Validation of Compressed Air
Validation of Compressed Air in Pharmaceuticals
Compressed air is widely used in pharmaceutical manufacturing for processes like cleaning, drying, aeration, packaging, and equipment operation. Since compressed air may directly or indirectly come in contact with products, its validation is critical to ensure compliance with GMP.
Key Aspects of Validation:
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Risk Assessment – Identify points of use and evaluate criticality (direct vs. indirect contact with product).
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Standards & Guidelines – Follow ISO 8573-1, USP, and GMP requirements.
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Critical Parameters to Validate:
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Non-viable particles (ISO Class limit compliance).
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Oil content (must be negligible or within specified limit).
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Moisture/Dew Point (controlled to avoid microbial growth).
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Microbial contamination (bioburden monitoring at point of use).
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Pressure & Flow (as per process requirement).
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Sampling & Testing Frequency – Initial qualification, periodic monitoring, and requalification.
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Documentation – Protocols, reports, acceptance criteria, and deviations must be recorded.
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Preventive Maintenance & Filters – Regular maintenance of compressors, dryers, and filters is essential.
Outcome:
A validated compressed air system ensures product quality, prevents contamination, and meets regulatory expectations during audits.
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