SmartSC Pure Steam Sampler

Steam is widely used in various steps of pharmaceutical production, such as heating, humidification, power driving, and drying.  Steam is a good sterilization medium, and pure steam has strong sterilization capabilities and very few impurities, mainly used for sterilization of pharmaceutical equipment and systems.  When pure steam is used for moist heat sterilization, the condensate must meet the requirements of injectable water, and it must also meet the requirements of EN 285 and HTM 2010 standards in terms of non-condensable gases, overheating, and dryness.

China Guide

The Chinese《Pharmaceutical GMP Inspection Guide》has the following requirements for pure steam:

1.  Microbial Limit, the same as injectable water

2.  Conductivity, the same as injectable water

3.  TOC, the same as injectable water

4.  Endotoxin, 0.25EU/ml (if used for injectable preparations)

patent number: 201822231201.9

The unique air-cooled design eliminates the need for external cooling water.

Product Purpose

The SmartSC pure steam sampler is used for the condensation sampling of pure steam.   The instrument meets the GMP requirements, and the components in contact with pure steam are made of 316L stainless steel material, which meets the GMP requirements for pharmaceutical appliances.   After sampling, the condensed water is analyzed for microorganisms, conductivity, TOC, endotoxins, etc.

Working Principle

The instrument is equipped with a built-in return pipe bundle that is embedded in a large power aluminum alloy heat sink.   As the pure steam passes through the return pipe bundle, heat is continuously and smoothly transferred to the heat sink.   The powerful fan blows a large volume of air into the heat sink, carrying away the heat on the heat dissipation fins.   The steam gradually condenses and flows out through the outlet.

Instrument Function

• One-button sampling, only one person is needed to complete the sampling operation, sampling speed: 120 ml/min

• One-button sterilization, sterilize and blow the inside of the pipe to ensure reliable sampling

• One-button air blowing, filtered air blows the residual water in the pipeline, preventing the growth of microorganisms

• Both the inlet and outlet of the return type disk tube are equipped with one-way valves to prevent external pollutants from entering the return type disk tube

• Small size (length*width*height cm: 31*17*30), light weight (10.7kg), convenient for moving between different areas, easy to disinfect the surface

• Lithium battery power supply, meet various sampling scenarios, continuous sampling can be achieved

• Humanized sampling bracket design, no need to hold, avoid the risk of steam scalding

Parameter of Apparatus