Modular equipment

Therefore the authors introduced the concept of holistic validation where the whole chromatographic system was also qualified to evaluate the performance of the system. The concept of holistic qualification is important as some laboratories operate with a policy of modular equipment purchase. Here they select components with the best or optimum performance from any manufacturer. Furthermore, some of these laboratories may swap components when they malfunction. Thus, over time the composition of a system may change. Therefore, to assure themselves and any regulatory bodies that the system continues to function correctly, holistic qualification is vital. 

Manufacturing instructions are the written procedures that personnel follow during actual product batch preparation. The instructions must document the modular equipment and materials to be used as well as the unit operations to be performed. (See Figs. 3 and 4.) The master document should also include step-by-step manufacturing instructions as well as GMP-required elements previously listed under the section on batch records. 

TABLE 8.33 Modular Equipment Spreadsheet Cost Analysis... 

Large specihc surface area is provided by HF membranes Diffusion paths are short Modular equipment is compact Energy consumption is low... 

Significant increase or decrease in batch size that affects the operation of modular equipment and... 

This includes proeedures and doeumentation to show that all important aspeets of the installation of the facility, support system, or pieee of modular equipment, having been properly ealibrated, meet its design specifications and that the vendor s reeommendations had been suitably eonsidered. 

Following IQ, proeedures and documentation show that the facility, support system, or piece of modular equipment perform as intended throughout all antiei-pated operating ranges under a suitable load. 

Thermal treatment is an effective and implementable option, but one which is relatively high in cost. For example, incineration of PCB-con-taminated wastes could range from 280 to l,000/ton. The cost per ton would be even higher when the volume to be treated is small due to the high fixed cost of thermal treatment equipment. This evaluation of thermal/hot-gas decontamination of the debris assumes on-site treatment with transportable modular equipment. 

For pharmaceutical applications small to medium sized, versatile, and often modular equipment is desired that must meet extreme cleanliness requirements (below). 

You find yourself for the first time in front of your HPLC equipment, consisting at least of an eluent delivery system (= pump), an injector, a column, a detector and a data evaluation system. If you see several separate devices, you have a modular equipment. If you are in front of a large box, you will work with a compact unit. 

To purchase a compact or a modular equipment is more a question of your personal taste and your priorities. In the following, the pros and cons of compact devices are listed. For modular instruments, the same arguments are true mutatis mutandis. 

Technologies of pressurized water reactors with modular equipment layout used in shipboard reactors of the Russian nuclear fleet. A well established reactor technology the operation experience with shipboard reactors of different destination exceeds 6000 reactor-years. 

Fig. 8.15 A facility for manual electroplating. The modular equipment is suitable for both rack- and barrel-plating. Construction materials include corrosion-resistant PVC-clad steel and stainless steel. Applications include precious-metal plating in the electronics industry. Power supply and control circuitry are located above the tanks. (Courtesy PMD Chemicals Ltd.)...

A design criterion for a modular system is to have standard flanging to allow the joining of modules from different manufacturers. This type of interfacing is sometimes referred to as SMIF (standard mechanical interfacing). Standards for such interfacing are being developed by the SEMI Modular Equipment Standards Committee. 

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