Cleaning Validation Protocol for Fluid Bed Dryer

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ABC Pharmaceutical Company

CLEANING VALIDATION PROTOCOL

Equipment Name

Issued on

Protocol Number

Date

CLVS 000

Location

Granulation Area

Model

Manufacturer

Written by Validation Officer Reviewed by QA Manager

QC Manager

Production Manager (Tablets) Approved by Production Director Authorized by QA Director

Name of the Equipment XYZ

Company Name and Country Signature & Date

Signature & Date

Signature & Date

Signature & Date

Signature & Date

Signature & Date

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20.1.1 Objective

The objective is to demonstrate that the cleaning procedure ABC-001 will successfully and consistently reduce the level of residues to a predetermined level of acceptability, so as to prevent contaminants (products or cleaning process related) from adversely affecting the safety and quality of the next product manufactured.

20.1.2 Scope

This protocol will cover cleaning validation of the fluid bed dryer used for the wet granulation of tablet products. As per the MVP grouping matrix, products are divided into various groups based on their a. Water solubility b. Therapeutic dosage c. Toxicity d. Batch size (in kg)

From each group, one worst-case product is considered for cleaning validation. Table 20.1.1 lists the worst-case products for the fluid bed dryer (Figure 20.1.1).

20.1.3 Responsibility

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

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

For details, please refer to Attachment II.

TABLE 20.1.1

Worst Case for Fluid Bed Dryer

Products

Reason for Selecting as Worst Case

Ciprofloxacin 500 mg tablets

Six ingredients are insoluble in water 1.0 mg minimum therapeutic dose LD50150 mg/kg oral rat Largest batch size (682 kg)

Ketotifen 1.0 mg tablets Diclofenac 50 mg tablets Sulfamethoxazole tablets

FIGURE 20.1.1

Fluid bed dryer.

FIGURE 20.1.1

Fluid bed dryer.

20.1.4 Description of the Cleaning Process

The fluid bed dryer is to be cleaned as per SOP No. ABC-001.

4.1 Fix "UNDER CLEANING" label

4.2 Wrap the electrical panel with a polythene sheet

4.3 Remove the bowl and dismantle the filter set

4.4 Soak the filter set in a 200-L drum filled with water overnight and then send it to laundry for washing and drying

4.5 Flush the bowl from both sides with water for 5 min

4.6 Clean the bowl with a nylon brush dipped in liquid soap

4.7 Flush the bowl with water for 3 min

4.8 Spray the bowl with 70% alcohol

4.9 Flush the fluid bed dryer from outside and inside and the filter basket and rinse with water for 5 min

4.10 Fix the filter set

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4.11 Operate the fluid bed dryer as described in SOP No. ABC-002 for 1 h at 60°C to dry the filter set. Check the sleeves of the filter set for integrity

4.12 Clean the electrical panel and ducts with a wet towel

4.13 Remove accumulated water from the floor

4.14 Label the machine "CLEAN" as per site SOP

4.15 Make entries in the equipment cleaning, maintenance, and utilization logbook asper site SOP.

20.1.4.1 Difficult-to-Clean Parts i. Filter set ii. Inside bottom corner of the bowl iii. Filter basket and ring

20.1.5 Description of the Sampling Process

20.1.5.1 Sampling Technique

The surface swab sampling technique will be used to take samples from the fluid bed dryer.

20.1.5.2 Sampling Precautions

Before taking the sample, wear i. Gloves ii. Face mask

Surface swabs (swabs with diluents including a suitable neutralizing agent)

20.1.5.3 Procedure for Sampling 20.1.5.3.1 Surface Swabs

Samples for the internal surfaces will be taken by moistening the swab (ready-made sterile cotton swab) with a suitable solvent (DIW). Sample a 25-cm2 area (refer to Figures 20.1.2 through 20.1.7) and place the swab in a test tube containing 10 mL of a suitable solvent. Swab samples from each part of the fluid bed dryer will be collected as per

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TABLE 20.1.2

Surface Swabs Sampling Description

Description

Fluid bed dryer

Sample Location

Sample ID

Reference

Bowl bottom left edge

S1

Figure 20.1.2

Bowl bottom center edge

S2

Bowl wall grove

S3

Bowl wall center

S4

Bowl bottom edge right

S5

Bowl wall right

S6

Bowl outer surface edge left

S7

Figure 20.1.3

Bowl outer surface edge right

S8

Filter bottom surface left

S9

Figure 20.1.4

Filter bottom surface center

S10

Filter bottom surface right

S11

Dryer inside surface left

S12

Figure 20.1.5

Dryer inside surface right

S13

Filter bags position 1

S14

Figure 20.1.6

Filter bags position 2

S15

Filter bags position 3

S16

Dryer bottom surface left

S17

Figure 20.1.7

Dryer bottom surface center

S18

Dryer bottom surface right

S19

Fluid bed dryer

Cleaning Validation Protocol

FIGURE 20.1.2

Bowl.

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FIGURE 20.1.3

Bowl.

Bed Positioning ProtocolSwab Sample Location For Fluid Bed Drier

FIGURE 20.1.4

Bottom of the filter bags.

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FIGURE 20.1.5

Inside wall.

S14

S15

Outer surface of filter bags.

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FIGURE 20.1.7

Inside surface of the lower part of fluid bed dryer.

20.1.5.4 Handling of Samples i. The swabs samples collected for maximum allowable carryover (MAC) will be kept in the refrigerator.

ii. Analysis of swab samples on HPLC will be completed within 24 h after collection.

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

20.1.6 Test Functions a. Visual inspection: Visual inspection of the fluid bed dryer will be performed as per SOP No. ABC-003.

b. Maximum allowable carryover: The test for MAC limits of the swab will be performed as per the HPLC method suitable for each product residue.

Notes:

• By pooling the 10 mL swab extraction for specific analysis, analysis will be carried out.

• The validated HPLC test method will be used for the determination of chemical residues. Standard test method (STM) Nos are as follows:

Your Company's Logo Company's Name c. Bio-burden test: The test for bio-burden will be performed as per STM No. MC-0001 by the QC Microbiology section.

d. Swab recovery challenge test: The swab recovery challenge test will be performed as per Parenteral Drug Association (PDA) Journal of Pharmaceutical Science and Technology.

e. Detergent detection: The test for detergent detection will be performed as per procedure ABC-004.

20.1.7 Verification of Documents i. Verify the fluid bed dryer cleaning procedure.

ii. Verify the fluid bed dryer cleaning logbook records.

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

20.1.8 Documentation i. All analysis results will be recorded in the analysis logbook.

ii. Printouts and chromatograms will be attached to the validation report and a copy of each will also be attached to the analytical logbook.

iii. All analysis and data have to be verified by a second analyst.

iv. The cleaning validation officer will check all training records.

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

20.1.9 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.

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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 will be the maximum amount of active ingredient of worst product that is allowed to be carried over to the next batch.

Calculation:

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 the corresponding equipment parts A-S

Z = Y1 + Y2 + Y3 + Y4 + Y5 + Y6 + Y7 + Y8 + Y9 + Y10 + Y11 + Y12 + Y13 + Y14 + Y15 + Y16 + Y17 + Y18 + Y19, where Z is the total active ingredient recovered from the machine, Y1 is the active ingredient recovered from part A, Y2 is the active ingredient recovered from part B, Y3 is the active ingredient recovered from part C, Y4 is the active ingredient recovered from part D, Y5 is the active ingredient recovered from part E, Y6 is the active ingredient recovered from part F, Y7 is the active ingredient recovered from part G, Y8 is the active ingredient recovered from part H, Y9 is the active ingredient recovered from part I, Y10 is the active ingredient recovered from part J, Y11 is the active ingredient recovered from part K, Y12 is the active ingredient recovered from part L, Y13 is the active ingredient recovered from part M, Y14 is the active ingredient recovered from part N, Y15 is the active ingredient recovered from part O, Y16 is the active ingredient recovered from part P, Y17 is the active ingredient recovered from part Q, Y18 is the active ingredient recovered from part R, and Y19 is the active ingredient recovered from part S.

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 NLT 70% of the known concentration of standard spiked.

e. Detergent detection: No foam was detected on the top of the sample after testing.

* 1/100 to 1/1000 of a normal daily dose for oral products (PDA Guideline).

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20.1.10 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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