장비개요

■ 장비 설명 바이오의약품제조소의 의약품용 단백질 생산에 사용되는 장비 및 기구의 내부 및 외부를 세척하고 건조하기 위한 장비로서 국제적 기준(cGMP, EU-GMP, KGMP)에 적합하도록 설계와 제작이 되고, 올바르게 설치되었음을 확인한 후 사용되고 있음.

장비상세정보

규격 및 특징

■ 구성 및 성능
1. Cleaning cycle, process
1) a standard cycle for cleaning process
- Prewash (Re-circulation & Non-circulation)
- Detergent Wash 1, 2 (Re-circulation)
- Water Rinse(Re-circulation)
- Once Through HWFI Hot Rinse - Dry with an integrated dryer using HEPA filtered forced air
2) Process
- Metering of cleaning chemicals shall be provided based on time/volume and/or conductivity.
- A conductivity monitor used for controlling the wash cycle and the monitoring and control of the final rinse cycle.
- Wash cycles will be verified as part of the commissioning
3) The washer shall allow automatic operation.
2. Process Control Systems
1) Software Development ; will be developed following GAMP methodology.
2) Control Platform (PLC) : Allen Bradley or Simense or equivalent
3) Manual and Automatic Control
4) Power Failure / Recovery
5) Emergency Stops 6) Alarms and Warnings : fail or out of range of operating parameters such as pressure, temperature.
7) User Interfaces : touch panel screen for operation
8) WFI supply valve control : dry contact electrical control by PWD