350 KB39 KB200520252016Srčič, StankoTršan, Matejaštevilka:1letnik:67str. 25-37ISSN:0014-8229COBISSID_HOST:4049009URN:URN:NBN:SI:doc-7G0NC013slSlovensko farmacevtsko društvoFarmacevtski vestnik(a)pirogenostbakterijski endotoksiniendotoksinska mejakvantitativne analizeparenteralne raztopineImplementacija avtomatiziranega testnega sistema testiranja pirogenosti v bolnišnični proizvodnji parenteralnih raztopin| The implementation of the automatic test system for pyrogenicity testing in hospital parenteral production|Production of parental solutions from the hospital's point of view means a scientific and professional challenge. The demand for the in-house parenteral products is high and requires a fast or even immediate response. These products have lower stability and shorter shelf life compared to industrial products. The products must comply with all pharmacopoeian standards. That can only be performed in the production process, which ensures sterility and apyrogenicity of the final parenteral products. However, it is achievable with validated, welldesigned, and constantly controlled production process only. These processes must fully implement the principles of good manufacturing practices. In this regard, we have implemented and validated rapid point-of-use test system that provides quantitative results within 15 minutes. The test system (PTS) utilizes disposable cartridges that are pre-loaded with reagents and a portable and handheld reader to provide quantitative endotoxin amounts. Because of its portability, the PTS allows the testing to be performed at the point of sample collectionIzdelava parenteralnih raztopin v bolnišničnem merilu pomeni znanstveni in strokovni izziv. Ker v bolnišnici izdelane proizvode potrebujemo hitro ali celo takoj in ker imajo tudi bistveno krajši čas stabilnosti kot industrijsko izdelani, je hitrost ugotavljanja skladnosti izdelanih proizvodov s farmakopejskimi zahtevami ključnega pomena. Sterilnost in apirogenost tako izdelanih končnih proizvodov zagotovimo le z validiranimi proizvodnimi procesi in striktno implementacijo dobre proizvodne prakse. V ta namen smo vpeljali in validirali hitri prenosni testni sistem, ki zagotavlja kvantitativne rezultate v 15 minutah. Kvantitativne rezultate dobimo z uporabo predhodno napolnjenih testnih ploščic za enkratno uporabo in ročnim spektrofotometrom. Ker je sistem prenosen, ga lahko uporabimo že na mestu vzorčenjaTEXTznanstveno časopisjejournalsSlovenian National E-content AggregatorNational and University Library of SloveniaSlovensko farmacevtsko društvo