UV Cabinet Calibration in Pharma: Quality Control Standard Procedure

This document outlines a Standard Operating Procedure (SOP) for the calibration of UV cabinets within the quality control department of Lifeline Pharmaceutical Pvt. Ltd. The SOP details the purpose, scope, responsibilities, and step-by-step procedure for calibrating UV cabinets, which are essential for chromatographic analysis, fluorescence studies, and nucleic acid denaturation. The calibration process involves using a sodium salicylate solution at specific wavelengths (254nm and 369nm) and observing the resulting fluorescence. The document also includes a distribution list for relevant departments and references to ICH guidelines and other scholarly articles, ensuring adherence to quality standards and proper maintenance of the UV cabinet.

Lifeline Pharmaceutical Pvt. Ltd.
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Lifeline pharmaceuticals Pvt. Ltd.
Quality control department
Standard Operating Procedure Lifeline pharmaceuticals Pvt. Ltd.
Calibration of UV Cabinet
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2. Purpose: The UV cabinet is important equipment that is used in pharmaceutical quality control
department. This equipment emits UV light using, which, several quality related parameter are checked and
determined. The prime purpose of this standard of procedure is to train individual to operate the UV cabinet
with proper maintenance (ICH 2018).
3. Scope: The primary purposes of using UV cabinets are Chromatographic analysis by Ultraviolet
fluorescence. Further, these Cabinets used for screening the Chromatogram by combines the both long and
short wave UV Lights and the White Light in a compact tabletop unit. This develops a self-contained unit
that helps to easy viewing and production of Chromatograms (Syed et al. 2015). Furthermore, it also helps in
the general Florescence Studies. These Cabinets are made up of powerful UV Lights that denatures Nucleic
Acids in 5 to 30 minutes making them inappropriate for Amplification and Contamination of the PCR
reactions. These lights are controlled by timers and are inclusive of safety switches on the Cabinet
Doors through which putting on and off the UV lights are easier when opened to prevent user exposure
to UV light (Krzyścin et al. 2012).
4. Tasks, responsibilities and accountabilities
Task Authorize
d
Responsibl
e
Determines the verifiers that verifies the documents QC QA QC head
Verification QC QA QC head
develops quality related documents QC QA QC head

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5. Procedure:
 The frequency of the process will be once in every 3 months.
 The desired wavelength will be 254nm
 A 0.04%w/v sodium salicylate solution will be prepared in ethanol of 95% strength.
 From this solution, 5μ will be taken on silica gel and a diameter of 5nm will be taken.
 Further, for the observation process the distance between the lamp and plates under
observation for pharmacopeial tests should be maintained as per the testing protocol.
 The light should be capable of revealing without a doubt a standard spot of sodium salicylate.
 Further for the 369 nm wavelength, the above mentioned process will be repeated (Syed et al.
2015).
7. Distribution list:
 The quality control chemical department
 The microbiological quality control department
 The media preparation and raw material testing department

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8. References
ICH 2018. Quality Guidelines : ICH. [online] Ich.org. Available at:
http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html [Accessed 11 Apr. 2018].
Krzyścin, J.W., Jarosławski, J., Rajewska-Więch, B., Sobolewski, P.S., Narbutt, J., Lesiak, A., Pawlaczyk,
M. and Janouch, M., 2012. Space-based estimation of the solar UV-B doses for psoriasis heliotherapy in
Poland using OMI data for the period 2005–2011. Journal of Photochemistry and Photobiology B:
Biology, 117, pp.240-246.
Syed, H.K., Liew, K.B., Loh, G.O.K. and Peh, K.K., 2015. Stability indicating HPLC–UV method for
detection of curcumin in Curcuma longa extract and emulsion formulation. Food chemistry, 170, pp.321-
326.