Objectives

The primary objective is to procure a fully automated double-door steam autoclave for installation in a controlled pharmaceutical and biological production facility. The tender seeks a qualified supplier capable of designing, manufacturing, delivering, installing, testing, and commissioning the equipment while ensuring strict adherence to safety, quality, and regulatory standards. Bid evaluation follows an 80/20 weighted scoring model, allocating 80% to price and 20% to preferential procurement goals aligned with South African legislation.

Scope of Supply

The supplier must provide one complete double-door steam autoclave system, encompassing all integral components, accessories, and support services. Deliverables include:

• Design, manufacture, and supply of the autoclave unit
• Delivery, positioning, installation, and utility connections
• Mandatory Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
• Commissioning, operator training, and formal handover
• Comprehensive documentation: general arrangement drawings, equipment data sheets, maintenance schedules, critical spares list, calibration certificates, and compliance reports for pressure/steam systems

Technical Requirements

• Configuration: Fully automated, double-door system with horizontal sliding doors enabling clean/dirty side segregation. Interlocks must prevent simultaneous or unsafe door operation.
• Chamber: Minimum usable volume of 2,300 litres. Approximate external dimensions: 1,280 mm (W) × 1,270 mm (H) × 1,500 mm (D). Mounted approximately 430 mm above finished floor level.
• Steam Generation: Four integral steam generators (4 × 36 kW total). Supplier to specify steam output, feedwater quality/consumption, and electrical supply requirements.
• Operating Parameters: Maximum temperature 140°C; maximum pressure 300 kPa. Supplier must clarify gauge vs. absolute pressure basis and provide design/allowable working pressure ratings.
• Controls & HMI: Human-Machine Interface for cycle control, alarm management, event/history logging, user access levels, and recipe storage. Boiler/steam-generator pressure must display on the HMI.
• Instrumentation: Calibrated chamber and jacket pressure gauges, plus chamber and media temperature probes. All instruments require traceable calibration certificates.
• Safety Systems: Emergency stop buttons on both sides, pressure/temperature/door interlocks, safe depressurisation mechanisms, and compliance with applicable statutory and industry standards.
• Materials: Clarification required on “25 mm thick stainless steel” specification, including material grades for the chamber, doors, and pressure-retaining components.
• Power Backup: Uninterruptible Power Supply (UPS) for the control system and designated auxiliary loads.
• Printer: Installed on the front panel (dirty side) for operational data recording.

Skills & Qualification Requirements

• Must be the Original Equipment Manufacturer (OEM) with verifiable proof.
• Demonstrated experience supplying equivalent equipment within the past 36 months, supported by minimum two reference letters from pharmaceutical, research, or healthcare environments.
• Valid CIDB contractor grading of 02ME or higher for mechanical engineering works.
• Proven capability to execute FAT/SAT, site installation, commissioning, and staff training.
• Working knowledge of Good Manufacturing Practice (GMP) principles, pressure equipment regulations, and biological/pharmaceutical processing standards.
• Compliance with Broad-Based Black Economic Empowerment (BBBEE) criteria to qualify for preferential procurement points.

Explanation of Key Terms & Services

• Factory Acceptance Test (FAT): A mandatory pre-shipment verification conducted at the manufacturer’s facility. The purchaser must witness and formally approve test results before the equipment can be dispatched.
• Site Acceptance Test (SAT): Post-installation validation at the client’s premises to confirm operational performance, safety interlocks, and integration with site utilities.
• CIDB 02ME: A South African Construction Industry Development Board contractor classification indicating competency in medium-scale mechanical engineering construction projects.
• Clean/Dirty Side Operation: A dual-chamber workflow design that physically separates contaminated input from sterilised output, essential for maintaining aseptic conditions in vaccine and biological product manufacturing.