Pure steam detection

NegotiableUpdate on 01/09

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Overview

Specific items for pure steam testing: According to relevant regulations and standards, provide condensate water sampling testing, as well as a series of key indicators related to the thermodynamic performance and purity of pure steam, such as non condensable gases, dryness, and superheat values. The detection indicators for condensate water may include conductivity, pH, nitrate, nitrite, ammonia, easily oxidizable substances, non-volatile substances, heavy metals, microbial limits, etc.

Product Details

Provided by Suzhou Yikang Environmental Testing Co., LtdPure steam detectionPurified water testing, injection water testing, and condensate water testing are one of its key services for industries with cleanliness requirements such as pharmaceuticals and food. The relevant introduction is as follows:

Having professional qualificationsIt is a professional third-party testing organization withCMAQualifications and testing reports have legal effect and can meet the requirements of enterprises to comply withGMPCompliance testing with regulations is required.
Specific items for pure steam detectionAccording to relevant regulations and standards, provide condensate water sampling and testing, as well as a series of key indicators related to the thermodynamic properties and purity of pure steam, such as non condensable gases, dryness, and superheat values. The detection indicators for condensate water may include conductivity, pH, nitrate, nitrite, ammonia, easily oxidizable substances, non-volatile substances, heavy metals, microbial limits, etc.

Association verification serviceIn addition to basic testing, it can also provide a pure steam systemIQ/OQ/PQVerification service. At the same time, we provide consultation for the establishment and improvement of enterprise verification systems, offer guidance on the development of verification schemes and report writing, and assist enterprises in improving their quality control system for pure steam systems

·The following is a table of pure steam core testing projects and extended content based on the information you provided, highlighting the standard requirements and testing significance:

Detection category	specific project	Purpose of testing	Standard requirements (based on)	remark
Core testing items	Non condensable gas content	Ensure effective release of latent heat from steam and avoid hindering heat conduction	Volume ratio ≤ 3.5% (EN 285, 2023 Drug GMP Guidelines)	-
	superheat	Prevent sterilization failure or equipment aging caused by excessive temperature	The difference between actual temperature and saturation temperature is ≤ 25 ℃	-
	Drying degree (dryness value)	Control steam humidity to avoid uneven moisture load or temperature distribution of sterilized items	Metal carrier ≥ 0.95, non-metal carrier ≥ 0.9	Different carriers have different requirements
Expand detection content	Quality of condensate water	Ensure that the condensed steam meets high purity requirements	Must meet the standards for injection water, including: -conductivity - TOC -Bacterial endotoxin ≤0.25 EU/mL -Microbial Limit	Directly related to the purity of pure steam source
Expand detection content	Periodic verification	Continuously monitor system stability to meet compliance requirements	GMPSuggestion: -Key Points Monthly 1 time -Non key points each 2 moon 1 time	Commonly used fully automatic detectors to improve efficiency

Expand detection content

‌Quality of condensate water‌Must meet the standards for injection water, including conductivityTOCBacterial endotoxins（≤0.25 EU/mL）And microbial limits.
‌Periodic verification‌：GMPSuggest monthly inspection of key points1Next, non key points every two months1Secondly, fully automatic detectors are often used to verify equipment

2025 The testing items for pure steam condensate water in the Chinese Pharmacopoeia

Test Item	standard requirements	Instructions
trait	Colorless and clear liquid	Visual appearance inspection, with no abnormalities such as turbidity or discoloration
conductivity	25℃Time not exceeding2.1μS/cm(General rules) 0681 Injection water determination method); If it exceeds the standard, it needs to be combined withpHFurther determination of value	Conductivity is the core indicator of purification degree, directly reflecting the content of ion impurities
PH value（pHValue)	Should be in5.0-7.0Within the scope (tested if necessary)	Non mandatory item, only assists in judgment when conductivity exceeds the standard
ammonia	Compliant with regulations（0.00002%）Compared with ammonium chloride solution1.0ml	When the conductivity is judged as qualified in the first step, this item can be exempted from testing
nitrate	According to the method of purified water inspection, it meets the requirements	Control the risk of nitrogen-containing organic impurity pollution
nitrite	According to the method of purified water inspection, it meets the requirements	Avoid nitrite toxicity and potential carcinogenic risks
heavy metal	Content not exceeding0.1ppm(General rules) 1143）	Testing as necessary, based on conductivity results or risk assessment
Total organic carbon（TOC）	Not allowed to pass0.50mg/L(General rules) 0682）	Reflecting the level of total organic impurities, and“oxidizable substance”Choose one of the two items for testing
oxidizable substance	10mlAdd dilute sulfuric acid to the sample0.02mol/L potassium permanganatetitrant0.10mlBoil it 10 Pink won't disappear in minutes	andTOCChoose one from two, used to evaluate the content of reducing impurities
non-volatile matter	Usually not exceeding1mg/ml(Testing as necessary based on risk assessment)	Control the residual solid impurities after steaming and drying
bacterial endotoxin	each1mlThe endotoxin content is less than0.25EU	Key indicators to avoid pyrogen contamination, especially suitable for sterile formulation related scenarios
Microbial Limit	According to the general rules 0261 Implementation of Microbial Monitoring Requirements for Pharmaceutical Water	Need to combine dynamic monitoring strategies throughout the process to control the risk of microbial contamination

Note:

The detection of pure steam condensate water should refer to the injection water standard, reflecting the strict requirements for steam purity.
The detection of some projects (such as ammonia and heavy metals) can be simplified based on the preliminary judgment results of core indicators such as conductivity to improve detection efficiency.
2025 The "Guidelines for Pharmaceutical Water Inspection (Draft for Comments)" further clarifies the limit requirements for condensate water to be consistent with injection water, and strengthens compliance guidance.