Customer Overview

Tofflon Group is a global pharmaceutical equipment company founded in 1993 and owned by Plano Pharmaceuticals. They supply equipment, engineering, and process solutions for the pharmaceutical, biotech, and life science industries. In July, the company opened a new modular-built production plant in the city of Dongtai, China designed for advanced sterile injectable manufacturing. The facility spans more than 9,000 square meters and includes two state-of-the-art aseptic injectable production lines, including a flexible three-in-one isolator filling system compatible with vials, pre-filled syringes, and cartridges. A fully automated packaging line supports intelligent control from filling through finished product handling.

Challenge

The customer was constructing a new manufacturing building on a previously developed site located in Zion, Illinois, USA. The green space modular project would be fabricated from scratch in China then transported to the site in the USA. It was imperative that the modules meet stringent U.S. regulatory and building standards while accelerating delivery through modular construction. The project required full alignment with current Good Manufacturing Practice standards, International Building Code requirements, and National Fire Protection Association standards. Because the facility would be prefabricated offshore and assembled in the United States, every design, construction, inspection, and pre-commissioning activity had to be traceable, verifiable, and ready for U.S. approval.

Solution

ICC NTA supported the project by providing third-party inspections during fabrication, with the State responsible for reviewing the drawings for compliance. It was paramount to establish a line of communication between ICC NTA and Tofflon early in the project so that the inspector could plan accordingly to finish the job properly at the factory.

All 50 prefabricated modules were manufactured, assembled, and pre-commissioned at Tofflon’s Dongtai production base before shipment to the United States for site assembly.

Throughout the offshore prefabricated construction cycle, NTA provided continuous third-party oversight on behalf of U.S. regulatory requirements. NTA’s role extended across the full fabrication process, including raw material entry inspection, implementation-standard verification, construction-process inspection, and multidimensional quality-control reviews. This full-process oversight helped ensure that each module, assembly step, and critical connection point met the rigid constraints of applicable U.S. regulations before shipment.

By utilizing NTA experts throughout offshore production, the project created a transparent manufacturing and compliance record for U.S. reviewers. Rather than relying solely on final inspections, NTA’s resident supervision model made quality and compliance traceable at every stage, allowing trust to be built on verifiable facts documented throughout the construction process.

Results

  • S. certification achieved: The modular project officially passed U.S. certification following inspection and labeling by project stakeholders.
  • 50 prefabricated modules delivered: Modules were manufactured, assembled, and pre-commissioned in China before shipment to the United States.
  • 9,000+ square meters of facility space: The greenfield site was designed to maximize function and efficiency within a compact footprint.
  • Two aseptic injectable production lines: The facility supports advanced sterile manufacturing capacity, including flexible filling for vials, pre-filled syringes, and cartridges.
  • One-time drawing approval: The complete drawing package received official U.S. government approval after compliance review and professional engineer sign-off.
  • End-to-end regulatory alignment: The project was executed in accordance with cGMP, IBC, and NFPA standards, supported by continuous third-party oversight.

“The third-party inspection model (from ICC NTA) allows trust to be based on traceable and verifiable facts and also allows Dongfulong Manufacturing to win authoritative endorsement in the field of international high-end pharmaceutical engineering.”

Ready to accelerate your next modular manufacturing project with global compliance, and integrated engineering expertise? Contact NTA to explore how a modular facility strategy can support faster, more flexible, and more compliant production capacity.