TOC and HPLC Cleaning Validation Results
| Area (cm2) | Sampled Area (cm2) | TOC (ppm C) Results (3 cycles) | Coating Machine Limits (ppm C) | HPLC1050 (ppm API A′) Results (3 cycles) | Coating Machine Limits API A′ (ppm API A′) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CSN (combustion) | WP (wet chemistry) | ||||||||||||
| 1° | 2° | 3° | 1° | 2° | 3° | 1° | 2° | 3° | |||||
| Coating pan | 3433.90 | 400 | 0 | 0 | 0 | 0 | 0 | 0 | 5.34 | 0 | 0 | 0.10 | 9.320 |
| Base | 2700 | 400 | 2.01 | 0.79 | 2.01 | 1.38 | 0.97 | 0.78 | 5.34 | 0.621 | 0.22 | 0.21 | 9.320 |
| Entrance | 395.84 | 395.84 | 0 | 0 | 0 | 0.04 | 0 | 0 | 5.29 | 0 | 0 | 0.15 | 9.220 |
| Air entrance | 360 | 360 | 0.36 | 0 | 0 | 0 | 0 | 0 | 4.81 | 0 | 0 | 0.15 | 8.390 |
| Cover | 2474 | 400 | 0 | 0 | 0.61 | 0.06 | 0 | 0.78 | 5.34 | 0.031 | 0.10 | 0.23 | 9.320 |