Compressed air and nitrogen systems are critical utilities in the pharmaceutical, biotech, food, and healthcare industries. They are widely used in production processes, packaging, cleanroom environments, and laboratory operations. Despite being classified as utilities, compressed air and nitrogen systems directly impact product quality and safety, making their validation a regulatory and operational necessity.
At Incredible Pharmaceutical Pvt. Ltd., we offer comprehensive Compressed Air & Nitrogen System Validation services that ensure these systems meet strict regulatory standards such as USFDA, WHO, ISO, GMP, and cGMP. Our validation process is designed to confirm the purity, quality, and consistency of compressed air and nitrogen used in your operations.
Why Compressed Air & Nitrogen Validation is Essential
Compressed air and nitrogen, when in direct or indirect contact with products or cleanroom environments, can become potential sources of contamination. Contaminants may include:
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Particulates (dust, oil, rust)
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Moisture
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Microbial contaminants
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Oil vapors
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Residual hydrocarbons
Validation helps identify and control these risks, ensuring your air and gas systems deliver clean, dry, and contaminant-free output that is compliant with ISO 8573-1, GMP guidelines, and your internal quality standards.
Our Compressed Air & Nitrogen System Validation Includes:
✅ Particulate Testing
We measure non-viable particles using laser particle counters to assess the cleanliness level of air and gas lines, in line with ISO 8573-1 Class 1 to 7.
✅ Oil Content Testing
Detects and quantifies residual oil content in aerosol or vapor form. This is essential for ensuring the air or gas supply is free from compressor oil or lubricants.
✅ Moisture / Dew Point Testing
We evaluate the moisture levels by measuring the dew point, ensuring the dryness of compressed air and nitrogen systems, which is crucial to prevent corrosion and microbial growth.
✅ Microbial Testing (Bioburden)
Sampling and microbial analysis to detect viable microorganisms, ensuring that gases used in sterile and clean environments remain contamination-free.
✅ Pressure and Flow Testing
Verification of pressure stability and flow rates to ensure consistent delivery during operational cycles.
✅ Filter Integrity Testing
We assess the performance of filters installed in air and gas lines, checking for efficiency and pressure drop.
✅ Line Qualification
Verification of installation, cleaning, sterilization, and operational performance of air and gas pipelines.
✅ Sampling Point Mapping
Strategic testing across various sampling points to provide a comprehensive system validation map.
Our Approach
At Incredible Pharmaceutical Pvt. Ltd., we follow a systematic and documentation-driven approach:
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Protocol Development – Custom validation protocols based on your process, critical control points, and regulatory guidelines.
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Execution of Tests – On-site testing using NABL-calibrated instruments and trained personnel.
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Data Review & Analysis – Complete analysis of test results to assess system performance.
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Final Validation Report – Detailed documentation including test results, deviations (if any), conclusions, and compliance status.
Industries We Serve
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Pharmaceutical Manufacturing
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Biotechnology & Life Sciences
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Medical Device Industries
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Healthcare Facilities
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Food & Beverage Plants
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Chemical & Petrochemical Plants
