- Objective :To lay down procedure for Calibration of Tablet Hardness Tester (Inweka).
- Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company name with location.
- Operator shall be responsible for calibration of the equipment as per this SOP.
- Production Supervisor / Officer shall be responsible for implementation of this SOP.
- Head-Production / designee shall be responsible for compliance of this SOP.
- Abbreviations and Definitions
SOP – Standard Operating Procedure
Kg – Kilogram
Oz – Ounce
lb – Pound
N – Newton
KN – kilo Newton
QA -Quality Assurance
- Calibration Procedure
- Insert the four batteries in the battery pocket of equipment by taking care of ± sign.
- Place the Tablet Hardness Tester with the back of the tester, resting on the shelf.
- Switch ‘on’ the Tablet Hardness Tester.
- Press ‘Max’ key until two triangular arrows pointing away from each other are showing on display.
- Press the ‘Units Button’ until the kg symbol appears. The reading shall be displayed in units’ kg, oz, lb, N and KN.
- Place the stirrup between the jaws of the tester.
- Stirrup should not be clamp with anvil.
- Carefully place the Standard Weight of 5.0 kg on to stirrup.
- Reading of Calibrated Weight display on the screen.
- After calibration put the calibrated tag on the equipment.
- Calibration shall be recorded in Annexure-I.
- Calibration Procedure
Note: Calibration of Hardness Tester shall be done monthly / as or when required.
- Forms and Records
- Tablet Hardness Tester Calibration Record – Annexure-I
- Master Copy Documentation Cell (QA)
- Controlled Copies Production and Quality Assurance
|Reason for revision|
Tablet Hardness Tester Calibration Record
|Date and Time||Standard Weight
5.0 kg/ 49.03N
|Certificate Number||Certificate Valid Upto||Actual Weight Observed||Tolerance
|Calibration OK/NOT OK||Next Due Date||Done by||Checked By|
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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube