What is cleaning validation?
Cleaning validation is the documented proof that a cleaning procedure consistently brings surfaces to an acceptable level of cleanliness and safety. It is not enough to have an SSOP (Standard Sanitation Operating Procedure) — you must demonstrate that it works.
The validation process in 5 steps
Define the SSOP
Fully document the cleaning procedure: chemicals, concentrations, contact times, temperatures, methods and frequency. This is your baseline.
Select measurement points
Choose representative measurement points: high-risk areas, hard-to-clean spots and product contact surfaces. Minimum 3 measurement points per piece of equipment.
Baseline measurements
Conduct at least 6 measurement cycles to understand typical RLU values after correct cleaning. This forms the statistical basis for your limits.
Set limits
Calculate PASS/FAIL limits based on your baseline data and Charm Sciences TECH-137 recommendations. Document the rationale.
Validation report
Create a validation report including: measurement point descriptions, statistical analysis, established limits and conclusion. This report is your audit evidence.
Recommended RLU limits by surface type (Charm Sciences TECH-137)
| Surface type | Limit | PASS | FAIL |
|---|---|---|---|
| Stainless steel | 1000 RLU | PASS ≤ 1000 | FAIL > 1000 |
| Teflon/PTFE | 4500 RLU | PASS ≤ 4500 | FAIL > 4500 |
| Plastic | 2500 RLU | PASS ≤ 2500 | FAIL > 2500 |
| Aluminum | 6000 RLU | PASS ≤ 6000 | FAIL > 6000 |
| Rubber/silicone | 4500 RLU | PASS ≤ 4500 | FAIL > 4500 |
Source: Charm Sciences TECH-137 (recommended initial limits). PASS = RLU ≤ limit; FAIL = RLU > limit. Limits must be validated with parallel microbiological testing.