Germfree Validation Services

Germfree Laboratories has a product lifecycle approach to validation. We use our collective industry experience to bring forward a risk, science, engineering and compliance-based approach to validation taking into consideration the inputs to design, manufacturing, quality control, validation and the continued operation and maintenance of the equipment through its lifetime. Our validation engineering team members have a deep understanding of global health authority expectations and work to industry best practices.

Validation Services are Available for Germfree’s Complete Line of Standard Equipment:
Factory Acceptance Testing
Installation Qualification
Operational Qualification
Operator Training

Validation Services for Germfree’s Custom Designed Equipment: Germfree utilizes a matrixed approach to validation for custom equipment as a model for all activities. The model starts with the development of the Validation Master Plan (VMP) which describes and plans the project and it links the User Requirement Specification (URS), Functional Requirement Specification (FRS) and Design Specification to verification and validation activities, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ) and Operational Qualification (OQ). Requirements are mapped to their corresponding testing utilizing a validation trace matrix. A Validation Summary Report (VSR) is provided to summarize the completion of all validation activities, and that all user, functional and design specifications have been met.

For custom equipment, our validation engineering team is involved from the time of project concept through the final validation summary report. Germfree Laboratories Custom Equipment Services Include:

User Requirement Development Support
Validation Master Plan Development
Design Specification Documents
Factory and Site Acceptance Testing
Installation Qualification
Operational Qualification
Validation Trace Matrix
Validation Summary Report
Operator Training

Germfree supports the initial equipment install and validation but Germfree Validation Services are also available for re-qualification events as required during the product life cycle.

Please contact us for more information about our comprehensive range of validation services.

News Releases

Germfree Launches Novel Mobile Cleanroom Technology for Advanced Therapies
A first of its kind, mobile platform for advanced therapeutic medicinal products was introduced this week by Germfree Labs, a...
Germfree Featured in Pharmacy Practice News
Germfree was featured in the May issue of Pharmacy Practice News (PPN) as a mobile compounding pharmacy solution. The article...
BSL-2+ Mobile Wastewater Testing
Wastewater testing is a valuable surveillance tool for public health laboratories. The rapid rise of COVID-19 variants makes it increasingly...

Join our mailing list for updates

Would you like to receive updates from Germfree about new products, special offers, and events? Enter your e-mail address below to be included on our mailing list.