10994609 Cleaning Validation Maco Swab Rinse Ovais
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- Words: 888
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Equipment Name: Example Location: Tabletting Block Compiled By: Ovais
Determination of Acceptance Criteria for Cleaning Validation (CV) Studies
Add Company Name/Logo Here
ORAL PRODUCTS
Sampling Method Swab Sampling
Date 2/7/2007
INSTRUCTIONS: Fill in the Coral input fields as mentioned (read the comments if needed)
Parameter Product A AI Product B1
Description Product selected for cleaning validation study (worst case) Active ingredient in Product A
Product B2 CA I J
Product with smallest batch size Ciprofloxacin HcL Tablet Active principle present in the cleaning agent AlkylBenzene Sulphonate Smallest strength of Product A manufactured 500.000 mg/day Maximum number of dosage units of Product B1 taken/day 16.000 Units/day Number of dosage units per batch of final mixture of Product B 240000.000 Units
K LD50-AI LD50-Detergent W
Value Units Product No. 5 Mefenamic Acid
Product with largest MDD (Maximum Daily Dose) value
Product No. 1
Lethal Dose 50 for active ingredient in Product A
740.000 mg/kg
Lethal Dose 50 for the detergent Average human body weight Equipment surface area in common between Product A & B L Batch size of Product B2 N U Swab area SF Safety Factor * * Give justification for using safety factor other than 0.001 in the CV Protocol
240.000 mg/kg 70.000 kg 5000.000 cm² 15.000 kg 25.000 cm²/Swab 0.001
Limit (mg/25cm²)
Summary: MACO for both AI & CA to subsequently manufactured product MACO 1.0 Criterion Active Ingredient Cleaning Agent 0.8 Dose 37.500 mg/25 cm² Toxicological 1.943 mg/25 cm² 0.630 mg/25 cm² 0.5 0.750 mg/25 cm² 10 ppm 0.750 mg/25 cm² 0.3 1.000 mg/25 cm² 1.200 mg/25 cm² Visual Limit 0.0 Dose
Tox. 10 ppm
Visual Criterion Criterion
Formulas used for calculation:
This spreadsheet may not be resold or distributed. Please request author ([email protected] for any changes required to be made).
A) Dose criterion (0.001)
This spreadsheet may not be resold or distributed. Please request author ([email protected] for any changes required to be made).
mg of active ingredient in product A permitted per 25 sq cm swab area = (I/J) X (K/L) X U Where I = (SF * Smallest strength of product A manufactured)/day expressed as mg/day & based on the number of mg of active ingredien J = Maximum number of dosage units of Product B1 taken/day K = Number of dosage units per batch of final mixture of Product B1 L = Equipment surface area in common between Product A & B1/B2 expressed as cm² U = Swab area (25 cm²/swab)
B) Toxicological Criterion mg of active ingredient in product A permitted per 25 sq cm swab area =
NOEL x K x U SF x J x L
Where NOEL = LD50 X (W/E) NOEL = No observed Effect Level = LD50 = Lethal Dose 50 in mg/kg animal for active ingredient in product A E = Empirical Constant = 2000 S = Safety Factor = 0.01 - 0.001 (for Oral Products) J = Maximum number of dosage units of Product B1 taken/day K = Number of dosage units per batch of final mixture of Product B1 L = Equipment surface area in common between Product A & B1/B2 expressed as cm² U = Swab area (25 cm²/swab)
C) 10 ppm Criterion mg of active ingredient in product A permitted per 25 sq cm swab area = Where R = 10 mg active ingredient in product A/kg Product B2
R X (N/L) X U
N = Number of kgs per batch of final mixture of Product B2 L = Equipment surface area in common between Product A & B1/B2 expressed as cm² U = Swab area (25 cm²/swab)
Reference: Fourman, G.L. and Mullen, M.V., "Determining Cleaning Validation Acceptance Limits for Pharmaceutical Manufacturing Operatio
© 2009 Mohammad Ovais Pharmaceutical Scientist
v1.1
ve ingredient
g Operations," Pharm. Technol. 17(4), 54-60 (1993).
Equipment Name: Example Location: Tabletting Block Compiled By: Ovais
Determination of Acceptance Criteria for Cleaning Validation (CV) Studies
Add Company Name/Logo Here
ORAL PRODUCTS
Date 2/7/2007
Sampling Method Rinse Sampling Parameter Product A AI Product B1 Product B2 Detergent I J K LD50-AI LD50-Detergent W L R N V SF * Give justification
Description Product selected for cleaning validation study (worst case) Active ingredient in Product A
Value Units Product No. 5 Mefenamic Acid
Product with largest MDD (Maximum Daily Dose) value
Product No. 1
Product with smallest batch size Ciprofloxacin HcL Tablet Active principle present in the cleaning agent AlkylBenzene Sulphonate Smallest strength of Product A manufactured 400.000 mg/day Maximum number of dosage units of Product B1 taken/day 8.000 Units/day Number of dosage units per batch of final mixture of Product B 300000.000 Units Lethal Dose 50 for active ingredient in Product A
2300.000 mg/kg
Lethal Dose 50 for the detergent Average human body weight Equipment surface area in common between Product A & B Surface area of the rinsed surface Batch size of Product B2 Rinse Volume Safety Factor * for using safety factor other than 0.001 in the CV Protocol
437.000 mg/kg 35.000 kg 31627.944 cm² 1000.000 cm² 97.500 kg 50.000 L 0.001
Limit (mg/25cm²)
Summary: MACO for both AI & CA to subsequently manufactured product MACO 1.0 Criterion Active Ingredient Cleaning Agent 0.8 Dose 9.485 mg/L 0.5 Toxicological 0.954 mg/L 0.181 mg/L 0.3 0.617 mg/L 10 ppm 0.617 mg/L 1.000 mg/L 1.200 mg/L Visual Limit 0.0
Dose
Tox. 10 ppm
Visual Criterion Criterion
© 2009 Mohammad Ovais Pharmaceutical Scientist
v1.1
Determination of Acceptance Criteria for Cleaning Validation (CV) Studies
Add Company Name/Logo Here
ORAL PRODUCTS
Sampling Method Swab Sampling
Date 2/7/2007
INSTRUCTIONS: Fill in the Coral input fields as mentioned (read the comments if needed)
Parameter Product A AI Product B1
Description Product selected for cleaning validation study (worst case) Active ingredient in Product A
Product B2 CA I J
Product with smallest batch size Ciprofloxacin HcL Tablet Active principle present in the cleaning agent AlkylBenzene Sulphonate Smallest strength of Product A manufactured 500.000 mg/day Maximum number of dosage units of Product B1 taken/day 16.000 Units/day Number of dosage units per batch of final mixture of Product B 240000.000 Units
K LD50-AI LD50-Detergent W
Value Units Product No. 5 Mefenamic Acid
Product with largest MDD (Maximum Daily Dose) value
Product No. 1
Lethal Dose 50 for active ingredient in Product A
740.000 mg/kg
Lethal Dose 50 for the detergent Average human body weight Equipment surface area in common between Product A & B L Batch size of Product B2 N U Swab area SF Safety Factor * * Give justification for using safety factor other than 0.001 in the CV Protocol
240.000 mg/kg 70.000 kg 5000.000 cm² 15.000 kg 25.000 cm²/Swab 0.001
Limit (mg/25cm²)
Summary: MACO for both AI & CA to subsequently manufactured product MACO 1.0 Criterion Active Ingredient Cleaning Agent 0.8 Dose 37.500 mg/25 cm² Toxicological 1.943 mg/25 cm² 0.630 mg/25 cm² 0.5 0.750 mg/25 cm² 10 ppm 0.750 mg/25 cm² 0.3 1.000 mg/25 cm² 1.200 mg/25 cm² Visual Limit 0.0 Dose
Tox. 10 ppm
Visual Criterion Criterion
Formulas used for calculation:
This spreadsheet may not be resold or distributed. Please request author ([email protected] for any changes required to be made).
A) Dose criterion (0.001)
This spreadsheet may not be resold or distributed. Please request author ([email protected] for any changes required to be made).
mg of active ingredient in product A permitted per 25 sq cm swab area = (I/J) X (K/L) X U Where I = (SF * Smallest strength of product A manufactured)/day expressed as mg/day & based on the number of mg of active ingredien J = Maximum number of dosage units of Product B1 taken/day K = Number of dosage units per batch of final mixture of Product B1 L = Equipment surface area in common between Product A & B1/B2 expressed as cm² U = Swab area (25 cm²/swab)
B) Toxicological Criterion mg of active ingredient in product A permitted per 25 sq cm swab area =
NOEL x K x U SF x J x L
Where NOEL = LD50 X (W/E) NOEL = No observed Effect Level = LD50 = Lethal Dose 50 in mg/kg animal for active ingredient in product A E = Empirical Constant = 2000 S = Safety Factor = 0.01 - 0.001 (for Oral Products) J = Maximum number of dosage units of Product B1 taken/day K = Number of dosage units per batch of final mixture of Product B1 L = Equipment surface area in common between Product A & B1/B2 expressed as cm² U = Swab area (25 cm²/swab)
C) 10 ppm Criterion mg of active ingredient in product A permitted per 25 sq cm swab area = Where R = 10 mg active ingredient in product A/kg Product B2
R X (N/L) X U
N = Number of kgs per batch of final mixture of Product B2 L = Equipment surface area in common between Product A & B1/B2 expressed as cm² U = Swab area (25 cm²/swab)
Reference: Fourman, G.L. and Mullen, M.V., "Determining Cleaning Validation Acceptance Limits for Pharmaceutical Manufacturing Operatio
© 2009 Mohammad Ovais Pharmaceutical Scientist
v1.1
ve ingredient
g Operations," Pharm. Technol. 17(4), 54-60 (1993).
Equipment Name: Example Location: Tabletting Block Compiled By: Ovais
Determination of Acceptance Criteria for Cleaning Validation (CV) Studies
Add Company Name/Logo Here
ORAL PRODUCTS
Date 2/7/2007
Sampling Method Rinse Sampling Parameter Product A AI Product B1 Product B2 Detergent I J K LD50-AI LD50-Detergent W L R N V SF * Give justification
Description Product selected for cleaning validation study (worst case) Active ingredient in Product A
Value Units Product No. 5 Mefenamic Acid
Product with largest MDD (Maximum Daily Dose) value
Product No. 1
Product with smallest batch size Ciprofloxacin HcL Tablet Active principle present in the cleaning agent AlkylBenzene Sulphonate Smallest strength of Product A manufactured 400.000 mg/day Maximum number of dosage units of Product B1 taken/day 8.000 Units/day Number of dosage units per batch of final mixture of Product B 300000.000 Units Lethal Dose 50 for active ingredient in Product A
2300.000 mg/kg
Lethal Dose 50 for the detergent Average human body weight Equipment surface area in common between Product A & B Surface area of the rinsed surface Batch size of Product B2 Rinse Volume Safety Factor * for using safety factor other than 0.001 in the CV Protocol
437.000 mg/kg 35.000 kg 31627.944 cm² 1000.000 cm² 97.500 kg 50.000 L 0.001
Limit (mg/25cm²)
Summary: MACO for both AI & CA to subsequently manufactured product MACO 1.0 Criterion Active Ingredient Cleaning Agent 0.8 Dose 9.485 mg/L 0.5 Toxicological 0.954 mg/L 0.181 mg/L 0.3 0.617 mg/L 10 ppm 0.617 mg/L 1.000 mg/L 1.200 mg/L Visual Limit 0.0
Dose
Tox. 10 ppm
Visual Criterion Criterion
© 2009 Mohammad Ovais Pharmaceutical Scientist
v1.1
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