Commissioning & Qualification Service Archives

To support growing global demand for its trusted vaccines, parasite-control products, and pharmaceuticals, our client—the second-largest animal health company in the U.S.— undertook a major expansion of its sterile fill and freeze-dry (FFD) vaccine production
facilities. This strategic investment significantly enhanced the company’s manufacturing capacity for critical biologic products.

The project scope included the addition of a 6,000 SF cold storage warehouse, infrastructure upgrades to optimize material and personnel flow between new and existing production areas, and the installation of comprehensive new mechanical and electrical systems. These systems included HVAC, steam boilers, chillers, cooling towers, switchgear, emergency generators, and process utilities such as RO water, clean steam, compressed air, and liquid / gaseous nitrogen.

New process areas were constructed to meet stringent regulatory standards, including Grade A through Grade D cleanrooms. The facility was outfitted with a fully integrated fill line, lyophilizers, cappers, and associated support equipment—all of which were installed, commissioned, and qualified.

Our team provided end-to-end commissioning and qualification (C&Q) services, including building and process commissioning, development of commissioning and qualification plans, scheduling, and overall C&Q management. Leveraging more than 15 years on this campus, we were engaged early in the design phase to ensure alignment with our client’s production and
regulatory goals.

Despite the project’s fast-tracked schedule—from initiation in 2016 to completion in Q3 2019—our team delivered on time and to specification. Lessons learned during execution were captured and applied to improve future project delivery for the client.

The successful completion of this expansion not only increased our client’s production capabilities but also reinforced our long-standing partnership. The client expressed high satisfaction with our C&Q performance, leading to our selection for two additional large-scale projects and a further expansion of the FFD area.

May 31, 2018/in Glass Engineering, Commissioning & Qualification, Data / Fire / Security (DFS), Architecture U.S., Southeast U.S. Markets - Glass /by david

SSOE suggested the use of steel eccentrically braced frames in lieu of ordinary steel moment frames on a new building in a seismic zone saving the client $80,000.

A long-term client enlisted SSOE to design a laminator addition that would enable them to manufacture a new shingle product. This involved reconfiguring the shingle manufacturing process and designing a building to house the new equipment.

The strategy included two major phases: Phase 1 included relocation of the existing packaging system equipment to make room for the new laminator. Phase 2 included the installation of the new laminator and auxiliary systems. SSOE engineered and designed extensive controls to handle process changes to the granule, asphalt, and new laminator system.

The expansion also involved joining a manufacturing facility on one property to an adjacent warehouse facility that was owned separately. Electrical service had to be fed separately to the two adjacent sites and underground piping for a fire main rerouted. SSOE provided architectural, structural, electrical and process controls design, and upgraded the alarm system and fire protection for the expanded facility. The team assisted the client with attaining permits and installation and commissioning of equipment.

SSOE fast-tracked the project in order to meet the client’s schedule for plant start-up and manufacture of the new product.

May 31, 2018/in Food & Beverage Commissioning & Qualification, Master Planning, Engineering Southeast U.S., U.S. /by david

Phased construction to compress schedule by three months.

When American Snuff wanted to convert a recently purchased facility into new processing facilities, SSOE had the EPCM expertise needed to lead the project. With the goal to increase capacity and achieve FDA compliance, a new requirement for its product, SSOE proved key to renovating and expanding the site, largely due to its expertise serving FDA regulated industries and renovating brownfields.

Originally designed in the 1970s by SSOE, the site, previously operated by Union Carbide, produced large carbon electrodes for the steel industry. The brownfield site had been abandoned for eight years, making the conversion challenging. However, SSOE’s extensive cGMP and renovation experience allowed it to accommodate immediate and future manufacturing needs while transforming an idle general manufacturing environment to one that satisfies new FDA regulations for the industry.

SSOE’s scope of services included conceptual planning and budgeting, design, procurement, cost control, scheduling, monitoring and reporting, commissioning, and construction management services.

In an effort to achieve American Snuff’s ambitious schedule, SSOE recommended construction sequencing (phased construction with multiple primes) to compress the project construction schedule by three months. Aggressive cost management and early identification of cost trends put the project on track to be delivered within budget.

SSOE suggested the use of steel eccentrically braced frames in lieu of ordinary steel moment frames on a new building in a seismic zone saving the client $80,000.

Phased construction to compress schedule by three months.

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SSOE suggested the use of steel eccentrically braced frames in lieu of ordinary steel moment frames on a new building in a seismic zone saving the client $80,000.

Phased construction to compress schedule by three months.

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