Pure Steam Solution

Pure steam is primarily obtained through a pure steam generator, which is a device that uses purified water as the raw material, and produces pure steam meeting pharmaceutical standards by utilizing industrial steam or electric heating. The generated pure steam is free from pyrogens and condensate, making it mainly suitable for the sterilization and disinfection of pharmaceutical equipment and production lines, as well as humidity control in cleanrooms. The pure steam generator is currently one of the key pieces of equipment used for sterilizing tank systems, pipeline systems, and filters.

Main Characteristics of Pure Steam

High purity, free from additives
Free from pyrogens (bacterial endotoxins)
High dryness value (high dryness fraction)
Low non-condensable gas content
Stable pressure/temperature relationship

Technology of Pure Steam Generation

Modular components of Pure Steam Generation

Feedwater System (optional)

Feedwater Pump

Feedwater Analyzer

System Components

Evaporator

Steam Seperator

Condensor

Sampling

Controls

Frame

Pure steam is a highly clean, pyrogen-free, and impurity-free vapor widely used in industries with stringent requirements for hygiene and sterility, particularly in pharmaceuticals, biotechnology, and medical devices. Below is a classification of its main applications:

1. Pharmaceutical and Biopharmaceutical Industry

Sterilization: High-temperature sterilization in autoclaves; Sterilization-in-Place (SIP) of pipelines, valves, storage tanks, and filters; sterilization of aseptic filling systems.
Equipment Cleaning: High-temperature cleaning of sterile production line equipment; surface disinfection and depyrogenation in clean areas.

2. Medical Devices and Hospital Applications

Sterilization of surgical instruments;
Disinfection of sterile packaging;
Sanitization of hemodialysis equipment;
High-temperature sterilization processes in Central Sterile Supply Departments (CSSD).

3. Food and Beverage Industry

Sterilization of packaging containers;
Cleaning of production line equipment;
Contamination-free heat source in cooking processes.

4. Electronics and Precision Industries

Heat source for high-purity water systems;
Sterile treatment of cleanroom equipment;
Auxiliary heat treatment in semiconductor processes.

Global Standards on Key Physical Parameters for Pure Steam

Physical Parameters

EN 285:2015

HTM 2010 & NHS

ASME BPE & Industry Practice

WHO GMP Annex

China GMP / Industry Practice

Dryness

≥ 0.95

(i.e., ≥ 95%)

≥ 0.9

(Typically ≥ 0.95)

≥ 0.95

(Widely Accepted Best Practice)

≥ 0.95

(Refers to EN Standard)

≥ 0.9

(Generally ≥ 0.95, aligning with EN)

Non-condensable Gases

≤ 3.5%

(v/v volume ratio)

≤ 3.5%

(Consistent with EN)

≤ 3.5%

(Widely Accepts EN Standard)

≤ 3.5%

(Refers to EN Standard)

≤ 3.5%

(Widely Accepts EN Standard)

Superheat

≤ 25 K

(Measured at 101.3 kPa, 100°C)

≤ 25 K

(Consistent with EN)

≤ 5°C

(Measured at the sterilizer chamber inlet, more stringent requirement)

≤ 25 K

(Refers to EN Standard)

≤ 25 K

(Widely Accepts EN Standard)

Pressure Range

Meets sterilization process requirements