Cleaning Validation - Report / Decision

VALIDATION REPORT AND DECISION

Validation Decision:

Date: Signed:
Team Details
Name: Position: Role:

Chemicals
Name: Type: Concentration: Volume:

Parameters
Time: Temp: Flow Rates: Pressure: Rinsing:

Cleaning Runs
Number: Notes:

Equipment
Make: Model: Notes:

Training
Employee Name: Training Conducted: Date: Competent: Training By:

Monitoring Equipment
Make: Model: Type: Purpose:

Sampling Procedures Analytical Methods

Acceptance Criteria
Limits: Unit: Rationale:
Cleaning Validation - Cleaning Run Reports

Validation Details:
No: Date: Time: C Conc: Temp: Time: Press: Notes:
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
Result:
Cleaning Validation - Process Capability Study

General Details:
Date: Cleaning SSOP: Criteria:
Line No: Hazard: Addition variables:
Product / Group: Risk:

Capability Study:
Criteria Maximum: 200 Histogram Maximum: 231
Criteria Minimum: 0 Coded data point:
224.7 Histogram Minimum: -21
Date 1 50 5.6349206349 Upper bound cell 20 231 Count above Cell Midpoint
212.1
Date 2 60 6.4285714286 Upper bound cell 19 218.4 0 224.7
Date 3 75 199.5 7.619047619 Upper bound cell 18 205.8 1 212.1
Date 4 100 186.9 9.6031746032 Upper bound cell 17 193.2 2 199.5
Date 5 150 174.3 13.5714285714 Upper bound cell 16 180.6 2 186.9
Date 6 200 161.7 17.5396825397 Upper bound cell 15 168 2 174.3
Date 7 210 149.1 18.3333333333 Upper bound cell 14 155.4 2 161.7
Date 8 10 2.4603174603 Upper bound cell 13 142.8 5 149.1
136.5
Date 9 50 5.6349206349 Upper bound cell 12 130.2 5 136.5
Date 10 75 123.9 7.619047619 Upper bound cell 11 117.6 6 123.9
Date 11 75 111.3 7.619047619 Upper bound cell 10 105 6 111.3
Date 12 80 98.7 8.0158730159 Upper bound cell 9 92.4 15 98.7
Date 13 70 86.1 7.2222222222 Upper bound cell 8 79.8 21 86.1
Date 14 150 73.5 13.5714285714 Upper bound cell 7 67.2 26 73.5
Date 15 150 13.5714285714 Upper bound cell 6 54.6 27 60.9
60.9
Date 16 100 9.6031746032 Upper bound cell 5 42 29 48.3
Date 17 100 48.3 9.6031746032 Upper bound cell 4 29.4 29 35.7
Date 18 100 35.7 9.6031746032 Upper bound cell 3 16.8 29 23.1
Date 19 100 23.1 9.6031746032 Upper bound cell 2 4.2 30 10.5
Date 20 100 10.5 9.6031746032 Upper bound cell 1 -8.4 30 -2.1
Date 21 100 -2.1 9.6031746032 Lower bound cell 1 -21 30 -14.7
Date 22 75 7.619047619
-14.7
Date 23 80 8.0158730159
Date 24 80 8.0158730159 Average: 96.6666666667
Date 25 80 8.0158730159 Standard Deviation: 41.5918869189
Date 26 80 8.0158730159 Upper 3 Sigma Value: 221.4423274232 "# of Sigmas Capability": 2.3
Date 27 80 8.0158730159 Lower 3 Sigma Value: -28.1089940899 2-tail PPM "Traditional": 20116.319011334
Date 28 120 11.1904761905 Cp Index: 0.8014383526 1-tail PPM "Traditional": 10058.159505667
Date 29 100 9.6031746032 Cpk: 0.7747237408 PPM "w/1.5 Sigma Shift": 204921.137977889
Date 30 100 9.6031746032 Average to max 103.3333333333