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Pharma essence

21 CFR



An outlook to Analytical instrumentations

Quality is the key elements that plays a major roles in Pharma health care sector. Every role we do or act impacts human life. 

Temperature, pressure  and level measurement equipment plays a huge role in pharmaceutical Current Good Manufacturing Practices (cGMP) and quality assurance, so it is essential for these devices to be checked for accuracy on a regular basis.

This can be done through instrument calibration, the process of comparing measurements from a device against a standard. The standard is a device with known accuracy, traceable to national or international standards. Deviation from the standard (uncertainty or “drift”) is recorded and the instrument under test may then be adjusted to correct it.

Calibration is particularly important for process-critical devices, where measurements affect final product quality or safety.

So based on this, find below the video where the insight to basics what one should know has been presented.

https://youtu.be/N4YFa_SU36o

In Calibrations, temperature sensors and pressure gauges play a vital role. Below are the types that is used in Instrumentation:

Common types of temperature sensors
Temperature measurement devices typically used in pharmaceutical manufacturing processes include:

  • Thermistors
  • Thermocouples
  • Spring-type or bimetal thermometers
  • Resistance-temperature detectors (RTDs)
  • Infrared radiation (IR) detectors
  • Thermal imaging cameras
Common types of pressure gauges
While many pressure gauge types are available, some of the most common ones used in pharmaceutical manufacturing are:

  • Commercial pressure gauges
  • Industrial pressure gauges
  • Process pressure gauges
  • High-precision test gauges
  • Low-pressure gauges
  • Seal gauges
  • Absolute pressure gauges
  • Duplex pressure gauges
  • Differential gauges
Key points to highlight:

 1.Analytical balance standard weights classified into - E1, E2, F1,F2,M1,M2

2. Infrared spectroscopy: Based on Transmission and Absorption which directly proportional to the bonds present in molecules.

3. UV visible spectrophotometer: Based on Beer Lambert law which states that the absorption of light is directly proportional to the concentration of solutions.

4. Polarimeter : Based on levo and dextro rotation. 

5. Halogen moisture analyzer: Based on moisture content analysis. 

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