The pharmaceutical industry is precisely that branch of industry, where the purity of production plays a major role. Even a minimal violation of technological processes will directly affect human health.
The way, by which finished product enters the human body, has a great influence on the requirements for the drug purity. For example, balms and gels go through the greatest number of protective systems of the body before getting into the blood – if the purity of this drug is insufficient, allergic reactions may occur;intravenous injections fall directly into the blood – non-compliance with sterility standards in the manufacture of such drugs can cause the most serious consequences.
Steam, like any other medium, can carry a variety of microorganisms and bacteria (especially steam, which has a low temperature) – for this reason, high demands are being made at pharmaceutical plant.
Steam generators at pharmaceutical plants are used mainly for following purposes:
- For heating various drugs;
- To maintain a predetermined humidity level in production facilities;
- For drugs treatment, industrial equipment and premises in order to maintain them in sterile purity.
Heating of preparations and various media
In this case, steam produced by steam generator (steam boiler) is used to heat the closed volumes of various media preparations media. In this case, steam does not directly interact with heated object, it heats the hermetically sealed container, containing the drug. Special requirements to the quality of steam used for this purpose are not presented – the main condition is the exact adherence to the temperature regime.
Maintaining specified humidity level
When using a steam generator to maintain required humidity in production premises, level of steam purity differs depending on the purpose of the room.
In pharmaceutical industry, there are several different levels of sterility of production facilities. Depending on the level of room, the permissible content of foreign mechanical particles also differs:
|Premises level||Maximum permissible amount of particles contained in 1 m3 of air|
|During premises’ standing time||During room operation|
|Particle size from 0,5 micron||Particle size from 5 micron||Particle size from 0,5 micron||Particle size from 5 micron|
|A||3 500||1||3 500||1|
|B||350 000||2 000||3 500||1|
|C||3 500 000||200 000||350 000||2 000|
|D||is not regulated||3 500 000||20 000|
This classification takes into account only content of mechanical particles (dust) in steam supplied for humidification. But it is also necessary to take into account the possible content of chemical compounds to the steam coming from the steam generator (they may appear during oxidation of metal surfaces of heat exchanger of steam generator, or in process of water treatment). Acid with the steam in production premises, chemical compounds can interact with manufactured products and entail a change in their properties.
Generators of pure steam are most often used for maintain the humidity of industrial premises. In such generators, water that has passed many degrees of purification (and practically free of neither physical, nor chemical impurities) is heated by means of ordinary steam through a heat exchanger made of stainless steel. The pure steam generator itself and the steam lines leading clean steam to the production premises are also made of stainless steel.
Sterilization of equipment and premises
Maximum level of steam purity is required when using steam for drugs maintaining, production equipment and premises in a sterile state. According to this application, steam directly contacts the product that produces its equipment and the packaging in which the product will be stored – the use of unsealed steam will lead to a serious deterioration in quality of finished product.
A steam suitable for such purposes is obtained in special generators of pyrogen-free steam (steam produced in such steam generators is of higher purity than after the pure steam generator), the liquid obtained during the condensation of such steam, by properties with water for injection. The water in such generators is heated (through the heat exchanger) by the technical steam, which is obtained using a conventional steam generator.
Vapor used for sterilization of medicinal products must meet following requirements:
- Dryness of steam is not less than 0,9;
- Condensate steam must meet the requirements of water for injection;
- Content of non-condensable gases in steam is not more than 3.5%;
- Overheating of steam not more than 25°C;
- Range of deviation of vapor pressure – not more than 10% of calculated one.
Server Service Company supplies technical steam generators to the pharmaceutical industry in Uzbekistan. Our specialists will help you to choose necessary steam generator, we will realize its delivery to Uzbekistan, installation and adjustment.