CLEANING VALIDATION FOR ESTIMATION OF OXYTOCIN RESIDUE ON THE SURFACE OF THE INSTRUMENTS USED IN MANUFACTURING & FILLING LINES OF PARENTERAL PREPARATION IN THE PHARMACEUTICAL INDUSTRY USING SWAB/RINSE SAMPLING AND BY HPLC & TOC TECHNIQUE

Registration ID: IJNRD_186014

Published ID: IJNRD2301143

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Sanjay Kumar Shah , ms. Gulbahar , mr. Saurabh Pant

Acceptance Criteria, Cleaning Validation, HPLC (High-Performance Liquid Chromatography), Methods of cleaning, MACO (Maximum Allowable Carry Over), Recovery Study, Sampling Method, Selection of Worst Case, TOC (Total Organic Carbon).

Cleaning validation refers to the cleaning-specific processes and outcomes that have been demonstrated to yield permissible results even in the worst-case situation. It is possible for cleaning agents, extraneous material, microorganisms, or other active pharmaceutical ingredients (API) to contaminate pharmaceutical products to a level that is above predetermined levels. To prevent cross-contamination, manufacturing and cleaning equipment must be designed for efficient and reliable cleaning, and the cleaning procedures must be approved as efficient. The residual residues on the equipment must be regulated based on the findings of confirmed analytical data since human safety depends on them.

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Sanjay Kumar Shah, ms. Gulbahar, & mr. Saurabh Pant (January-2023). CLEANING VALIDATION FOR ESTIMATION OF OXYTOCIN RESIDUE ON THE SURFACE OF THE INSTRUMENTS USED IN MANUFACTURING & FILLING LINES OF PARENTERAL PREPARATION IN THE PHARMACEUTICAL INDUSTRY USING SWAB/RINSE SAMPLING AND BY HPLC & TOC TECHNIQUE. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 8(1), b368-b376. https://ijnrd.org/papers/IJNRD2301143.pdf

Volume 8 Issue 1, January-2023

Pages : b368-b376

Paper Reg. ID: IJNRD_186014

Published Paper Id: IJNRD2301143

Downloads: 000122001

Research Area: Pharmacy

Country: Dehradun, Uttarakhand, India

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