Equipment justification

If the equipment is classified as a SIS, then the next task is equipment justification. This must be done by either a "prior use" justification or equipment must be assessed per lEC 61508 (Ref. 2). Most choose the lEC 61508 certification route, especially for the logic solver, since the documentation burden is high and data gathering can be painful and fruitless when good systems are not in place. This is discussed in detail in Chapter 7. 

This method is a good risk indicator and measure which can be nseful to indicate the projects that would be worth considering for closer study, but the actual profitability of new equipment depends on how mnch useful life is left after the payoff period. Some caution is therefore advised if the payoff period is to be the sole determinant for equipment justification, because cheaper equipment having a low useful life will always appear to be the best investment opportunity. 

Workload status and the justification of equipment Regulatory agency compliance Audit trail for all database transactions Security class or hierarchy... 

Lastly, but quite frequently, the sole justification for a planned maintenance policy is that there is no feasible alternative to the use of a corrodible material of construction, usually because the item of equipment in a non-corrodible material is not commercially available or delivery is slow such that the construction programme would be jeopardised. 

There is unusually strong justification for the historical approach in presenting the important facts about x-rays to analytical chemists the information these chemists need in their work is largely that discovered in the early researches. This is particularly clear in connection with absorption and emission spectra, in which more refined investigations with more powerful equipment later revealed important complexities that the analytical chemist may ignore. Several of these complexities will be recorded below. 

Describe individual items of equipment and how they are connected in sufficient detail to enable unambiguous set-up. List minimum performance requirements and verification requirements, cross-referenced to the calibration section and any relevant instrument manuals. Number for later reference. For glassware, include grade where applicable (bear in mind that use of a particular grade may require justification and that proof of compliance may be required). Include environmental requirements (fume cupboards, etc.). 

Some companies identify the equipment that should be used and require justification of equivalence when these differ between transferring and receiving units (Agut et al., 2011). However, this approach may be flawed and... 

Suppose your employer intends to develop a new laboratory to characterize particles in the colloidal size range. Your assignment is to prepare a list of the equipment that should be purchased for such a facility. A brief justification for each major item should be included along with a priority ranking based on the versatility of the method. Assume that your laboratory is already well stocked with such nonspecialized items as laboratory glassware, balances, and the like. 

Testing procedures were established for each vendor selected for on-site demonstration of filtration equipment. These procedures were based on the need for testing data to properly complete the final equipment specifications and purchase justification. 

The acceptance criteria may also specify the amount of active ingredient that may be present in the swab and/or rinse samples taken. This section of the protocol should also provide a scientific rationale or justification for the limits for active(s) remaining on the equipment. This particular topic is so significant that it is addressed in greater detail in Sec. XV. 

The titrimetric modifications described above exemplify either an instrumental adaptation (as in the case of the potentiometric and conductometric titrations) or a chemical manipulation (olfactory indicators). The first uses the sense of hearing, while the latter type appeals to the sense of smell. Unfortunately, instrumental adaptations that utilize one-of-a-kind homemade instruments are not readily available to the typical educator or may even be out of circulation. Also considered is the fact that at institutions where the enrollment of handicapped people is low, the justification of specialized equipment can be very difficult to obtain. On the other hand, the chemical manipulations discussed rely on readily available chemicals (onions and cloves) and represent comparable costs and laboratory preparation times as traditional titrimetric experiments. Since all students may perform these... 

Some individual monographs already describe and require noncompendial equipment, such as Felodipine extended-release tablets, for dissolution testing.19 For example, one monograph describes a noncompendial probe inserted into Apparatus 2 as a wafer-like basket to the side of the paddle. Monographs with dissolution tests that require special equipment for low-dose products would most likely use a noncompendial apparatus in this manner. Use of noncompendial equipment should not be an obstacle as long as appropriate justification is provided and necessary qualification of the equipment is performed. 

Available apparatuses for low-dose drug products were discussed earlier in this chapter. Any of the equipment mentioned, including compendial and noncompendial, can be considered as long as there is proper justification for its use and proof that the equipment is qualified according to GMP regulations. There are also references for small volume apparatuses that may be helpful in understanding this issue.24-27... 

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