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Equipment Validation
Equipment Validation ensures that an instrument is appropriate for its intended use. Typical validation phases are:
- Design qualification (DQ) for setting functional and performance specifications (operational specifications).
- Installation qualification (IQ) for performing and documenting the installation in the selected user environment.
- Operational qualification (OQ) for testing the equipment in the selected user environment to ensure that it meets the previously defined functional and performance specifications.
- Performance qualifications (PQ) for testing that the system consistently performs as intended for the selected application.
Design Qualification
Design qualification (DQ) defines the functional and operational requirement and specifications of the instrument and details the conscious decisions in the selection of the supplier. DQ should enable them to be successfully implemented for the intended application and to meet business requirements. Errors in DQ can have a tremendous technical and business impact, and therefore a sufficient amount of time and resources should be invested in the DQ phase. PSC consultants can facilitate requirements gathering and validation to ensure that the equipment your company selects will meet your needs.
Installation Qualification
Installation qualification establishes that the instrument is received as designed and specified, that it is properly installed in the selected environment, and that this environment is suitable for the operation and use of the instrument.
Installation qualification includes:
- Ensure that all equipment, software, spare parts, accessories are received in good condition.
- Check documentation for completeness (operating manuals, maintenance instructions, standard operating procedures for testing, safety and validation certificates).
- Install hardware (computer, equipment, fittings and tubings for fluid connections, columns in HPLC and GC, power cables, data flow and instrument control cables).
- Switch on the instruments and ensure that all modules power up and perform an electronic self-test.
- Install software on computer following the manufacturer's recommendation.
- Verify correct software installation, e.g., are all files loaded.
- Configure peripherals, e.g., printers and equipment modules.
Operational Qualification
Operational or equipment qualification (OQ) is the process of demonstrating that an instrument will function according to its operational specification in the selected environment.
Performance Qualification
Performance qualification (PQ) is the process of demonstrating that an instrument or equipment consistently performs according to the specification appropriate for its routine use.
PQ can mean system suitability testing, where critical key system performance characteristics are measured and compared with documented, preset limits. For example, a well characterized standard can be injected five or six times and the standard deviation of amounts are then compared with a predefined value.
Performance qualification includes:
- Definition of performance criteria and test procedures.
- Selection of critical parameters with some allowance to drift out of predefined specifications.
- Determination of the test intervals, e.g.,
- Everyday.
- Every time the system is used.
- Before, between and after a series of runs.
- Define corrective actions on what to do if the system does not meet the established criteria.
Temperature Distribution and/or Penetration Studies
The Pharmaceutical Services Corporation performs temperature mapping studies utilizing Kaye Instruments metrology equipment. These studies are conducted to demonstrate that temperature controlled equipment is maintaining the specified temperature ranges. The Kaye application software can be configured to perform data calculations such as minimum, maximum, average, lethality etc. Representative equipment tested includes autocalves, lypholizers, refrigerators, freezers and incubators.
PSC can validate all types of manufacturing, packaging, shipping, and laboratory equipment, including:
- Environmental Chamber
- Laminar Flow Hood
- Water System - HPW, WFI
- Incubator
- Clean Room
- Autoclave
- Depyro Oven
- Refrigerator
- Freezer
- Centrifuge
- Dissolution Tank
- Drying Oven
- Fluid Bed Coater
- Heat Tunnel
- Induction Sealer
- Capper
- Labeler
- Cottoner
- Neckbander
- Retorquer
- Filler
- Fluoro Plate Reader
- Spectro Plate Reader
- Endotoxin Analyzer
- UV/Vis Spectrometer
- Tablet Press
- Encapsulator
- Metal Detector
- PLC
- DCS
- Nitrogen Gas
- HPLC
- Ion Chromatography
- Mass Spec
- LCMS
- RF
- Microwave
- NMR
- IR
- NIR
- Gas Chromatography
- Reactor
- Compressed Air
- Cooling Tower
- Mixing Room
- Dehumidifier
- Milling Equip
- Pasteurizer
- Fermentor
- Atomic Absorption
- Lyophilizer
- Imaging System
- Crystallography
- Flow Cytometer
- Hematology Analyzer
- Chemistry Analyzer
- Thermocycler
- Lab on Chip
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