Cleaning Validation Maco Swab Rinse Ovais
This document was uploaded by user and they confirmed that they have the permission to share it. If you are author or own the copyright of this book, please report to us by using this DMCA report form. Report DMCA
Overview
Download & View Cleaning Validation Maco Swab Rinse Ovais as PDF for free.
More details
- Words: 1,121
- Pages: 5
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: INSTRUCTIONS: Fillin in the the Coral Coralinput inputfields fieldsas asmentioned mentioned(read (readthe the Fill comments ifif needed) needed) comments
Parameter Product A AI Product B1
Description Product selected for cleaning validation study (worst case) Active ingredient in Product A
Product B2
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
CA I J
Value Units Product No. 5 Mefenamic Acid
Product with largest MDD (Maximum Daily Dose) value
Product No. 1
K LD50-AI
Number of dosage units per batch of final mixture of Product B1 Lethal Dose 50 for active ingredient in Product A
740.000 mg/kg
LD50-Detergent
Lethal Dose 50 for the detergent Average human body weight Equipment surface area in common between Product A & B1/B2
240.000 mg/kg 70.000 kg
W L
240000.000 Units
5000.000 cm²
Batch size of Product B2 N U Swab area SF Safety Factor ¹ (for "Dose criterion" only) RF Risk Assessment Factor (for "Toxicological criterion" only) ¹ Give justification for using safety factor other than 0.001 in the CV Protocol
15.000 kg 25.000 cm²/Swab 0.001 0.001
Limit (mg/25cm²)
Summary: MACO for both AI & CA to subsequently manufactured product 40.0 MACO 35.0 Criterion Active Ingredient Cleaning Agent 30.0 25.0 Dose 37.500 mg/25 cm² 20.0 Toxicological 1.943 mg/25 cm² 0.630 mg/25 cm² 15.0 0.750 mg/25 cm² 10 ppm 0.750 mg/25 cm² 10.0 1.000 mg/25 cm² 1.200 mg/25 cm² Visual Limit 5.0
Active
Cleaning Agent
0.0 Dose
Tox.
10 ppm
Criterion
Visual
Dose
Tox.
10 ppm
Criterion
Visual
Formulae used for calculation: A) Dose criterion
This spreadsheet spreadsheet may may not not be be resold resold or or distributed. distributed. Please Please request request This author ([email protected] for any changes required to be be author ([email protected] for any changes required to made). made).
mg of active ingredient in product A permitted per 25 sq cm swab area = ((SF x I)/J) x (K/L) x U Where I = Smallest strength of product A manufactured/day expressed as mg/day & based on the number of mg of active ingredient
B) Toxicological Criterion mg of active ingredient in product A permitted per 25 sq cm swab area =
(NOEL x RF) x K x U JxL
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 RF = Risk Assessment Factor = 0.01 - 0.001 (for Oral Products)
Note: (NOEL x RF) = ADI (Acceptable Daily Intake)
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 N = Number of kgs per batch of final mixture of Product B2
R x (N/L) x U
All the abbreviations used in the formulae are defined in the table above (see Description)
References: 1. Fourman, G.L. and Mullen, M.V., "Determining Cleaning Validation Acceptance Limits for Pharmaceutical Manufacturing Operations Pharm. Technol. 17(4), 54-60 (1993). 2. W.E. Hall, “Validation of Cleaning Processes for Bulk Pharmaceutical Chemical Processes”, Cleaning Validation - An Exclusive Publication, Institute of Validation Technology, 1997. 3. CEFIC - Active Pharmaceutical Ingredients Committee (APIC), Guidance on aspects of cleaning validation in active pharmaceutical ingredient (CEFIC, Brussels, December 2000), available at http://apic.cefic.org/pub/pub-cleaning-validation.pdf, accessed Feb 5, 2009.
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
Description Product selected for cleaning validation study (worst case) Active ingredient in Product A
Product B2
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
Detergent I J
Value Units Product No. 5 Mefenamic Acid
Product with largest MDD (Maximum Daily Dose) value
Product No. 1
K LD50-AI
Number of dosage units per batch of final mixture of Product B1 Lethal Dose 50 for active ingredient in Product A
740.000 mg/kg
LD50-Detergent
Lethal Dose 50 for the detergent Average human body weight Equipment surface area in common between Product A & B1/B2
240.000 mg/kg 70.000 kg
W L RS
Surface area of the rinsed surface Batch size of Product B2
240000.000 Units
5000.000 cm² 1000.000 cm²
N V Rinse Volume SF Safety Factor ¹ (for "Dose criterion" only) RF Risk Assessment Factor (for "Toxicological criterion" only) * Give justification for using safety factor other than 0.001 in the CV Protocol
15.000 kg 50.000 L 0.001 0.001
Limit (mg/25cm²)
Summary: MACO for both AI & CA to subsequently manufactured product 30.0 MACO 25.0 Criterion Active Ingredient Cleaning Agent 20.0 Dose 30.000 mg/L 15.0 Toxicological 1.554 mg/L 0.504 mg/L 10.0 0.600 mg/L 10 ppm 0.600 mg/L 5.0 0.0 1.000 mg/L 1.200 mg/L Visual Limit
Active
Dose
Tox.
10 ppm
Criterion
Cleaning Agent
Visual
Dose
Tox.
10 ppm
Visual
Criterion
Formulae used for calculation: A) Dose criterion mg of active ingredient in product A permitted per 'Litre' of rinsate =
((SF x I)/J) x (K/L) x (RS/V)
B) Toxicological Criterion mg of active ingredient in product A permitted per 25 sq cm swab area =
(NOEL x RF) x K x RS JxLxV
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 RF = Risk Assessment Factor = 0.01 - 0.001 (for Oral Products)
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 N = Number of kgs per batch of final mixture of Product B2
R x (N/L) x (RS/V)
All the abbreviations used in the formulae are defined in the table above (see Description)
References: 1. Fourman, G.L. and Mullen, M.V., "Determining Cleaning Validation Acceptance Limits for Pharmaceutical Manufacturing Operations Pharm. Technol. 17(4), 54-60 (1993). 2. W.E. Hall, “Validation of Cleaning Processes for Bulk Pharmaceutical Chemical Processes”, Cleaning Validation - An Exclusive Publication, Institute of Validation Technology, 1997. 3. CEFIC - Active Pharmaceutical Ingredients Committee (APIC), Guidance on aspects of cleaning validation in active pharmaceutical ingredient (CEFIC, Brussels, December 2000), available at http://apic.cefic.org/pub/pub-cleaning-validation.pdf, accessed Feb 5, 2009.
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: INSTRUCTIONS: Fillin in the the Coral Coralinput inputfields fieldsas asmentioned mentioned(read (readthe the Fill comments ifif needed) needed) comments
Parameter Product A AI Product B1
Description Product selected for cleaning validation study (worst case) Active ingredient in Product A
Product B2
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
CA I J
Value Units Product No. 5 Mefenamic Acid
Product with largest MDD (Maximum Daily Dose) value
Product No. 1
K LD50-AI
Number of dosage units per batch of final mixture of Product B1 Lethal Dose 50 for active ingredient in Product A
740.000 mg/kg
LD50-Detergent
Lethal Dose 50 for the detergent Average human body weight Equipment surface area in common between Product A & B1/B2
240.000 mg/kg 70.000 kg
W L
240000.000 Units
5000.000 cm²
Batch size of Product B2 N U Swab area SF Safety Factor ¹ (for "Dose criterion" only) RF Risk Assessment Factor (for "Toxicological criterion" only) ¹ Give justification for using safety factor other than 0.001 in the CV Protocol
15.000 kg 25.000 cm²/Swab 0.001 0.001
Limit (mg/25cm²)
Summary: MACO for both AI & CA to subsequently manufactured product 40.0 MACO 35.0 Criterion Active Ingredient Cleaning Agent 30.0 25.0 Dose 37.500 mg/25 cm² 20.0 Toxicological 1.943 mg/25 cm² 0.630 mg/25 cm² 15.0 0.750 mg/25 cm² 10 ppm 0.750 mg/25 cm² 10.0 1.000 mg/25 cm² 1.200 mg/25 cm² Visual Limit 5.0
Active
Cleaning Agent
0.0 Dose
Tox.
10 ppm
Criterion
Visual
Dose
Tox.
10 ppm
Criterion
Visual
Formulae used for calculation: A) Dose criterion
This spreadsheet spreadsheet may may not not be be resold resold or or distributed. distributed. Please Please request request This author ([email protected] for any changes required to be be author ([email protected] for any changes required to made). made).
mg of active ingredient in product A permitted per 25 sq cm swab area = ((SF x I)/J) x (K/L) x U Where I = Smallest strength of product A manufactured/day expressed as mg/day & based on the number of mg of active ingredient
B) Toxicological Criterion mg of active ingredient in product A permitted per 25 sq cm swab area =
(NOEL x RF) x K x U JxL
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 RF = Risk Assessment Factor = 0.01 - 0.001 (for Oral Products)
Note: (NOEL x RF) = ADI (Acceptable Daily Intake)
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 N = Number of kgs per batch of final mixture of Product B2
R x (N/L) x U
All the abbreviations used in the formulae are defined in the table above (see Description)
References: 1. Fourman, G.L. and Mullen, M.V., "Determining Cleaning Validation Acceptance Limits for Pharmaceutical Manufacturing Operations Pharm. Technol. 17(4), 54-60 (1993). 2. W.E. Hall, “Validation of Cleaning Processes for Bulk Pharmaceutical Chemical Processes”, Cleaning Validation - An Exclusive Publication, Institute of Validation Technology, 1997. 3. CEFIC - Active Pharmaceutical Ingredients Committee (APIC), Guidance on aspects of cleaning validation in active pharmaceutical ingredient (CEFIC, Brussels, December 2000), available at http://apic.cefic.org/pub/pub-cleaning-validation.pdf, accessed Feb 5, 2009.
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
Description Product selected for cleaning validation study (worst case) Active ingredient in Product A
Product B2
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
Detergent I J
Value Units Product No. 5 Mefenamic Acid
Product with largest MDD (Maximum Daily Dose) value
Product No. 1
K LD50-AI
Number of dosage units per batch of final mixture of Product B1 Lethal Dose 50 for active ingredient in Product A
740.000 mg/kg
LD50-Detergent
Lethal Dose 50 for the detergent Average human body weight Equipment surface area in common between Product A & B1/B2
240.000 mg/kg 70.000 kg
W L RS
Surface area of the rinsed surface Batch size of Product B2
240000.000 Units
5000.000 cm² 1000.000 cm²
N V Rinse Volume SF Safety Factor ¹ (for "Dose criterion" only) RF Risk Assessment Factor (for "Toxicological criterion" only) * Give justification for using safety factor other than 0.001 in the CV Protocol
15.000 kg 50.000 L 0.001 0.001
Limit (mg/25cm²)
Summary: MACO for both AI & CA to subsequently manufactured product 30.0 MACO 25.0 Criterion Active Ingredient Cleaning Agent 20.0 Dose 30.000 mg/L 15.0 Toxicological 1.554 mg/L 0.504 mg/L 10.0 0.600 mg/L 10 ppm 0.600 mg/L 5.0 0.0 1.000 mg/L 1.200 mg/L Visual Limit
Active
Dose
Tox.
10 ppm
Criterion
Cleaning Agent
Visual
Dose
Tox.
10 ppm
Visual
Criterion
Formulae used for calculation: A) Dose criterion mg of active ingredient in product A permitted per 'Litre' of rinsate =
((SF x I)/J) x (K/L) x (RS/V)
B) Toxicological Criterion mg of active ingredient in product A permitted per 25 sq cm swab area =
(NOEL x RF) x K x RS JxLxV
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 RF = Risk Assessment Factor = 0.01 - 0.001 (for Oral Products)
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 N = Number of kgs per batch of final mixture of Product B2
R x (N/L) x (RS/V)
All the abbreviations used in the formulae are defined in the table above (see Description)
References: 1. Fourman, G.L. and Mullen, M.V., "Determining Cleaning Validation Acceptance Limits for Pharmaceutical Manufacturing Operations Pharm. Technol. 17(4), 54-60 (1993). 2. W.E. Hall, “Validation of Cleaning Processes for Bulk Pharmaceutical Chemical Processes”, Cleaning Validation - An Exclusive Publication, Institute of Validation Technology, 1997. 3. CEFIC - Active Pharmaceutical Ingredients Committee (APIC), Guidance on aspects of cleaning validation in active pharmaceutical ingredient (CEFIC, Brussels, December 2000), available at http://apic.cefic.org/pub/pub-cleaning-validation.pdf, accessed Feb 5, 2009.
Related Documents
Cleaning Validation Maco Swab Rinse Ovais
December 2019 12
Choosing The Correct Swab For Cleaning Validation
October 2019 19
Cleaning Validation
November 2019 15
Cleaning Validation Guidelines
December 2019 8