UltraSC Pure Steam Sampler

UltraSC 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, which meets the GMP requirements for pharmaceutical utensils. After sampling, the condensed water is analyzed for microorganisms, conductivity, TOC, and endotoxins.

Pure steam sampler industry background

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.

Instrument composition

UltraSC Pure Steam sampler features

Pure air-cooled design

• Patent technology, patent number: 201822231201.9

• The pure steam sampling speed greater than 240mL/min.

• No need to add cooling liquid, reducing operation steps, maintaining constant sampling  speed.

Portable design

• Equipped with a pull handle and roller wheels for easy transfer of samples between different points

• High-capacity lithium-ion battery with a long-lasting battery life of over 5 hours

• Dimensions (LWH): 38×20x53mm

One-button for sterilization design

The instrument comes with a sterilization program, and a visual reminder is provided during the sterilization process, along with a buzzer notification when the sterilization is complete.

Pollution prevention design

The magnetic dust shield can effectively blocks the entry of particles during storage.

Both the inlet and outlet of the ring shape pipe are equipped with one-way valves to prevent external pollutants from entering the ring shape pipe.

The filtered air blows out the residual water in the pipes, preventing the growth of microorganisms.

Sample tray design

The magnetic sample tray can hold a weight of 3kg and can be freely adjusted up and down without the need for hand-holding the container.

UltraSC Pure Steam sampler device parameters