GB/T 36030-2018 in English
VALIDGeneral technical requirements of CIP and SIP for pharmaceutical machinery
- Issued on:2018-03-15
- Implemented on:2018-10-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$136.00
《GB/T 36030-2018制药机械（设备）在位清洗、灭菌通用技术要求》由TC356（全国制药装备标准化技术委员会）归口，主管部门为国家标准化管理委员会。
Introduction
GB/T 36030—2018 Interpretation of Technical Requirements for Cleaning and Sterilization in Place for Pharmaceutical Machinery
| Standard Dimensions | Technical Requirements | Implementation Recommendations |
|---|---|---|
| Cleaning in Place (CIP) | The equipment can be cleaned without disassembly to ensure that there are no dead corners for cleaning. The pressure, flow, temperature and time of the cleaning liquid must be verified. | It is recommended to use a dynamic spray device and replace the cleaning agent regularly to avoid microbial tolerance. |
| Sterilization in Place (SIP) | The equipment can be sterilized without disassembly to ensure that all material contact surfaces reach the specified temperature and time. It is recommended to use steam sterilization, and the coldest point monitoring F0 value ≥ 15 minutes. | It is recommended to conduct a challenge test and use heat-resistant spores as biological indicators. |
| Material and surface quality | Equipment materials must be non-toxic and corrosion-resistant, and the surface roughness must be controlled at Ra≤0.4μm (sterile equipment) or Ra≤0.8μm (other equipment). | It is recommended to use food-grade stainless steel and conduct regular cleaning verification to ensure surface quality. |
Actual application case
A pharmaceutical company used a dynamic spray device to clean the liquid oral preparation production equipment in place. The results showed that the residue removal rate reached 99.5%, which met the requirements of GB/T 36030. At the same time, during the sterilization process, the coldest point temperature is monitored through the steam sterilization system to ensure that the F0 value is ≥15 minutes, effectively ensuring a sterile environment.
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