The application of cleaning validation principles on dietary supplements production equipment

• Published in: Acta Periodica Technologica Vol. 2017; no. 48; pp. 141 - 153
• Main Authors: Korčok Davor J., Tršić-Milanović Nada A.
• Format: Journal Article
• Language: English
• Published: Faculty of Technology, Novi Sad 01-01-2017
• Subjects: cleaning validation; dietary supplements; microbiological criteria
• ISSN: 1450-7188; 2406-095X
• DOI: 10.2298/APT1748141K

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.