Category SOP

Principle of Autoclave and SOP for Pharmaceutical Sterilization

principle of autoclave

An autoclave is a critical piece of equipment in pharmaceutical manufacturing and microbiology laboratories that achieves sterilization through moist heat under controlled pressure. The principle underlying autoclave sterilization—moist heat sterilization—works by generating saturated steam at temperatures of 121–134°C and pressures…

Stability Chamber Working Principle and SOP in Pharmaceutical Industry

Stability Chamber Working Principle and SOP in Pharmaceutical Industry

A stability chamber is a specialized environmental control instrument used to simulate real-world storage conditions and evaluate the quality, safety, and shelf life of pharmaceutical products over time. Regulatory agencies such as the US FDA, EMA, and WHO require stability studies in qualified chambers before granting…

ALCOA Principles in Pharma: Definition, Examples & FDA Requirements

ALCOA principles comparison chart for pharmaceutical data integrity

ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate—the five fundamental data integrity principles established by the FDA in the 1990s to ensure pharmaceutical data quality and regulatory compliance. These principles form the cornerstone of Good Documentation Practices (GDP) and…

SOP for Calibration of Dissolution test appratus

Gas Chromatography GC Principle

Principle of Dissolution Test Apparatus Dissolution is the analysis process in which the analyzed substance forms a solution. In this testing measurement of the content and rate of dissolving in the solution from a dosage form, such as a tablet,…

UV-Visible Spectrophotometer SOP, Calibration and Advantages

UV-Visible Spectrophotometer SOP

SOP, Calibration, and features of UV-visible spectrophotometer UV-Visible Spectrophotometry is an analytical technique that is widely used in the pharmaceutical industry for qualitative and quantitative analysis of substances. It works by measuring the intensity of light passing through the prepared…

Karl Fischer titration and calibration Procedure

Karl Fischer

In the quality control department Instrument section is an essential part because every test requires a specific instrument to perform a valid analysis. Karl Fischer titration is very essential in many analyses including finding the water content in any substance.…