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, Vijaya Enviro Labs is giving you the best service with sophisticated Equipment- Gas Analyzers to monitor the Nitrogen.

Validation activities can be applied to all aspects of the product in any of its intended environments such as operation, training, manufacturing , maintenance and support services. Vijaya Enviro Labs validate Compressed Air in all kinds of industries as the demand for compressed air quality depends on its usage and Vijaya Enviro Labs can also validate Compressed Air in some industries where they require extremely high quality air along with Breathing Air Validation, Instrument Air Validation and Nitrogen Gas Validation.

The most common gases used in Pharmaceutical Industries are compressed air used for instruments or product contact, and Nitrogen used for providing an inert gas in the vial, ampoule or WFI tanks and used for creating an inert pressure pad in processes where solvents are present.

The Quality of Nitrogen Gas is important to ensure that product is safe. The most important parameters in specifying Nitrogen Gas quality are:

• Purity
• Gases such as O2, CO & CO2
• Odor
• Dew Point
• Oil Content
• Particulate matter
• Moisture Content
• Viable Count
• Identification Test

The European and US Pharmacoepia sets quality standards for Nitrogen Gas.

Dew Point - The Dew point temperature or Saturation temperature can be defined as the temperature at which Water vapour begins to condense. The quantity of any gas in a mixture can be expressed as a pressure. Gas of unknown water vapor concentration is passed over a temperature-controlled surface. The surface is cooled until condensation forms. The temperature at which condensation forms is called the “Dew Point temperature.” Because there is a unique correlation between temperature and saturation vapor pressure, measuring the Dew point temperature of a gas is a direct measurement of the partial pressure of water vapor. Desiccant drying systems absorb water vapor from the air stream and can produce air with a Dew point of -40 °F (–40 °C) and drier if required.

Oil Content- A Nitrogen Oil content test is a measure of the Oil Content of Nitrogen systems. The test can accurately determine the amount of Oil flowing in a Compressed Air stream and assess whether the system complies with relevant requirements. Many Compressed air systems are supplied using lubricated compressors. These Compressors often blow small particles of Oil throughout the system, which can cause a range of problems for components when the Oil emulsifies with water in the system. Oil free air is generally required for a Nitrogen System and an Oil content of less than 0.01 mg/m3 is generally specified.

Particulate Matter- Nitrogen is used in a broad range of applications in the industries and used in the mixing of ingredients, cutting, sparging, drying of product, transporting/propelling product through processing systems and packaging of final product. In many of these applications, Nitrogen is in direct contact or indirect contact with product and the impurities in the Nitrogen may contaminate the product which can result in change of color and taste, reduced shelf life, in addition to exposure to bacteria and other microorganisms can result in product recalls. Compressed air, which is generated on site by pulling in ambient air and compressing it, contains water vapor, particulate matter (atmospheric air typically contains 140-150 million dirt particles/m3). More importantly, the filtration systems that are employed are designed to protect process equipment from large slugs of water, oil, rust and pipe scale with a nominal rating of 25 to 40 micron and are not capable of removing submicron contaminates. Nitrogen has the particulate matter of < 5 mg/m3.

Moisture-All atmospheric air contains some water vapor which will begin to condense into liquid water in the Nitrogen gas system when the air or gas cools past the saturation point, i.e., the point where it can hold no more water vapor. The condensed moisture must be removed by a separator and trap. Moisture in Nitrogen used in a manufacturing plant causes problems in the operation of pneumatic air systems, solenoid valves and air motors. This moisture causes rust and increased wear of moving parts as it washes away lubrication. Corrosion of gas operated instruments from moisture can give false readings, interrupting or shutting down plant processes. The malfunctioning of these controls due to rust, scale, and clogged orifices can result in damage to product or in costly shutdowns. Additionally, the freezing of moisture in control lines in cold weather commonly causes faulty operation of controls. Moisture content should be less than < 67ppm v/v for Nitrogen Gas System.

Viable Count- When the Nitrogen supply system is operating, it may unleash contaminants which could adversely affect the product, including operational characteristics, by compromising sterile claims, or product aesthetics. The condition or the quality of the supplied gas, from a microbiological standpoint, may not be obvious unless microbiological testing is performed. A simple air impaction microbial assay of compressed air lines, however, will alert the manufacturer to the various types of viable microorganisms that might be present. Manufacturers of medical devices, pharmaceutical operations, or those classified as sterile fill, are constantly assessing the environmental impact on the product during the manufacturing process. This assessment usually includes the facility, the equipment, and the personnel involved in the assembly process. Sampling may include, but is not limited to, surface sampling, particulate counts, water analysis, and product testing. For Nitrogen Gas system, Viable count should be <1 CFU/m3.

 

TESTING ENQUIRY FORM