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EMPQ Case Study: Carolina Components Group

Read this case study to learn how Alcami supported Carolina Components Group in the successful completion of their comprehensive cleanroom qualification.


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CLIENT PROFILE

Carolina Components Group (CCG) supports the biotech and pharmaceutical industries with a full range of products including stainless steel tubing and fittings, valves, process hoses, and an increasing focus on custom single-use assemblies. Based on the growing market for disposable assemblies in flexible manufacturing environments, CCG recently expanded their ISO 7 and ISO 8 cleanroom capacities with a new facility in Durham, North Carolina. With a team of industry veterans with more than 200 years of combined experience in the industry, CCG is committed to using this new facility and their current product offerings for local, national, and global support of biopharmaceutical customers.

PROjeCT BACKGROUND

The Alcami Environmental Monitoring (EM) team was brought in to provide support with holistic qualification of new cleanroom settings through baseline and room recovery study and qualification of the compressed gas distribution system, along with environmental monitoring performance qualification (EMPQ). With its customized support features, Alcami worked hand-in-hand with CCG to scale their cleanroom capacity in their latest facility build.

PARTNERING WITH ALCAMI

Utilizing Alcami’s expertise with cleanroom and gas system validations, CCG was able to move efficiently through their qualification and address challenges in real-time to ensure no delays in the project timeline to support their customers. Specifically, Alcami provided design guidance for optimized airflow in the ISO 7 and ISO 8 spaces and start-up recommendations for the compressed air system. Working closely with Alcami during the design and start-up phases on the project allowed CCG to identify potential problems ahead of testing and minimize issues during the qualification.

“From the start of the project, Alcami SMEs provided exceptional technical support and worked closely not just with our company but with other project vendors on coordination activities ahead of qualification. Throughout this process, Alcami was very flexible with their time, extremely impactful with technical support, and showed care and ownership over their aspects of the project scope. During qualification activities, we leaned on Alcami’s experience and industry knowledge to ensure a smooth and successful completion.”  - Adam Miller, General Manager Single-Use at Carolina Components Group

“Alcami SME’s worked hand-in-hand with us through the EMPQ process, to capture all documentation needed throughout the qualification process, providing guidance when needed. The documents provided were specific to our project and cleanroom design to ensure we met (and exceeded) ISO Class 7 standards.”   - Tara Moore, Quality Manager at Carolina Components Group

“Working with Carolina Components Group was an exciting opportunity for both teams to maximize facility potential and be the gold standard in ISO operations. I’m proud of the teamwork exemplified and look forward to continued partnerships with CCG."  - Anna Dormady, Director, Laboratory Operations at Alcami

WHERE ARE THEY NOW?

The new Durham facility includes three state-of-the-art ISO 7 assembly rooms, a large kit-to-quantity ISO 7 corridor, and ISO 8 transition spaces for personnel and materials. The 5,000 square foot facility allows CCG to provide single-use assemblies to support sterile processing facilities throughout the world. With Alcami’s help, each cleanroom space was qualified under both static and dynamic conditions to thoroughly test the operational conditions and ensure compliance to ISO standards.