Protocol Jacketed MFG Tank LV02

CORAL LABORATORIES LIMITED Plot No. 27-28, Pharmacity Selaqui Industrial Area Dehradun – 248197 Uttarakhand, India

PROTOCOL FOR CALIBRATION OF JACKETED MANUFACTURING TANK

Equipment Name

Jacketed Manufacturing Tank

Reason for Qualification

Periodic Qualification

Equipment ID No.

LV02

Document No.

QP-PPQ-LV02-02

Supersede No.

Nil

Calibration Frequency

Yearly

Effective Date

PROTOCOL FOR CALIBRATION OF MANUFACTURING TANK Coral Laboratories Ltd. Location: Dehradun

Equipment Name: Jacketed Manufacturing Tank

Equipment ID No.: LV02

Document No.: QP-PPQ-LV02-02

Page No.: 2 of 7

1.0 PROTOCOL APPROVAL: 1.1 This protocol is prepared by validation task force member: Department

Quality Assurance

Sign Name

Rajvar

Designation

Chemist

Date

1.2 This protocol is reviewed by validation core committee: Quality Assurance

Production

Quality Control

Engineering & Maintenance

Name

Puja Aswal

Nilesh Patel

Rajesh Suthar

Nand Kishor

Designation

Executive

Manager

Manager

Incharge Utility

Department

Sign

Date 1.3 This protocol is approved for implementation by Head-QA:

Sign Name

Sunil Kumar Gupta

Designation

Manager

Date 1.4 This protocol is authorized for implementation by Plant -Head:

Sign Name

B.H. Patel

Designation

Plant Head

Date

PROTOCOL FOR CALIBRATION OF MANUFACTURING TANK Coral Laboratories Ltd. Location: Dehradun

Equipment Name: Jacketed Manufacturing Tank

Equipment ID No.: LV02

Document No.: QP-PPQ-LV02-02

Page No.: 3 of 7

2.0 TABLE OF CONTENT: SR. NO.

CONTENT

PAGE NO.

1.0

PROTOCOL APPROVAL

2

2.0

TABLE OF CONTENT

3

3.0

OBJECTIVE

4

4.0

SCOPE

4

5.0

RESPONSIBILITIES

4

6.0

DOCUMENTATION

5

7.0

MATERIAL REQUIREMENT FOR CALIBRATION

5

8.0

PROCEDURE

5

9.0

OBSERVATION

7

10.0

CONCLUSION

7

PROTOCOL FOR CALIBRATION OF MANUFACTURING TANK Coral Laboratories Ltd. Location: Dehradun

Equipment Name: Jacketed Manufacturing Tank

Equipment ID No.: LV02

Document No.: QP-PPQ-LV02-02

Page No.: 4 of 7

3.0 OBJECTIVE: To establish evidence that the manufacturing tank is calibrated for the volume with dip rod marking, equipment ID No-LV02 is acceptably verified in liquid manufacturing area at CORAL LABORATORIES LTD, Dehradun. 4.0 SCOPE: This is applicable at the time of calibration of manufacturing tank ID No-LV02 Liquid manufacturing area at CORAL LABORATORIES LTD, Dehradun. The details are given below: Sr. No.

Equipment Name

Equipment ID

Parameter

1

Jacketed Manufacturing Tank

LV02

Calibration

5.0 RESPONSIBILITIES: 5.1 RESPONSIBILITIES : 5.2.1 Quality Assurance: 5.2.1.1 Preparation and review of Protocol and report. 5.2.1.2 Execute the protocol as per procedure. 5.2.1.3 Approval of Protocol and report. 5.2.2 Quality Control: 5.2.2.1 Providing the equipment for validation. 5.2.2.2 Review the protocol and Report. 5.2.3 Engineering & Maintenance: 5.2.3.1 Providing the utility services. 5.2.3.2 Review the protocol and report. 5.2.4 Production Department:5.2.4.1 Check the calibration protocol 5.2.4.2 Provide the materials used during calibration 5.2.5 Store Department:-Dispensing of material for the calibration of tank

PROTOCOL FOR CALIBRATION OF MANUFACTURING TANK Coral Laboratories Ltd. Location: Dehradun

Equipment Name: Jacketed Manufacturing Tank

Equipment ID No.: LV02

Document No.: QP-PPQ-LV02-02

Page No.: 5 of 7

6.0 DOCUMENTATION All Calibration work will be performed as defined in the protocol. This will include the information, data and analysis of Calibration results. All required documentation (Approved Protocol & Report) would be filled. Any deviation or abnormality observed during the execution of the protocol will be documented. Upon completion of the Calibration process, a final summary report will be prepared, that summarizes the Calibration of the Manufacturing tank. The summary report will be reviewed and approved by Head-QA . 7.0 MATERIAL REQUIREMENT FOR CALIBRATION 7.1 Test Equipment/Instrument Calibration Verification:

1.

Manufacturing tank to be calibrated – I.D. No: LV02

2.

Dip rod for marking of calibrated points

3.

Sodium Chloride IP

4.

Calibrated 50 Ltr SS container.

8.0 PROCEDURE: For the calibration of the tank, maintain the manufacturing area with 25°C. Confirm that there are no traces of chloride in the Purified water used and weigh 49.801 kg of Purified water in the SS container which is equivalent to 50 Lts of water considering the specific gravity of 0.99602. Mark the container with permanent marker at the water level. Weigh the Purified water of 49.801 Kg x 10 and transfer it to the manufacturing tank. Take exact weight of 4.5kg NaCl (Sodium chloride) in calibrated 50 ltrs SS tank & complete dissolve in purified water, make volume up to 50 Ltrs. And transfer it in to manufacturing tank. Now the total volume in the tank is 500 ltr. Stir for 5 minutes. After stirring take out 15 ml of Sodium chloride solution & titrate for content of Sodium chloride content. Based on the content of Sodium chloride calculate the actual volume of purified water content in the tank. If the volume of purified water is within the acceptance criteria as stated in the volume verification chart, permanent mark on Dip rod for 500 ltr. The above same procedure shall followed for calibration point for 1000, 1500, 2000, 2500 and finally 3000 Justification for Addition of Sodium Chloride: The purpose of use of tank is for manufacturing of Oral liquid batches at different batch sizes with appropriate Active Pharmaceutical Ingredients. Hence for to ensure it is essential to determine whether the actual input are getting at different batch size accurately at calibrated points. Hence 0.9%w/v of Sodium Chloride Solution is used as active Pharmaceutical Ingredient in Calibration activity

PROTOCOL FOR CALIBRATION OF MANUFACTURING TANK Coral Laboratories Ltd. Location: Dehradun

Equipment Name: Jacketed Manufacturing Tank

Equipment ID No.: LV02

Document No.: QP-PPQ-LV02-02

Page No.: 6 of 7

Procedure for Estimation of Sodium Chloride: Titrate the water sample with the 0.1N silver nitrate solution using Potassium chromate indicator and note the burette reading for the amount of 0.1N Silver nitrate consumed by NaCl available in the water. Content of Sodium Chloride: Assay =

BR X 0.1N Normality of Ag No3 X 0.005844 X 1000

=

X gm/ltr

For example if we want of verify the volume of purified water for 500 Ltrs :1 X Exact wt. of Sodium Chloride in gms

= Y

Ltr of water in the tank

X gms /Ltr. Y – 500 = + Z ltrs of actual difference of Purified water in tank. (Limit: Difference ± 1%) Determination of % of difference of Purified water in the tank. Z (Actual Difference in Volume) x 100 Calibrated Volume (500)

= W % of Difference)

Repeat the same procedure at different water level listed below in the Observation chart Volume verification Sr.No. 1 2 3 4 5 6

Volume of water 500 1000 1500 2000 2500 3000

Burette Reading

Factor

Assay (g/Ltr)

0.005844

Normality of 0.1N AgNO3 =

9.0 OBSERVATION: Sr. No.

To be

Wt. of water

Volume

NaCl

Assay

Actual

Limit

calibrated

added in Kg

of water

Added

(%w/w)

Water

(± 1.0%)

Result

PROTOCOL FOR CALIBRATION OF MANUFACTURING TANK Coral Laboratories Ltd. Location: Dehradun

Equipment Name: Jacketed Manufacturing Tank

Equipment ID No.: LV02

Document No.: QP-PPQ-LV02-02

Page No.: 7 of 7

at volume

added in

volume

Ltr.

1

(Ltr.) 500

49.801 x 10

Ltr 500

4.5kg

495-505

2

1000

49.801 x 10

1000

4.5kg

990-1010

3

1500

49.801 x 10

1500

4.5kg

1485-1515

4

2000

49.801 x 10

2000

4.5kg

1980-2020

5

2500

49.801 x 10

2500

4.5kg

2475-2525

6

3000

49.801 x 10

3000

4.5kg

2970-3030

10.0 CONCLUSION :

After calibration at different point of manufacturing vessel shall verify and it should be within the 1% of the verification as specified in the Observation table. Than only the tank can be used for the routine commercial batch preparation at calibrated points only.