Commissioning and Validation Services

Temperature Distribution

TEHS Scientific specialize in equipment commissioning and validation for the pharmaceutical, biotechnology, and healthcare industries.  We deliver unparalleled services through quality and partnerships.  Our team of engineers have been mentored by the leaders in the industry and strive towards subject matter expertise.  Working directly with the manufacturers and using industry experience, our validation engineers are able to solve equipment performance issues and provide our clients with industry trends and knowledge to enhance their commissioning and validation needs.   Commissioning and Validation when planned and performed correctly in an integrated manner, ensures operational efficiency, effectiveness and compliance.

Commissioning:

Working along side your validation team and executing the validation using your protocol.   

Providing turn-key validation services

  1. We prepare an authentic risk and science based approach to the design, validation, operation and maintenance of your research facility. 
  2. We partner with our clients to understand their equipment needs and design a laboratory workspace that allows efficient workflow to save time and money.
  3. We work in advance with the equipment manufacturer to ensure engineering requirements within the laboratory space have been accounted for in the design.  
  4. We perform Site Acceptance Test (SAT) to ensure the equipment can be installed in the client site.
  5. Our equipment is calibrated and maintained against ISO 17025:2005 standards
  6. All our commissioning and validation plans are written to meet GXP industry requirements and your company’s operational requirements.
  7. We follow ISO 9000:2015 to ensure that your reports are accurate and error-free.  Our team follows documented guidelines for proper documentation and validation reports undergo an in-depth quality assurance review and approval prior to releasing it to our clients.   

Validation:      

Installation, operational, and performance qualifications of stability chambers are critical to effective process validations. We provide you with a thorough understanding of qualification protocols and will prepare, execute and complete the qualification tests and present a comprehensive Final Report.

  • Installation Qualification (IQ)

We establish that the equipment is properly and safely installed per manufacturer’s requirements. All model and serial numbers are verified and recorded and all utility requirements are documented.

  • Facility & Environmental
  • Documentation Verification
  • Operating Procedures & SOP Development
  • Preventative Maintenance Review
  • Operation Qualification (OQ)

We establish that the chamber consistently meets manufacturer specifications by demonstrating various operating set points at unloaded conditions. Temperature and relative humidity uniformities are verified using thermocouple and RH sensors.

  • Functional Verification
  • Calibration & Laboratory Service
  • Process Development
  • Temperature Mapping
  • Performance Qualification (PQ)

We establish that the chamber consistently meets performance specifications by demonstrating various operating set points at loaded conditions. This test is generally performed at the chamber’s operating set point and a simulated product load is used to replicate typical product storage. Temperature and relative humidity uniformity is verified using thermocouple and RH sensors.

  • Load Configuration Validation
  • Temperature Mapping
  • Open Door Testing
  • Penetration Studies
  • Biological Testing
  • Process Validation