Cleaning Validation Acceptance Limits for Topical Formulations

This spreadsheet calculates acceptance criteria for cleaning validation studies as per following reference:
Reference: M.Ovais and Lai Yeo Lian, "Setting Cleaning Validation Acceptance Limits for Topical Formulations," Pharm Technol. 32(1):96 - 102. The article is available at
http://pharmtech.findpharma.com/pharmtech/Article/Setting-Cleaning-Validation-Acceptance-Limits-for-/ArticleStandard/Article/detail/481947

Acceptance Criterion: Criterion based on strength of product - Worst Case II

Calculation of dose for topical formulations (in mg/cm², as per Long and Finley's approach)
Parameter Value Unit
Area (of skin) covered by 1 FTU 286.000 cm²
Amount of formulation applied in 1 FTU 0.500 g
Amount of formulation applied/cm² 1.748 mg/cm²

Doses for Product A & Product B:

Formula used:
Daily dose (mg/cm²/day) = A x C x F

Parameter Product A Product B

A 1.748 mg/cm² 1.748 mg/cm²
C 2.000% 100.000%
F 1.000 4.000
Daily dose 0.035 mg/cm²/day 6.993 mg/cm²/day

MACO of Product A to Product B (in mg of active / batch of Product B)

Formula used:
(minimum daily dose for Product A) x (Batch Size for Product B)
MACO =
(safety factor) x (maximum daily dose for Product B)

Parameter Value Unit

Minimum daily dose for Product A 0.035 mg/cm²/day
Batch Size for Product B 300.000 Kg
Maximum daily dose for Product B 6.993 mg/cm²/day
Safety factor 1000.000
MACO of Product A to Product B 1500.000 mg/batch

MACO of Product A to Product B (in mg of active / 25cm² of swab area)

Formula used:
(0.1% x C x BS x SA)
MACO =
(MF x ESA)

Example
Parameter Value Unit
C = Lowest available strength of the active ingredient in the product A 2.000 %
BS = Batch Size for Product B 300.000 Kg
SA = Swab area 25.000 cm²
ESA = Equipment surface area in common with product A and product B 10000.000 cm²
MF = Maximum number of times Product B that can be applied daily 4.000
MACO of Product A to Product B 3.750 mg/25cm²
Cleaning Validation Acceptance Limits for Topical Formulations

This spreadsheet calculates acceptance criteria for cleaning validation studies as per following reference:
Reference: M.Ovais and Lai Yeo Lian, "Setting Cleaning Validation Acceptance Limits for Topical Formulations," Pharm Technol. 32(1):96 - 102. The article is available at
http://pharmtech.findpharma.com/pharmtech/Article/Setting-Cleaning-Validation-Acceptance-Limits-for-/ArticleStandard/Article/detail/481947

Acceptance Criterion: Criterion based on permitted daily exposure

Calculation of dose for topical formulations (in mg/cm², as per Long and Finley's approach)
Parameter Value Unit
Area (of skin) covered by 1 FTU 286.000 cm²
Amount of formulation applied in 1 FTU 0.500 g
Amount of formulation applied/cm² 1.748 mg/cm²

Doses for Product A & Product B:

Formula used:
Daily dose (mg/cm²/day) = A x C x F

Parameter Product A Product B

A 1.748 mg/cm² 1.748 mg/cm²
C 2.000% 100.000%
F 1.000 4.000
Daily dose 0.035 mg/cm²/day 6.993 mg/cm²/day

MACO of Product A to Product B (in mg of active / batch of Product B)

Formula used:
(minimum daily dose for Product A) x (Batch Size for Product B)
MACO =
(safety factor) x (maximum daily dose for Product B)

Parameter Value Unit

Minimum daily dose for Product A 0.035 mg/cm²/day
Batch Size for Product B 300.000 Kg
Maximum daily dose for Product B 6.993 mg/cm²/day
Safety factor 1000.000
MACO of Product A to Product B 1500.000 mg/batch

MACO of Product A to Product B (in mg of active / 25cm² of swab area)

Formula used:
(0.1% x C x BS x SA)
MACO =
(MF x ESA)

Example
Parameter Value Unit
C = Lowest available strength of the active ingredient in the product A 2.000 %
BS = Batch Size for Product B 300.000 Kg
SA = Swab area 25.000 cm²
ESA = Equipment surface area in common with product A and product B 10000.000 cm²
MF = Maximum number of times Product B that can be applied daily 4.000
MACO of Product A to Product B 3.750 mg/25cm²