Request for Quotation – Passive Blood Transportation Cooler

Dear Sales Team, We are interested in purchasing a Passive Blood Transportation Cooler for a blood bank facility in Mozambique. Please provide your technical and commercial quotation for a new insulated transport box designed for the transportation of whole blood bags between blood collection sites and blood bank facilities. 1. Minimum Technical Requirements Please confirm compliance with the following specifications: 1. Capacity: Minimum capacity of 20 blood bags of 450 mL each. 2. Temperature maintenance:** The internal temperature must remain between +2°C and +10°C for at least 24 hours, under an ambient temperature of +43°C, using properly conditioned coolant packs. 3. Thermal performance testing:Tested according to the applicable WHO PQS E004 cold-box performance verification protocol, or an equivalent validated thermal performance test. Please provide the test report and identify the protocol used. 4. Insulation: Polyurethane insulation or material with equivalent thermal performance. 5. Handles: Two carrying handles. 6. Lid: Secure lid with a locking or fastening mechanism. 7. Maximum loaded weight: 50 kg, including blood bags and coolant packs. 8. Internal lining: Washable and resistant to hospital disinfectants. 9. Internal dividers: Dividers or protective inserts preventing direct contact between blood bags and coolant packs. 2. Required Accessories The quotation must include: - One complete set of coolant packs compatible with the proposed cooler. - One additional spare set of coolant packs. - One temperature data logger compatible with the cooler, suitable for monitoring and recording the internal temperature during transportation. Please specify the data logger's temperature measurement range, accuracy, resolution, recording interval, memory capacity, battery autonomy and method of data export. 3. Regulatory and General Requirements The proposed equipment must: - Be brand-new, unused and supplied in the manufacturer's original packaging. - As a passive, non-electrical cooler, electrical supply requirements under RG2 shall be considered not applicable to the cooler itself. Any electrical requirements applicable to the supplied data logger must be specified separately. - Have CE marking, FDA approval or equivalent regulatory approval, as applicable to the equipment and its intended use. - Be manufactured under an ISO 13485-certified quality management system or equivalent, as applicable. - Provide applicable safety and regulatory documentation. - Have the required ANARME import authorization or a formal commitment to obtain it before delivery. - Include a user manual and quick-start guide in Portuguese, a service manual in Portuguese or English, and the original manufacturer's catalogue. - Guarantee spare parts and consumables availability for at least 5 years. - Include technical support in Mozambique or a formal commitment to provide it. - Ensure that all supplied accessories and consumables are manufactured by or validated by the equipment manufacturer. - Include manufacturer authorization if the bidder is not the original manufacturer. 4. Model Status and Manufacturer Declaration The proposed model must be the latest generation for this application and currently marketed in the European Union or the United States, or in its country of origin if that country is an IMDRF member. Please provide a manufacturer declaration confirming: - Model launch year. - Current commercial availability in the relevant reference market. - Confirmation that the model is not discontinued or replaced by a newer version. - Confirmation that the model is not manufactured exclusively for export markets. - Commitment to spare parts and technical support for the required period. Please clearly indicate whether each requirement is fully compliant, partially compliant, optional or unavailable. Important clarification: Our required blood storage temperature range during transportation is +2°C to +10°C. Please do not propose a system designed to freeze the blood bags or maintain them at negative temperatures. Best regards, Albino Mozambique