Cleaning Validation Protocol for Sugar Coating

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ABC Pharmaceutical Company

CLEANING VALIDATION PROTOCOL

Equipment Name

Issued on

Protocol Number

Date

CLVS-000

Location

Coating Area

Room No. 000

Equipment Sugar-Coating Pan

Model XX kg

Manufacturer Company, Country

20.10.1 Objective

The objective of this protocol is to demonstrate that the cleaning procedure No. ABC-001 will successfully and consistently reduce the level of residues to a predetermined level of acceptability, so as to prevent contamination (product or cleaning process related) from adversely affecting the safety and quality of the next product manufactured.

20.10.2 Scope

This protocol will cover cleaning of the sugar-coating pan of the tablets products. In the grouping matrix, products are divided into various groups based on their a. Water solubility b. Therapeutic dosage

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c. Toxicity d. Batch size (quantity of active used)

From each group, one worst-case product is considered for cleaning validation (Table 20.10.1).

20.10.3 Responsibility

The following personnel are responsible for the execution of this protocol:

Validation officer/production officer/QA inspector/QC chemist/analyst/machine operator.

For details, please refer to Attachment II.

20.10.4 Description of the Cleaning Process

Sugar-coating pan is cleaned manually as per SOP No. ABC-001.

4.1 Remove the arm from the coating pan and send it to the washing room.

4.2 Clean the arm with DIW in the washing room.

4.3 Charge 30 L of DIW inside the coating pan.

4.4 Operate the pan for 30 min.

4.5 Discharge the water outside the coating pan by means of a vacuum pump or manually.

TABLE 20.10.1

Sugar-Coated Worst Products

Products

Reason for Selecting as Worst Case

Sennoside 12 mg tablet Three ingredients insoluble in water are as follows:

Avicel

Magnesium stearate Aerosil 200

Bisacodyl 5 mg. Ibuprofen 200 mg Ibuprofen 200 mg

Minimum therapeutic dose (5 mg) Toxicity. LD50 636 mg/kg oral rat Largest batch size (495 kg)

4.6 Charge 10 L of 95% alcohol outside the coating pan.

4.7 Operate the pan for 30 min.

4.8 Use a brush to remove the residues remaining inside the surface of the coating pan.

4.9 Discharge the alcohol outside the coating pan by means of a vacuum pump or manually.

4.10 Charge 25 L of DIW inside the pan.

4.11 Operate the coating pan for 10 min.

4.12 Discharge the water outside the coating pan.

4.13 Apply 80°C hot air to dry the coating pan for 15 min.

4.14 Repeat steps 4.10, 4.11, and 4.12 if required.

4.15 Clean the outside of coating pan and panel with a clean towel wetted with 10% liquid soap, followed by a wet clean towel.

4.16 Label the equipment "CLEAN".

4.17 Ask the production supervisor to check the cleanliness.

4.18 Make entries in the equipment cleaning, maintenance, and production usage record as per SOP No. ABC-002.

20.10.4.1 Difficult-to-Clean Parts i. Suspension coater ii. Arms

20.10.5 Description of the Sampling Process 20.10.5.1 Sampling Technique

The swab sampling technique is used to take the sample from the sugar cota pan.

Sampling Precautions For sampling, wear the following:

i. Gloves ii. Face mask

20.10.5.2 Handling of Samples i. HPLC analysis should be completed within 24 h of collection.

ii. HPLC samples should be kept at room temperature for at least 2 h before testing.

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20.10.5.3 Surface Swabs 20.10.5.3.1 Procedure for Sampling

Samples of the internal surfaces are taken by moistening the swab (ready-made sterile cotton swab) with a suitable solvent (DlW/alcohol-water-alcohol). Sample a 25-cm2 area (see Figures 20.10.1 through 20.10.3) and place the swab in a test tube containing 10 mL of solvent (suitable solvent). Swab samples from each part of the sugar-coating pan are collected as per Table 20.10.2.

TABLE 20.10.2

Surface Swabs Sampling Description

TABLE 20.10.2

Surface Swabs Sampling Description

Description

Sample Location

Sample ID

Reference

Sugar-coating pan

Pan surface left

S1

Figure 20.10.1

Pan surface center

S2

Pan surface right

S3

Arm

S4

Figure 20.10.2

Arm

S5

Figure 20.10.3

Suspension coater

S6

Solution tank wall surface

S7

Solution tank wall surface pipe

S8

Solution tank wall surface

S9

Maximum Allowable Carryover

S1

S2

Sugar-coating pan.

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FIGURE 20.10.2

Coating pan arm.

FIGURE 20.10.3

Solution preparation wall surface and pipe.

20.10.6 Test Functions a. Visual inspection: Visual inspection of sugar-coating pan is performed as per SOP No. ABC-003. Sampling procedure for cleaning validation b. Maximum allowable carryover: The test for MAC of the final rinse/swab is performed as per the HPLC method suitable for each product residue.

Notes:

• Analysis will be carried out by pooling the 10 mL swab extraction for specific analysis.

• The validated HPLC test method is used for the determination of chemical residues.

c. Bio-burden test: The test for bio-burden is performed as per STM No. MC-001 by the QC Microbiology section.

d. Swab recovery challenge test: The recovery challenge test of the swab sample is performed as per PDA Journal of Pharmaceutical Science and Technology.

20.10.7 Verification of Documents i. Verify the sugar-coating pan cleaning procedure.

ii. Verify the sugar-coating pan cleaning logbook records.

iii. Verify the cleaning operators and analyst training record (refer to Attachment V).

20.10.8 Documentation i. All analysis results are recorded in the analysis logbook.

ii. Printouts and chromatograms are attached to the validation report and a copy of that is also attached to the analytical logbook.

iii. A second analyst will verify all analyses and data.

iv. The QA officer will check all training records.

v. The final report for cleaning validation is prepared by the QA officer.

20.10.9 Acceptance Criteria a. Visual inspection: The visible internal equipment surfaces and all critical and difficult-to-clean parts are optically free from residue and the color of the final rinse water is comparable to DIW.

b. Maximum allowable carryover: The active ingredient calculated (Z) is either equal to or less than the MAC.

MAC _ TDx BS x SF MAC _ LDD , where MAC is the maximum allowable carryover, TD is a single therapeutic dose, BS is the batch size of the next product to be manufactured in the same equipment, SF* is the safety factor (0.001), and LDD is the largest daily dose of the next product to be manufactured in the same equipment.

The calculated value is the maximum amount of active ingredient of worst-case product that is allowed to be carried over to the next batch.

Calculation:

Y = X x surface area where Y is the active ingredient on the corresponding equipment part, X is the active ingredient recovered from 25 cm2 by swab from the corresponding equipment part, and surface area is the area of corresponding equipment parts A-I.

Z = Y1 + Y2 + Y3 + Y4 + Y5 + Y6 + Y7 + Y8 + Y9, where Z is the total active ingredient recovered from the machine, Y1 is the active ingredient recovered from part S1, Y2 is the active ingredient recovered from part S2, Y3 is the active ingredient recovered from part S3, Y4 is the active ingredient recovered from part S4, Y5 is the active ingredient recovered from part S5, Y6 is the active ingredient recovered from part S6, Y7 is the active ingredient recovered from part S7, Y8 is the active ingredient recovered from part S8, and Y9 is the active ingredient recovered from part S9.

Acceptance criteria:

c. Bio-burden: The bio-burden should not be more than 33 cfu/25 cm2 for the swabs.

d. Swab recovery challenge test: The swab recovery challenge test should be 70% of the known concentration of standard spiked.

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20.10.10 List of Attachments

Attachment I Attachment II Attachment III Attachment IV Attachment V Attachment VI

Description of equipment and product Cleaning/testing responsibilities Sampling and testing plan. Calculations for surface swabs. Training record verification Swabs analysis results

Attachment VII Swab sampling recovery challenge test results

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