Quality of our products
The medicament PT-12 is manufactured in a very elaborate process, every production step has to be according to the GMP-guidelines (guidelines for “Good Manufacturing Practice”). Thus, every company involved in the production chain (manufacturer of the agent, packaging company, external lab analyser) has to be equipped with an own GMP-certificate and has to document all production steps. These companies are controlled by an expert commissioned to audit by re-scha. In these audits, the expert verifies that all companies work according to GMP-guidelines and comply with the specifications of the manufacturer.
The actual production starts with the provision of the bacterial culture. According to the Budapest Treaty, this bacteria culture is safety deposited at the DSMZ. To start with, based on distinctive characteristics the manufacturer of the culture verifies the accuracy of the lactobacilli strain.
Via various breeding stages in a sterile culture medium the strain is cultivated until the amout sufficient for the inoculation of a larger amount of sterile culture in the main fermentation is reached.
After the main fermentation the quantity of the grown germs (= lactobacilli) is
checked. If the count corresponds with the calculated target, freeze-drying (lyophilisation) will start. That is to say, the living lactobacilli are put in a condition that keeps them durable for a longer period of time. This powder will undergo a quality check once more. If it meets the requirements, the powder will be released for compounding, i.e. the production of the so-called bulk (raw ingredients).
The ready-made bulk is again tested by the company of the culture for the amount of effective component (in this case: amount of living lactobacilli germs) and also for potential contamination. The producer of the culture has to meet the requirements according to Ph. Eur. 2005, 5 th Edition Kat. 3b.
For supervision the bulk is once more tested by an independent, external test lab for the number of living lactobacilli germs and potential contamination. If the bulk meets the requirements, i.e. they all suit the specification, release will be ensured via re-scha’s expert.
The bulk is now sent off to the packaging company. There, the product is stored in a cool place until the final packaging. The filling is conducted according to quality standards predefined by re-scha. For instance, quality inspection encompasses identity of the filler, homogeneity of the filler, identity of the foils, format of the sealed-edge bags, filling quantity of the bags (weight control) and consistence. Likewise particular value is placed on a constant observance of a low degree of humidity in the room.
Once the commodity is packed, it is immediatly transported to re-scha. There it is deep-freezed (at the minimum at minus 18°C) and retained in quarantine. From this quarantine commodity re-scha’s expert draws a sample of the finished product and forwards it to an independet, external lab for further inspection. If the inspection results correspond to the predefined specifications in all areas, the expert will release the finished product. Henceforth it can be sold.
Further quality check by re-scha encompasses the biannual testing of the stored finished product for the count of living lactobacilli germs. Concerning the stability of the effective component (= amount of living lactobacilli) prospective long-term studies have shown that deep-freezing and storing the finished product for more than three years does not have an influence on the amount of living lactobacilli germs. Thus it appears that the elaborate quality requirements prove to be effective.
Additionally re-scha has tested the product PT-12 for safety during transport under worst case conditions. Results of these tests have shown that the products could also be unhesitatingly transported unchilled in summer at a high ambient temperature.