LII:Elements of Laboratory Technology Management - Revision history

Shawndouglas: Year clarification

2024-06-19T18:49:30Z

Year clarification

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	'''License for content''': [https://creativecommons.org/licenses/by/4.0/ Creative Commons Attribution 4.0 International]		'''License for content''': [https://creativecommons.org/licenses/by/4.0/ Creative Commons Attribution 4.0 International]

	'''Publication date''': 2014		'''Publication date''': Originally published 2014; republished here February 2021

	==Introduction==		==Introduction==

Shawndouglas: Text replacement - "\[\[Accelrys, Inc.(.*)" to "[[Vendor:Accelrys, Inc.$1"

2024-03-29T16:17:45Z

Text replacement - "\[\[Accelrys, Inc.(.*)" to "[[Vendor:Accelrys, Inc.$1"

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	At the time of this writing, there is no standardized definition of an ELN, though a forthcoming update of [[ASTM E1578]] intends to rectify that. However, given the current hype about ELNs, any product with that designation is going to get noticed. Let’s avoid the term and replace it with a set of software types that addresses similar functionality:		At the time of this writing, there is no standardized definition of an ELN, though a forthcoming update of [[ASTM E1578]] intends to rectify that. However, given the current hype about ELNs, any product with that designation is going to get noticed. Let’s avoid the term and replace it with a set of software types that addresses similar functionality:

	1. Scripted execution systems – These are software systems that guide an analyst in the conduct of a procedure (process); examples include Velquest (now owned by [[Accelrys, Inc.\|Accelrys]]) products and the scripting notebook function (vendor's description) in [[Vendor:LabWare, Inc.\|LabWare LIMS]].		1. Scripted execution systems – These are software systems that guide an analyst in the conduct of a procedure (process); examples include Velquest (now owned by [[Vendor:Accelrys, Inc.\|Accelrys]]) products and the scripting notebook function (vendor's description) in [[Vendor:LabWare, Inc.\|LabWare LIMS]].

	2. Journal or diary system - These are software systems that provide a record of laboratory work; a word processing system might fill this need, although there are products with features specifically designed to assist lab work.		2. Journal or diary system - These are software systems that provide a record of laboratory work; a word processing system might fill this need, although there are products with features specifically designed to assist lab work.

Shawndouglas: Text replacement - "\[\[PerkinElmer Inc.(.*)" to "[[Vendor:PerkinElmer Inc.$1"

2024-03-28T01:40:42Z

Text replacement - "\[\[PerkinElmer Inc.(.*)" to "[[Vendor:PerkinElmer Inc.$1"

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	Mercury switches and timers triggered by cams on a rotating shaft provided chromatographs with the ability to automatically take [[Sample (material)\|samples]], actuate back flush valves, and take care of other functions without operator intervention. This left the analyst with the task of measuring peaks, developing calibration curves, and performing calculations, at least until data systems became available.		Mercury switches and timers triggered by cams on a rotating shaft provided chromatographs with the ability to automatically take [[Sample (material)\|samples]], actuate back flush valves, and take care of other functions without operator intervention. This left the analyst with the task of measuring peaks, developing calibration curves, and performing calculations, at least until data systems became available.

	The direction of laboratory automation changed significantly when computer chips became available. In the 1960s, companies such as [[PerkinElmer Inc.\|PerkinElmer]] were experimenting with the use of computer systems for data acquisition as precursors to commercial products. The availability of general-purpose computers such as the PDP-8 and PDP-12 series (along with the Lab 8e) from Digital Equipment, with other models available from other vendors, made it possible for researchers to connect their instruments to computers and carry out experiments. The development of microprocessors from Intel (4004, 8008) led to the evolution of “intelligent” laboratory equipment ranging from processor-controlled stirring hot-plates to chromatographic integrators.		The direction of laboratory automation changed significantly when computer chips became available. In the 1960s, companies such as [[Vendor:PerkinElmer Inc.\|PerkinElmer]] were experimenting with the use of computer systems for data acquisition as precursors to commercial products. The availability of general-purpose computers such as the PDP-8 and PDP-12 series (along with the Lab 8e) from Digital Equipment, with other models available from other vendors, made it possible for researchers to connect their instruments to computers and carry out experiments. The development of microprocessors from Intel (4004, 8008) led to the evolution of “intelligent” laboratory equipment ranging from processor-controlled stirring hot-plates to chromatographic integrators.

	As researchers learned to use these systems, their application rapidly progressed from data acquisition to interactive control of the experiments, including data storage, analysis, and reporting. Today, the product set available for laboratory applications includes data acquisition systems, [[laboratory information management system]]s (LIMS), [[electronic laboratory notebook]]s (ELNs), laboratory robotics, and specialized components to help researchers, scientists, and technicians apply modern technologies to their work.		As researchers learned to use these systems, their application rapidly progressed from data acquisition to interactive control of the experiments, including data storage, analysis, and reporting. Today, the product set available for laboratory applications includes data acquisition systems, [[laboratory information management system]]s (LIMS), [[electronic laboratory notebook]]s (ELNs), laboratory robotics, and specialized components to help researchers, scientists, and technicians apply modern technologies to their work.

Shawndouglas: Text replacement - "LabWare LIMS" to "LabWare LIMS"

2024-03-28T00:32:14Z

Text replacement - "LabWare LIMS" to "LabWare LIMS"

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	At the time of this writing, there is no standardized definition of an ELN, though a forthcoming update of [[ASTM E1578]] intends to rectify that. However, given the current hype about ELNs, any product with that designation is going to get noticed. Let’s avoid the term and replace it with a set of software types that addresses similar functionality:		At the time of this writing, there is no standardized definition of an ELN, though a forthcoming update of [[ASTM E1578]] intends to rectify that. However, given the current hype about ELNs, any product with that designation is going to get noticed. Let’s avoid the term and replace it with a set of software types that addresses similar functionality:

	1. Scripted execution systems – These are software systems that guide an analyst in the conduct of a procedure (process); examples include Velquest (now owned by [[Accelrys, Inc.\|Accelrys]]) products and the scripting notebook function (vendor's description) in [[LabWare, Inc.\|LabWare LIMS]].		1. Scripted execution systems – These are software systems that guide an analyst in the conduct of a procedure (process); examples include Velquest (now owned by [[Accelrys, Inc.\|Accelrys]]) products and the scripting notebook function (vendor's description) in [[Vendor:LabWare, Inc.\|LabWare LIMS]].

	2. Journal or diary system - These are software systems that provide a record of laboratory work; a word processing system might fill this need, although there are products with features specifically designed to assist lab work.		2. Journal or diary system - These are software systems that provide a record of laboratory work; a word processing system might fill this need, although there are products with features specifically designed to assist lab work.

Shawndouglas: /* Why "process" is important */ Fix

2023-11-18T00:09:58Z

Why "process" is important: Fix

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	At the time of this writing, there is no standardized definition of an ELN, though a forthcoming update of [[ASTM E1578]] intends to rectify that. However, given the current hype about ELNs, any product with that designation is going to get noticed. Let’s avoid the term and replace it with a set of software types that addresses similar functionality:		At the time of this writing, there is no standardized definition of an ELN, though a forthcoming update of [[ASTM E1578]] intends to rectify that. However, given the current hype about ELNs, any product with that designation is going to get noticed. Let’s avoid the term and replace it with a set of software types that addresses similar functionality:

	1. Scripted execution systems – These are software systems that guide an analyst in the conduct of a procedure (process); examples include Velquest (now owned by [[Accelrys, Inc.\|Accelrys]]) products and the scripting notebook function (vendor's description) in [LabWare, Inc.\|LabWare LIMS]].		1. Scripted execution systems – These are software systems that guide an analyst in the conduct of a procedure (process); examples include Velquest (now owned by [[Accelrys, Inc.\|Accelrys]]) products and the scripting notebook function (vendor's description) in [[LabWare, Inc.\|LabWare LIMS]].

	2. Journal or diary system - These are software systems that provide a record of laboratory work; a word processing system might fill this need, although there are products with features specifically designed to assist lab work.		2. Journal or diary system - These are software systems that provide a record of laboratory work; a word processing system might fill this need, although there are products with features specifically designed to assist lab work.

Shawndouglas: Cats

2022-02-09T19:39:42Z

Cats

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	==References==		==References==
	{{Reflist\|colwidth=30em}}		{{Reflist\|colwidth=30em}}

			<!---Place all category tags here-->
			[[Category:LII:Guides, white papers, and other publications]]

Shawndouglas: /* Abbreviations, acronyms, and initialism */

2021-02-18T19:23:35Z

Abbreviations, acronyms, and initialism

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	==Abbreviations, acronyms, and ~~initialism~~==		==Abbreviations, acronyms, and initialisms==

	'''AIA''': Analytical Instrument Association		'''AIA''': Analytical Instrument Association

Shawndouglas: /* Abbreviations */

2021-02-18T19:22:10Z

Abbreviations

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	==Abbreviations==		==Abbreviations, acronyms, and initialism==

	'''AIA''': Analytical Instrument Association		'''AIA''': Analytical Instrument Association

Shawndouglas: Finished adding rest of content.

2021-02-18T18:40:32Z

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Shawndouglas: Saving and adding more.

2021-02-18T16:40:48Z

Saving and adding more.

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	'''Stage 4: Production-level automation (scientific manufacturing and production)'''		'''Stage 4: Production-level automation (scientific manufacturing and production)'''

			Depending on what is necessary for sample preparation, it may not be much of a stretch to have automated sample prep, injection, data collection, analysis, and reporting (with automated updates into a LIMS) performed in a small footprint with equipment available today. One vendor has an auto-injection system that is capable of dissolving material, performing extractions, mixing, and barcode reading, as well as other functions. Connect that to a chromatograph and data station, with programmed connection to a LIMS, and you have the basis of an automated sample preparation–chromatographic system. However, there are some issues that have to be noted and addressed.

			The goal with such a system has to be high-volume, automated sample processing with the generation of high-quality data. The intent is to reduce the amount of work the analyst has to perform, ideally so that the system can run unattended. Note that “high-quality” in this case means to have a high level of confidence in the results. There is more to that than the ability to do calculations for quantitative analysis or having a validated system; you have to validate the right system.

			Computer systems used in chromatographic analysis can be tuned to control how peaks are detected, what is rejected as noise, and how separations are identified so that baselines can be properly drawn and peak areas allocated. The analyst needs to evaluate the impact of these parameters for each analytical procedure and make sure that the proper settings are used.

			As previously noted regarding manual processes, the inspection of the chromatogram for elements that don’t match the expectations for a well-characterized sample (the number of peaks that should be there, the type of separations between peaks, etc.) is vital. This screening of samples has to be applied to every sample whether by human eye or automated system, the latter giving lower labor costs and higher productivity. If we are going to build fully automated production systems, we have to be able to describe a screening template that is applied to every sample to either confirm that the sample fits the standard criteria or has to be noted for further evaluation. That “further evaluation” may be frustrated by not having the data system keep sufficient data for that evaluation, and require rerunning the sample.

			The data acquired by the computer system undergoes several levels of filtering and processing before you see the final results. The sampling algorithms don’t give us the level of detail in the analog chromatogram. The visual display of a chromatogram is going to be limited by the data collected and the resolution of the display. The stair-stepping of a digitized chromatogram is an example of that, while an analog chromatogram is a smooth line. Small details and anomalies that could be evidence of contamination may be missed because of the processing.

			Additionally, the entire process needs to be continually monitored and evaluated to make sure that it is working properly. This is process-level statistical quality control, and it includes options for evolutionary operations updates, small changes to improve process performance. Standard samples have to be run to test the system. If screening templates are used, samples designed to exhibit problems have to be run to trigger those templates to make sure that problem samples are detected. These in-process checks have to include every phase of the process and be able to evaluate all potential risks. The intent is to build confidence in the data by building confidence in the system used to produce it.

			The goals of higher productivity can be achieved for sample processing, but in doing so, the work of the analyst will change from carrying out a procedure to managing and continuously tuning a system that is doing the work for them. The science has to be well-understood, as does the implementation of that science. As we shift to more automation, and use analytical techniques to monitor in-process production systems, more emphasis has to be placed on characterizing all the assumptions and possible failure points of the technique and building in tests to ensure that the data being used to evaluate and control a production process is sound.

			During the development of the process described above, the analyst has to first determine the sequence of steps, demonstrate that they work as expected, and prepare the documentation needed to support the process and guide someone through it’s execution. This includes the details of how the autosampler programming is developed, stored, and maintained. The same holds true for the data systems parameters, screening templates, and processing routines. This is process engineering. Then, when the system is being used, the analyst has to ensure that the proper programming is loaded into each component and that it is set up and ready for use.

			This is a very simple example of what is possible and an illustration of the changes that could occur in the work of lab professionals. The performance of a system such as that described could be doubled by implementing a second process stream without significantly increasing the analyst workload.

			The key element is the skill level of those working in the lab (Figure 20): are they capable of meeting the challenge? Much of what has been described is process engineering, and there are people in manufacturing and production who are good at that. We need to combine process engineering skills with the science. Developing automation teams is one approach, but no matter how you address the idea, those working in labs need an additional layer of skills, beyond what they have been exposed to in formal education settings.


			[[File:Fig20 Liscouski ElementsLabTechMan14.png\|700px]]
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			{\| border="0" cellpadding="5" cellspacing="0" width="700px"
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			\| style="background-color:white; padding-left:10px; padding-right:10px;"\| <blockquote>'''Figure 20.''' The skills and education required at the various stages of the lab-based scientific manufacturing and production process</blockquote>
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			\|}
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			Of the sciences, clinical chemistry has moved the furthest into the advanced application of laboratory automation in the lab (Figure 20), transforming lab work in the process, moving from lab staff executing procedures manually to managing systems. The following quote from Diana Mass of Associated Laboratory Consultants {{Efn\|Formerly Professor and Director of Clinical Laboratory Sciences Program, Arizona State University. Quote from private communications, used with permission.}} helps delineate the difference in lab work styles:

			<blockquote>What I have observed is that automation has replaced some of the routine repetitive steps in performing analysis; however, the individual has to be even more knowledgeable to troubleshoot sophisticated instrumentation. Even if the equipment is simple to operate, the person has to know how to evaluate quality control results and have a quality assurance system in place to ensure quality test information.</blockquote>

			And here's a quote from Martha Casassa, Laboratory Director of Braintree Rehabilitation Hospital{{Efn\|Also from private communications, used with permission.}}, who has experience in both clinical and non-clinical labs:

			<blockquote>Having a background both clinical (as a medical technologist) and non-clinical (chemistry major and managing a non-clinical research lab), I can attest to the training/education being different. I was much more prepared coming through the clinical experience to handle automation and computers and the subsequent troubleshooting and repair necessary as well as the maintenance and upkeep of the systems. During my non-clinical training the emphasis was not so much on theory as practical application in manual methods. I learned assays on some automated equipment, but that education was more to obtain an end-product than to really understand the system and how it produced that product. On the clinical side I learned not only how to get the end-product, but the way it was produced so I could identify issues sooner, produce quality results, and more effectively troubleshoot.</blockquote>