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Breathing Air Validation

Breathing Air Validation Breathing Air- The Quality of air is important to ensure that Respiration System will function properly and reliably. Clean, '. Natural Air is an odourless, colourless gas mixture. Air contains three major elements make up about 99.97% of Dry Air: Nitrogen (N2) at 78.09%, Oxygen (02) at 20.95, Argon (Ar) at 0.93%. An important minor component of natural air is Carbon Dioxide (C02) at 0.03% (300ppm).

Nitrogen Gas Validation

Nitrogen Gas is a critical component in the production of pharmaceutical industry and effects on the quality of the end product. Therefore it should be monitored to ensure that desired quality of the compressed air is using in production. So, Sandy Industry Solutions are giving you the best service with sophisticated Equipment-GasAnalyzers to monitor the Nitrogen.

Pure Steam Testing

Steam quality test equipment to qualify plant/utility/clean/pure steam generators, steam distribution systems and steam supplies to autoclaves in accordance with cGMP (Orange Guide), HTM 01, HTM 2010 (replaced by CFPP01-0l): 1994, HTM 2031 (replaced by CFPP01-0l): 1997, EN 285: 2006, DIN 58950, ISO14937:2000, AAMIST79, ISPEBaselineGuideforSteam and Water, and PDATechnical Reports No.l&48 Non-condensable gases (inert gases): condensable gases (inert gases): Mainly NH3 (Ammonia), C02, N2, 02 and halogenated Hydrocarbons Why we have to test non-condensable gases? EN 285: The steam quality test, noncondensable gases, is used to demonstrate that the level of non-condensable gases contained in the steam will not prevent the attainment of sterilization conditions in any part of the sterilizer load. Dryness Value: The dryness fraction of steam is a number without units that describes the amount of moisture present. A value of 0 indicates the presence of 100% water and a value of 1 represents dry saturated steam (absence of any moisture). Therefore steam having a dryness fraction of 0.97 is a mixture of 3% moisture and 97% dry saturated steam. When we carry out steam quality testing using either EN 285 or HTM2010, the term "dryness value" is used in place of "dryness fraction". Other than in this application, the term dryness value is neither known nor used Superheat Testing: Superheated steam poses a risk to sterilization as it contains no moisture, which, combined with temperature, is essential for the coagulation of bacterial cell walls. Superheated steam will have the same sterilizing effect as hot air and will require very long hold times at the temperatures used within sterilizers. Superheated steam, while not common can be present either for short durations or throughout the cycle. The cause of superheated steam is usually as the result of large pressure drops between the steam distribution system and the sterilizer. EN 285 recommends that the pressure drop ratio should not exceed 2:1. If you are sterilizing at 121 degrees Celsius (nominal 1 Barg), the supply pressure to the sterilizer should not exceed 2 BarG. The test is carried out by reducing the supply steam pressure to atmospheric through an orifice (pitot tube) and measuring the steam temperature a fixed distance away. If the measured temperature does not exceed the boiling point at the local pressure (typically 100 degrees Celsius) by more than 25 degrees Celsius the test is deemed to have passed (EN 285). When testing, we try to ensure that we measure the highest temperature and adjust the temperature sensor position to ensure that this is the case.

Pharmaceutical Process Air & Gas Validation

Pharmaceutical Process Air & Gas: Testing and monitoring of compressed air and other process gases such nitrogen, oxygen, argon, and carbon dioxide that comes into direct contact with pharmaceutical products is vital to assuring the quality and safety of those products. Compressed air is a Critical Process Parameter (CPP)whose variability has an impact on the Critical Quality Attribute (CQA) and therefore should be monitored' or controlled to ensure the process produces the desired quality. [ICH Q8 (R2) II 4.0] During commercial manufacturing, a well-defined system for process performance and product quality monitoring should be applied to assure performance within a state of control and to identify improvement areas. [ICH Q10 3.2.1] Quality risk management should include facilities, equipment, and utilities. [ICHQ9] An important international standard, ISO 8573-1, provides a variety of Purity Classes that can be incorporated into a robust quality assurance plan for this critical utility. Testing and monitoring of compressed air and other process gases such nitrogen and oxygen that come into direct contact with the product is vital to assuring the quality and safety of the product