63 Leak Tester

SYSTACARE REMEDIES, AMRITSAR
STANDARD OPERATING PROCEDURE
SOP Title OPERATION AND CALIBRATION OF LEAK TESTER

SOP No. SYS/SOP/QC/63/01 Version No. 01 Page 1 of 21
Section General
Role Designation Name Signature/Date
Prepared By Sr. Executive/ Executive -QC Ms. Sukhmandeep Kaur
Reviewed By Manager/Designee-QC Mr. Rajendra Kumar
Approved By Head Quality Mr. Shashikant Sharma
Authorized By Plant Head Mr. Arjun Seth
Issuing Quality Assurance

Department
Supersedes NIL
Effective Date: Next Review Date:
1.0 OBJECTIVE:
The purpose of this SOP is to provide a procedure for Operation and Calibration of Leak
tester in Quality control department at “Systacare Remedies, Amritsar” facility.
Adherence to the instructions stated in this procedure will ensure to maintain the
accuracy in all respects.
2.0 SCOPE:
This procedure is applicable to all the personnel working in Quality control department
at Systacare Remedies, Amritsar.
3.0 RESPONSIBILITIES:
Roles Responsibilities
Quality control  All the personnel working in Quality control department are
Department(Off responsible Operation and Calibration of Leak tester.
icer/Executive/
Sr. Executive)
Department  Quality control Manager to provide proper Training as per the
Head/ procedure.
authorized  Quality control Manger is responsible to ensure the compliance
designate by with this SOP.
the Head
Engineering  Engineering supervisor is responsible for maintenance.
Department
Quality  To review and approve the SOP.
Assurance
SOP Title OPERATION AND CALIBRATION OF LEAK TESTER

Section General
Department  To issue the controlled copy of SOP to respective department.
4.0 DEFINITIONS:
Automatic Leak Test Apparatus can be used for quality control purposes to find leaks,
holes or other such deficiencies in packaging of injection blisters packs and Vials.
5.0 INSTRUMENT DESCRIPTION
5.1 Instrument Details:
1. Equipment Name : Leak Tester
2. Make : Lab India
3. Model No. : NLHC71S1
4. Serial No. : NLHC-0320-0239
5. Location : (QC-002) Instrument room
6. Power : 230 Volts AC
7. Capacity : 1000 Liters
8. Instrument ID No. : SYS/qc/INST/
9. Temp. & Humidity : 25 ̊C±2 ̊ C & 60 % ±5% RH
5.2 OPERATION PROCEDURE:
5.2.1 General Instructions:
5.2.1.1 Ensure that the apparatus is always clean and free from dust.
5.2.1.2 Always ensure the presence of dye in desiccator tank up to perforated plate.
5.2.1.3 The electrical supply should be as per equipment specification.
5.2.1.4 Ensure there are no remnants of previous product before using the instrument.
5.2.1.5 Check the leak test apparatus is calibrated.
Preparation of Methylene Blue Dye:
Weigh 5.00 gm of methylene blue in 1000 ml beaker. Add 1000 ml of purified water.
5.2.12.10 Mix and pour the solution in the dessicator tank.
Operation :
Switch ON the MAINS power.
5.2.12.11 Take number of vials specified in the SOP.
Open the desiccator tank and take out the perforated plastic plate.
Place the vials in the methylene blue solution , place the plastic sieve backl to the
position and cover the tank with cover.
Press the menu button on the instrument screen.
Select the user ,method and press Enter.
Select the pressure requirement from the options. And select retain time to 2 minutes
SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

Section General
after the desired pressure is reached.

Once the test is completed, the vaccum releases.
Failure of Test:
Take out the samples which are placed in the desiccatr and inquire about any
leakages by observing any colour change of injection, blue spots,wetting of dry
powder.
If moistness or blue color observed the test fails in leak test.
Stop the machine immediately
Quarantine the batch that has failed.
Inform the QA department for raising a deviation/ incident.
.5.3 Cleaning of Leak tester:
5.3.1 It shall be cleaned daily from outside.
5.3.2 Cleaning agent: 70 % IPA
5.3.3 Weekly: Clean the desiccator. Discard the methylene blue solution and clean the
desiccator from inside.
5.3.5 After cleaning fresh Methylene blue solution shall be filled.
5.3.6 NOTE: Do not clean the electrical parts with wet cloth.
5.4 Calibration:
5.4.4 Qualification frequency : Yearly
5.4.5 If the response of the instrument is not satisfactory, then put label ‘UNDER
MAINTENANCE’ on the instrument and intimate maintenance department by
providing Breakdown intimation slip.
5.5 Caution:
5.6 Maintenance:
5.6.1 Initiate the breakdown request in case of any system failure. Refer SOP No.
SYS/SOP/MTN/49/01
Prepared By Reviewed By
Sign/Date
CONFIDENTIAL DOCUMENT- DO NOT COPY

Section General
5.6.2 In case the chamber is out of order , affix Under maintenance label on the instrument.
5.6.3 Only in case of major breakdown which cannot be restored until the visit from service
personnel, the chamber should be evacuated. Incident shall be raised in such condition.
7.0 REFERENCES
IH, Instrument DQ,PQ,OQ and manual.
8.0 ABBREVIATIONS
SOP- Standard Operating Procedure
No.- Number
NA- Not Applicable
QA- Quality Assurance
QC- Quality control
9.0 LIST OF ANNEXURES

ANNEXURE FORMAT TITLE FORMAT NUMBER NUMBER
NUMBER OF PAGES
Annexure-I User ID Creation Record of Stabilty SYS/SOP/QC/45- 1
Chamber-III F01/00
10.0
REVISION HISTORY
Supersedes Effective Date Reason for Revision
SOP Number
01 -------------- New document
11.0
ENVIRONMENT, HEALTH AND SAFETY ASPECT
This section is not applicable for this SOP
Sign/Date

Section General
Annexure-I

User ID Creation/Modifcation/Deletion Record of Stabilty Chamber-III
SOP Ref. No.: SYS/SOP/QC/45/01 Format No.: SYS/SOP/QC/45-F01/00
Name
Designation
Department
User ID
Date of Creation/Modi/Del
Rights granted/added
Training
I certify that the information submitted in this application is true and correct to the best of my
knowledge. I further understand that any false statements may result in denial or revocation
of the duty. I will not disclose my password to anyone during my work tenure and will ensure
that the information in the instrument remain confidential.
Sign/Date

Section General
User Signature/ Date
QA Administrator Remarks
Signature/Date
Sign/Date

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SYSTACARE REMEDIES, AMRITSAR

STANDARD OPERATING PROCEDURE

SOP Title OPERATION AND CALIBRATION OF LEAK TESTER

Role Designation Name Signature/Date

Prepared By Sr. Executive/ Executive -QC Ms. Sukhmandeep Kaur

Reviewed By Manager/Designee-QC Mr. Rajendra Kumar

Approved By Head Quality Mr. Shashikant Sharma

Authorized By Plant Head Mr. Arjun Seth

Issuing Quality Assurance

SOP Title OPERATION AND CALIBRATION OF LEAK TESTER

Department  To issue the controlled copy of SOP to respective department.

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

after the desired pressure is reached.

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

9.0 LIST OF ANNEXURES

This section is not applicable for this SOP

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

SYSTACARE REMEDIES, AMRITSAR

SOP Ref. No.: SYS/SOP/QC/45/01 Format No.: SYS/SOP/QC/45-F01/00

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

User Signature/ Date

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