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Gossman Consulting, Inc

GCI TECH NOTES©


Volume 4, Number 04                  A Gossman Consulting, Inc. Publication                    April, 1998


Analytical Laboratory Design and Development

Craig Cape

Gossman Consulting, Inc. (GCI) personnel have been designing and developing analytical laboratories for more than 18 years. From the beginning the emphasis has always been on determining the most practical and needs-oriented designs for the company or client for whom the designs have been done. Many factors go into the mix of design and development work. This Tech Notes will provide some brief guidelines that are important to the laboratory design and suggest areas that should be high priorities in the development phase.

The first step in the design process is to understand the purpose of the laboratory. A laboratory designed for typical commer-cial analysis of samples can be far different from a laboratory designed for meeting the needs of a process quality control lab, or an analytical research laboratory. All conduct analysis and may use some of the same instrumentation but it is at this very basic point that they begin to differ in purpose and, therefore, also need to differ in design.

The purpose of the commercial lab is to be a profit center unto itself. It does not create a product to sell per se, other than the analytical results that they produce for each sample they receive. Therefore, the number of samples worked on, along with the quality of the analytical results as normally directed by a regulatory frame-work, are of paramount importance to the typical commercial laboratory. Thus economies of scale must be realized and integrated into the design of such a laboratory.

The process quality control lab may use some of the same instrumentation as the commercial lab. However, the analytical information obtained is not an end product as in a commercial lab, but rather assistance and support in process quality control decision making. The analyst usually has other information and uses the lab analysis to confirm or support a process decision. Processes are normally continuous or ongoing, thus turnaround time of the analysis, along with quality of the analytical results as directed by the process parameters, are of critical importance to a typical process quality control laboratory.

A research lab differs in purpose from both of the previous two examples even though it may use some of the same instruments. The purpose is to originate or improve analytical methods or products. Neither sample number nor turnaround time are immediately critical factors to the design. The designs should provide for flexible lab space to setup and change experiments, to run parallel testing, and to provide access to large and varied reference materials. It also needs to provide for quality controls which may vary according to the stage of research, yet support reproducibility. Clearly the purpose has a major influence on the design of a laboratory.

Most of the laboratories that GCI has designed and/or developed have been a combination of the process quality control and commercial laboratory purpose. The laboratory designs were often based more on process quality control but because of regulatory analysis requirements and the number of samples coming into the labs, the designs contained features that follow a design for a commercial laboratory.

To examine the design and development, a checklist of items that GCI has used can be drafted which provides an oversight to this process. This checklist is generic in its content because each individual project would require a specific list based on the scope of activities to be performed by the laboratory.

#1 Of course the first item is defining the purpose of the laboratory. The need for this is briefly elaborated above. The following are key points in this item:

#2 The physical location of laboratory is an early important item. Is the laboratory going to be attached to or modified from an existing facility? Will it be located on an existing facility, a partner facility or on a separate site?

#3 Examining and determining the needs and use of analysis information was probably started with #1 while deciding on the purpose of the laboratory. Item #3 of the design/development process will describe some items that must be accounted for in providing for efficient flow of sample analysis and results. It would be normal for a lab analyzing for process quality control information to need to communicate some results to the decision-maker immediately or within minutes. In order to accomplish this, the sample prep area and key analytical instruments and equipment must be located close by and in efficient order. The analysis may require several different analytical steps to be performed to obtain the quick turnaround information needed. A commercial or research lab would not normally have this requirement. The commercial lab would more likely need to departmentalize the sample prep and various analysis areas so that economies of scale can be achieved while analyzing many samples at once. The research lab has need of neither arrangement but is clearly served by good organization of similar analytical instru-ment type. As an example of designing for specific needs, a checklist of items for a process quality control lab would have consideration for at least the key following points:

The above points to be considered are supported by some additional more detailed considerations for the actual physical plant of the laboratory, such as:

Some of these items are decided by ergonomics, some are economics, some are safety but how each one is configured into the design is critical to achieving efficient operations in the process quality control laboratory.

#4 This key item may seem to have less to do with the design of the physical plant of the laboratory than the actual operation. However, serious consideration should be made to lab staffing, not just staff numbers but also their functions. Some administrative functions require more space and electronic support than the actual lab. The following are key points for this item:

A good lab design will support the efforts of the lab staff in meeting analytical and economic goals and yet accommodate some flexibility. Practical work experience in labs of various designs with all of these issues and lab design experience will lead to a superior design. GCI recommends that if you are seeking to redesign your lab or design a new lab, that your design take into critical review most, if not all, of these items.