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 basis for the work, e.g., for 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:
DQ IQ OQ PQ.
Design Qualification (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 and a comparison is made with the supplier's system design.
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 prototyping protocols
- Design programs
- Documentation requirements
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/electricity/control cables
- If necessary, integration into the process environment and its connection to other systems
- Cleaning and, if necessary, initial disinfection as required- Handover of operating instructions with maintenance instructions and maintenance measures, flow charts, consumables lists, and 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 operates within the planned working range.
Functional qualification (OQ) essentially includes:
- Creation of specifications for the operational verification
- Verification of the functional compatibility of the system components, interlocks, alarms, and sensors
- Checking the operating instructions for conformity
- Protocol recording
Performance Qualification (PQ)
Documented confirmation that the water purification system supplies water of the required quality—purified water (aqua purificata/ultra pure water)— and that required performance is achieved.
Performance qualification (PQ) essentially includes:
- Creation of specifications for the process verification
- Verification of the performance of the process under worst-case conditions
- Determination of the regular requalification
A documentation folder with all necessary documents for qualification and validation is handed over to the user.
- LaboStar RO DI
- UltraClear RO
- UltraClear RO DI
- UltraClear RO EDI
The documents in the workbook are the basis for the work, e.g., for 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:
DQ IQ OQ PQ.
Design Qualification (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 and a comparison is made with the supplier's system design.
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 prototyping protocols
- Design programs
- Documentation requirements
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/electricity/control cables
- If necessary, integration into the process environment and its connection to other systems
- Cleaning and, if necessary, initial disinfection as required- Handover of operating instructions with maintenance instructions and maintenance measures, flow charts, consumables lists, and 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 operates within the planned working range.
Functional qualification (OQ) essentially includes:
- Creation of specifications for the operational verification
- Verification of the functional compatibility of the system components, interlocks, alarms, and sensors
- Checking the operating instructions for conformity
- Protocol recording
Performance Qualification (PQ)
Documented confirmation that the water purification system supplies water of the required quality—purified water (aqua purificata/ultra pure water)— and that required performance is achieved.
Performance qualification (PQ) essentially includes:
- Creation of specifications for the process verification
- Verification of the performance of the process under worst-case conditions
- Determination of the regular requalification
A documentation folder with all necessary documents for qualification and validation is handed over to the user.