Sanitary ROTARY VALVE Cleaning Validation

Sanitary ROTARY VALVE Cleaning Validation

H1: Achieving FDA Compliance in Pharmaceutical ROTARY VALVE Systems
Protocol

1. Pre-Clean Sampling: ATP swabs <25 RLU

2. CIP Parameters:

• 2% NaOH @ 80°C for 25 mins

• 0.5% HNO3 rinse @ 60°C

3. Final Verification: TOC <500 ppb

Documentation Requirements

• IQ/OQ/PQ reports per GAMP 5

• 21 CFR Part 11 electronic records