16 Fribility Test Appratus 016 4t1i2s
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OASIS
LABORATORIES PRIVATE LIMITED, DEHRADUN
SOP No.: QCG0016 Supersedes : 00
QUALITY CONTROL DEPARTMENT STANDARD OPERATING PROCEDURE
Version No. : 01 1.0
SOP FOR OPERATION AND CALIBRATION OF FRIABILITY TEST APPARATUS
Page 1 of 3 Effective: April 2010 Review date: March 2013
OBJECTIVE: To describe the procedure for the “Operation and Calibration Friability Test Apparatus”.
2.0
SCOPE: This SOP is applicable to “Calibration of Friability Test Apparatus” at M/s. Oasis Laboratories Private Limited, Dehradun.
3.0
RESPONSIBILITY: Quality Control Department
4.0
ABILITY: HOD – QC
5.0
PROCEDURE : 5.1
Ensure that the instrument and its surrounding area is clean and free from dust.
5.2
Weigh accurately the number of tablets and carry out the procedure as described in the monogram.
5.3 5.4
Open the apparatus from one removable side of the drum. Transfer the tablets in it and close the drum tightly.
5.5
Switch on the apparatus, and count the revolution as specified in the monogram.
5.6
The tablets are tumbled at each turn of the drum by a curved projection that extends from the middle of the drum to the outer wall.
5.7
Rotated the drum 100 times, and after completion of revolution remove the tablets from the drum. Remove any loose dust or broken tablets and weigh.
5.8
Prepared by Reviewed by Approved by
Designation Chemist - QC Manager - QC Manager - QA
Signature
Date
OASIS SOP No.: QCG0016 Supersedes : 00
QUALITY CONTROL DEPARTMENT
6.0
Page 2 of 3
STANDARD OPERATING PROCEDURE
Version No. : 01 5.9
LABORATORIES PRIVATE LIMITED, DEHRADUN
SOP FOR OPERATION AND CALIBRATION OF FRIABILITY TEST APPARATUS
Effective: April 2010 Review date: March 2013
Switch of the instrument when not required.
CALIBRATION RECORD:-
The apparatus is calibrated by TIME CONTROLLER and calculate RPM as follows:PROCEDURE:Calibration of RPM Set Time
Limit
Set time
0 – 4 min
±1 RPM
5.00 min
±0.05 min
4 – 8 min
±1 RPM
10.00 min
±0.05 min
0 – 8 min
±1 RPM
15.00 min
±0.05 min
Date
No of revolution
Calibration of Time Controller
Observed RPM/min.
observed / Display time
Limit
Frequency of calibration: Monthly 7.0
RECORDS: “Calibration Record of Friability Test Apparatus” (Annexure-1).
8.0
ANNEXURES: Annexure-1: Format for “Calibration Record of Friability Test Apparatus.”
9.0
ABBREVIATIONS & DEFINITIONS: SOP
: Standard Operating Procedure.
Dept.
: Department.
HOD
: Head of the Department.
QC
: Quality Control
Annexure-1
CALIBRATION OF FRIABILITY TEST APPARATUS
Prepared by Reviewed by Approved by
Designation Chemist - QC Manager - QC Manager - QA
Signature
Date
OASIS
LABORATORIES PRIVATE LIMITED, DEHRADUN
SOP No.: QCG0016 Supersedes : 00 Version No. : 01
QUALITY CONTROL DEPARTMENT STANDARD OPERATING PROCEDURE SOP FOR OPERATION AND CALIBRATION OF FRIABILITY TEST APPARATUS
SOP REF NO – QCG0016 Name of Instruments Name of Manufacturer Instrument ID Number Frequency of calibration
Set Time
No of revolution
: : : :
Friability Test Apparatus Satish Enterprises Delhi QC/CS/016 Monthly
Review date: March 2013
Instruments location: Q.C. LAB.
Calibration OF TIME CONTROLLER Limit
Set time
0 – 4 min
±1 RPM
5.00 min
±0.05 min
4 – 8 min
±1 RPM
10.00 min
±0.05 min
0 – 8 min
±1 RPM
15.00 min
±0.05 min
Prepared by Reviewed by Approved by
Effective: April 2010
QC-F-019-01
Calibration of RPM Date
Page 3 of 3
Observed RPM/min.
Designation Chemist - QC Manager - QC Manager - QA
observed / Display time
Limit
Signature
Next due date
Remark
Performed by
Date
Checked by
LABORATORIES PRIVATE LIMITED, DEHRADUN
SOP No.: QCG0016 Supersedes : 00
QUALITY CONTROL DEPARTMENT STANDARD OPERATING PROCEDURE
Version No. : 01 1.0
SOP FOR OPERATION AND CALIBRATION OF FRIABILITY TEST APPARATUS
Page 1 of 3 Effective: April 2010 Review date: March 2013
OBJECTIVE: To describe the procedure for the “Operation and Calibration Friability Test Apparatus”.
2.0
SCOPE: This SOP is applicable to “Calibration of Friability Test Apparatus” at M/s. Oasis Laboratories Private Limited, Dehradun.
3.0
RESPONSIBILITY: Quality Control Department
4.0
ABILITY: HOD – QC
5.0
PROCEDURE : 5.1
Ensure that the instrument and its surrounding area is clean and free from dust.
5.2
Weigh accurately the number of tablets and carry out the procedure as described in the monogram.
5.3 5.4
Open the apparatus from one removable side of the drum. Transfer the tablets in it and close the drum tightly.
5.5
Switch on the apparatus, and count the revolution as specified in the monogram.
5.6
The tablets are tumbled at each turn of the drum by a curved projection that extends from the middle of the drum to the outer wall.
5.7
Rotated the drum 100 times, and after completion of revolution remove the tablets from the drum. Remove any loose dust or broken tablets and weigh.
5.8
Prepared by Reviewed by Approved by
Designation Chemist - QC Manager - QC Manager - QA
Signature
Date
OASIS SOP No.: QCG0016 Supersedes : 00
QUALITY CONTROL DEPARTMENT
6.0
Page 2 of 3
STANDARD OPERATING PROCEDURE
Version No. : 01 5.9
LABORATORIES PRIVATE LIMITED, DEHRADUN
SOP FOR OPERATION AND CALIBRATION OF FRIABILITY TEST APPARATUS
Effective: April 2010 Review date: March 2013
Switch of the instrument when not required.
CALIBRATION RECORD:-
The apparatus is calibrated by TIME CONTROLLER and calculate RPM as follows:PROCEDURE:Calibration of RPM Set Time
Limit
Set time
0 – 4 min
±1 RPM
5.00 min
±0.05 min
4 – 8 min
±1 RPM
10.00 min
±0.05 min
0 – 8 min
±1 RPM
15.00 min
±0.05 min
Date
No of revolution
Calibration of Time Controller
Observed RPM/min.
observed / Display time
Limit
Frequency of calibration: Monthly 7.0
RECORDS: “Calibration Record of Friability Test Apparatus” (Annexure-1).
8.0
ANNEXURES: Annexure-1: Format for “Calibration Record of Friability Test Apparatus.”
9.0
ABBREVIATIONS & DEFINITIONS: SOP
: Standard Operating Procedure.
Dept.
: Department.
HOD
: Head of the Department.
QC
: Quality Control
Annexure-1
CALIBRATION OF FRIABILITY TEST APPARATUS
Prepared by Reviewed by Approved by
Designation Chemist - QC Manager - QC Manager - QA
Signature
Date
OASIS
LABORATORIES PRIVATE LIMITED, DEHRADUN
SOP No.: QCG0016 Supersedes : 00 Version No. : 01
QUALITY CONTROL DEPARTMENT STANDARD OPERATING PROCEDURE SOP FOR OPERATION AND CALIBRATION OF FRIABILITY TEST APPARATUS
SOP REF NO – QCG0016 Name of Instruments Name of Manufacturer Instrument ID Number Frequency of calibration
Set Time
No of revolution
: : : :
Friability Test Apparatus Satish Enterprises Delhi QC/CS/016 Monthly
Review date: March 2013
Instruments location: Q.C. LAB.
Calibration OF TIME CONTROLLER Limit
Set time
0 – 4 min
±1 RPM
5.00 min
±0.05 min
4 – 8 min
±1 RPM
10.00 min
±0.05 min
0 – 8 min
±1 RPM
15.00 min
±0.05 min
Prepared by Reviewed by Approved by
Effective: April 2010
QC-F-019-01
Calibration of RPM Date
Page 3 of 3
Observed RPM/min.
Designation Chemist - QC Manager - QC Manager - QA
observed / Display time
Limit
Signature
Next due date
Remark
Performed by
Date
Checked by
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