Pilot-laboratory batches factors

Pilot-laboratory batches are usually prepared in small pilot equipment within a designated current GMP approved facility. The number and size of these pilot-laboratory batches may vary, depending on one or more of the following factors ... 

In this option, the batch is seeded at much lower supersaturation to avoid excessive nucleation, as experienced in Option 1 at higher supersaturation. The modified approach was successfully scaled up from the laboratory 50 gm scale to pilot plant and manufacturing 200 kg over 4000 x scale-up factor. The crystals size increased to an average length of 60 microns and a width of 4 microns, compared to the Option 1 procedure that produced crystals with a length of 25 microns and a width of -2 microns. The filtration rate was improved substantially from several days operation to less than 8 hours in the pilot plant. 

Other factors such as materials of construction, gas-tight seals, and safety are also vital. The order of procedure may vary, especially if there will be batch rather than continuous operation. Steps (7), (8), and (10)—in essence, the reactor design—can be drastically affected by changes in scale. So it is important to consider in detail the scale-up of the reactor. Scale-up has three stages laboratory tests, pilot scale runs, and commercial or semicommercial operation. A critical point is the transition from laboratory to pilot plant scale operation, using a scaled-down version of the commercial reactor. Compatibility of performance of other plant units is an important feature. 

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