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Suzhou Yikang Environmental Testing Co., Ltd
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Suzhou Yikang Environmental Testing Co., Ltd

  • E-mail

    changliu006@126.com

  • Phone

    18915420690

  • Address

    Room 402, Building 117, Shuangyin International, No. 1388 Dongfang Avenue, Wuzhong District, Suzhou

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Three indicators for pure steam quality testing

NegotiableUpdate on 01/09
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Overview
The three indicators for pure steam quality testing involved in Suzhou Yikang Environmental Testing are non condensable gas content, dryness, and superheat.
Product Details
The three indicators for pure steam quality testing involved in Suzhou Yikang Environmental Testing are non condensable gas content, dryness, and superheat. as follows:


  • Non condensable gas content (NCG)Non condensable gases such as air and CO ₂ can reduce steam heat transfer efficiency and affect sterilization effectiveness. According to the EN285 standard, the non condensable gas content should be ≤ 3.5%, while the pharmaceutical industry typically requires ≤ 2.5%. Suzhou Yikang Environmental Testing may use cooling method (measuring residual gas volume after condensing steam) or temperature difference method (calculating the difference between steam and saturation temperature) for testing.

  • Dryness Value (DV)Dryness refers to the ratio of gas phase (dry steam) to liquid phase (liquid water) in steam, and the ideal dryness of pure steam should be ≥ 95%. If the steam drying degree is insufficient, it will hinder heat transfer, causing moisture load on porous materials for sterilization, and uneven temperature distribution for non porous materials for sterilization. Suzhou Yikang may use a steam separator to collect liquid water and calculate dryness, or calculate by measuring the thermodynamic state of steam.

  • Superheat (SH)Overheating refers to the degree to which the steam temperature exceeds its saturation temperature. Excessive overheating can lead to sterilization failure and may also accelerate the aging of rubber products. According to the EN285 standard, the degree of superheat should be ≤ 25 ℃, but the pharmaceutical industry typically requires ≤ 5 ℃. The detection method is generally the direct temperature measurement method, which measures the steam temperature and compares it with the saturation temperature

Three indicators for pure steam quality testing

scene

execution standard

key parameters

Validation of sterilization cabinets in EU pharmaceutical factories

EN 285 + GMP

non-condensable gas≤3.5%, dryness≥0.9, overheating≤25℃The condensed water meets the standards for injection water

China Biological Products Production Line

GMP +Internal standards of the enterprise

non-condensable gas≤2.5%, dryness≥95%, overheating≤5℃Endotoxin<0.25 EU/mL

Wet heat sterilization of medical devices

EN 285 + ISO 11138

Dryness degree≥0.95(Metal load), overheating degree≤25℃Validation of biological indicators