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Environment Monitoring

Areas/ Zones:

→ ISO-Classified Cleanrooms (ISO 5–8 / Grade A–D)
→ Aseptic & Sterile Processing Areas
→ Manufacturing & Production Areas (Open Product)
→ Weighing, Dispensing & Compounding Areas
→ Personnel Gowning Rooms & Airlocks
→ Material Airlocks & Pass-Throughs
→ Clean Corridors & Controlled CNC Areas
→ Isolators & RABS
→ Environmental Monitoring for Utilities (HVAC, HEPA, Compressed Air)
→ Viable & Non-Viable Monitoring Locations

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Other Compliance Services
Data Integrity Lifecycle

Proactively identify and close compliance gaps    

  cGMP Validation       

End to end URS/ DQ/ IQ/ OQ/ PA execution      

Compressed Air Testing

Testing per ISO 8573 and GMP purity standards

Temperature Mapping

Seasonal studies and validation for Storage areas

Documentation Preparation

Audit Ready documentation preparation

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Compressed Air Testing

ISO 8573 · Purity · Sampling

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Data Integrity Lifecycle

ALCOA+ · FDA-DI · 21 CFR Part 11

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Temperature Mapping

Storage · Transport · Mapping

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Validation/ Qualification

URS · IQ · OQ · PQ

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Environmental Monitoring

Sampling · Trends · Cleanrooms

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GMP Documentation

SOPs · Protocols · Records

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