Pharmaceutical Plant Design

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1. INTRODUCTION

The dilemma of arranging an industrial process has been as far back in existence as the Industrial revolution. Since the concept of scientific management was first developed, industrialists have been wrestling with the problem of arranging facilities for years. Although plant layout evolved as a distinct industrial function relatively recently, it was a dominant factor of production throughout the development of the factory system.1

Development of a new plant or process from concept evaluation to profitable reality is often an enormously complex problem.

This is a detailed dossier to advice about the considerations and steps that need to be addressed in building the new facility in which DNA vaccines are going to be produced. The report discusses how a plant design project moves to completion through a series of stages such as is shown in the following:

  • Inception
  • Preliminary evaluation of economics and market
  • Development of data necessary for final design
  • Final economic evaluation
  • Detailed engineering design
  • Procurement
  • Plant location and Erection
  • Startup and trial runs
  • Production

This brief outline suggests that the plant design project involves a wide variety of skills. Among these are research, market analysis, and design of individual pieces of equipment, cost estimation, computer programming, and plant-location surveys.

2. PLANT DESIGN

The term ‘plant design’ and ‘plant layout’ are often confused; hence they are clarified in order to facilitate further discussion. Richman describes plant design as “the over-all design of an enterprise.”2 It is a broad function taking in the origin of the enterprise, the planning of finances, the plant location, and all the planning necessary for the physical requirements of a plant.

On the other hand, plant layout is concerned with spatial arrangement of process plant and its interconnections, such as piping.  The term ‘plant layout’ has been given a generic meaning covering all aspects of layout, as in the detailed arrangement of equipment and piping etc.  Therefore, plant layout is one of many activities required for the effective overall design of an enterprise. A strategically well established layout achieves a balance between requirements for safety, economics, the protection of the public and the environment, construction, maintenance, operation, space for future expansion and process needs. 3 

There are a number of factors involved in a design of a plant, namely; location, layout, materials of construction, structural design, utilities, buildings, storage, materials handling, safety, waste disposal, international and local laws or codes, and patents.

The design of a plant plays a broad role and the layout is considered one of its important factors. Over the past decade or two the two terms have been further defined and the idiom ‘Factory Planning’ substantiates the idea of the over-all planning.  Factory Planning as defined by Ireson, is “the formulation of a complete plan for the creation of goods or services. The term embraces the determination of the location, production processes, equipment, physical arrangement, provision for personnel, offices, and all function that are necessary to the completion of the goods. This implies that a careful study should be made of the several alternatives at each phase of the process and the course that has the greatest likelihood of providing the required service most economically in the long run adopted.”4

Design has become a three-stage process:

  • Stage 1: pre-design sanction
  • Stage 2: between design and project sanctions
  • Stage 3: after project sanction.

Figure 1 shows the sequence and interrelationship between some of the activities with plant design. Though this figure is not broad enough to show all plant-design activities, it does not demonstrate the relationship of plant layout in the overall design of an enterprise.

etc                                                                                                                                                                                                     etc

Figure1. Graphic portrayal of some of the phases of plant design.5

2.1. Site Layout Objectives

The purpose of a good site layout is to provide safe and economical flow of the materials and people and a socially acceptable environment for people working in the plant and living in the adjoining community. Possible disasters can be foreseen so that plans for containment at source put in place. For example fire and accidental harmful releases that may spread throughout and beyond the site can be quickly controlled.

Selection and layout of a new plant is one of the less common design operations because the majority of the projects are carried out as additions or extensions of an existing site. However, when the need arises to plan a new development on new land great care must be taken.

2.2. Segregation

In many industrial activities different parts of a manufacturing plant are purposely placed adjacent to each other to minimize interstage transport. Most process industry sites though, are laid out with plant units deliberately segregated.  . However, segregation of plants costs money in extra transportation, longer pipe-work connections and higher manning levels and must, therefore be justified and based on the best data available.

The main considerations for this policy of segregation are:

  1. Safety and loss prevention.
  2. Housekeeping (cross-contamination).
  3. Access for construction and maintenance.

It is necessary to test for these considerations positively because otherwise they can be easily overridden by purely economic considerations. Segregation for safety and loss prevention aims to prevent a major accident of fire in one plant from spreading to another plant. Good housekeeping may dictate segregation of plants, which release fumes or dust if these emissions would contaminate the products in adjacent plants. Access spaces around plants, normally intended to allow crane access, lifting clearance or space for temporary placing of equipment during erection or maintenance, are generally less than those dictated by safety and housekeeping requirements. In order to control entry or restricted access to hazardous areas, it may be necessary to erect a security fence around a plot, and institute an ‘official access only’ system.

It is essential that hazardous processes should be segregated from other’ hazardous plants in particular so that they fall clear of each other in the event of collapse. For instance in the case of vaccine production, although it may be safe now to have a hazardous pro-site boundary, should, as far as possible, be sited away from the site boundary because future development on the other side may alter the situation. At the least this could prevent further development of the process.

A hazardous operation must be kept away from the public as sometimes onlookers to a fire can interfere with firefighting and even be injured themselves

2.3. Emergencies

Emergencies and potential emergencies on the site can arise from a wide range of causes and it is necessary to develop plans to deal with all emergencies up to and including a major accident. Hardware to implement the company’s emergency plans will be built into the site layout, e.g. access, control and water supply.

2.3.1. Access

The road systems should be adequate to allow firefighting and damage control vehicles to approach ideally from all directions without any risk or hazard to factory traffic. Water supply should be available at these places. This means in many cases the site should have a peripheral road with access to the public road system at a minimum of two points.  The internal road system should be checked so that no area is likely to be cut-off by debris, fumes or leakages.

2.3.2. Control

A major accident control point should be planned. This, together with the fire station, medical center, emergency stores and main entrance must be located away from hazardous sources.

It is desirable to have a number of additional sub control points about the site.11 Also safe areas with shelter from weather, easily reached on foot, should be set aside as emergency assembly points for staff. This ensures simple and quicker accounting for personnel after an incident.

2.3.3. Water

Firefighting water is usually taken from public mains, as a supplement from natural sources or large-scale static storage reservoirs.11 Access to the sources must be maintained. The layout of mains and hydrants and details of connectors should be reviewed with the local fire authority officers to obtain their advice and to ensure their staff are suitably equipped and trained for tackling likely fires.

Special provisions may be necessary for disposal of water used in fire-fighting operations to prevent the spread of fire by carrying floating flammable and to stop the mixing of fire effluents and normal effluents which may hamper the emergency services by producing toxic fumes etc.

2.4. Central Facilities

The location of the plants and buildings housing the central services are to be determined initially by reference to the service flows into and around the site. It is economical to minimize the lengths of supply cables and piping to the largest users. However, care is needed to ensure that a central service generation or distribution plant is not exposed to serious interference by fire, explosion, or natural occurrences such as flood or wind.  Substations, transformers, pumping stations etc. should also be put in areas, which permit standard electrical equipment to be used unless they form an integral part of the plant, in which case flameproof equipment may be needed.

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Cooling towers should be sited so that water droplets will not restrict visibility or cause exterior corrosion or ice formation on other parts of the plants, roads, rail or public amenities. Siting should prevent the entrainment into the cooling towers of vapours and dusts from adjacent plants, chimneys, flare stacks, etc.

It is desirable that plant expansion plans should be known when positioning central services plants. They are often centrally placed (but not necessarily together)12  so that site expansion can proceed in all directions, providing the services will not later become part of a hazardous area. Service ...

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