Archives: What We Do

AFVS studies to map air movement, detect dead zones, and ensure cleanroom integrity for unidirectional flow systems.

CSV, CSA, and PLC validation ensuring your computerized systems meet 21 CFR Part 11 and GAMP 5 requirements.

PSQT services verifying steam purity meets pharmacopoeial limits for non-condensable gases, superheat, and dryness fraction.

Autoclaves, ovens, and sterilization equipment thermal validation ensuring uniform heat distribution and process repeatability.

Cold room, warehouse, and storage area temperature mapping validations for compliant pharmaceutical storage conditions.

Compressed air quality testing per ISO 8573 and pharmacopoeial standards — moisture, particulates, and microbial analysis.

Comprehensive validation ensuring controlled environments meet stringent pharmaceutical standards.

 Our systematic approach guarantees successful project delivery and regulatory compliance.

Audits, QMS, investigations, CSV/CSA training, QC data review, and vendor audits.

Cleanstep provides comprehensive turnkey solutions for pharmaceutical, biopharmaceutical, medical device, and healthcare facilities—from concept and design to commissioning, validation, regulatory compliance, and lifecycle support.