The application of cleaning validation principles on dietary supplements production equipment
| Autor: | A Nada Trsic-Milanovic, J Davor Korcok |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
microbiological criteria Waste management Computer science 030106 microbiology General Engineering cleaning validation Cleaning validation dietary supplements 03 medical and health sciences 0302 clinical medicine lcsh:Technology (General) lcsh:T1-995 Production (economics) 030212 general & internal medicine |
| Zdroj: | Acta Periodica Technologica, Vol 2017, Iss 48, Pp 141-153 (2017) |
| ISSN: | 2406-095X 1450-7188 |
| DOI: | 10.2298/apt1748141k |
| Popis: | Cleaning validation for pharmaceutical production equipment is a documented proof of the efficient cleaning, and one of prerequisites of good manufacturing practice in medicine production. Successful validation confirms the efficiency of the procedures of cleaning, washing, and disinfecting of the manufacturing equipment, and records results of the chemical and microbiological analyses, which are a prerequisite for a safe final dietary product. The main goal of this study was to improve the cleaning process of the production equipment by using cleaning validation procedures on the solid form production line (capsules) in the Abela Pharm d.o.o. The validation principles that are used in manufacturing of medicines can be applied to determine more efficient cleaning methods that will ensure longer periods of the status clean in the production of dietary supplements. The outcome is a practical analysis of the production equipment in view of regulatory demands, confirming that the cleaning validation measures ensure prevention of unwanted microbial growth or removal of contamination from the production equipment in order to preserve the activity, efficacy, and safety of the final dietary product. |
| Databáze: | OpenAIRE |
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