Streamlining Environmental Monitoring: A CMO's Success with 3P® ENTERPRISE

Selkirk Pharma is a U.S. based contract manufacturing organization specializing in the sterile fill and finish of injectable drugs, including vaccines and biological therapies.

Their state-of-the-art facility in Spokane, Washington boasts cutting-edge technology and recently completed the implementation of 3P® ENTERPRISE.

This end-to-end solution streamlines environmental monitoring processes by automating workflows, enhancing data integrity, and boosting overall efficiency.

The Microbiology and Environmental Monitoring team at Selkirk spoke to their journey and how 3P® ENTERPRISE aligns with Selkirk’s vision of becoming a digital leader in the CMO space. They discussed how 3P® ENTERPRISE will help Selkirk prioritize efficiency and data integrity within their environmental monitoring program.

Selkirk was founded in 2018 by industry veterans with a vision for building a world class contract manufacturing organization. With construction finished in the fall of 2022, a team of 80 employees began facility and equipment qualification and validation activities. As Selkirk moves through 2024 and into 2025, technical transfers for commercial products have begun as we work towards releasing our first client batch. We are the Microbiology Environmental Monitoring team in the quality department, and we have been involved in the qualification of the GMP operations which has included building a robust risk-based environmental monitoring program.

Selkirk Pharma’s vision was to develop a purpose-built facility with infrastructure that enables the successful implementation of Pharma 4.0 programs. These programs include deployment of digital solutions spanning quality, manufacturing, supply chain, engineering, and validation with a goal to remove paper-based data and process barriers.

The 3P® ENTERPRISE automated plate reading system integrated with an EM software platform establishes a semi-automated and entirely paperless EM Program. 

This ecosystem - integrated with our EM software, streamlines our entire EM process, eliminating paper-based workflows and maximizing efficiency. The automation of plate incubation and reading will allow us to free up valuable team members’ time for more strategic tasks. Additionally, real-time data capture and tracking allows us to proactively make decisions and ensure faster response times to potential issues, giving us greater peace of mind.

Given how critical the EM process is in our industry, we were looking for a reliable partner that we could trust. bioMérieux’s partner-centric approach resonated strongly with our team. We really appreciate the continued support we have had from bioMérieux, especially during the implementation project.

Our goal was to ensure we implement the solutions that can bring us efficiencies in our processes. For this reason, we decided to implement a single-temperature approach in our incubation strategy as it will help reduce potential errors, while optimizing resource allocation.

Ultimately, with the implementation of digitalization and automation solutions such as 3P® ENTERPRISE, Selkirk strives to provide reliable delivery of quality products to the pharmaceutical market in the shortest time possible. The increase in quality achieved through the implementation of automated technology accelerates our ability to rapidly bring our customers’ injectable drug products to the market.

Like Selkirk Pharma, you can unlock the future of pharmaceutical quality with automated environmental monitoring. With 3P® ENTERPRISE, you can experience streamlined processes, enhanced reliability, and superior results.