Process instructions

Processing instructions. This is what must be done with the stuff in order to make the desired product. 

Cyclical hatch. Both the formula and the processing instructions are the same from batch to batch. Batch operations within processes that are primarily continuous often fall into this category. The catalyst regenerator within a reformer unit is a cychcal batch process. 

Flexible batch. Both the formula and the processing instructions can change from batch to batch. Emulsion polymerization reactors are a good example of a flexible batch facility. The recipe for each produc t must detail Both the raw materials required and how conditions within the reac tor must be sequenced in order to make the desired product. 

Batches and Recipes Each batch of product is manufactured in accordance with a produc t recipe, which contains all information (formula and processing instructions) required to make a batch of the produc t (see Fig. 8-56). For each batch of product, there will be one and only one product recipe. However, a given product recipe is nor-... 

You should be careful not to omit any steps. Care should be taken not to make the job hazards too detailed. Too much detail will make a JHA ineffective. Make sure that only safety steps are recorded. One of the common mistakes is to mix work elements with job hazards. A JHA is not intended to document work process instructions, although some people believe that they should be included. 

Process instructions including set-up and set-up verification Handling requirements Operator competency requirements Measurement systems analysis plan... 

Inadequate PIFs Inadequate data presentation Inadequate process instructions etc. 

Although the SIMCA method is very versatile, and a properly optimized model can be very effective, one must keep in mind that this method does not use, or even calculate, between-class variability. This can be problematic in special cases where there is strong natural clustering of samples that is not relevant to the problem. In such cases, the inherent interclass distance can be rather low compared to the mtraclass variation, thus rendering the classification problem very difficult. Furthermore, from a practical viewpoint, the SIMCA method requires that one must obtain sufficient calibration samples to fully represent each of the J classes. Also, the on-line deployment of a SIMCA model requires a fair amount of overhead, due to the relatively large number of parameters and somewhat complex data processing instructions required. However, there are several current software products that facilitate SIMCA deployment. 

Manufacturing formulae should clearly indicate the product name, potency or strength, and exact batch size. It lists each of the starting raw materials required, and the quantity in which each is required. The processing instructions should contain step-by-step manufacturing instructions. The detail given should be sufficient to allow a technically competent person, unfamiliar with the process, to successfully undertake the manufacturing procedure. 

Process batch record Process sequence Process instructions Material usage Product testing... 

At the wet milling step we encounter a situation similar to preblending that is, only two of the 30 study batches are prepared using the no. 5 drilled screen. The no. 7 is obviously the screen of choice. The purpose of this step is to produce particles of reasonably uniform size, which in turn will improve drying. From the records, we also know that the no. 5 screen was used only with batches that were tray dried. Elapsed drying time and residual moisture were compared for the two batches from the no. 5 screen process and the other 13 batches that were tray dried. No important differences were detected. Still, in fight of the limited use of the no. 5 screen, it would not be inappropriate to recommend this option be eliminated from the processing instructions. 

As a chemometric quantitative modeling technique, ANN stands far apart from all of the regression methods mentioned previously, for several reasons. First of all, the model structure cannot be easily shown using a simple mathematical expression, but rather requires a map of the network architecture. A simplified example of a feed-forward neural network architecture is shown in Figure 8.17. Such a network structure basically consists of three layers, each of which represent a set of data values and possibly data processing instructions. The input layer contains the inputs to the model (11-14). 

If the trial pool does not meet the specification the Senior Chemist will use his/her judgement to assess a second trial pool. Record the details of further pools on a purification deviation sheet and attach to this process instruction. 

Prepare a trial pool in a snap cap vial consisting of 50 mm3 of each fraction that meets the required specification by HPLC. Label the pool PX/FY-Z, where X is the purification number and Y to Z covers the fraction range in the pool. Dilute the pool 10 times and carry out a HPLC of this pool to confirm that the pool meets the required specification. Attach the HPLC traces to this process instruction. Record the following ... 

This process instruction is used to summarize the fate of fractions from up to four purifications carried out according to PI0043 (prior to the desalt process). 

The fate of fractions that are not combined for desalt will also be retrospectively recorded on this process instruction. 

Sometimes the term recipe is used to designate only the raw material amounts and other parameters to be used in manufacturing a batch. Although appropriate for some batch processes, this concept is far too restrictive for others. For some products, the differences from one product to the next are largely physical as opposed to chemical. For such products, the processing instructions are especially important. The term formula is more appropriate for the raw material amounts and other parameters, with recipe designating the formula and the processing instructions. 

---