The task of the pharmaceutical manufacturer is to combine the medicinally active agents provided by a fine chemicals plant, or by extraction from vegetable, animal or other source, with suitable inactive ingredients so that the end product may be used in the correct dosage to produce the effect needed. Thus, pharmaceuticals may be liquids or emulsions to be taken by mouth; solids, which may be swallowed; or combined with oil or fats to make creams and ointments which, like some liquid products, are applied externally.
Despite the vast range of end products, much of the manufacturing plant is semi standard equipment, used across most of the industry. Heating, cooling, evaporating and drying units all use the normal plant services, alongside the mixing and shaping operations which lead eventually to filling and packaging to give the familiar end products.
In the recent years, due to economic reform, development of new technologies and competition in the market, production of utilities like steam has become paramount important to have better quality and desired quantity of steam at a lower price in the pharmaceutical Industry.
Melting may be achieved by storing the drums in a heated cupboard for some hours just before the fats are required and steam coils below the drums provide an economical heat source. Clamp-on electric heating jackets may also be seen. One of the most effective methods is the use of a steam coil, which is suspended above the open ended drum, and lowered into the contents as these are melted. The effect is that of a steam immersion heater.
Temperature Controls, Steam Trap Module, including Strainers, Ball Float Steam Traps,Spiratec and Isolating Valves, Filters and Compressed Air Units will be required during the melting process.
Paralleling the need for pyrogen free water is the need for clean steam where this is likely to be in direct contact with the product. The steam may be raised in a generator with plant steam on the primary side, and all the equipment in the clean steam system will be of stainless steel. Pressure Reducing Valves, Separators Strainers and Steam Traps, and the too often overlooked Air Vents, are all needed.
In many diary and pharmaceutical applications, process equipment is cleaned and sterilized in-line without disturbing the pipework system. These systems are known as CIP and SIP (Clean In Place and Sterilize In Place) systems. They incorporate acid, alkali, detergent, and water washing facilities, together with the ability to steam sterilize the whole system. (The pipe complex can be very complex, but it is clear that any residue left by the cleaning and sterilizing system could find its way into the end product. So clean steam is essential to ensure that the product is not at risk.)
Clean steam is also used for direct contact sterilization in other associated areas, such as bioreactors and other vessels in the biotechnology industry, autoclaves, etc. Another application for clean steam is to provide sterile barrier between a critical biological process and the environment – for example, the harvest line of a bioreactor.
Clean steam is frequently used in many industries to heat a product by direct injection. These may be food or drugs, so any contamination that could affect product quality must be avoided.
Steam is ideal for humidifying rooms and process since it is a clean, sterile medium. In certain applications, clean or pure steam is used to minimize particular emissions, for example, in clean room humidification in the electronic (silicon chip manufacture) and pharmaceutical industries. For this application, Spirax Marshall Humidifiers are always the best choice.
Heating, Ventilating, Air Conditioning
Many of the pharmaceutical manufacturing operations are carried out in atmospheres which are carefully controlled at a required temperature and also at a described humidity. Where the humidity is ensuring comfort conditions it is often necessary to use Humidifiers to add moisture to the air. In other cases, the product may be hygroscopic and it is necessary to ensure that the air is dried until the R.H. is below a limiting value. This can mean cooling the considerable volumes of air to the appropriate dewpoint temperature. Reciprocating and rotating refrigeration machines are both used, while in some cases steam driven absorption plants can chill the circulation cold brine.
Forbes Marshall RH 1000 and RH 2000 Humidity and Temperature transmitters are perfect solution for humidity measurement and signal transmission.
The reheating of the air is almost always by the use of steam-to-air heaters. Preheating is more usually limited to general ventilation systems, and these exhibit the usual need for care when draining condensate under light conditions.