LIS–lnterlink—connecting laboratory information systems to remote primary health–care centres via the Internet

A pilot study was performed to evaluate the feasibility of using the Internet to securely deliver patient laboratory results, and the system has subsequently gone into routine use in Poland. The system went from design to pilot and then to live implementation within a four-month period, resulting in the LIS-Interlink software product. Test results are retrieved at regular intervals from the BioLinkTMLIS (Laboratory Information System), encrypted and transferred to a secure area on the Web server. The primary health-care centres dial into the Internet using a local-cell service provided by Polish Telecom (TP), obtain a TCP/IP address using the TP DHCP server, and perform HTTP ‘get’ and ‘post’ operations to obtain the files by secure handshaking. The data are then automatically inserted into a local SQL database (with optional printing of incoming reports)for cumulative reporting and searching functions. The local database is fully multi-user and can be accessed from different clinics within the centres by a variety of networking protocols.

Available options for doing more with less: laboraory automation as one tool in the arsenal

Projects that require analytical support can evolve from a number of different situations, for example new molecular entities from drug discovery; process changes; packaging changes; site changes; line extensions; and inlicensed projects and compounds. Laboratory automation has been shown to provide a viable and practical solution to assisting in analytical development. However, it is not always the most logical answer. A truly flexible and responsive analytical unit will make a decision on a case-by-case basis, when faced with a new project, whether it is best to: automate some or all aspects/testing involved; contract out to a reputable and approved contract research organization (CRO); hire temporary help; use available in-house resources; use a combination of the options shown above (for example to evaluate the complexity of the new project versus what the in-house resources are currently working on). The paper discusses the advantages and disadvantages of the various options with respect to providing analytical support and suggests optionsfor the most effective use of resources. The role of automation as one of the important tools in the arsenal of these options is highlighted.

Laboratory automation —some perspectives on the challenges in the implementation of the technology in pharmaceutical development

The intensifying pressure on reducing the development time for new pharmaceutical products is resulting in an increasing need for laboratory automation. A key element for the successful implementation of robotics for drug product analysis is the establishment of a reliable process for interaction of the automation team with its various customers, for example development product team and manufacturing group. The reduction of cycle time for product development appears to be resulting in more stability studies to support NDA/MAA filings for several reasons. Key clinical information may not be available before initiation of the stability studies and simultaneous world-wide development may result in an increase in the number of product strength and pack options.

Managing automation developrent in harmony with the rest of an international company—a QC laboratory manager's perspective

Significant opportunities and challenges are presented when transitioning from managing laboratory automation development of pharmaceutical products at a single site to collaborative management with multiple domestic and international sites. Prior to integrating Glaxo and Burroughs Wellcome about two years ago, each company had expertise in laboratory automation, but neither had a strategy for consistent business-justified laboratory automation. The approach for international harmonization of automation development of pharmaceutical test methods that the integrated company has adopted is presented. Some items to consider before undertaking a company-wide automation development harmonization programme are offered for consideration. Experiences encountered and future planned benefits are discussed.

Automation photometer of Hitachi U–2000 spectrophotometer with RS–232C–based computer

The interfacing of a commonly used spectrophotometer, the Hitachi U2000, through its RS–232C port to a IBM compatible computer is described. The hardware for data acquisation was designed by suitably modifying readily available materials, and the software was written using the C programming language. The various steps involved in these procedures are elucidated in detail. The efficacy of the procedure was tested experimentally by running the visible spectrum of a cyanine dye. The spectrum was plotted through a printer hooked to the computer. The spectrum was also plotted by transforming the abscissa to the wavenumber scale. This was carried out by using another module written in C. The efficiency of the whole set-up has been calculated using standard procedures.

Conversion of a sequential inductively coupled plasma emission spectrometer into a multichannel simultaneous system using a photodiode array detector

A monochannel plasma emission spectrometer was converted to a multichannel instrument by the introduction of a detection system based on an array of 1024 photodiodes and a low-resolution dispersion device. The new, relatively inexpensive equipment, features both the high speed typical of simultaneous instruments and the versatility of scanning systems. This paper reports on an evaluation of the modified equipment for quantitative analysis with the simultaneous determination of Al, Mn, Mg, Ca, Fe and Cu in a natural water matrix. An average relative prediction error of 2.4% was found which is the same as the error obtained with the conventional analytical method. Data acquisition with the modified instrument is up to 40 times faster.

Simultaneous spectrophotometric determination of manganese, zinc and cobalt by kernel partial least–squares method

Simultaneous spectrophotometric determination of Mn, Zn and Co was studied by two methods, classical partial least-squares (PLS) and kernel partial least-squares (KPLS), with 2-(5-bromo-2- pyridylazo)-5-diethylaminephenol (5-Br-PADAP) and cetyl pyridinium bromide (CPB). Two programs, SPGRPLS and SPGRKPLS, were designed to perform the calculations. Eight error functions were calculated for deducing the number of factors. Data reductions were performed using principle component analysis. The KPLS method was applied for the rapid determination from a data matrix with many wavelengths and fewer numbers of samples. The relative standard errors of prediction (RSEP) for all components with KPLS and PLS methods were the same (0.0247). Experimental results showed both methods to be successful even where there was severe overlap of spectra.