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Steam grades and application requirements for biopharmaceuticals

Steam refers to water steam, as a heat carrier medium, widely used in heating, humidification, power drive, drying and other fields.

Although steam is colorless and tasteless, its purity is graded. Different grades of steam are used in different processes in different industries due to their different qualities.

At present, three different grades of Steam are commonly used in the food industry: industrial Steam (Utility Steam or Black Steam), vapor ( cooking ) superheated, and Clean Steam.

Industrial steam

Usually used in heat exchange applications, it contains impurities and other chemicals and is not suitable for use in direct contact with food applications.

Industrial steam is the steam produced by boilers, also known as “black steam”. Usually, boilers and pipes are made of carbon steel, and the water supply is softened water. Under the condition of high temperature and oxygen, corrosion and scaling are easy to occur.

In order to protect boilers and pipelines, chemicals are often added, such as deoxidizer, scale inhibitor, corrosion inhibitor, and there are dirt and rust in carbon steel pipelines during transportation.

Industrial steam contains a variety of chemical substances, rust, dirt, in the food industry, when the steam and food or food contact surface contact, steam contains a variety of pollutants will affect the taste and quality of the product, at the same time will bring chemical risks and physical risks to product production.

vapor superheated

Also known as cooking steam, it passes through a sophisticated stainless steel filter to remove impurities from the steam.

The sophisticated filter can filter 95% of impurities larger than 2 microns, but not impurities smaller than 2 microns. And it doesn’t filter and remove chemicals from the steam.

Therefore, the boiler water treatment additive is required to meet the requirements of food grade. At the same time, the filter needs to be cleaned regularly, otherwise the filtering capacity will be significantly reduced, resulting in risks.

Clean steam

The steam generated by industrial steam heating pure water (deionized water or reverse osmosis water, without any chemicals), while the material of the clean steam generator must be stainless steel to avoid the risk of impurities and chemical contaminants.

It is widely used in direct heating, sterilization, cleaning, spraying, cooking and other applications in the food industry. It is an ideal choice for the food industry.

Different grades of steam generation and characteristics are also different. The temperature and relative humidity of the clean room of pharmaceutical enterprises should be adapted to the production requirements of drugs, so as to ensure the comfort of the production environment of drugs and personnel. The use of industrial steam or filter steam in pharmaceutical manufacturing processes has a significant potential pollution risk. There are also the following provisions in national cGMP, the impact of which should be fully considered:

1)Steam is recommended for humidification because it inhibits microbial growth.

2)Additives in humidifying steam can have an adverse effect on the product or process, so the humidifying system must be verified to be free of those additives.

3)When using steam humidification, boiler water additives must not cause unsafe risks to human respiration, some specific products and processes may be sensitive to these additives. When the environment must be controlled by humidity and the chemical addition of boiler steam is not allowed by the process, pure water can be used to prepare steam for humidification to avoid this problem.

4) Humidified steam additives should ensure indoor breathing safety, and comply with the relevant indoor air quality standards and local regulations.

Industrial steam and filter steam are not suitable for humidification in pharmaceutical industry. Chemical Free Steam is needed to protect pharmaceutical enterprises. The quality of clean steam can be guaranteed from water source, pipeline material to equipment material, design, control and other aspects. Clean steam can be used for humidification applications where the product is not exposed to air. If humidification steam endangers the quality of the product, pure steam is needed.

Watt clean steam produced using industrial steam as heat source, conforms to the requirements of pure water, heating system equipped with high performance in heat and drain system, achieve high efficiency heat transfer, at the same time, specially designed for steam pneumatic pressure control valve can accurately control the desired clean steam pressure, equipped with perfect level control, automatic on-line sampler and continuous blowdown system, guarantee the stability of the steam quality.

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