Beschreibung
Creation of a workbook as proof of qualification for the following UltraClear TP ED EDI ultrapure water Systeme:
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:
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 and a comparison is made with the supplier's system design.
Design qualification (DQ) essentially includes the following:
- 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 documentation
- 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/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
Performance Qualification (PQ)
Documented confirmation that the water treatment system 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 the process verification
- Verification of the performance of the process under worst-case conditions
- Determination of the regular requalification
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:
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 and a comparison is made with the supplier's system design.
Design qualification (DQ) essentially includes the following:
- 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 documentation
- 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/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
Performance Qualification (PQ)
Documented confirmation that the water treatment system 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 the process verification
- Verification of the performance of the process under worst-case conditions
- Determination of the regular requalification
A documentation binder containing all necessary documents for qualification and validation is handed over to the user.