EOI FOR AUTOMATED BLOOD COMPONENT PROCESSOR

" Automated Blood Component Processor-Qty-1 . " , complete as per below mentioned configuration and specifications:

cGMP- compliant device which is a closed Automated Blood Component Processing System for End- to- End Manufacturing of Cell Therapy Products as per below mentioned configuration and specifications

The system should be a fully integrated single-unit platform capable of processing and executing fully automated cellular and gene therapies within a closed and sterile environment, ensuring compliance with applicable Good Manufacturing Practice (cGMP) standards.

The system should be suitable for the processing of heterogenous starting biological materials, as per below and also additional applications if any (Please specify) -Leukapheresis products -Blood samples

The system should be capable of performing, at a minimum, the following functions: -Target cell labeling -Cell separation -Cell cultivation -Volume reduction -Viral transduction -Cell expansion and differentiation (including adherent cell types) -Cell culture and medium exchange -Density gradient centrifugation -Buffer exchange

The system should be roburst enough to ensure reproducible results with consistently high cell purity and yield

The system should be equipped with a high fold Magnification microscopic camera, for boundry Layer Detection to differentiate interlayers (e.g., plasma and cells) during centrifugation.

The system should be equipped with sterile sampling pouches for in-process control (IPC) and quality control (QC) sample removal

The system should include an integrated barcode scanner, sealer and LED-based visual indicators should be provided for system status and process monitoring

The system should incorporate dark-field microscopy capability to enable enhanced visualization of cellular components

The system should provide control environmental factor for cultivation of cells requiring temperature range from +4 °C to +38 °C and gas-mix unit for controlled supply of O₂, CO₂ and Nitrogen.

The system should feature user-friendly software with a graphical user interface (GUI) capable of executing all available protocols and to retrive the log file data for each indivitual process.

The system should be equipped with a monitor, Software interface, TFT LCD touchscreen, USB port, glove-friendly operation, and detergent-resistant surface.

The system should be supplied with pre-installed and validated applications covering a wide range of cell processing workflows

The system should allow the creation, modification, and execution of cultivation protocol.

The system should be equipped with intuitive software enabling easy on-screen navigation and operation

The system should be equipped with tube sealer and bar code reader

The system should have a pump speed range of approximately 2–400 mL/min.

The gas-mix unit should operate within a minimum inlet pressure of 1.0 bar and a maximum inlet pressure of 2.5 bar

-Single-use closed-system process hardware for one manufacturing run, including run-specific process cassettes, integrated fluid path assemblies, biocompatible tubing sets, weldable/sealable tubing, sterile connectors and clamps, extension and interconnector tubing, flushing/conditioning sets, and single-use accessories for setup and dry-run validation.

-Sterile single-use bags for closed processing,for one run including cell input and vial bags, filtration bags, harvest and collection bags, formulation bags, and integrated waste or drain collection bags for one complete run.

-Single-use sterile filtration components for one run, including inline sterile filters for buffers/media/cell suspensions, cytokine filters (if applicable), sterile sampling filters, and luer-lock inline filters for aseptic fluid transfer.

-Single-use sterile connectors and adaptors for one run for closed-system processing, including male and female luer-lock connectors, tubing interconnectors, extension adaptors, and specialized system-compatible single-use adaptors.

-Single-use consumables for one run,for process transfer and monitoring per run, including liquid transfer tubing sets, in-process sterile sampling bags or ports, sample collection tubes, and reagents for in-process cell viability or counting assessments.

-Single-use harvest and formulation consumables for one run, including non-media harvest/formulation buffers, sterile harvest collection bags, final product formulation and transfer bags, and closed-system tubing sets for product collection and transfer.

Single-use waste handling consumables per run, including integrated sterile waste bags, biohazard waste liners, and sealed disposal tubing for safe containment and disposal of process waste.

Please quote cGMP-approved consumables for all the above mentioned procedures in clauses I-4 and I-5 for end-to-end Cell and gene therapy manufacturing. The rate of consumables should be fixed for at least 2 years without any cost escalation.

The yearly consumption of kit can be considered 1 kit per 4-6 months.

Provide the list of proprietory consumables if any for the quoted equipment along with the technical bid (Not to include price as it may lead to disqualification) If no list is provided, it implies that there are no proprietory consumables.

The vendor/ manufacturer supplying the instrument should have application Support laboratory in India for efficient after sales service-support. The address of the Application Lab should be clearly mentioned.

Please visit the site to check whether quoted model can be accomodated in the available space.

Performance parameter required as below: ( like accuracy, sensitivity, sample volume requirement, resolution or such performance parameters to be highlighted)

Standard accessories (Which comes along with the machine, pricing of which is part of the equipment)

Periodic Calibration

Regulatory Approvals, If any. Details with copies of approvals.

Proper customized table, specifically designed for installation of main equipment, accessories supplied along with the equipment including but not limited to computer work station compatible for Software integrations.

Safety requirements and Certifications

It should follow International / national safety requirement. Please specify certification with certifying agency and country with copies of certificate.

The system should be compliant for use in cGMP or used in GMP facilities nationally or internationally. Documentation should be provided

System and Software shall support 21 CFR Part 11- compliant electronic records/ audit trails, either natively or through validated software

The Equipment/ System should comply to US FDA/ European CE (Notified body)/ BIS/ ICMED certification . Please attach copy of the certificate(s).

Performance certificates of IQ,OQ,PQ tests to be submitted at the time of installation/commissioning.

Vendor to submit the technical data sheet, brochure etc as a tender document with reference to the quoted make & model. Please mention the reference page no., quoted model name/number against each item etc in these documents against each technical specifications in the compliance.

Please submit pre installation requirements [electrical, HVAC, Compressed air along with air pressure mentioned), water requirement (RO/DI/Distilled water with its pressure, flow rate per hour) ; if any of the above is essential]

Vendor to submit details of footprint size & weight of the quoted model.

Vendor to submit power consumption.

Demo of the quoted model , will be required if so desired by the user, after the opening of the technical bid and prior to opening of financial bid. This is for technical evaluation. All technical specifications mentioned above to be mandatorily shown in the demo unit.

User's/Installation list: A list of installations of the quoted model with the address and contact numbers to be provided.

Predispatch inspection at factory will be required if desired by authorities.

Should be CE/US FDA/BIS/ICMED /CDSCO approved.

Vendor should provide the User manual copy during the installation of the equipment.

Unpacking and shifting the consignment to the installation site is to be included in the vendor's scope of supply. Bidder/manufacturer/authorized service provider should take responsibility to lift /shift the consignment from unloading site to the installation site. Unloading site shall be Stores department, ACTREC If needed ,bidder has to arrange for the labours at no charge to ACTREC.(Before submitting the quotation,bidders may visit ACTREC GMP Facility. to know unloading and installation site.

Training:

Operational training to be provided onsite to all departmental staff and primary level maintenance training to be provided to inhouse Biomedical Engineers.

Local Service Support: Should have local office and service support/service engineer for attending the breakdown calls. Details to be submitted.

Response Time: Should not be more than 06 hrs from lodging a breakdown complaint on toll free or by email.

Warranty- 2 years

Should include a) 4 nos. preventive maintenance/ year and unlimited breakdown calls along with spares.b) All bought out items quoted along with the main system (local/non-local) to be covered. c) Yearly calibration/Validation/QA, Testing and measuring equipment used should be traceable to SI units through National/ International starndards (as per NABL/NABH norms). d) PM kit if any. f) All upgrades/update cost, no seperate licence fees will be payable.

CMC- cost per annum will be considered for all bidders for 8 years after warranty

Should include a) 4 nos. of preventive maintenance/ year and unlimited breakdown calls. b) All bought out items quoted along with the main system (local/non-local) to be covered under CMC. c) Yearly calibration/Validation/QA during CMC. Testing and measuring equipment used should be traceable to SI units through National/ International standards (as per NABL/NABH norms). All spare parts , upgrade/update cost should be included.

Back to back assurance to be taken by the supplier from OEM to supply spares for minimum 10 years and to be submitted.

Penalty Clause:

L1 Calculation: