In the pharmaceutical industry, clean steam finds use in a variety of pharmaceutical applications, such as the sterilization and sanitation of equipment and materials, creation of chemical compounds, and the dilution of IV drugs. The following blog post outlines typical applications of clean steam in the pharmaceutical industry and the benefits of using it.
Clean Steam in the Pharmaceutical Industry
The use of clean steam in the pharmaceutical industry ranges from sanitization to inclusion in pharmaceutical products. Typical applications include:
The pharmaceutical industry frequently employs clean steam to sterilize equipment, avoid the cross-contamination of ingredients in consecutive batches of pharmaceutical products, and prevent the growth of biological contaminants. A sterilize-in-place or steam-in-place (SIP) system is typically installed in pharmaceutical facilities to further clean equipment between production cycles after the completion of the clean-in-place (CIP) process.
SIP systems employ superheated water purified to USP standards for sterilization operations. According to ISO 13405:2006, they must heat manufacturing equipment for sterile healthcare products to a temperature of 250° F for a minimum of 30 minutes. The systems monitor the temperature and times of the sterilization process to ensure it complies with the process requirements.
Generating the clean steam needed for sterilize-in-place and other pharmaceutical applications necessitates the use of one of two types of equipment: clean steam generators or water purification systems. Clean steam generators create superheated purified steam for the sanitization of equipment and surfaces. Water purification systems generally consist of a larger purification network that often incorporates a clean steam generator.
Compound Distillation and Extraction
Clean steam plays a role in a variety of pharmaceutical compound manufacturing processes, including:
- Steam distillation to isolate fatty acids
- Extraction and purification of organic compounds
- Heat generation for distillation, extraction, and formula creation
As these processes often produce compounds intended for human use, they require high-purity steam. This requirement demands the use of a clean steam generator.
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Benefits of Clean Steam Generators
Clean steam generators offer a number of benefits for users in the pharmaceutical industry, such as:
Reduced Corrosion Potential
Due to the purification process, clean steam is less corrosive than standard utility steam, which must often be treated with corrosion-inhibiting chemicals to avoid corroding system components. Clean steam does not have the same corrosive effect, thereby allowing equipment to last longer and produce higher purity products.
Prevention of Microbial Growth
Clean steam is maintained at temperatures that are sufficiently high enough to ensure the prevention of microbial growth in the system. Clean steam generators must be specifically designed to prevent the collection of condensed water in any part of the system where microbes and endotoxins may be exposed to the steam and contaminate the product.
Stainless Steel Clean Steam Generators From Electro-Steam
At Electro-Steam Generator Corp., we offer a wide range of clean steam systems, including:
- LG Models with power ratings of 10, 15, 20, 25, 30 and 40 kW
- LB Models with power ratings of 40, 50, 60, 80, 100, 120, 150, 180, and 240–480 kW
- Indirect Models with power ratings of 30 kW to 240 kW (based on utility input)
- Models with pressure capacities from 0–100 psi and pressures over 100 psi