R&D process validation
Made to measure Process Validation
All validation instruments are ISO 17025 traceable.
European Lab Services performs made-to-measure process validation services for R&D, kilo-lab and pilot plant setups in compliance GMP/GLP regulation for following equipment:
- Stirred tank reactor systems
- Bioreactors
- Flow reactors
- Filtration equipment
- Distillation, extraction and evaporation equipment
- High pressure autoclaves
Parameters:
- Temperature
- Revolutions
- Weight
- Flow and pump speed
- Gas flow (O2, Air, C02, Nitrogen, ...)
- Pressure
- Vacuum
- Volume
- Time
- ...
Water baths & TCU's
Validation of Water Baths and Temperature Control Units
All validation instruments are ISO 17025 traceable, while in accordance with GMP validation method and validation protocol. Reporting of data results complies to CFR21 part 11.
European Lab Services provides on-site temperature validation of water baths, thermostatic circulators chillers and other temperature control units in accordance with ISO 17025 and GMP regulations.
Validation includes:
- Validation of the bath temperature (range from -80°C up to +300°C)
- Programming and verification of offsets
- Certificate
Refrigerators & Freezers
Validation/Mapping of Refrigerators & Freezers
All validation instruments are ISO 17025 traceable, while in accordance with GMP validation method and validation protocol. Reporting of data results complies to CFR21 part 11.
European Lab Services provides services for on-site validation/mapping, in compliance with GMP/GLP regulations for following instruments:
- Refrigerators
- Freezers
- Cold storage facilities (see Environmental Mapping)
The instrument is tested by comparison with a metrologically traceable reference thermometer. After validation and programming the offsets, you will receive a ISO 17025 test certificate.
Ovens & Incubators
Validation/Mapping of Ovens & Incubators
All validation instruments are ISO 17025 traceable, according to the DIN 12880 validation method and IQ/OQ/PQ protocol.
European Lab Services provides services for on-site validation/mapping, in compliance with GMP/GLP regulations for the following instruments:
- Heating ovens & cabinets
- Incubators
Parameters:
- Temperature
- Relative Humidity
- CO2
Centrifuges
Validation and maintenance of Centrifuges
All reference instruments used for measurements are traceable to international standards.
European Lab Services is accredited for the validation of centrifuges for research and medical applications, according to the internal procedure TP-ELS-105.
- Laboratory centrifuges for research
- Medical centrifuges (e.g. blood centrifuges)
- Process centrifuges (e.g. downstream bioprocess)
Part 1: Maintenance
- Exterior cleaning of the instrument (e.g. cooling vents)
- Safety check (e.g. over-temperature protection)
- Factory settings checks & adjustment according to manufacturer guidelines
- Rotor check
- Sealing check
Part 2: Validation
- Temperature control
- Offset programming
- Rotation speed & timer
- ISO 17025 certification
Autoclaves
Validation/Mapping of Autoclaves
All validation instruments are ISO 17025 traceable, in accordance with the GMP validation method and IQ/OQ/PQ protocol.
European Lab Services provides services for on-site validation/mapping, compliant with GMP/GLP regulations for the following instruments:
- Lab & process autoclaves
- Chambers for biological steam sterilization
Parameters:
- Temperature
- Pressure
- Steam/ Relative Humidity