vashishtaengg.com

Our Services

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Thermal Validation

We qualify equipment that relies on precise temperature control to ensure product stability and sterility.

  • Autoclave / Sterilizer Qualification

  • Lyophilizer Qualification

  • Depyrogenation Tunnels & Ovens

  • Dry Heat Ovens

  • Stability & Photostability Chambers

  • Incubators

  • BOD, Deep Freezers & Walk-In Freezers

  • Washer Disinfectors

  • CIP (Clean-in-Place) & SIP (Steam-in-Place) Systems

HVAC & Clean Room Validation

We certify your controlled environments to ensure they meet defined classifications and operational parameters as per ISO 14644, EU GMP, and WHO guidelines.

  • Clean Room Certification & Classification (Particle Count)

  • HEPA/ULPA Filter Integrity Leak Testing (PAO/DOP)

  • Airflow Velocity & Volume (ACH) Measurements

  • Room Recovery Testing

  • Airflow Visualization (Smoke Studies)

  • Room Pressure Differential Mapping

  • Temperature & Humidity Uniformity Mapping

  • Containment Leak Testing

  • Light and Sound Level Testing

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Utility Systems Validation

We test and validate critical process utilities to ensure they meet purity and quality specifications.

  • Pure Steam Quality Testing:

    • Non-Condensable Gases

    • Dryness Fraction

    • Superheat

  • Compressed Air/Gas Validation:

    • Oil Content & Hydrocarbons (HC)

    • Moisture Content & Dew Point

    • Non-Viable Particle Count

    • Purity Analysis (CO, CO₂, SO₂, NOx, H₂S, O₂)

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