GB/T 36030-2018 Translated English of Chinese Standard. (GBT 36030-2018, GB/T36030-2018, GBT36030-2018): General technical requirements of CIP and SIP for pharmaceutical machineryhttps://www.chinesestandard.net, 02/02/2019 - 18 من الصفحات This Standard specifies the general technical requirements for pharmaceutical machinery implementing cleaning in place and sterilization in place in the Good Manufacturing Practice (2010 Revision). This Standard is applicable to the pharmaceutical machinery implementing cleaning in place and sterilization in place during the pharmaceutical production process. |
عبارات ومصطلحات مألوفة
active pharmaceutical ingredients activity or toxicity adsorption area converted form calculated according China 2015 Edition CIP and SIP cleaning agent cleaning and sterilization cleaning device cleaning fluid cleaning in place cleaning procedures clear the name clear the sampling determined according drug production equipment flow rate form the total GB/T kilograms kg limit per unit Manufacturing Practice 2010 material contact surface MDDB microbial limit milligrams per square minimum batch minimum treatment daily People's Republic pharmaceutical equipment pharmaceutical production process Pharmacopoeia pipe place and sterilization place system Practice 2010 Revision production batch quality standards recovery rate Republic of China sampling eluent SIP for pharmaceutical SIP pharmaceutical machinery solubility spores spray device square centimeter mg/cm2 square centimeters cm2 steam sterilization Sterile drug production sterilization in place sterilization media sterilization parameters sterilization procedures sterilization quality Test Method tested according total residual amount treatment daily dosage unit area converted viscosity water for injection wipe sampling method