Development in-house

Many developers of software for finite-element analysis (18) provide drafting of pipelines and associated flow analysis. These companies include Algor, McAuto, MacNeal-Schwindler, and ElowDesign. In software, in-house developed pipe fittings are modularized and isometric views of the piping systems with three-dimensional detailing are now commonplace. 

Hunt and Kulmala have solved the full turbulent fluid flow for the Aaberg system using the k-e turbulent model or a variation of it as described in Chapter 13— the solution algorithm SIMPLE, the QUICK scheme, etc. Both commercial software and in-house-developed codes have been employed, and all the investigators have produced very similar findings. 

New entries are built via an in-house-developed ISIS application called REGISTER. 

One disadvantage of in-house development is that a large committment to development and support is required. Another is that if commercial software has been available for a while, other users have probably found most of the bugs, with in-house software, in-house users must be patient and supportive during the debugging process. 

Despite the market explosion of data management software, there are still situations which justify in-house development. When it is appropriate to develop software In-house, design philosophies such as those Implemented in the MARS system will help reduce the development and maintenance investment and enhance the effectiveness of the system. 

Firstly, there are technical reasons concerning catalyst and reactor requirements. In the chemical industry, catalyst performance is critical. Compared to conventional catalysts, they are relatively expensive and catalyst production and standardization lag behind. In practice, a robust, proven catalyst is needed. For a specific application, an extended catalyst and washcoat development program is unavoidable, and in particular, for the fine chemistry in-house development is a burden. For coated systems, catalyst loading is low, making them unsuited for reactions occurring in the kinetic regime, which is particularly important for bulk chemistry and refineries. In that case, incorporated monolithic catalysts are the logical choice. Catalyst stability is crucial. It determines the amount of catalyst required for a batch process, the number of times the catalyst can be reused, and for a continuous process, the run time. 

The controls of duration/sequence of stages and on/off of peristaltic pumps, mixer, air supply were automatically achieved by an in-house developed data acquisition and control (DAC). 

The appearance of expert systems to solve practical problems, also in chemistry, started in the eighties. During this period much experience has been acquired through the expected and unexpected problems that arose during such projects. Until now there are only a few commercially available expert systems and this is not likely to change in the near future. This implies that expert systems will be mostly in-house developments. The different steps to consider are ... 

In-house developed tests Clinical labs No Inspection by HCFA of use of in-house test in the clinical lab site Same as HCFA if state has deemed status... 

In the current, price-sensitive environment, which is the hallmark of modem healthcare and certainly new drug development, expenses necessary to support clinical research are a major concern for sponsors. Both fixed and variable costs can be managed effectively compared to complete in-house development budgets. As product development costs are a significant element influencing pharmaceutical pricing, the role of innovative CROs is expected to grow. 

NMR-tomographic method, any commercially available NMR spectrometer can be used. To inject samples from 384-format deep-well microtiter plates into the bundle automatically, an in-house-developed pipetting robot with a modified tray was used. 

Standardization is a comparison with a standard of known and accepted value. Standards may be of several sources primary standards [prototype state-of-the-art standards found at NIST the National Institute of Standards and Technology (formerly known as the National Bureau of Standards (NBS), or national equivalent outside the United States] secondary, working standards (standards calibrated to primary standards, which are used for working tools and instruments) and in-house-developed or interim standards (standards developed and used by a particular facility when no primary standard is available). 

ChemSelect AQB (Advanced Query Builder) A Pfizer in-house developed reusable Java component that allows users to query various molecular structure databases within Pfizer based on molecular structural information and/or other properties, retrieve, manage, and export retrieved hits. It has a functional role similar to MDL ISIS/BASE, but with many enhanced capabilities. PGVL Hub has embedded this reusable Java component within itself so that users can search for suitable reactants from various corporate reactants databases and inventory houses and return the hits seamlessly back into PGVL Hub design session. From user s point of view, the ChemSelect AQB component is just part of PGVL Hub. 

In order to qualitatively and quantitatively evaluate the various deactivation channels of the electronically excited bilatriene chromophore in Pr, the photophysical and photochemical parameters of this chromophore were determined by stationary fluorescence [76] and time-resolved spectroscopic methods (for in-house developments and first applications of fluorescence and optoacoustics see [77-80] and [81,82], respectively) [2,9,10,83,84], Furthermore, a time-resolved fluorescence study has been carried out also with the selectively excited tryptophane residues of Pt and Pfr. The results are discussed in Sections II.A-C and III.A. Unless specified otherwise, the experiments were performed in vitro with 124-kDa phytochrome isolated from etiolated oat seedlings (Avena sativa L ), and the measurements were carried out with ethylene glycol-containing phosphate buffer solutions at 3s 275 K. 

In conclusion, the recent increase in the number of water-insoluble drug candidates will doubtless enhance the importance of oral lipid-based formulations in the coming years. If a candidate has adequate solubility in the vehicles described in this chapter, lipid-based systems will usually provide an attractive approach for efLcient in-house development of clinical and commercial formulations. 

This article gives a review and a strategy for the validation of analytical methods for both in-house-developed as well as standard methods and a recommendation on the documentation that should be produced during and at the end of method validation. 

Data evaluation was performed with a in-house developed software... 

Fig. 5.2 An in-house-developed robotic system for hydrothermal synthesis detail of solid dispensing operation.

FIGURE 12.4 In-house developed, fully automated reformatting system. Compounds stocked in individually barcoded and sealed tubes are transported (A). A robot (B) delivers the tubes in a 96-tube rack to a liquid handler (C), where samples can be added to 96-, 384-, or 1536-well plates. 

In pre-1975 dollars, the cost of a minimal laboratory system ran as high as 900,090- for a in-house developed package. That was the extreme cited, but not far behind were numbers like 700,990, 550,900, 500,000, and ranging down to 100,990. What was a minimal system A minimal system was one "having some of the automated instruments in chemistry and hematology on-line, along with any three of the following functions" ... 

The validation life-cycle approach applies to both in-house developed and purchased computer systems. Supplier responsibilities are indicated later in this chapter. Suppliers include internal development or support groups, external vendors, and outsource organizations. 

Computer systems supplied by third parties (often known as system integrators) to specific user requirements should be validated entirely prospectively along the same lines that pharmaceutical and healthcare companies take for in-house developments. This, of course, requires that validation requirements are clearly identified and understood by the supplier at the outset of a project. 

The prerequisite requirements for testing should be clearly defined (e.g., interlocks and utility systems). It is a good idea to coordinate Factory Acceptance Testing (FAT) along with the mechanical system checkout. Consider using the same testing approach for both in-house developed systems and vendor-provided packaged systems in situations when both types of systems exist on the project. 

Turner (16), in his presentation at PPS 99, reported his results of studying some of the variables in the guideline which included mapping studies of his, in-house developed photostability chamber. The chamber was 70 x 140 cm and housed six, 120 cm fluorescent tubes. 

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