Calibration records are critical quality records kept by pharmaceutical manufacturers. A long list of measuring instruments is frequently used in making decisions which can impact product quality.
Showing posts with label Calibration. Show all posts
Calibration of Class A and Class B Glassware in Pharmaceuticals
In pharmaceutical labs, having an accurate measurement is one of the key requirements to ensure that the different tasks required to correctly execute these pharmaceuticals are performed correctly, irrespective of whether it is preparing a buffer solution, diluting a sample, or conducting an Assay test; so much so that any slight mistakes made when measuring the volumetric quantity of some substa…
Difference Among Calibration, Validation and Qualification
To ensure the quality, consistency, and compliance of pharmaceutical products, controlled and reliable equipment, systems and processes are required. Pharmaceutical manufacturers follow three basic procedures calibration, validation, and qualification to control their operations.
Why Dissolution Test Apparatus Calibration with Salicylic Acid Tablets was Stopped?
Prednisone and Salicylic acid tablets USP were used for the calibration of dissolution test apparatus. Prednisone tablets were disintegration type and Salicylic acid tablets were non-disintegration type.
Handling of Out of Calibration Instruments and Equipment
Procedure for Instruments / Equipment other than Quality Control Laboratory
1. Stop usage of instrument/ equipment if it fails in calibration test or if there is a sudden malfunction in the instrument.
2. Affix “UNDER MAINTENANCE” label to the instrument/ equipment.
3. Fill an “Incident Report” and inform engineering department.
4. Engineering department shall carry out the investigation to find th…
2. Affix “UNDER MAINTENANCE” label to the instrument/ equipment.
3. Fill an “Incident Report” and inform engineering department.
4. Engineering department shall carry out the investigation to find th…
Principle and Calibration of TOC (Total Organic Carbon) Analyzer
Introduction of organic matter into water systems occurs not only from living organisms and from decaying matter in source water but also from purification and distribution system materials. A relationship may exist between endotoxins, microbial growth, and the development of biofilms on pipeline walls and biofilm growth within pharmaceutical distribution systems. A correlation is believed to exi…
Principle and Calibration of Ultraviolet and Visible Absorption Spectrophotometry
Ultraviolet and visible absorption spectrophotometry is the measurement of the absorption of monochromatic radiation by solutions of chemical substances, in the range of 185 nm to 380 nm, and 380 nm to 780 nm of the spectrum, respectively. The magnitude of the absorption of a solution is expressed in terms of the absorbance, A, defined as the logarithm to base 10 of the reciprocal of transmittance…
Calibration of Volumetric Glassware used in Pharmaceuticals
Calibration of volumetric flasks
Weigh a clean & dry volumetric flask. Calibrate the flask by filling it with recently boiled and cooled distilled water at room temperature up to the mark and weigh the flask. Determine the volume in ml by the formula;
Volume (in ml) = (Weight in g / 0.99602) Where 0.99602 g is the weight of 1 ml water determined at temperature 25°C.
For the volumetric flask…
Volume (in ml) = (Weight in g / 0.99602) Where 0.99602 g is the weight of 1 ml water determined at temperature 25°C.
For the volumetric flask…
Calibration of Centrifuge Apparatus
PROCEDUREEnsure that all connection of instrument are properOperate the instrument as per the operating instructionsUse duly calibrated tachometer, digital thermometer and stopwatch during calibration of the equipment.
Calibration of timeSet the time for five minutes using set parameters. Record the results by using a digital stopwatch. Repeat the test for ten minutes.Calibration of revolutions …
