2 research outputs found
The application of cleaning validation principles on dietary supplements production equipment
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
The influence of a cryoprotective medium containing glycerol on the lyophilization of lactic acid bacteria (NOTE)
The aims of liophilization (freeze-drying) of lactic acid bacteria are to preserve pure cultures or to prepare starters for the dairy industry. In both cases, the choice of the cryoprotectant is very important. In this work, samples of Bifidobacterium breve A71 and Bifidobacterium bifidum BbTD were freeze-dried in a new cryoprotective medium containing lactose, gelatine and glycerol (medium B). The reference medium contained saccharose, gelatine and skim milk (medium A). Before liophilization, the eutectic points of both media were determined, because the products must be cooled to a temperature below its freezing point. The success of the cryoprotectants was estimated in terms of the number of surviving organisms after lyophilization. Bifidobacterium breve A71 and Bifidobacterium bifidum BbTD freeze-dried in media A and B showed high survival rates. Bifidobacterium breve A71 showed a greater percentage survival in combination with medium B than with medium A. These results could be utilized in the manufacture of Bifidobacterium breve A71 as a starter in the diary industry because it is a human isolate which, except for acidification, has probiotic activity