Beschreibung
For the following LaboStar® and Ultra Clear® pure water systems:
- LaboStar RO DI
- UltraClear RO
- UltraClear RO DI
- UltraClear RO EDI
The documents in the workbook are the working basis for, e.g., the operator of the system 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 the manufacturer's recommendations (order specifications).
Installation qualification (IQ) essentially includes:
- Acceptance reports for trial operation by the manufacturer (FAT)
- Creation of specifications for delivery and assembly
- Conformity of the offer with delivery and execution
- On-site plant construction
- Establishment of media connections, e.g. water/wastewater/electricity/control cables
- If necessary, integration into the process environment and its connection to other systems
- Cleaning and, if necessary, initial disinfection as required
- Operating instructions with maintenance instructions and maintenance measures
- Flow charts
- List of consumables and spare parts
- Acceptance and handover reports
Operational Qualification (OQ)
Documented confirmation that the quality-related functions of the water treatment system are reproducibly triggered by the control system and system operates within the planned working range.
Operational qualification (OQ) essentially includes:
- Creation of specifications for the operational verification
- Verification of the functional compatibility of the system components, interlocks, alarms, and sensors
- Verification of the operating instructions for conformity
- Protocol recording
A documentation folder containing all necessary documents for qualification and validation is provided to the user.
- LaboStar RO DI
- UltraClear RO
- UltraClear RO DI
- UltraClear RO EDI
The documents in the workbook are the working basis for, e.g., the operator of the system 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 the manufacturer's recommendations (order specifications).
Installation qualification (IQ) essentially includes:
- Acceptance reports for trial operation by the manufacturer (FAT)
- Creation of specifications for delivery and assembly
- Conformity of the offer with delivery and execution
- On-site plant construction
- Establishment of media connections, e.g. water/wastewater/electricity/control cables
- If necessary, integration into the process environment and its connection to other systems
- Cleaning and, if necessary, initial disinfection as required
- Operating instructions with maintenance instructions and maintenance measures
- Flow charts
- List of consumables and spare parts
- Acceptance and handover reports
Operational Qualification (OQ)
Documented confirmation that the quality-related functions of the water treatment system are reproducibly triggered by the control system and system operates within the planned working range.
Operational qualification (OQ) essentially includes:
- Creation of specifications for the operational verification
- Verification of the functional compatibility of the system components, interlocks, alarms, and sensors
- Verification of the operating instructions for conformity
- Protocol recording
A documentation folder containing all necessary documents for qualification and validation is provided to the user.