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Nothing is more crucial to the pharmaceutical sector than hygiene. As a producer of injectables, oral solid dosages, biologics, vaccines, or any other pharmaceutical preparation, you must always put the health and safety of your customers first. The safety of your goods is largely determined by your standard operating procedures, the suppliers of your API and excipients, and the equipment you select. Since this pure steam will come into contact with the same surfaces as your sterile raw materials and finished goods, your choice of pure steam generator for pharma applications is also very important. This is why, it is vital what clean steam generator manufacturers you subscribe to.
What is pure steam?
Pure steam, also known as clean steam, has a lot of technical requirements in terms of purity, allowable endotoxin level, and presence of non-condensable gases, despite the concept sounding rather straightforward. Its purity and intended use set it apart from other forms of steam.
Pure steam is dry, saturated, pyrogen-free steam generated by a specialized clean steam generator for the pharmaceutical industry. When condensed, pure steam must meet the standards for water for injection (WFI), as outlined in the European Medicines Agency’s guideline on the quality of water for pharmaceutical use, or in accordance with the recommendations included in other internationally recognized pharmacopoeia, such as the United States Pharmacopoeia or Japan’s Pharmacopoeia. When equipment surfaces come into direct touch with pharmaceuticals or medical devices, pure steam is employed to keep them clean, as well as process pipe networks and other sterile environments.
Pure steam can be created by distilling purified water, but the quality of the feed water used to make it matters. A perfect, pure steam production system for the pharmaceutical industry or wife plant supplier generates saturated steam from additive-free water and non-condensable gases. Pure steam should satisfy the same endotoxin level, conductivity, and total organic carbon requirements as WFI, with a recommended endotoxin level of less than 0.25Eu/ml.
Pure steam is a great heat transfer medium with particular uses in the pharmaceutical industry. You could probably service your sterilization in situ (SIP) procedures for process pipework, tanks, reactors, and any other surface that comes into contact with products using a pure steam generation system for pharma. In controlled industrial environments where even the air quality matters, a pure steam generator for pharma may also be utilized for air humidification.
What is a pure steam generator?
In a pure steam generating system for pharmaceuticals, incoming feed water is driven into a single pass where it is transformed into pure steam. Heat from hot gases, steam from plants, or energy supplied to the system allows for this conversion. Pure steam is produced by distilling purified water. Typically, reverse osmosis is used to cleanse water to lower its impurity level by the use of a semi-permeable membrane.
What makes a good pure steam generator for pharma purposes?
Durability and resilience to corrosion of the building material.
Under pressure, pure steam passes through process pipelines and apparatus. You may also have to cope with the fallout of the pipe network corroding under such strain. Additionally, the quality of the steam is at risk since contact with non-corrosion-resistant objects can pollute the steam itself. For this reason, TSA pre-passivates the system and electropolishes all contact parts to a size of less than 0.4 Ra microns.
How is it manufactured?
In addition to the building materials, you should carefully consider the pure steam generator’s design for pharmaceutical uses. Features include fewer moving parts mean less downtime and maintenance requirements; fewer internal components mean less hassles for inspection, repair, and maintenance; and video-borescopes provide more alternatives for system and process monitoring. In the modern world, sustainability is also highly significant, thus design elements that incorporate energy efficiency are highly advantageous.
Is that customized for you?
To ensure the success of your business, you could require heat exchangers, double tube sheeting, pre-heaters, and other related equipment. Choose for highly flexible pure steam generators, such as TSAs, which may vary their output capacity by up to 80% without requiring any further plant adjustments.
Adherence to regulations and guarantee of quality
Make sure the pure steam generator you select conforms with current Good Manufacturing Practices (cGMP), which are established by globally recognized regulatory authorities such as the US FDA or ASME.
Avoiding the presence of contaminants at the point of entry, through leaks, or through air being drawn into the system is crucial. Pharma manufacturers must take extra care to keep condensate from building up in the system since it can serve as a haven for microorganisms. Effective interventions such as steam traps, air vents, or air eliminators are necessary to keep steam safe from airborne intruders because even the presence of air in pure steam can lower its optimal temperature and lead to a failed sterilization process.