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In 2011, the FDA implemented a Quality by Design (QbD) pilot program to support their review and approval process. After gathering several years worth of research, the FDA decided to push forward with a QbD approach to evaluate the manufacturing processes used by pharmaceutical companies. The central idea is to focus on improving control in […]

In 2011, the FDA implemented a Quality by Design (QbD) pilot program to support their review and approval process. After gathering several years worth of research, the FDA decided to push forward with a QbD approach to evaluate the manufacturing processes used by pharmaceutical companies. The central idea is to focus on improving control in […]

The standard cleanroom classification range is ISO 1 to ISO 9, with ISO 1 being the cleanest and ISO 9 representing a standard room. The most common cleanroom projects fall within the ISO 3 to ISO 8 range, which means that an ISO 8 cleanroom allows for the most particles in the air before reaching […]

AM Technical Solutions (AMTS) recently completed a large-scale Lean construction project for a global technology company. The project called for AMTS to deliver an automated material handling system at the client’s microelectronics facility. Our method to complete the project was implementing Lean processes, specifically following the Last Planner System (LPS). How Did AMTS Utilize the […]

Quality by design (QbD) is often associated with construction projects. The idea is to develop processes that support quality throughout the construction project from planning to building to operations. In the pharmaceutical industry, the U.S. FDA has taken significant steps to adopt QbD principles in their pre-market processes that guide the approval process. In fact, […]

AM Cleanroom Build and Performance (AMCBP) recently completed a Cleanroom construction project for a global equipment manufacturer on the west coast. The project called for an expedited timeline for material procurement and installation of a custom cleanroom system, constructed using P5001 Unistrut to support the wall framing and ceiling framing. AMCBP was commissioned to provide […]

AM Cleanroom Build and Performance (AMCBP) recently completed an “As Build” Certification of Cleanrooms project for a growing high-technology company in the Pacific Northwest. The client required cleanroom authentication to support their production of technology products in an emerging market. AMCBP was commissioned to provide the following services: Leak Test on 15 filters Airflow Volumetric […]

Element 3: Cleanroom Classification *Updated in August 2018 from original 2014 post date. One way AMCBP is “Constructing an Intelligent Tomorrow” is through the work of our Cleanroom Performance Solutions group. In this 4-part series, our very own Emil Bordelon, a NEBB Certified Professional, outlines the four main elements of a cleanroom that are considered […]

Element 1: HEPA/ULPA Filters *Updated in August 2018 from original 2014 post date. One way AMCBP is “Constructing an Intelligent Tomorrow” is through the work of our Cleanroom Performance Solutions group. In this 4-part series, AM Cleanroom Build and Performance’s very own Emil Bordelon, a NEBB Certified Professional, outlines the four main elements of a […]

Element 2: Airflow *Updated in August 2018 from original 2014 post date. One way AMCBP is “Constructing an Intelligent Tomorrow” is through the work of our Cleanroom Performance Solutions group. In this 4-part series, our very own Emil Bordelon, a NEBB Certified Professional, outlines the four main elements of a cleanroom that are considered during […]