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Compressed Air Validation
 
 
 
Compressed Air / Nitrogen Gas Testing or Validation
 
  • * Compressed air and its impact in Pharmaceutical Industries
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  • Clean dry air is essential for many different types of industrial applications. This air is supplied by compressors which draw in large volumes of air from the surrounding atmosphere containing contaminants. Typically, drying and hydrocarbon removal systems are in place prior to filtration and then release to the compressed air line system of the plant. However, having these treatments in place is no guarantee of their efficacy. In some cases the air compressor itself can add contaminants.
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  • Compressed air is air kept under a pressure that is greater than atmospheric pressure. It serves many domestic and industrial purposes. Compressed Air is a vital energy source and is utilized in multiple operations in industries. When properly treated, Compressed air is regarded as a safe, clean utility, as compared to other energy sources. Compressed provides the energy source for pneumatic conveyers that transport liquids, powders and moisture sensitive product throughout the plant.
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    Following tests to be performed for Checking Compressed Air Quality
     
  • 1. Dew Point
  • 2. Oil Content
  • 3. Particulate matter
  • 4. Moisture Content
  • 5. Viable Count.
  • 6. The International Standard Organisation sets quality standards for Compressed air as ISO:8573.
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    1. Dew Point
     
  • The dew point is the temperature below which the water vapor in air at constant barometric pressure condenses into liquid water at the same rate at which it evaporates. The condensed water is called dew when it forms on a solid surface.
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    2. Oil Content
     
  • A Compressed Air Oil content test is a measure of the Oil Content of Compressed air 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 an Compressed Air System and an Oil content of less than 0.01 mg/m3 is generally specified.
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    3. Particulate matter
     
  • Compressed air 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, compressed air is in direct contact or indirect contact with product and the impurities in the compressed air 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. Compressed Air is generally filtered to remove Particulate Matter to a level less than 0.02 mg/m3 (size 100% <0.01 micron).
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    4. Moisture Content
     
  • All atmospheric air contains some water vapor which will begin to condense into liquid water in the compressed air or 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 compressed air 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. Moisture adversely affects the color, adherence, and finish of paint applied by compressed air. Corrosion of air or 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 <0.01% for Compressed Air System.
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    5. Viable Count
     
  • Viable Organism testing is performed using a Slit to Agar sampler, where a high velocity of air through the sampler impacts upon a sterile agar plate allowing the air to deflect away from the plate while any particles remain in the collection plate. A 24-48 hour incubation period will then determine the presence, or otherwise, of any viable micro-organisms within the air system.
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    Remaining test with gas detector tube :
     
  • Compressed air, oxygen, nitrogen, and carbon dioxide are often used in pharmaceutical production environments and are subject to the Good Manufacturing Practices.
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  • Analyzing gases within a production environment involves testing them upon receipt at the facility as well as subsequent tests when the system is operational and after any changes or intervention to the production systems are made. The aim is to verify the absence of any potentially hazardous or disruptive materials.
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  • Creative consultancy provides advice, sampling, and GMP compliant analysis of media in a pharmaceutical environment based on the requirements of the pharmacopoeias (e.g. EP, BP and USP).
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    What is validation?
     
  • Validation is a process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages.
  • In Pharma Industry it is very important apart from final testing and compliance of product with standard that the process adapted to produce itself must assure that process will consistently produce the expected results
  • Here the desired results are established in terms of specifications for out come of the process. Qualification of systems and equipment is therefore a part of process of validation.
  • It is a requirement of food and drug, pharmaceutical regulating agencies like FDA's good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
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    Validation Services
     
  • Clean Room and HVAC/AHU Validation/Qualification
  • Compressed Air/Nitrogen Gas Testing or Validation
  • Pure steam Quality test
  • Documentation services
  • Equipment validation
  • Facilities validation
  • HVAC system validation
  • Cleaning validation
  • Process Validation
  • Analytical method validation
  • Computer system validation
  • Packaging validation
  • Cold chain validation
  • Compressed Air Validation
  • HVAC Validation
  • Clean Room Validation
  • cold chain Validation
  • PLC Validation
  • Thermal Validation
  • Steam Quality Test
  • Design validation services
  • Pharma Validation Services
  • Data-verification validation services
  • Clean Room AHU Area Validation Services
  • Calibration validation
  • Equipment Validation Services
  • Flow Calibration
  • IAQ - Indoor Air Quality
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    The Validation Process:
     
  • The validation scope, boundaries and responsibilities for each process or groups of similar processes or similar equipment's must be documented and approved in a validation plan. These documents, terms and references for the protocol authors are for use in setting the scope of their protocols. It must be based on a Validation Risk Assessment (VRA) to ensure that the scope of validation being authorised is appropriate for the complexity and importance of the equipment or process under validation. Within the references given in the VP the protocol authors must ensure that all aspects of the process or equipment under qualification; that may affect the efficacy, quality and or records of the product are properly qualified. Qualification includes the following steps:
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    Design qualification (DQ)
     
  • Demonstrates that the proposed design (or the existing design for an off-the-shelf item) will satisfy all the requirements that are defined and detailed in the User Requirements Specification (URS). Satisfactory execution of the DQ is a mandatory requirement before construction (or procurement) of the new design can be authorised.
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    Installation qualification (IQ)
     
  • Demonstrates that the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.
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    Operational qualification (OQ)
     
  • Demonstrates that all facets of the process or equipment are operating correctly.
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    Performance qualification (PQ)
     
  • Demonstrates that the process or equipment performs as intended in a consistent manner over time.
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    Component qualification (CQ)
     
  • This term refers to the manufacturing of auxiliary components to ensure that they are manufactured to the correct design criteria. This could include packaging components such as folding cartons, shipping cases, labels or even phase change material. All of these components must have some type of random inspection to ensure that the third party manufacturer's process is consistently producing components that are used in the world of GMP at drug or biologic manufacturer.
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