Description
For the following LaboStar® and Ultra Clear® ultrapure water systems:
- Ultra Clear TP ED UV TM
- Ultra Clear TP ED UV UF TM
- LaboStar Pro DI
- LaboStar Pro UV
Creation of a workbook as proof of qualification for the following series:
- Ultra Clear TP ED UV TM
- Ultra Clear TP ED UV UF TM
- LaboStar Pro DI
- LaboStar Pro UV
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:
DQ IQ OQ PQ.
Design Qualification (DQ)
Design qualification combines the specifications from the requirements and functional specifications and evaluates them. If no design qualification has been carried out, the order specifications are used.
Design qualification combines the specifications from the requirements and functional specifications and evaluates them. If no design qualification has been carried out, the order specifications are used and a comparison is made with the system configuration of the supplier.
Design qualification (DQ) essentially includes:
- Creation of specifications for equipment, delivery, assembly, and operation
- Monitoring of functional suitability by the system control, in particular the interlocks, alarms, and sensors (with certificates if necessary)
- Calculations and logging
- Design programs
- Documentation requirements
Installation Qualification (IQ)
Documented confirmation that the water treatment plant, as installed or modified, complies with the approved design and manufacturer's recommendations (order specifications).
Installation qualification (IQ) essentially includes:
- Acceptance reports from the manufacturer for 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/power/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
- Consumables lists
- Spare parts lists
- 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 is operating within the planned working range.
Functional qualification (OQ) essentially includes:
- Creation of specifications for the operational verification
- Checking the functionality of the plant components, interlocks, alarms, and sensors
- Checking the operating instructions for conformity
- Logging
Performance Qualification (PQ)
Documented confirmation that the water treatment plant delivers water of the required quality—purified water (aqua purificata/ultra pure water)—and that the required performance is achieved.
Performance qualification (PQ) essentially includes:
- Creation of specifications for process verification
- Verification of process performance under worst-case conditions
- Determination of regular requalification
A documentation folder containing all necessary documents for qualification and validation is provided to the user.
- Ultra Clear TP ED UV TM
- Ultra Clear TP ED UV UF TM
- LaboStar Pro DI
- LaboStar Pro UV
Creation of a workbook as proof of qualification for the following series:
- Ultra Clear TP ED UV TM
- Ultra Clear TP ED UV UF TM
- LaboStar Pro DI
- LaboStar Pro UV
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:
DQ IQ OQ PQ.
Design Qualification (DQ)
Design qualification combines the specifications from the requirements and functional specifications and evaluates them. If no design qualification has been carried out, the order specifications are used.
Design qualification combines the specifications from the requirements and functional specifications and evaluates them. If no design qualification has been carried out, the order specifications are used and a comparison is made with the system configuration of the supplier.
Design qualification (DQ) essentially includes:
- Creation of specifications for equipment, delivery, assembly, and operation
- Monitoring of functional suitability by the system control, in particular the interlocks, alarms, and sensors (with certificates if necessary)
- Calculations and logging
- Design programs
- Documentation requirements
Installation Qualification (IQ)
Documented confirmation that the water treatment plant, as installed or modified, complies with the approved design and manufacturer's recommendations (order specifications).
Installation qualification (IQ) essentially includes:
- Acceptance reports from the manufacturer for 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/power/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
- Consumables lists
- Spare parts lists
- 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 is operating within the planned working range.
Functional qualification (OQ) essentially includes:
- Creation of specifications for the operational verification
- Checking the functionality of the plant components, interlocks, alarms, and sensors
- Checking the operating instructions for conformity
- Logging
Performance Qualification (PQ)
Documented confirmation that the water treatment plant delivers water of the required quality—purified water (aqua purificata/ultra pure water)—and that the required performance is achieved.
Performance qualification (PQ) essentially includes:
- Creation of specifications for process verification
- Verification of process performance under worst-case conditions
- Determination of regular requalification
A documentation folder containing all necessary documents for qualification and validation is provided to the user.