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Validation
The company takes active part in a great scope of validation activities in all validation levels:
- Validation master plan
- Design qualification
- Installation qualification
- Operational qualification
- Performance qualification
- Process validation
- Cleaning validation
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With regard to the company specialists´ experience and a wide range of measuring instruments we can carry out several different types of qualifications. These are e.g. qualifications of the following equipment and systems:
- Laminar zones
- Purified water systems
- Water for injection systems
- Pure steam systems
- Systems of compressed air, nitrogen and other gases
- CIP/SIP systems
- Steam sterilizers
- Dry heat sterilizers
- Sterilizing and depyrogenizing tunnels
- Reactors, storage tanks
- Washers
- Filling machines
- Viewing devices
- Dryers
- Stability boxes and thermostats
- Cooling, freezing and deep-freezing boxes
- Blistering and packaging machines
- Tablet presses
- Encapsulation machines
- Labelling machines
- Control and monitoring machines
- Others
New types of qualifications are prepared and the current ones are continuously improved so that requirements of current regulations were fulfilled in maximum degree.
The equipment used for qualification measurements is calibrated in regular intervals in European certified laboratories recommended by the respective equipment manufacturer. Minimum once a year the measuring instruments are sent to authorized servicing firms in which they undergo preventative examinations.
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