MTPL - Pure Steam Quality Test Kit
MTPL Pure Steam Quality Test Kit is equipped with all the components that are necessary to perform the required test and report the results in accordance with EN 2855, HTM 20102 and ISO 111343 for the following parameters.
Non-Condensable Gas Value
Non-condensable gas test is designed to demonstrate that the attainment of sterilization conditions in all parts of a sterilizer load (particularly for porous load items) is not impaired by the presence of non-condensable gases. There are two sight glasses provided for visualization of steam condensate and non- condensable gas level. These sight glasses are supported by zero adjustable, calibrated scales in the background. When the sampled steam is condensed, the non-condensable gases present are released. The Gas component is separated from the cooled condensate. The gas and steam condensate volumes are measured in the sight glasses.
The non-condensable gas value is considered to be acceptable for sterilization purposes on pharmaceutical and clinical sterilizers if the percentage of gas to condensate is less than 3.5%.
Steam Superheat Value
The amount of moisture in the steam needs to be known, to ensure that the amount of moisture in the steam supply is sufficient to prevent the steam from being superheated as it enters the expanded space of a sterilizer chamber. This is done by simulating the similar conditions in an expansion tube next to the Pitot tube as steam passes through its orifice. The temperature is measured by a thermo-couple placed at the center of expansion tube.
The temperature is considered to be acceptable if it is less than 25o C above that of the local temperature of boiling water.
Steam Dryness Value
The moisture amount needs be within the acceptable limits in the steam supply. If the steam has no moisture, there is a risk that it may superheat when entering the sterilizer and result in conditions where sterilization may not occur. If the moisture content is very high, the loads will remain wet and bacteria can grow in the wet conditions.
The experiment needs a flask, which is filled with known mass of water at a known temperature. Steam is condensed in the flask thus raising the water temperature. By measuring the temperature increase in the water and knowing how much steam has been condensed to produce this temperature increase, the amount of energy present can be calculated which in turn informs the amount of moisture.
A dryness value of 1.0 is equivalent to Dry Saturated Steam. The EN 285 acceptance criteria for the tests is that where metal loads are processed, the dryness value should be greater than 0.95 (less than 5% moisture) and 0.9 for porous loads (10% moisture).
- Non-Condensable Gas apparatus.
- Dual digital thermometer & welded tip type ‘K’ Thermocouple probe.
- Stainless steel flexible steam hose.
- Adjustable Spanner and Pair of industrial protective gloves.
- Pitot tube with a tri clover connection all in stainless steel, 0.4mm, 0.6mm and 0.8mm orifice and superheat expansion tube.
- 1 Litre flask with rubber stopper, dip tubes, rubber connecting tube, SS flask holder and radiant flow valve.
- USB flash drive with calculations and data input sheets, instruction manual, IQ/OQ documents, SOP and calibration certificates.
- Carrying case.
Pure steam is the most energy efficient, reliable, clean and sterile form of transferring heat. Steam can be produced in a range of different grades, each matching different industries and applications. Ensuring the correct grade of steam is important for many processes. Getting it wrong could prove expensive, resulting in product being contaminated, sub- standard or even rejected.
Historically, the healthcare industries have used filtered steam for sterilization. However, in demanding ever-higher levels of purity assurance these sectors have migrated to the adoption of clean and pure steam. Pure steam is also used in humidification of clean rooms in pharmaceutical and microelectronics production. In these environments, entrained contaminates may affect downstream products and processes exposed to the humidification system such as open aseptic processing.
Pure steam is often used in applications such as sterilization not only to remove contaminants, but also to ensure the quality control of critical attributes such as dryness, superheat and production of non-condensable gases, all of which could adversely affect the process and equipment. In unit operations, either the equipment or the pharmaceutical product may be exposed to steam or its condensate. Where this could affect product quality, strict practices needs to be in place in the form of Good Manufacturing Practices as enforced and regulated by the US FDA and the European EMEA. As with clean steam, pure steam is created within a dedicated generator, but one designed, built and operated in accordance with GMP requirements.
The purity of the steam produced is such that its condensate matches the regulatory specifications governing Water for Injection.
Original source for the test limits came from the British National Health Service with the first references appearing in HTM01-01 & EN 285.