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.
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.
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.
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
- 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:
- Carbon dioxide (CO2)
Measuring ranges and MPE-values depend on the equipment, but our validation equipment cover most needs