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Probiotic products are becoming more common in everyday use around the world, while at the same time, the interest of scientists in researching probiotic production and use is increasing. Stability of a probiotic product in pharmaceutical production is affected by the choice of probiotic strain, formulation, and packaging. Packaging is the final stage of production and presents a crucial factor for the stability of probiotic products to maintain declared probiotic viability during the products' shelf life. The present research describes the influence of additional packaging material on the encapsulated probiotic product, which contains Lactiplantibacillus plantarum 299v. In specific, the effect of additional blister protection within flow pack bags was investigated. Blisters were made of a chloride/poly-vinylidene chloride/polyethylene-triplex foil (PVC/PVdC/PE foil) and aluminum foil. Viability of probiotic lactobacilli cells protected in blisters only was compared to those packed in flow pack bags filled with nitrogen as an inert gas. Better protection of probiotic cells from oxygen, light, and moisture was determined in the capsules in the latter case. In specific, introduction of additional blister protection in flow pack bags resulted in ~11 % higher probiotic viability when compared to the other blister samples without such protection after 24 months, and therefore it enabled more efficient storage of the product during use.

In recent decades, probiotic products have been increasingly used to prevent certain gastro-intestinal and urogenital disorders, to improve the general condition of the body and as a supplement to pharmacological therapy. They are most often registered as dietary supplements, and less often as drugs in the form of capsules, powders, and solutions. Optimization of technological processes of production and packaging of these products aims to maintain probiotic characteristics while adhering to all criteria during production that ensure quality, bioavailability and optimal therapeutic effects. In this paper, the importance of choosing primary and secondary packaging materials was explored with the aim of preserving the viability of probiotic cells in capsules for two years, i.e. during the shelf life. By comparing the applications of polyvinyl chloride (PVC) and PVC/polyvinylidene chloride/polyethylene blister foils, better protection of probiotic cells was observed by applying the multilayer foil. In addition, in this research, further improvements of probiotic cell protection were achieved by applying a secondary packing-flow pack bag with inert gas for storing multilayered blisters.

Quality management is very important segment of business in pharmaceutical industry which primary objective is to provide a quality product to customer for the purpose of preserving human health. The increasing number of companies apply numerous quality systems, hence the need for a comparative review of quality management systems and its optimization in order to find suitable model for the integration of these systems. The improvement of integrated management and quality systems has become an imperative of company's business development and survival. It is economically acceptable to use synergy potential in the field of quality management for the purpose of significantly improving company's business competitive position with a relatively small investment. In addition to this, with the integration of different management systems companies become more agile, profitable and more competitive, which is a condition for its survival on the global marketplace. Integrated management systems combine all the components of management systems into a coherent system thus enabling the achievement of company's policy and goals. Basically, there are three approaches for establishment of integrated quality management systems: the Sequential approach, Parallel approach and Combined approach.

Probiotic pharmaceutical preparations are more and more popular because of the increasing level of evidence of their beneficial effect on human health. The goal of this study was to determine and develop the encapsulated probiotic formulation with the optimal filling amount of active ingredient - Lactobacillus plantarum that would, in combination with other active ingredients: iron, vitamin C and excipient starch, fulfil requirements for therapeutic action while maintaining process parameters’ requirements of manufacturing as well. The optimal formulation of a multicomponent probiotic-based formulation that fulfils requirements for sustaining all active ingredients while respecting technological process requirements, will enable a routine pharmaceutical manufacturing that could yield both efficient and safe dietary products.

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 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 mediaAandBshowed 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.