Pure Steam Quality Test Kit

Pure Steam Quality Test Kit,Pure steam quality tester, pure steam quality tester, pure steam quality tester

In the pharmaceutical and healthcare industries, there are basically two types of steam - process steam and pure steam. Process steam is also called factory steam, black steam, utility steam, boiler steam, etc. Pure steam is sometimes called clean steam.

Process steam is defined as a general purpose steam whose quality is not optimized for sterilization. If it is not intended to directly contact with medical devices, medicines or cooking products, there is no specific physical

Typically, in these processes, pure steam is injected into equipment or piping to create a sterile environment, or into an autoclave to disinfect loose equipment, components (such as vials and ampoules), or products. Pure steam can be used

Physical characteristics required for pure steam

Test acceptance criteria

Non condensable gas 3.5% (maximum)

Dryness value 0.9% (min)

Supercalorific value 250 ºC (large)

It is used for other functions where traditional public steam may cause pollution, such as humidification in some cleanrooms, and injection of high-purity water for heating before CIP operation.

Concept of pure steam quality inspection

Prior to the release of the 2010 Health Technology Memorandum (HTM 2010), there was no requirement for routine physical steam quality testing in the National Health Service (NHS). Pure steam is tested for chemical and biological specifications only. Although HTM 10 (4) provides details of dryness values and non condensable gas tests, these tests should be used as required by the situation. Prior to this, it was tested on the subjective assessment of the dryness of the load and the measurement of overheating as part of the routine temperature test.

In the mid-1970s, the NHS in the UK incurred huge costs due to the failure of the sterilization cycle of the porous load/equipment. The failure was mainly due to the wet load, the chemical indicator on the package and the failure to change the color and air detector correctly during the Boydik test, which led to the automatic failure of the cycle. In addition to the obvious quality problems, this also led to the need to repack and re disinfect the load at considerable cost.

The design quality of pure steam and pure steam distribution pipeline is poor, and the functional failure of steam trap of sterilizer leads to the failure of heat distribution.

It has been seen that wet steam, superheated steam or non condensable gas may adversely affect the sterilization of equipment loads in the pharmaceutical industry. The extent to which the process is affected will depend on the extent of the problem and the nature of the load. Good practice shows that we should know the condition of the steam we use for equipment or porous load sterilization, so as to confirm that the design requirements of our steam lifting equipment have been met and assist in troubleshooting. Although HTM 2010 stipulates that a routine test should be conducted once a year at the point of use, the time period between tests may not be sufficient to detect any temporary or seasonal problems.
Now, as a good manufacturing practice (GMP), the International Organization for Standardization (ISO), HTM 2010 and EN 285 have defined the steam quality for sterilization purposes. It is necessary to ensure and verify the quality of steam regularly.
For many years, steam quality testing has been the European Union (EU)'s EN 285 requirements, and has been adopted by pharmaceutical environments in many other countries and regions.
In order to determine the quantity of non condensable gas in pure steam, it is necessary to set the non condensable gas removal (NCGR) device before the pure steam generator.

Steam SQ pure steam quality tester, steam quality tester, pure steam generator verification

model
Configuration/Description
remarks
Steam SQ-Q
Pure steam sampling device (water for injection sampling sampler)
Including elbow, triangle foot, carrying case, etc
Steam SQ-B
Including non condensable gas test, overheat value test and dryness value test functions
No steam condensation sampler
Steam SQ-A
Including non condensable gas test, overheat value test and dryness value test functions
And pure steam sampling device (water for injection sampling sampler)
full set
characteristic:
Meet the requirements of HTM2010, HTM2031 and EM285, CGMP, EUGMP, FDA and China 2010GMP for steam quality test amount.
Provide equipment system calculation software, and provide equipment SOP documents, which comply with EN285 and HTM2031
There are four different models, A, B, Q, G, to meet different test needs of customers.
It is movable, convenient for on-site testing, and can test the steam quality at the generating end and the using end of the steam.
The equipment shall be provided with factory test report and original documents
Steam SQ Steam quality testing system is safe, simple, convenient, efficient, beautiful in appearance, light in weight, and convenient for mobile multi-point measurement.
 Provide equipment measurement and calibration services (temperature measurement system - overheat value; weighing system - dryness value; capacity measurement - non condensable gas content)
 Provide precautions for equipment maintenance. Provide training confirmation certificate.



Pure steam quality tester, pure steam quality tester, pure steam quality tester, pure steam quality testing system, pure steam tester, pure steam quality tester manufacturer