Objectives

The primary objectives of this tender are to procure two (2) pharmaceutical-grade Clean Steam Generators (CSGs) that meet current GMP standards, ensuring reliable, compliant, and efficient steam supply for critical pharmaceutical manufacturing processes. The solution aims to provide long-term spare parts availability, support validation and commissioning, and ensure operation within a highly regulated environment.

Scope

The scope encompasses the complete turnkey design, fabrication, supply, installation, testing, commissioning, validation support, documentation, and training for two pharmaceutical-grade CSGs. The equipment must be suitable for use within OBP's pharmaceutical manufacturing facility, adhering to international best practices and current GMP expectations. The scope includes:

• Design and engineering compliant with specified mechanical and process requirements
• Fabrication and factory testing
• Delivery and installation at the designated site
• Commissioning, validation, and qualification support
• Provision of comprehensive documentation, manuals, and certificates
• Training for operators, maintenance, QA, and validation personnel
• Provision of spare parts and after-sales support

Technical Requirements

Design Basis

Each CSG shall meet or exceed the following minimum design parameters:

• Shell Side:
  • Design Pressure: 750 kPa
  • Design Vacuum: -90 kPa
  • Maximum Allowable Working Pressure: 750 kPa
  • Operating Pressure: 600 kPa
  • Initial Hydrostatic Test Pressure: 995 kPa
  • Maximum Design Temperature: 175°C
  • Minimum Design Temperature: 10°C
  • Operating Temperature: 165.04°C
  • Internal Volume: 0.48 m³
• Tube Side:
  • Design Pressure: 900 kPa
  • Design Vacuum: -90 kPa
  • Maximum Allowable Working Pressure: 900 kPa
  • Operating Pressure: 800 kPa
  • Initial Hydrostatic Test Pressure: 1195 kPa
  • Maximum Design Temperature: 180°C
  • Minimum Design Temperature: 10°C
  • Operating Temperature: 175.43°C
  • Internal Volume: 0.035 m³

Performance & Quality

• Steam quality shall comply with pharmaceutical GMP standards and be suitable for SIP applications.
• The system shall operate using existing purified/RO water, with pretreatment identified if necessary.
• Complete process study and capacity determination based on site demand are required prior to final design.

Additional Technical Specifications

• Materials of construction: pressure parts and contact surfaces must meet specified standards with electropolished internal surfaces (Ra ≤ 0.5 µm) and brushed external finishes.
• All welding shall conform to recognised pressure vessel codes.
• Full insulation and cladding to ensure external temperature less than 50°C.
• Instrumentation includes pressure, temperature, level, flow transmitters, safety valves, rupture discs, vacuum breakers, steam traps, drain valves, sampling points, etc.
• Each generator shall include a dedicated PLC, with SCADA compatibility for future integration.
• Complete GMP documentation including design, validation, certificates, as-built drawings, manuals, and spare parts lists.
• Factory and site acceptance testing to verify performance, safety, and compliance.
• Provision for comprehensive training and warranty coverage.

Skills Requirements

• Proven experience in designing, manufacturing, and installing pharmaceutical-grade steam generation equipment, with at least five (5) installations in the last ten years.
• Demonstrated capability to operate within GMP-regulated environments, supported by at least two reference letters not older than five years.
• Qualified engineering team including process engineers, mechanical engineers, validation specialists, and automation engineers.
• Ability to provide comprehensive validation, commissioning, and documentation support.
• Knowledge of pressure vessel codes, pharmaceutical standards, and regulatory requirements.
• Capability to deliver ongoing after-sales support, spare parts, and maintenance services.