Validation services, ensuring GxP compliance

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For pharmaceuticals and medical device manufacturers where health and safety is never compromised, Element Metech offers validation services for laboratory equipment and processes 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 solutions meeting customer expectations and regulatory requirements.

 

  • Process validation

  • Transport validation

  • Cleanliness validation

Validation expertise

Our Validation team has broad knowledge and professional insights in:

Non-sterile validation of

  • Climate facilities including storage, other controlled areas and shipping
  • Equipment such as incubators, refrigerators and freezers

Sterile validation of

  • Sterilization processes for sterilization of process plants etc.
  • Sterilization processes performed by autoclaves and dry sterilizers etc.

Our trained experts always make sure that GxP-requirements, guidelines and special needs are being met.

 

Climate chamber
Validation expertise

Consultancy services

Our trained experts can support with:

  • Validation project management to follow your SOP
  • Preparation of validation master plans and validation plans
  • Preparation of protocols and related test plans
  • Test execution
  • Test data handling and interpretation
  • Final reporting and documentation

We also offer additional GxP-compliant expertise, including support with preparation, approval and documentation of:

  • Requirement specifications
  • Risk analyses
  • Change control
  • Deviations
  • Instructions and templates

Rental of validation equipment

We provide rental of our wide and versatile range of GxP-qualifed validation equipment, which is always calibrated at our accredited calibration laboratories.

The equipment covers measurement of:

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

Measuring ranges and MPE-values depend on the equipment, but our validation equipment cover most needs

Climate chamber