Description
For the following LaboStar® and Ultra Clear® Ultra pure water systems with Tab Water Feed (TWF):
- LaboStar PRO TWF
- LaboStar PRO TWF UV
- UltraClear TP ED TWF
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 the manufacturer's recommendations (order specifications).
The installation qualification (IQ) essentially includes:
- Acceptance reports from the manufacturer's trial operation (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/electricity/control cables
- If necessary, integration into the process environment and its connection to other systems
- Initial cleaning and, if necessary, initial disinfection as required and to the extent necessary
- Operating instructions with maintenance instructions and maintenance measures
- Flow charts
- Lists of consumables and spare parts
- Acceptance and handover reports
Operational Qualification (OQ)
Documented confirmation that the quality-relevant functions of the water treatment system are reproducibly triggered by the control system and that the system operates within the planned working range.
Operational qualification (OQ) essentially includes the following:
- Creation of specifications for the operational verification
- Verification of the functionality 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 provided to the user.
- LaboStar PRO TWF
- LaboStar PRO TWF UV
- UltraClear TP ED TWF
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 the manufacturer's recommendations (order specifications).
The installation qualification (IQ) essentially includes:
- Acceptance reports from the manufacturer's trial operation (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/electricity/control cables
- If necessary, integration into the process environment and its connection to other systems
- Initial cleaning and, if necessary, initial disinfection as required and to the extent necessary
- Operating instructions with maintenance instructions and maintenance measures
- Flow charts
- Lists of consumables and spare parts
- Acceptance and handover reports
Operational Qualification (OQ)
Documented confirmation that the quality-relevant functions of the water treatment system are reproducibly triggered by the control system and that the system operates within the planned working range.
Operational qualification (OQ) essentially includes the following:
- Creation of specifications for the operational verification
- Verification of the functionality 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 provided to the user.