PATH FINDER PROCESS VALIDATION OF MOIST HEAT STERILIZER IN PARENTRAL MANUFACTURING UNIT

  • R S Kalkotwar Dept. of Quality Assurance, S.N.D. College of Pharmacy, Bhabhulgoan,Tal- Yeola, Dist-Nashik.(MS) India Pin. 423401
  • M B Salve Dept. of Quality Assurance, S.N.D. College of Pharmacy, Bhabhulgoan,Tal- Yeola, Dist-Nashik.(MS) India Pin. 423401
  • T K Ahire Dept. of Quality Assurance, S.N.D. College of Pharmacy, Bhabhulgoan,Tal- Yeola, Dist-Nashik.(MS) India Pin. 423401

Abstract

Objective:- Moist heat sterilization is the most important in pharmaceutical Parentral manufacturing unit. Sterile products have several unique dosage form properties, such as freedom from microorganisms, freedom from pyrogens, freedom from particulates, and extremely high standards of purity and quality; however, the ultimate goal in the manufacture of a sterile product is absolute absence of microbial contamination. An attempt has been made in this research work to validate the Moist Heat Steriliser with technical  parameters  classified as Critical and Variable Parameters.

Method:- Moist Heat Sterilization method is used for Sterilization of  Accessories,Garments ,Silicon tubes, filtration assembly etc. on basis of coagulation of cell proteins. Moist Heat Steriliser  is validated every half year to ensure the system is liable to consistently, provide dehydrogenated or sterile product and meets the quality standards. Validation is done by proper planning by taking regular load and experimental load of regular batches of the product. The study is done on Heat distribution, Heat penetration, and Bio burden determination, Minimize the utility cost, and Man hours during sterilization cycle.

Result:- The result found in this research work  leads to setting up New approach to Validate Moist Heat Steriliser in Parentral manufacturing unit with cost effective way.

Conclusion:- The Path finder validation process setup through this project is Cost saving through Energy as well as Man Hour Saving and Breakage of Units also maintain Sterility in product. It is helpful to find out Hot and Cold Spots in Moist Heat sterilizer and Designing and   Placement of RTDs. The findings were submitted to the Parentral Department of Vital HealthCare Pvt. Ltd., Satpur. MIDC, Nashik.

KEYWORDS:-Moist heat Sterilization , Process Validation , Critical and Variable parameters.

Downloads

Download data is not yet available.

Author Biographies

R S Kalkotwar, Dept. of Quality Assurance, S.N.D. College of Pharmacy, Bhabhulgoan,Tal- Yeola, Dist-Nashik.(MS) India Pin. 423401

Dept. of Quality Assurance, S.N.D. College of Pharmacy, Bhabhulgoan,Tal- Yeola, Dist-Nashik.(MS) India Pin. 423401

M B Salve, Dept. of Quality Assurance, S.N.D. College of Pharmacy, Bhabhulgoan,Tal- Yeola, Dist-Nashik.(MS) India Pin. 423401

Dept. of Quality Assurance, S.N.D. College of Pharmacy, Bhabhulgoan,Tal- Yeola, Dist-Nashik.(MS) India Pin. 423401

T K Ahire, Dept. of Quality Assurance, S.N.D. College of Pharmacy, Bhabhulgoan,Tal- Yeola, Dist-Nashik.(MS) India Pin. 423401
Dept. of Quality Assurance, S.N.D. College of Pharmacy, Bhabhulgoan,Tal- Yeola, Dist-Nashik.(MS) India Pin. 423401

References

1. B. M .Boca , E. Pretorius , R Gochin , R Chapoullie, And Z. Apostolidess , An Overview Of The Validation Approach For Moist Heat Sterilization Part-I , Review Article In Pharmaceutical Technology Sept- 2002:10-20
2. Raymond G, Lewis P E, “Practical Guide To Autoclave Validation”, Review Article In Pharmaceutical Engineering, July/August-2002:1-8
3. B .Venkateswarwa Reddy , B.R. Reddy A Review on Qualification of Autoclave , RMG , FBD, Cone blender ,tablet compression machine ,journal of globle trends in pharmaceutical sciences Jan- march 2014: 1- 8.
4. Indian pharmacopoeia Volume I, sterilization, the Indian Pharmacopoeia Commission Ghaziabad 2014: 565-567.
5. British Pharmacopoeia united state pharmacopeia convection, twentieth Washington D.C 2014(II): 241.
6. USPXX the United State Pharmacopeia, NFXV the National Formulary2014: 1037- 1040.
7.Hugo and Russell’s Pharmaceutical Microbiology edited by Stephan P. Denyer, Norman A. Hodges and Sean P. Gorman , Blackwell publishing 1977, Chapter Sterilization procedure and sterility Assurance seventh edition 2005 355- 346
8.Bhana Nikhilesh et al ,ZanwarAartiSachin, Trivedi Vishal, Jain Dipesh A Review On “Steam Sterilization A Method Of Sterilization” Journal Of Biological And Scintific Opinion, 2013 (1 ):2-4
9. SOP of Vital Healthcare Pvt. Ltd, SOP on autoclave validation, SOP No. QA/042-00.
10. Robert A Nash, And Alfred H Walhter, “ Pharmaceutical Process Validation An International” ,Third Edition , Revised And Expanded Volume –I: 95-102.
11. Fredrick J. Carleton, James P Agalloco , “ Validation Of Pharmaceutical Processes , Sterile Product” SecondEdition, Chapter no-14, Edited By Phil Desantis, Fluor Daniel Inc.Marlton , New Jersey: 413-449.
12. Suat Kumser , Validation Of Sterilization Equipment , Aseptic Area Validations, Turkish Pharmaceutical And Chemical Industry Research And Devlopment Foundation. Istanbul Hilton , May,2002: 2-3
13.Dr. Felix Gmuender , RBP Baster And Hoffmann , “ Autoclave Validation For Microbiological And Biomedical Laboratories” Asia Pacific Biosafety Association , By Temasek Life Sciences , Singapore Jan 2010.(3)
Statistics
142 Views | 281 Downloads
How to Cite
1.
Kalkotwar R, Salve M, Ahire T. PATH FINDER PROCESS VALIDATION OF MOIST HEAT STERILIZER IN PARENTRAL MANUFACTURING UNIT. JDDT [Internet]. 15Nov.2015 [cited 30Mar.2020];5(6):35-2. Available from: http://jddtonline.info/index.php/jddt/article/view/1167