Monitoramento e Controle de Rotina
O objetivo do monitoramento e controle de rotina da esterilização por EO (Óxido de Etileno) é demonstrar que o processo de esterilização confirmado e especificado foi aplicado ao produto. Os dados de cada ciclo de esterilização devem ser registados e retidos para provar que as especificações confirmadas do processo de esterilização foram cumpridas. Isso deve incluir pelo menos o seguinte conteúdo:
a) Evidência de que a temperatura ambiente do produto atingiu a temperatura mínima confirmada ao entrar no pré-tratamento (se utilizado). Isto pode ser conseguido permitindo que a carga se aclimate ao ambiente durante um tempo mínimo especificado. Se a temperatura de armazenamento for conhecida, não há necessidade de determinar a temperatura do produto antes de entrar na área de pré-tratamento. Se o produto tiver sido exposto a temperaturas extremas, como durante o transporte, poderá ser necessário armazená-lo por um período antes do pré-tratamento para estabilizar sua temperatura interna e umidade dentro de uma faixa aceitável.
b) Monitoramento e registro da temperatura e umidade na área de pré-tratamento (se utilizada) em locais especificados.
c) The start time of the pretreatment for each sterilization load and the time the load is removed from the pretreatment area (if used).
d) The time interval between removing the sterilization load from the pretreatment area (if used) and the start of the sterilization cycle.
e) Indicators of proper operation of the gas circulation system in the chamber during the gas exposure phase (if used).
f) The temperature and pressure inside the chamber throughout the sterilization cycle.
g) The humidity inside the chamber during the processing phase, as measured by pressure or directly.
h) Confirmation that gaseous EO has been introduced into the sterilization chamber.
i) The pressure rise inside the sterilization chamber and the amount or concentration of EO used.
j) The processing time.
k) The exposure time.
l) Time, temperature, and pressure changes (if applicable) during the aeration phase and/or venting operations (if used).
EO Sterilization Release
a) Biological Indicator Method
If biological indicators (confirmed EPCD) are used, they should be distributed throughout the sterilization load, including the most difficult-to-sterilize locations or locations known to be related to these difficult spots. If pretreatment is used, the biological indicators should be placed before the pretreatment.
The biological indicators should be removed from the sterilization load after the sterilization cycle ends and cultured as soon as possible to allow the biological indicators to revive. If they are not cultured in a timely manner, the effects of exposure to residual EO during delayed revival should be evaluated.
The growth of the biological indicators should be analyzed to determine if the growth is not due to failure to meet the physical process specifications, which would require repeating the confirmation process.
b) Parameter Release Method
Parameter release relies on proving that all physical process parameters meet the specifications for release without the use of biological indicators. It is based solely on measurements and records of physical process parameters and serves as a sufficient declaration of the sterilization process’s adequacy.
Parameter release is only permissible when all process parameters are specified, controlled, and directly monitored. Therefore, when parameter release is used, there should be equipment for direct measurement of temperature and humidity inside the chamber and for direct analysis of EO concentration, to collect and record the sterilization process parameters and confirm that the sterilization process complies with the specifications.
In addition to proving that the sterilization process parameters meet the sterilization specifications, parameter release also requires measuring and recording the following additional data:
Measuring the temperature inside the chamber at least from two locations throughout the sterilization cycle.
Directly measuring the humidity inside the chamber during the processing phase.
Determining the EO concentration by direct analysis of the sterilization chamber’s gas at specified time intervals, to fully verify that the required conditions are met throughout the exposure period.
SE VOCÊ QUER SABER MAIS Sobre Esterilização por Óxido de Etileno
Telefone:+8619975258603
E-mail:hayley@hzbocon.com
Local: Sala 1202, Caitong Zhongxin, distrito de Xiasha, cidade de Hangzhou, província de Zhejiang, China
