Effect of dirty-hold time on cleaning process of pharmaceutical equipment

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22310%2F13%3A43896478" target="_blank" >RIV/60461373:22310/13:43896478 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.3109/10837450.2012.726997" target="_blank" >http://dx.doi.org/10.3109/10837450.2012.726997</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.3109/10837450.2012.726997" target="_blank" >10.3109/10837450.2012.726997</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Effect of dirty-hold time on cleaning process of pharmaceutical equipment

Popis výsledku v původním jazyce

The work was aimed at the evaluation of a cleanliness of pharmaceutical equipments after the end of the production and subsequent cleaning process. The influence of a dirty-hold time, a time interval between the end of the production period and the beginning of the cleaning process on its efficiency and the cleanliness of the equipment has been studied. The evaluation was performed for commercial tablet antihypertensive formulation with API losartan potassium. Sampling was carried out by a wet-swabbingmethod from the equipments and consequently obtained samples were analytically evaluated using HPLC. In the production of the concerned pharmaceutical, it has been found that the cleaning process is properly designed and validated. Despite the concentration of losartan in swabs from the equipment was in all cases within the limits of acceptance criteria, the effect of the dirty-hold time was proved. In the equipments with long hold-time period, the monitored substance was found in substa

Název v anglickém jazyce

Effect of dirty-hold time on cleaning process of pharmaceutical equipment

Popis výsledku anglicky

The work was aimed at the evaluation of a cleanliness of pharmaceutical equipments after the end of the production and subsequent cleaning process. The influence of a dirty-hold time, a time interval between the end of the production period and the beginning of the cleaning process on its efficiency and the cleanliness of the equipment has been studied. The evaluation was performed for commercial tablet antihypertensive formulation with API losartan potassium. Sampling was carried out by a wet-swabbingmethod from the equipments and consequently obtained samples were analytically evaluated using HPLC. In the production of the concerned pharmaceutical, it has been found that the cleaning process is properly designed and validated. Despite the concentration of losartan in swabs from the equipment was in all cases within the limits of acceptance criteria, the effect of the dirty-hold time was proved. In the equipments with long hold-time period, the monitored substance was found in substa

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

CI - Průmyslová chemie a chemické inženýrství

OECD FORD obor

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Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2013

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Pharmaceutical Development and Technology

ISSN

1083-7450

e-ISSN

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Svazek periodika

18

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

6

Strana od-do

274-279

Kód UT WoS článku

000312008200028

EID výsledku v databázi Scopus

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