WHAT IS CLEAN STEAM ?
Steam remains today the prime carrier of heat for the process industries, from food and dairy to biotechnology and pharmaceuticals. It is used for the process heating and working environment as well as for sterilization of products and equipments.
Normal factory or plant steam may contain small quantities of boiler feed water chemicals and traces of pipe scale and other debris which may not be acceptable in the production of the injectables or parenteral solutions, which are always sterile. In the production of these parenteral solutions, quality and purity of steam is of utmost importance, and special care need to be taken for the generation of this kind of steam. Such high purity steam with less risk of contamination is called as “Clean Steam” and can encompass a wide variety of purities ranging from pure, pyrogen free steam for biotechnology and pharma industries, filter steam etc.
CLEAN STEAM PURITY
Clean steam purity is often defined by the purity of the condensate, and this is often referred to one of the published water purity standards. Additionally, the parameters by which pharma water purity is measured are generally conductivity, total organic carbon, endotoxins and microbial content.
Why Clean Steam?
Problems with Plant Steam for higher purity applications:-
Chemical additives - In most cases Plant steam contains Amines and Hydrazines to help protect the Boiler shell and steam system from corrosion and scale – These chemicals can be harmful to the process of human health. So use of purest form of water is advisable for steam generation which gives rise to generation of pure steam.
Corrosion and scale particles from boiler and pipework are not acceptable in manufacturing of parenteral drugs (drugs which are not taken orally).
Relatively high pH has adverse effects on quality of steam and pure steam with low conductivity is recommended.
USES OF CLEAN STEAM
Clean steam is typically used for
• Sterilization of reactors, tanks and piping
• Maintaining Sterile barriers using block and bleed system
• Sterilization of process equipments.
• Autoclave / Sterilizer
• Direct heating and cooking.
While clean steam sterilization is encountered in the following production processes,
• Production of injectables or parenteral solutions, which are always sterile.
• Biopharmaceutical manufacturing, where a sterile environment must be maintained to grow the biological production organism.
• Production of sterile solutions, such as ophthalmic products.
Thus it is essential that the steam delivered to the point of use is of correct quality and purity for the process.
In order to achieve this end goal, there are three key areas of design which must be considered once the requirement of clean steam is identified, such as
• Point of use
Design and operation of equipment, piping, components etc. in all these three areas will influence the quality of the final process and product.
In this context we offer varied range of products to suit the sanitary requirements as follows,