeveloped.

After establishing the basic flow, a number of other factorsand relationships must be evaluated, including sample volume, staffing numbersand myriad support systems issues. Capacity is based not only on historical numbers, butconsiderations for future expansions and modifications based upon projectedbusiness plans and customer expectations for growth. The development of capacitymodels is used to determine not only space, but number of instruments, storagerequirements, and mechanical support issues such as glassware washing, fumehoods, network connections and piping of gas for instrumentation.

Several tools can aid in the brainstorming and development ofideas. Certainly the development of a more detailed functional process map thatfurther breaks down the basic flow chart into more specific steps and phasesshould be generated at some point. The level of minutia included in the diagramis highly dependent on the size and complexity of the operation and theknowledge base of those involved in the planning.For example, a breakdown ofvitamin analysis into extraction, separation and quantification may besufficient for some projects, whereas more specific assay information could beappropriate for other situations.

By using rudimentary CAD floor plans, a puzzle approach involving model activity blocks sized to capacity scale(Figure 2) can be employed to better visualize workflow. Although this may bereminiscent of childrens building blocks and appear to be a simplisticapproach, this tool can be very valuable in the brainstorming stage to exploremany possibilities for test sample flow and staff accessibility. In addition, if the laboratory is a stand-alone facility,space for administrative offices, technology hubs and platforms, and even acafeteria must be included.

Throughout this process, representatives of the design firmmust be involved to provide increasingly detailed versions of floor plans. This will encourage the discussion about features that couldpotentially increase the efficiency of the system. An open/generic concept isbest and most adaptable for future modifications. In addition open technicianareas within a reasonable proximity to work area facilitate staff interactionand open communication.

Making Modifications

Although sample flow is still a vital consideration, physicaland budgetary impediments might limit the flexibility to completely modifylaboratory space. Redesigning existing facilities is more than purchasing newfurniture and requires a step back to get the view from 50,000 feet. Whenlooking at modifying and updating operations, you must evaluate the entiresystem including staff, equipment, procedures and space to identify factors thatare critical to success. These are the components of the process that make theoperation successful. Like the purpose-built process, a good place to start isto generate a process map that identifies all the steps in the sample handlingand testing process. However, in modifying existing space, the prioritization ofthe issues that are identified as critical to success is essential.

Factors that are critical to success include:

Identify one or two of the critical success factors upon whichto set thedirection of the renovation.For example, in a laboratory setting, the mostcritical factors may not be cost and pricing, but be identified as error-free,accurate data. A further breakdown shows that well-trained and motivated staffis the key component in attaining this goal. Although education and experience are certainly a primaryfactor in maintaining an expert staff, other less obvious factors such as quietwork areas, easy access to computers, and proximity to supervisory and seniorscientific staff are essential for success. At a lower level, access to samplesand support areas such as sample preparation must also be a consideration.Regardless of the factors identified as most critical for success, design andre-engineer the operation based on priorities and customer expectations.

Innovation, Automation Upgrade Labs

Electronic data systems have revolutionized the scientificlaboratory. Tracking of samples, data collection, review and reporting are nowall done using automated systems. Computer systems must be a key component ofplanning. Data ports for network access should be spread liberally to providelinks to the laboratory information management system (LIMS) as well as to datacollection and storage systems. Wherever possible, common terminals should beused. With todays powerful systems, multiple instruments can be controlledfrom a common workstation that can reduce the number of acquisition devices andsimplifies the back-up process.Workstations housed in non-laboratory areas canpreserve precious space and increase efficiency and worker satisfaction.

There are several solutions to conserving space and promotingaccuracy. The use of racking systems and dedicated instrument rooms allows areduction of the clutter on lab counters and frees up bench space for moreefficient wet chemistry assays and extraction processes. Wherever possible,dedicated equipment should be employed for both scientific and economic reasons.One of the primary causes of assay variability is the setup of theinstrumentation. By designating space for specific assays, problems associatedwith instrument setup can be drastically reduced. In addition, moving aninstrument is time consuming and affects not only the bottom line but schedulesas well.

Look for centralization of chemicals, glassware washingfacilities and storage to reduce costs. Innovative approaches such as the use ofoff-shifting can dilute fixed costs and ease technician congestion. Adequate and comfortable space for staff is essential foremployee morale and to facilitate effective supervisory span-of-control. Otherstaffing considerations include the number of supervisory personnel andcorresponding office space. Many organizations have found that a headcount ofseven to 11 employees per manager is ideal. However this is dependent on theamount of technical or non-supervisory obligations.

Certainly there are a plethora of other financial and businessexercises involved in the due diligence process and construction of ananalytical facility. However, taking the time to thoroughly understand andevaluate sample volume and flow allows the modeling of different alternativesand ensures functional areas are balanced to best fit. In order toincrease efficiency and accuracy of testing programs, scientific methods arecontinually evolving. It is important that laboratory design and sample flow aresimilarly dynamic and play an integral role in maintaining accuracy as well aspromoting efficiency in the laboratory.

Randall Smith and Richard Crowley are with CovanceLaboratories, a full-service analytical laboratory serving the dietarysupplement and functional food industries. For more information, visitwww.covance.com/analytical.

Analytical Labs Facing Challenges

The work doneby an analytical laboratory provides the foundation for regulatory and legalcompliance on nutritional and microbial requirements, as well as the basis formarketing and health claims. Emerging issues of food safety and product credibility posemany challenges to the analytical chemist and quality-control staff responsiblefor ensuring accuracy and reliability of data.

To learn more about meeting consumer demands and regulatoryrequirements in todays marketplace, more than 80 professionals from thescientific and business sides of food and dietary supplement companies attendeda special regulatory and scientific symposium sponsored by Covance Laboratoriesand the University of Wisconsin Food Research Institute, Madison.

Sessions covered such topics as new analytical methods forantioxidant activity, lutein and contaminants; performance evaluation of testingmethodology; and implementation of Six-Sigma to ensure quality in a business. Inaddition, speakers addressed issues concerning proposed GMPs (good manufacturingpractices) for dietary supplements and the impact of Codex on the supplementindustry.

In response to questions on Codex and differing internationalregulations, Jim Roza, vice president of business development, technology andsciences with SourceOne Global Partners, said: One advantage Codex will have for companies that produceproducts and sell them overseas, it kind of levels the playing field. ... We can adhere to one standard and gain access to all thesecountries. It has been beneficial in that respect.

Panelists further addressed marketplace drivers for laboratoryneeds in the future. David Morrison, vice president of scientific and regulatoryaffairs at The Vitamin Shoppe, spoke about the need to build consumer confidencein a products quality and efficacy through testing and establishing thescience base behind ingredients. He added that effective strategies for assuringquality to consumers include company brands and branded ingredients.

Roza also identified market drivers for functional foods asease of compliance and convenience for consumers who might need to take manytablets or capsules of a supplement to get the same amount in a serving of afood; existing and new health claims that herald the good science behind theproduct; and the value-added aspectsflavormasking, increased bioavailabilityand improved flavor.

Putting the work of laboratories in perspective, DarrylSullivan, Covances senior manager, food and drug analysis, said there aremany similarities in the testing needs of supplements and functional foods. Headded that todays consumers are more informed and good companies need toinform them on product safety and the quality testing that supports it. Heconcluded: The scientific community, I think, has a huge responsibility inthis effort moving forward. It is incumbent on us to make sure that we have goodscience and that we have very, very good methodology to conduct these testswith.

Reporting contributed by AngelaMiraglio