Objectives

The primary objective of this tender is to identify and gather information from experienced market service providers capable of supplying, installing, commissioning, validating, and supporting a 40–60L reusable pilot fermenter designed for bacterial propagation. The project aims to develop high-specification, GMP-compliant infrastructure suitable for bioprocessing up to Biosafety Level 2 and 3 (BSL 2 and 3). The information collected will be used to refine technical specifications, assess market availability, inform future pricing, and establish realistic delivery timelines prior to a formal competitive bidding process.

Scope

The scope includes:

• Provision of a 40–60L pilot fermenter suitable for bacterial propagation.
• Installation, commissioning, and validation of the fermenter system.
• Support for high-containment requirements (BSL 2 and 3).
• Technical assessment of equipment capabilities against detailed specifications.
• Provision of documentation including design, qualification, and validation protocols.
• Support and maintenance services, including spare parts and technical support.

Technical Requirements

The technical specifications include, but are not limited to:

• Vessel volume: 40–60 liters with working volume approximately 25–75% of vessel volume.
• Vessel type: Double-jacketed with insulation, water-cooled, with automatic sterilization and control systems.
• Control systems: PID automatic control, temperature jacket heat exchanger, multiple sensors (pH, DO, temperature, turbidity, redox), and safety features.
• Agitation: 3-4 Rushton impellers, 20–1500 rpm, with mechanical or magnetic drive.
• Aeration: Gas sparger control via Mass Flow Controller (MFC) and Thermal Mass Flow Controller (TMFC).
• Instrumentation: Multiple ports for sampling, sensors, and probes, all compatible with sterilization and autoclaving.
• Materials: 316L stainless steel with SIP-rated components, weather-shrouded sensors, and hygienic fittings.
• Qualification: Design, Installation, Operational, and Performance Qualification (DQ, IQ, OQ, PQ) compliant with GAMP 5 and 21 CFR Part 11.
• Software: SCADA-based process control with full audit trails, electronic signatures, and disaster recovery protocols.
• Containment: Equipment designed for safe handling of BSL 1, 2, and 3 microorganisms.
• Support: Local technical support, spare parts availability, and compliance with ISO 9001 and CE/ASME standards.

Additional Technical Notes

The system must include features such as SIP sampling valves, inoculation ports, containment measures, and integration with process control software. Validation protocols should ensure system reliability, safety, and compliance with regulatory standards.

Skills Requirements

The tender requires suppliers to demonstrate:

• Relevant experience in supplying and supporting pilot fermenters for bacterial propagation.
• Capability to install, commission, and validate GMP-compliant bioprocess equipment.
• Proficiency in qualification and validation processes, including DQ, IQ, OQ, and PQ.
• Expertise in bioprocess control systems, SCADA software, and automation aligned with GAMP 5 frameworks.
• Ability to provide comprehensive technical support, maintenance, and spare parts management.
• Knowledge of biosafety containment requirements and handling of high-risk microorganisms.
• Compliance with ISO 9001, CE/ASME standards, and local electrical and safety standards.
• Experience in documentation, training, and software validation in regulated environments.