Validation services, ensuring GxP compliance

For the Life Science sector where health and safety is never compromised, Element Metech provides validation services for laboratory processes and equipment to ensure regulatory compliance. Our GxP compliant services are performed to ensure the accuracy and uncertainty of all equipment in use, by well-documented validation to national and international standards.

Validation of sterilization processes

Our validation services

Element Metech in Sweden and Denmark offers a complete service range for validation. Our experienced team has a proven track record of delivering customized validation solutions meeting your specific needs and regulatory requirements.

 

  • Process validation

  • Transport validation

  • Cleanliness validation

Validation areas

Our trained validation experts always make sure that your GxP requirements, guidelines and special needs are met. We perform validation in the following areas:

Temperature and humidity

  • Climate equipment (climate chamber, storage, refrigerator, freezer, incubator)
  • Sterilization process (dry sterilizer, autoclave etc.)
  • Production equipment (washing machine, packaging line, tablet machine)
  • Process plants (fermenters, mixing tanks etc.)
  • Climate controlled transport containers

Carbon dioxide (CO2)

Pressure

Particle measurement in cleanrooms

  • Measurements for classification of air cleanliness by particle concentration to ISO 14644.

 

Climate chamber
Validation expertise

Validation expertise

We offer expertise in

  • Design review
  • Commissioning (FAT / SAT)
  • Qualification (DQ / IQ / OQ / PQ)
  • Validation execution 
  • Calibration of validation equipment

Our validation consultants can help you prepare the following documents

  • Validation master plan and validation plan
  • Requirement specification
  • Risk assessment
  • Validation protocol including test plans
  • Data processing
  • Validation report

Including handling of:

  • Change control
  • Corrective and preventive actions
  • Deviations

Rental of validation equipment

Or rental services of validation equipment include calibration, programming and reading of data. The equipment covers most needs for measuring ranges and MPE values. All validation equipment is GxP qualified to EMEA and FDA guidelines and has undergone accredited calibration to ISO/IEC17025.

 

The equipment covers measurement of:

  • Temperature
  • Humidity
  • Carbon dioxide (CO2)
  • Pressure
Hygrometer calibration

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