JACKSON LABORATORIES PVT. LTD.

TITLE : CLEANING VALIDATION PROTOCOL OF PANTOPRAZOLE FOR INJECTION

Document No. :CVP/007/P-00 Date :
Revision No. : 00 Page No. : 1 of 8

PROTOCOL

FOR

CLEANING VALIDATION

Product Name : ACI-DT,PANTOJACK & PANTADOR

Generic Name : PANTOPRAZOLE FOR INJECTION

Location : JACKSON LABORATORIES PVT. LTD., SANSARPUR

TERRACE, KANGRA, HP.

Protocol Ref. No : CVP/007/P-00

Date of Effective :

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 JACKSON LABORATORIES PVT. LTD.

TITLE : CLEANING VALIDATION PROTOCOL OF PANTOPRAZOLE FOR INJECTION

Document No. :CVP/007/P-00 Date :
Revision No. : 00 Page No. : 2 of 8

INDEX

SR. NO. CONTENTS PAGE NO.

1 REPORT APPROVAL SHEET 3

2 INTRODUCTION 4
3 OBJECTIVE 4
4 PERSONAL RESPONSIBITIES 4
5 DETAILS OF EQUIPMENTS & CLEANING SOPs 5
6 SAMPLING TECHNIQUES 5
7 ANALYSIS METHOD 6
8 EXPERIMENTAL DETAILS 6
9 ACCEPTANCE CRITERIA 7
9.1 PHYSICALLY CLEAN 7
9.2 CHEMICALLY CLEAN 7
10 VALIDATION FREQUENCY 8
11 DOCUMENTATION 8
12 SUMMARY REPORT AND CONCLUSION 8

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 JACKSON LABORATORIES PVT. LTD.

TITLE : CLEANING VALIDATION PROTOCOL OF PANTOPRAZOLE FOR INJECTION

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Revision No. : 00 Page No. : 3 of 8

1 REPORT APPROVAL SHEET

Sr. Activity Designation Signature & Date

No.

1 Prepared by Officer –In charge

2 Checked by Manager Production

3 Checked by Quality Control Head

5 Approved by Quality Assurance Head

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 JACKSON LABORATORIES PVT. LTD.

TITLE : CLEANING VALIDATION PROTOCOL OF PANTOPRAZOLE FOR INJECTION

Document No. :CVP/007/P-00 Date :
Revision No. : 00 Page No. : 4 of 8

2 INTRODUCTION:

Drug products can be contaminated by other drug products, by cleaning agents, by

microorganisms or by other material (e.g. Air borne particles, dust, raw materials,
intermediates, auxiliaries. In many cases, the same equipment may be used for
processing different products. To avoid contamination of drug products, adequate
and validated cleaning procedures are essential.

3 OBJECTIVE:

To ensure that the Cleaning Procedures used for the cleaning of equipments after the
manufacture of Pantroprazole for Injection are effective and removes all residues up to
a predetermined acceptance level and that there is no possibility of any resultant cross
contamination.

4 RESPONSIBILITIES:

Development Of A Protocol
Officer QC / Officer QA/ Officer Production

Approval Of A Protocol
Head of Quality Assurance

Equipment Cleaning
Operator / Workman
Officer Tablet Production & Officer Quality Assurance

Sampling
Officer Quality Assurance

Analysis
Officer Quality Control

Evaluation And Approval Of Results

Head Of Quality Control And Quality Assurance

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 JACKSON LABORATORIES PVT. LTD.

TITLE : CLEANING VALIDATION PROTOCOL OF PANTOPRAZOLE FOR INJECTION

Document No. :CVP/007/P-00 Date :
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5 DETAILS OF EQUIPMENTS & CLEANING SOPs

For Pantoprazole for Injection:
EQUIPMENTS DETAILS
I.D. No CLEANING SOP
Filling Machine JL/DI/01 PD/DI/010-03
Capping &Sealing M/C JL/DI/02 PD/DI/011-03

6 SAMPLING TECHNIQUES:

Swabbing technique shall be used for cleaning validation exercise.

6.1 Cotton buds saturated with a solvent ( water ) is used to physically sample the
surfaces.

6.2 Swabbing Technique Uniformity

The “Squeegee Method” shall be employed to meet these criteria. This method
entails passing the swab over a defined area in two different directions, first from
top to bottom and then from side to side. The swab dimensions should be
10cmx10cm, unless otherwise specified.

OR

First Second
“Squeegee method

6.3 Sample sites

Areas which are difficult to access / hardest to clean (i.e. corners, joints, bents
etc.) shall be selected for sampling. The detailed swab sampling locations from
the equipments is enclosed with the protocol.

6.4 Sample Quantity

The number of sample sites selected should be based on

i) Equipment product contact surfaces, and

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TITLE : CLEANING VALIDATION PROTOCOL OF PANTOPRAZOLE FOR INJECTION

Document No. :CVP/007/P-00 Date :
Revision No. : 00 Page No. : 6 of 8

ii) Adequate coverage to provide a high degree of confidence that the validated
cleaning procedure ensures the overall equipment has been properly cleaned as
per the cleaning SOP.

5.5 Number of sample sites

For chemical analysis, a minimum of 2-5 sampling sites shall be selected per
major piece of equipment (i.e. Vial filling, Capping & sealing Machine etc.).

6.6 Sample Area / Volume

The amount of unit sample area is dependent of the validated analytical method
and sometimes other processing variables. For example, if the analytical method
refers to swab surface area of 10cmx10cm, then it should be consistent for the
cleaning validation.

7.0 ANALYTICAL METHOD:

Test Method: Reference to the validated analytical method is given as per attached
attachment-A

8.0 EXPERIMENTAL DETAILS

During manufacturing of Pantoprazole for Injection, equipments are cleaned after

completion of each subsequent process steps i.e. completion of Filling Capping &
Sealing, etc.

7.1 Clean the equipment as per the SOP.

7.2 Swab individually various parts of the equipment after cleaning
7.3 Estimate the content in swab as per the validated analytical method.
7.4 Visually inspect the equipment and its parts to ensure that it is clean.
7.5 Based on the above analysis; calculate the amount of residue present in each
Swab

9.0 ACCEPTANCE CRITERIA

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TITLE : CLEANING VALIDATION PROTOCOL OF PANTOPRAZOLE FOR INJECTION

Document No. :CVP/007/P-00 Date :
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9.1 PHYSICALLY CLEAN:

Equipment Should Be Visually Clean.

Visual inspection after cleaning of equipment is performed and documented. The

requirement for this component applies to all product contact surfaces of any
equipment that has been cleaned and dried. The surfaces of the equipment are
inspected, to the extent possible, to verify that they are clean and free of any visible
residue or film.

9.2 CHEMICALLY CLEAN:

The previous active content should be more than 10 ppm per swab.

After visual cleaning found OK , then collect the 10 x 10cm swab samples from
2 – 5 sampling site and check the active residue content of each sampling site.
The active content should be more than 10 ppm per swab.

Note : Series of equipment should be considered for calculation of ppm.

For e.g. Equipment –A,
Equipment –B,
Equipment –C,
Equipment –D.
Residue from A+B+C+D = X should not be more than 10 ppm. (total) of active
Ingredient and detergent from the previous batch
Residue from previous batch = X
Batch size of running product = Y
Formula :

Residue in ppm = X x 103

Y

Carry over of Residue in ppm should not be more than 10 ppm

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 JACKSON LABORATORIES PVT. LTD.

TITLE : CLEANING VALIDATION PROTOCOL OF PANTOPRAZOLE FOR INJECTION

Document No. :CVP/007/P-00 Date :
Revision No. : 00 Page No. : 8 of 8

10 VALIDATION FREQUENCY
Three validations exercise per equipment.
Three validations exercise per equipment for change in cleaning procedure.
Three validations exercise per equipment for major change in equipment.
Re – validation every two years.

11 DOCUMENTATION

Three batch of the Pantoprazole for Injection is considered for cleaning validation studies.

The results can either be in the form of raw data or a summary of data.
(Refer Table-1 & Table-2)

12 SUMMARY REPORT AND CONCLUSION

The average residue of the Pantoprazole for Injection content observed after swab
analysis of the cleaned equipments used for manufacturing of Pantoprazole Foe
Injection 40 mg is less than 10 ppm /swab.

Based on finding it is concluded that, cleaning procedure is effective to clean the

equipments up to removal of previous residue within acceptance limit.

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