COVID-19 Assembly Equipment Validation

Project Snapshot 

On the Friday evening before Labor Day weekend, Sterling was contacted by a client that had a very urgent need. Due to a requirement to launch and produce 50 million units per month of a new novel Covid-19 test, the client needed a team of validation engineers to be on site when the Labor Day weekend was over. The client is a medical device and healthcare company. They rank in the top 5 on the list of largest diagnostic companies. This client recently received emergency FDA approval to produce rapid Covid-19 tests. 

Sterling worked through the holiday weekend and met onsite on Sunday to estimate the manpower needs to complete this project. Within four days of the request, Sterling brought in a team manager and 7 Sterling validation resources. The project manager led the Sterling team and 6 of the client’s validation resources to validate over 500 pieces of equipment in four weeks’ time to meet the needs of the massive manufacturing push at their facility. 

Creating the team of experienced CVQ engineers that had done similar work for Sterling and could efficiently produce quality validation protocols with testing results for the large number of pieces of equipment. 

With this very aggressive schedule, there was no time for coming up to speed. With the quick actions, strong leadership, diverse skills and experience that Sterling engineers brought to bear, the challenges were met with successful outcomes and to the customer’s satisfaction. 

The goal of having all the equipment validated and the production rate 50 million units per month was met. With Sterling’s assistance, the client has launched this quick and easy test for Covid-19, which will be a game changer for the world. 

Sterling’s Solution 

Sterling provided a project manager and a resource team within four days of the request. 

Sterling created a project timeline for the 14 resources to meet the deadlines for the startup of four sections of the plant. Each section of the four sections has approximately 130 individual pieces of equipment. 

The protocols were studied to determine the time necessary for execution of the tests and approval through the Validation Review Board. 

There were only three days to do each section which determined the need for the Sterling led 14 resources. In total over 500 pieces of equipment had to be IQ/OQ/PQ validated in the 25 days.

Reference: CS59/2876540