The Supply, Delivery and Installation of a Formulation Tank

RFQ/OBP151/2026/27

Volume: 50L - 120L Mechanical & Material Design Material: Product contact parts must be AISI 316L stainless steel; non-contact parts AISI 304. Surface Finish: Internal roughness (Smooth internal surfaces (roughness of < 0.4 μ m electro-polished) to prevent bacteria from growing external < 0.8 μ m (satin/mirror). Vessel Geometry: Cylindrical shell with dished top and bottom heads (minimum 10% knuckle radius) for total drainage. The diameter of the tank should be approximately L( 70cm)x W (80cm) x H(≤1.9 m)- to fit through standard door. Tank Volume:50L – 120L Max working volume Glass to view the inside: (top and side glass?) Sight Glass Lighting (Internal Tank Viewing) Glass Type: Fused sight glass i.e. DIN 7079) or borosilicate glass compatible with CIP/SIP pressures (Manufacturer to specify) Thermal Rating: For SIP (Steam-In-Place) sterilization, use suitable glass material (i.e. conforming to DIN 7081) to prevent thermal shock from extreme heat. Light Technology: LED lamps. LEDs to prevent excessive heat buildup (which can ruin vaccine proteins). Certification: Ensure fixtures hold ATEX or Explosion-Proof ratings Antifog and self-lighting Seals and Gaskets: Made of sanitary materials (EPDM, Teflon (PTFE), or Viton.) Manufacturer to specify Pressure Rating: Minimum -1 bar (full vacuum) up to +3 bar (g) for clean-in-place (CIP) and steam-in-place (SIP) cycles. Insulation: Fully welded AISI 304 jacket with chloride-free rockwool or polyurethane insulation (Manufacture to specify). Vessel to be mobile :High performance engineering wheels. Wheels on a stand. To have a handle in the middle to push the tank. Washing system – Tank should be capable of Clean-In-Place (CIP) and Sterilize-In-Place (SIP). CIP Spray Balls: Installed at the top for automated, high-pressure cleaning. Designed to handle vacuum and pressurized conditions up to 0.3 MPa for safe sterilization To include inline Filters (Strainers): (to catch any clumps or particles before they reach the filler. Material: 316L Stainless Steel (electropolished to limit particle shedding). Mesh/Micron Size: 100 μ m to 200 μ m (e.g., 100 to 150 mesh). Agitation & Mixing Drive Mechanism: Bottom-mounted magnetic mixer to eliminate mechanical seal leak risks and preserve sterility. Impeller Type:6 -8 Low-shear hydrofoil or marine propeller to prevent damage to shear-sensitive vaccine proteins or adjuvants. Speed Control: Variable Frequency Drive (VFD) operating from 20 to 500 RPM. Variable speed magnetic or mechanical agitators. ( 0 to 500 rpm) that enable mixing without creating "shear" forces that could break apart fragile biological proteins Thermal Control: Double-walled "jacketed" design for heating and cooling (between 4°C and 130°C) to keep the vaccine at optimal formulation temperatures. Volume graduations marked outside the tank with 10L graduation intervals Ports at Top of tank: 1 removable glass lid 1x filtration port with stainless steel pipe extending to bottom of tank 1 port for air filter Ports at the bottom of tank: 1xSampling port: Aseptic zero dead-leg sampling valve. 1 x Flush-fitting bottom outlet valve . 1 port for connection for vaccine packaging (Tri clover adaptor). Load Cells: Weight sensors built into the tank legs to measure ingredients highly accurately (specify the accuracy you need). Instrumentation & Automation · Temperature: Dual PT100 RTD sensors (one for control, one for validation) placed in a bottom thermowell. · Level Control: Non-contact radar level transmitter or load cells (weighing modules) under tank legs for high accuracy. · Pressure: Sanitary diaphragm pressure transmitters to monitor CIP, SIP, and nitrogen blanketing overlay pressure. · Integration: PLC system · Compliance: Automation software compliant with 21 CFR Part 11 for electronic records and signatures. Sterilization & Validation CIP/SIP: Fully design-optimised for automated cleaning and steam sterilization at 121°C to 134°C. Documentation: Full validation package required including Material Test Reports (MTRs), Weld Logs, IQ/OQ protocols, and FAT/SAT documentation.

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2026/08/19 16:00:00

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RFQ/OBP151/2026/27