This Request for Supplier Qualification is to solicit information from interested proponents seeking to provide the services of a highly qualified Clean Room vendor with substantial experience in the design/construction of modular clean rooms for the pharmaceutical and/or radiopharmaceutical industry. This RFSQ process will remain open until cancelled by McMaster.
McMaster is in the planning stages of a project to construct modular clean rooms within a larger fit-out for handling and processing of radioactive labelled pharmaceuticals. This Request for Supplier Qualification is to invite firms who have significant experience in the design, installation, commissioning and qualification of modular clean rooms, associated air locks, ancillary rooms, and the required HVAC systems to support such a facility, including supply air handling units, a nuclear exhaust system, and their respective control systems.
The constructed production rooms must provide an environment suitable for the GMP manufacturing of aseptic therapeutic radiopharmaceuticals for commercial distribution.
Vendors must have a demonstrated proficiency and understanding of the Canadian and international industry standards and regulations (FDA, HPFBI, EMA) for sterile pharmaceutical and radiopharmaceutical product GMP manufacturing, Canadian Nuclear Safety Commission regulations, and all local and national codes and standards for construction, commissioning and validation of the required facility and systems.
The anticipated size of the modular clean room production area is approximately 5,000-7,000 square feet.
