Objectives

The primary objective of this tender is to evaluate the market availability and capabilities for a benchtop, high-containment 1L Reusable Fermenter System suitable for Onderstepoort Biological Products (OBP). The system should support scalable bioprocessing configurations, including standalone units, multiple independent units, or multi-vessel cascade/parallel setups, all controlled via a unified software interface. The overarching goal is to identify solutions that meet OBP’s requirements for manufacturing animal vaccines with high biosafety standards.

Scope

The scope encompasses the supply, commissioning, and long-term support of a high-containment, reusable fermenter system with a 1L volume capacity. The system must include:

• Autoclavable, double-jacketed vessel with integrated exhaust and cooling
• Real-time monitoring and control of critical parameters (pH, dissolved oxygen, temperature, foam/level)
• Gas management and emission monitoring capabilities
• Aseptic sampling and inoculation features
• Safety interlocks and pressure sensors
• Compatibility with poor-quality utility steam filters
• Control software compliant with 21 CFR Part 11
• Containment features suitable for BSL-2/3 environments
• Power infrastructure with UPS backup for at least 30 minutes
• Support for sterilization, calibration, and maintenance protocols
• Warranty, spares, and technical support including regional service access

The system footprint must be compatible with Class III biosafety cabinets or containment isolators, ensuring high biosafety standards.

Technical Requirements

The technical specifications include:

• Volume range: 0.25L to 0.75L
• Vessel: Autoclavable, double-jacketed borosilicate glass or similar, baffled, with integrated water-cooled exhaust condenser
• Gas management: Exhaust cooler, gas valve assembly, and real-time emission analyzers for O2 and CO tracking
• Agitation: Top-driven magnetic or mechanical shaft with seals, equipped with 2–3 Rushton impellers
• Monitoring: Continuous, real-time control of pH, DO, temperature, foam/level with high-stability probes
• Safety: Pressure sensors, safety interlocks, and filters for utility steam
• Control System: Central control panel with touchscreens, integrated UPS, and software compliant with 21 CFR Part 11
• Containment: Dual hydrophobic filters, compact footprint, compatible with biosafety cabinets

Skills and Capabilities Requirements

Respondents must demonstrate:

• Relevant experience in supplying benchtop/fermenter systems, particularly for biopharmaceutical or vaccine sectors
• Company or individual profile highlighting expertise in high-containment bioreactor systems
• Capability to provide detailed proposals including specifications and pricing
• Registration on the Central Supplier Database (CSD) and valid SARS tax clearance
• Proven track record with ISO 9001 certification and CE/ASME ratings for pressurized modules
• Ability to provide comprehensive warranty, preventative maintenance, and critical spares support for at least 5 years
• Regional technical support with rapid response times (within 24–48 hours) for critical failures
• Compliance with South African electrical standards (230V, 50Hz, single-phase) and built-in surge protection
• Experience with sterile sampling, autoclave sterilization, and training on operation and maintenance protocols
• Knowledge of biosafety levels (BSL-2/3) and containment architecture requirements