Definition of fundamental criteria in the design of an air conditioning system for pharmaceutical laboratories.
By Eng. Camilo José Botero
Normally when pharmaceutical projects are developed, the different actors involved in them define all the fundamental criteria required to meet the proposed product objective. Therefore, it is defined whether it will be a solid product or a liquid product.
Likewise, the way of using this medicine is defined, example: oral consumption, injectable, topical application. In the definition of the objectives also enters the category if it will be a drug that will be for over-the-counter consumption in the pharmacy or will be a sterile injectable drug for cancer treatment.
To the short summary of steps narrated above, other series of questions could be added such as: 1. In which country and under what regulation this new drug will be sold, 2. The product will be validated by the local health authorities either for consumption or export, 3. The product will be approved by the internal validation guidelines of the Pharmaceutical laboratory.
Once the Pharmaceutical Laboratory or client has resolved all the questions raised and decides to proceed with the implementation of the project, it initiates the contact of all the specialists of the different branches of engineering and architecture. This is where the consultants of air conditioning and ventilation systems enter, and we receive some requirements and criteria from the laboratory to carry out our designs (Example: Air changes per hour, differential pressures between rooms, flow senses, percentages of external ventilation, temperature ranges and relative humidity, redundancy levels, etc.).
The information and parameters received were certainly defined by personnel specialized in areas of Pharmaceutical, production and marketing, but the question that arises is: are there awareness of the economic impacts on the implementation and operation of air conditioning and ventilation systems? In most cases complete designs are made with the parameters received and when these are finalized and delivered, the response of the client tends to be the same, "the budget and operating costs are above those conceived in the structuring of the project", therefore it goes to the painful work of making redesigns, "negotiations" of parameters between all those involved and sometimes acceptance of technologies not ideal for this type of project.
The conclusion at first glance could be that there is a disconnect between the Pharmaceutical team and the air conditioning consultant, since in a certain way defining parameters without all the knowledge and psychrometric implications is complex. In addition to this, there is the "drawback" premise of making comparisons of similar projects that have been executed in other latitudes, since location and environmental conditions are crucial to determine investment and operating costs. Therefore, because they were executed and put into operation, it should not be presumed that they were exactly the best decisions taken and if so, they may not apply to the new project than their own conditions.
The criterion set out above leads us to reflect that before starting the designs we must work intensively with the Pharmaceutical team, letting them know the implications of the defined parameters, the critical factors that impact on the calculations and the best technical proposals that can cover the highest percentage of initial parameters required, within the framework of the available budget.
Among the technical proposals could be to work hand in hand with the client in the constructive part of the facilities, informing and instructing him that to the extent that he builds more hermetic laboratories, he will require smaller systems to meet his objectives. All this can be explained in a simple way with the Excel tables they use to perform arithmetic calculations. With this tool you can convey to the customer the sensitivity and impacts of the decisions that are made, such as that a higher differential pressure between rooms requires more air flow traveling between them, that the air losses through doors depend on the shape and dimensions of these, and of course that the great impact of air changes per hour increases or substantially reduces the size of the systems. With the result of the exercise in the Excel table and the criteria of air recirculation or non-air recirculation, the respective psychromometries are carried out taking into account the area where the project will be installed to complete the calculation scenario.
With this information based on precise calculations, it can be evaluated from the beginning how to implement these adjustments in the architectural design and especially in the evaluation of the fundamental design criteria that of course leave in accordance with what was proposed to the entire technical team.
Once the entire client-consultant team is in accordance with the criteria and parameters, it will be possible to proceed with the execution of the design in detail. Already at this stage it will be up to the consultant to meet the objective of keeping the cost of the project within the available budget and operating costs at a fair value. This is where the next stage of information about the types of systems to be used for a specific project and the elements that exist to maintain stable conditions, recover energy when possible and use more efficient systems begins. As mentioned above, here comes back and plays the criterion and the premise that in such a place the systems were installed of such a brand and technology and therefore this pattern must be repeated. Each project must be unique and specific, therefore the conditions of the place where it will be built, the available technology and the training of the premises and of course the environmental conditions where it will operate must be evaluated. Based on this chosen technology, the client must be informed of all available energy recovery possibilities, so that by implementing them, the operational costs of the project can be maintained within the considerations of the business framework.
As a summary and conclusion of those exposed so far, a greater benefit is obtained when the client is informed of the implications of the defined fundamental criteria that he is delivering, their economic impacts and their possibilities of improvement according to the architectural design. In this way, early consensual adjustments can be made to the different designs involved in the project for the benefit of the project.
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