Design and Fabrication of QC Sterility and Endotoxin Testing Laboratory

This procurement is for the design and fabrication of a Quality Control sterility laboratory specifically for sterility and endotoxin testing. The lab must comply with DRAP requirements and GMP standards. It will include an instrument room, washing area, sample preparation area, decontamination area (Class C/D), and a Class B area equipped with laminar flow cabinets and a biosafety cabinet for testing purposes. The lab area is approximately 9750mm in length and 7200mm in width, with controlled environmental conditions such as positive pressure, temperature, and humidity. The scope covers cleanroom construction and finishing, HVAC system installation compliant with ISO 14644 and BMS/EMS, QC environmental monitoring equipment, validation documentation, execution, personnel training, and handover. Key components include installation of galvanized steel cleanroom wall and ceiling panels, cleanroom doors with digital interlocking systems, epoxy flooring, high-quality lighting with power cabling, HVAC equipment with air handling and condensing units, HEPA filters with 99.97% efficiency, glass wool insulation, air curtains, laminar flow cabinets, biosafety cabinets, pass boxes, air particle counters, air velocity meters, stainless steel furniture, mandatory accessories like SS corner guards and GMP sealants, and all necessary documentation and qualification tests. Eligible bidders should have relevant PEC categories, valid FBR and ATL registration, and proven experience in similar turnkey cleanroom projects. The tender emphasizes the importance of Earnest Money and CDR submission along with technical and financial bids within the stipulated financial year. The submission deadline is **1st November 2023**. Bidders are advised to carefully review the technical specifications and ensure compliance with GMP and DRAP standards. A practical tip for bidders is to prepare detailed validation and execution plans along with training schedules to demonstrate capability and compliance, which can significantly enhance the technical bid evaluation.