Protocol/Report Development
We have the expertise to deliver documentation that meets all testing and sample size requirements. Our comprehensive and easy to read protocols will fit into your project’s design history file (DHF) and will link to all necessary documentation for a streamlined audit.
Installation, Operation & Process Qualification
If new equipment integration is needed, our engineers will review all specifications to provide a seamless integration (IQ) to your facility. We will also provide you with a design of experiments protocol to nail down the optimal operating parameters of your equipment (OQ). Lastly, we will challenge the equipment to meet typical processing conditions and expose the equipment to the minimum and maximum processing parameters to ensure the efficiency of your process (PQ).
Package Integrity Testing ISO 11607: Integrity, Shelf Life & Distribution Testing
With our experience with integrity, shelf life, and distribution testing, we will ensure all the ISO 11607 requirements are met. Our experience with the materials and testing methods will also help to avoid costly failures that could be detrimental to your project timeline.
Sterilization Testing ISO 11137: Bacteriostasis and Fungistasis (B/F), Bioburden ,VDmax or EO residuals
Sterilization validations are a crucial step to ensure your product is provided sterile. Our engineers have experience developing validation documentation to ensure all testing guidelines are met to ensure a sterile product.