Validation in Pharma

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
• ...

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

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.

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

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

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