| Avtor/Urednik | Škof, Anita; Kofler, Miroslava; Krbavčič, Aleš | |
| Naslov | Mikrobiološka kakovost farmacevtskih snovi | |
| Prevedeni naslov | Microbiological quality of raw materials for pharmaceutical use | |
| Tip | članek | |
| Vir | Farm Vestn | |
| Vol. in št. | Letnik 50, št. 1 | |
| Leto izdaje | 1999 | |
| Obseg | str. 13-25 | |
| Jezik | slo | |
| Abstrakt | The importance of the microbiological quality of raw materials for pharmaceutical use must not be underestimated. Microbial contaminants have spoilage effects on product and toxic effects on patient. It is not always possible to take steps to reduce the number of microorganisms during manufacture so as to obtain a finished product of acceptable quality. Great variations in microbiological quality can be expected depending on the origin of the raw material. Raw materials from natural sources are highly contaminated because of inadequate hygiene during extracting and processing. The microbial contamination of synthetically produced starting materials, on the other hand, is mostly very low after production but contamination can occur subsequently as a result of improper processing, during transport or in storage. Since no data on microbial purity is to be found in the pharmacopoeias for the majority of raw materials, the producers must lay down their own specifications. | |
| Izvleček | Pri proizvodnji farmacevtskih izdelkov ne smemo podcenjevati pomembnosti mikrobiološke kakovosti vstopajočih snovi. Mikroorganizmi kvarno vplivajo na končni izdelek, škodijo pa lahko tudi bolniku. S samimi proizvodnimi procesi težko zmanjšamo visoko mikrobno obremenitev tako, da bo končni izdelek ustrezne kakovosti. Glede na izvor farmacevtskih snovi prihaja do velikih razlik v mikrobiološki kakovosti. Snovi naravnega izvora so zaradi načina pridobivanja mikrobno precej onesnažene. Nasprotno je kakovost snovi sinteznega izvora po sintezi neproblematična, vendar lahko pride do mikrobnega onesnaženja kasneje zaradi neustrezne obdelave, transporta ali shranjevanja. Ker za večino snovi še ni farmakopejskih zahtev glede mikrobiološke kakovosti, si morajo proizvajalci postavljati lastne zahteve. | |
| Deskriptorji | DRUG CONTAMINATION TECHNOLOGY, PHARMACEUTICAL QUALITY CONTROL INDUSTRIAL MICROBIOLOGY DRUG INDUSTRY REFERENCE STANDARDS |