December 6, 2017

IQ/OQ/PQ in Less Than a Week? Yes!

Recently, the PCL team took on a new IQ/OQ/PQ project in the lab. Our client approached the team explaining how they were tasked with validating a new sealer as quickly as possible. To get started, our VP of Packaging Engineering Ryan Erickson drafted custom IQ/OQ/PQ protocols on behalf of the client that they were able to adopt into their Quality Management System.  This customer considered trying to do it themselves, but were challenged with availability of engineering resources, sealing qualification know-how, and testing capabilities.  This is where our team could assist them. To expedite the project, both our engineering and laboratory teams jumped into action.   With close collaboration between Ryan and the client these protocols were able to get written and approved the same day, potentially weeks faster than what is typical!

In parallel, the client delivered their sealer to our lab for temporary installation in our Controlled Environment Room.  By installing the sealer at the lab it allowed our client to avoid disrupting on-going production activities in their clean room and also provided direct access to the sealer.

The engineering team worked together to quickly conduct the IQ and then assess the sealer’s process window and optimum seal settings in the Operational Qualification (OQ).  PCL’s well-experienced and dedicated laboratory team offered at the elbow support to expedite seal testing, including peel strength (ASTM F88), visual inspection (ASTM F1886), seal width (ASTM F2203), and dye leak seal integrity (ASTM F1929).

Throughout this process, we used the opportunity to take pictures and create detailed work instructions including equipment setup, loading & sealing, and seal inspection.  As we transitioned from Operational Qualification (OQ) to Process Qualification (PQ) activities, we invited the client’s team to visit the lab and receive formal training, aided by the new work instructions and on-site demos.  The client’s team had fun rolling up their sleeves and building dummy production lots for the Process Qualification (PQ).  Again, Sean and Sydney were on point to quickly conduct the necessary seal testing to support PQ.

And just as easily, we helped the client reinstall the sealer into their clean room and verify its performance before introducing it back into production.

Typically, this would be a 3-4 week project if handled by the client on their own.  By coming to PCL, the entire effort took less than 1 week from initial “ask” to product launch—now that’s speed to market!