Laboratory automation

Computer Automated Laboratory System/ Environmental Waste Database System... 

The question that arises next is how automated laboratory methods can be applied in and/or should be adapted to plant control. In principle those methods can be devoted to this role191 193 provided that some additional field effects (see Table 5.1) are taken into account, viz., special sampling and measuring requirements we shall confine ourselves to these aspects and not consider extra safety measures against hazards such as contact explosions in plants. 

Laboratory automation has traditionally meant laboratory instrument automation. While the automated collection and analysis of data from laboratory instruments is still a significant part of laboratory automation, in the modern automated laboratory it is only a part of a larger perspective with the focus on task automation. Simply stated, the goal should be to automate tasks, not instruments. 

The RC1 is an automated laboratory batch/semi-batch reactor for calorimetric studies which has proven precision. The calorimetric principle used and the physical design of the system are sound. The application of the RC1 extends from process safety assessments including calorimetric measurements, to chemical research, to process development, and to optimization. The ability of the RC1 to generate accurate and reproducible data under simulated plant scale operating conditions may result in considerably reduced testing time and fewer small scale pilot plant runs. 

Beckman Robotic Biomek 1000 automated laboratory The Biomek 1000 integrates the work formerly done by four instruments sample preparation system, diluter/dispenser, plate washer and a spectrometer finish. In can handle assays such as radio-immunoassays (RIA), fluorescence immunoassays (FIA), enzyme immunoassays EIA and enzyme-linked immunoassays (ELISA). 

Since the introduction of the first fully automated laboratory-based mercury analysers in 1989, a number of other systems have been introduced. Around 20 different systems are available with varying levels of performance, and many claim to measure mercury at low levels. The analyst can therefore be forgiven if the determination of mercury is considered a trivial problem. Despite the various claims, the determination of low levels of mercury... 

Particular attention is appropriately paid immediately following a system failure or problem. There is concern that improperly close files may result in corruption of existing data, or in misaUocation of newly entered data. Most automated laboratory equipment and systems have built-in operational checks and tests to guard against problems. This requirement calls for confirmation of the existence or IQ/OQ features and for the creation of supplemental checks when automated diagnostics are inadequate or absent. 

The goal of Part 11 is to assure the same level of control in a fully automated laboratory (or other) environment. 

With these four strategies comphance with Part 11 can be cost-effectively integrated into the management of any automated laboratory, and while primary consideration must be paid to compliance with requirements and to adding safety controls as necessary beyond those requirements, cost-effectiveness can appropriately be utdized as a third-level criterion in laboratory system selection, design, and management. 

The requirements of 21 CFR Part 11 apply well beyond the laboratory environment, but do stand as supplemental to and interpretative of the GLP in automated laboratory environments. Comphance requires an understanding of the key elements of the Part 11 document, and the formulation of a strategy that assures safety, regulatory acceptance, and cost-effective management. 

The essential objective behind most data management is control. As such, it is the EPA s ultimate issue in extending its GLP requirements to automated laboratories through the GALPs. The effectiveness of an automated laboratory cannot be assured unless the use and design of the automated systems in that laboratory are consistent with standards intended to assure system control. 

These basic GALP principles have led to the development of a list of specific requirements that provide an appropriate template for effective management and operations of an automated laboratory. 

An automated laboratory requires written SOPs to demonstrate adequate control over automated data collection systems. The minimum SOP topics are... 

Complete, accurate, appropriate, and available documentation is a necessity for automated laboratory operations. 

While the GALPs apply only to the EPA laboratories, and specifically only to EPA contract labs, they provide importance guidance for the manager of any automated regulated lab. Coupled with the specifications of 21 CFR Part 11 the GALPs can serve as important interpretive material in applying the content and principles of the GLPs to the realities of the modern automated laboratory. 

The result of this combination of history, reahty, and attitude is a general regulatory dismissal of any presumption of system control. The default situation, the unproven norm expectation, is that a system is not adequately controlled. Until firm evidence of that control is provided, an automated laboratory is considered to be without appropriate controls, and both the management and the data of that laboratory are suspect. The GALPs define the controls that are appropriate, and the validation portion of those GALPs define the proof that is necessary to estabhsh comphance. 

Validation estabhshes the credibility of laboratory data and automated procedures. Without a credible validation review it is certainly possible to foUow the GALP guidelines or equivalent industry consensus vahdation provides the proof that those guidehnes are incorporated in daily and ongoing activities. TTie GALPs serve two important proposes they es-tabhsh the agenda for managing an automated laboratory... 

As a result, vahdation represents a prudent, cost-effective, and efficient way of assuring regulatory acceptance as well as internal control of automated laboratories and the system upon which they rely. 

NASA has designed and contracted a water testing, purification, and retest (certification) system that is a self-contained unit about the size of a small automobile. Human involvement is restricted to putting hose A into a puddle, polluted stream, saltwater bay, or almost any other liquid source, and to drinking pure water from liose B. The fully automated laboratory (and processing) system is intended for an eventual Mars base. It is currently used on navy ships and some desert warfare army units. 

Six general predictions have been derived from expectations in the changing world of automation, laboratory function, and regulation. 

Automated Laboratory Standards Current Automated Laboratory Data Management Practices, Final. June 1990. 

Automated Laboratory Standards Evaluation of the Standards and Procedures Used in Automated Clinical Laboratories, Draft. May 1990. 

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