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Published Paper Details
Paper Title:
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 And TOC Technique
Authors Name:
Mr. Sanjay Kumar Shah
, Ms. Gulbahar , Mr. Saurabh Pant , Dr. Praveen Kumar Ashok
Cleaning validation is the method used to ensure that the cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids used in the cleaning process and the microbial characteristics. Cleaning certification is a document demonstrating that an approved cleaning procedure will provide equipment suitable for the processing of pharmaceutical products and APIs, with a high degree of assurance.
For sample analysis, the tolerance limit of 500ppb was set for sucrose as a general solution in TOC. When the method of microbial counting is used, colonies of microbes that were present in samples during incubation at 370 c via soya bean casein digestion agar media are counted after 5 days.
"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 And TOC Technique", International Journal of Science & Engineering Development Research (www.ijrti.org), ISSN:2455-2631, Vol.8, Issue 6, page no.559 - 564, June-2023, Available :http://www.ijrti.org/papers/IJRTI2306088.pdf
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ISSN:
2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator