Description
Creation of a workbook as proof of qualification for the following UltraClear TP ED EDI ultrapure water systems:
Ultra Clear TP ED 20 TWF EDI 30 UV TM
Ultra Clear TP ED 20 TWF EDI 30 UV UF TM
Ultra Clear TP ED 20 TWF EDI 60 UV TM
Ultra Clear TP ED 20 TWF EDI 60 UV UF TM
Ultra Clear TP ED 20 TWF EDI 80 UV UF TM
The documents in the workbook form the basis for the operator of the system, for example, to be able to carry out the system qualification independently.
It also serves as a template for monitoring institutions such as the FDA (Food and Drug Administration).
The workbook contains the following sections:
IQ OQ
Installation Qualification (IQ)
Documented confirmation that the water treatment system, as installed or modified, complies with the approved design and manufacturer's recommendations (order specifications).
Installation qualification (IQ) essentially includes:
- Acceptance reports for trial operation from the manufacturer (FAT)
- Creation of specifications for delivery and assembly
- Conformity of the offer with delivery and execution
- On-site system setup
- Establishment of media connections, e.g., water/wastewater/power/control cables
- If necessary, integration into the process environment and its connection to other systems
- Cleaning and, if necessary, initial disinfection as required and to the extent necessary
- Operating instructions with maintenance instructions and maintenance measures
- Flow charts
- Consumables and spare parts lists
- Acceptance and handover protocols
Operational Qualification (OQ)
Documented confirmation that the quality-related functions of the water treatment system are reproducibly triggered by the control system and that the system operates within the planned working range.
Functional qualification (OQ) essentially includes:
- Creation of specifications for the operational verification
- Verification of the functional suitability of the system components, interlocks, alarms, and sensors
- Verification of the operating instructions for conformity
- Protocol recording
A documentation binder containing all necessary documents for qualification and validation is handed over to the user.
Ultra Clear TP ED 20 TWF EDI 30 UV TM
Ultra Clear TP ED 20 TWF EDI 30 UV UF TM
Ultra Clear TP ED 20 TWF EDI 60 UV TM
Ultra Clear TP ED 20 TWF EDI 60 UV UF TM
Ultra Clear TP ED 20 TWF EDI 80 UV UF TM
The documents in the workbook form the basis for the operator of the system, for example, to be able to carry out the system qualification independently.
It also serves as a template for monitoring institutions such as the FDA (Food and Drug Administration).
The workbook contains the following sections:
IQ OQ
Installation Qualification (IQ)
Documented confirmation that the water treatment system, as installed or modified, complies with the approved design and manufacturer's recommendations (order specifications).
Installation qualification (IQ) essentially includes:
- Acceptance reports for trial operation from the manufacturer (FAT)
- Creation of specifications for delivery and assembly
- Conformity of the offer with delivery and execution
- On-site system setup
- Establishment of media connections, e.g., water/wastewater/power/control cables
- If necessary, integration into the process environment and its connection to other systems
- Cleaning and, if necessary, initial disinfection as required and to the extent necessary
- Operating instructions with maintenance instructions and maintenance measures
- Flow charts
- Consumables and spare parts lists
- Acceptance and handover protocols
Operational Qualification (OQ)
Documented confirmation that the quality-related functions of the water treatment system are reproducibly triggered by the control system and that the system operates within the planned working range.
Functional qualification (OQ) essentially includes:
- Creation of specifications for the operational verification
- Verification of the functional suitability of the system components, interlocks, alarms, and sensors
- Verification of the operating instructions for conformity
- Protocol recording
A documentation binder containing all necessary documents for qualification and validation is handed over to the user.