Journal :   Research Journal of Pharmacy and Technology

Volume No. :   2

Issue No. :  1

Year :  2009

Pages :   147-150

ISSN Print :  0974-3618

ISSN Online :  0974-360X


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Cleaning Validation Study of Amoxycillin Trihydrate



Address:   Narendra Chotai 1, Vishnu Patel1, Harsha Patel2, Uren Patel1, and Rajendra Kotadiya2,*
1Pharmaceutics Department, A. R. College and G.H. Patel Institute of Pharmacy Vallabh Vidyanagar – 388 121, Gujarat, India
2Pharmaceutics Department, Indukaka Ipcowala College of Pharmacy, New Vallabh Vidyanagar – 388 121, Gujarat, India
*Corresponding Author
DOI No:

ABSTRACT:
Cross contamination is a major problem in a multi product manufacturing facility. This problem can multiply into major problem in a bulk drug manufacturing facility as cross contamination in one batch may end up in several batches. Hence cleaning validation is of utmost importance in these facilities. The present study was under taken to assess the effectiveness of cleaning procedure being used in one of the WHO approved Pharmaceutical plant in Gujarat having common facilities for manufacture of dosage forms of Beta Lactam group of antibiotics where there is a risk of potential hazards of cross contamination. Cleaning validation studies were carried according to the cleaning validation protocol. The study showed good swabs recovery (91.84 %). The actives residue values on different sampling point were found within acceptance limit of 10mcg/sqcm recommended by USFDA guidelines and Lilly criteria. It may be concluded that the cleaning procedure being used in Beta Lactam manufacturing plant was found satisfactory.
KEYWORDS:
Cleaning validation, Swab method, Rinse water method, Recovery Studies and Acceptance criteria.
Cite:
Narendra Chotai, Vishnu Patel, Harsha Patel, Uren Patel, Rajendra Kotadiya. Cleaning Validation Study of Amoxycillin Trihydrate. Research J. Pharm. and Tech. 2(1): Jan.-Mar. 2009; Page147-150.
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