2._Bill_of_Materials_(BOM)_-_RFQ-NIAID-23-2168438.pdf

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Knauer branded IJM NanoScaler (Brand Name or Equal)
Solicitation number
RFQ-NIAID-23-2168438
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This document is a bill of materials for a Knauer branded IJM NanoScaler system or equal product solicited by the National Institute of Allergy and Infectious Diseases. The bill lists 31 line items including the IJM NanoScaler base unit, pumps, mixers, valves, detectors, software licenses and various accessories. Key components of the NanoScaler are five impingement jet mixers to determine optimal formulation conditions, three pumps, sample loops, eluent bottles and a quench mixer. The system is designed for lipid nanoparticle formations up to 50 ml/min total flow. The solicitation also requires factory acceptance testing, site acceptance testing, documentation on material compliance, a one-year service agreement and freight. Products will be delivered CIP to Baltimore Airport with a two-year warranty excluding certain consumables.

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Bill of Materials/Line Items

# Part# Qty: Description:

0. A48035V1 1.00 pcs

IJM NanoScaler The IJM NanoScaler contains five different Impingement Jets mixers allowing researchers to determine the optimum process conditions before scaling up the process to run on a larger IJM NanoProducer unit. Each system contains three pumps. To minimize the sample volume, API solution is transferred via a loop to be mixed with the organic phase. Finally, the LNP mixture is quenched in a second mixer.

The maximum operating parameters for flow and pressure depend on the specific Impingements Jets Mixer used and customer application. The system is designed for lipid nanoparticle formations up to a total flow rate of 50 ml/min.

IJM NanoScaler for LNP formulation, consisting of:

• 3 x Pumps

• 5 x Impingement jets mixers

• 1 x Quench-Mixer

• 1 x 6-port 2-position Valve

• 1 x 2 port 2-position Valve

• Internal piping

• Capillary Customization and labeling

1. A0000FAT 1.00 flrt Quality assurance FAT Factory Acceptance Test 1 System, fixed rate FAT-standard test protocol of KNAUER is the basis for FAT. Change requests of customer are handled before order confirmation with KNAUER.

2. A0000QS 2.50 flrt Quality Service Capillary Customization

3. A0567 1.00 pcs Sample loop, 1000 μl, stainless steel 1/16", ID 1.0 mm

4. A0568 1.00 pcs Sample loop, 2000 μl, stainless steel 1/16", ID 1.0 mm

5. A0586-2 1.00 pcs Sample loop, 5 ml stainless steel, 1/16" connection

1/8" capillary ID 1.6, UNF 10-32 400 bar

6. A5324-2 1.00 set Set of 4 eluent bottles 1000 ml, 1 bottle 250 ml for piston backflushing, incl.

caps for eluent tubing, GL45

7. A5831 1.00 pcs Impingement Jets Mixer Certified

8. A5881 1.00 pcs Impingement Jets Mixer No. 1 Certified

9. A5882 1.00 pcs Impingement Jets Mixer No. 2 Certified

10. A5883 1.00 pcs Impingement Jets Mixer No. 3 Certified

11. A5884 1.00 pcs Impingement Jets Mixer No. 4 Certified

12. A5885 1.00 pcs Impingement Jets Mixer No. 5 Certified

13. A71018-6 1.00 pcs Assembling inclusive tubing and small parts of IJM R&D Systems

A48031/A48035

14. A9862 1.00 pcs Installation box set incl. box for small parts, file folder, support sticker

15. AVD26AE 1.00 pcs 6Port 2Pos Valve V 4.1 w/o drive, 500 bar, 10-32 UNF

0.75 mm bore, SST-DLC, 1/16"

16. AY03752 1.00 pcs ASM 2.2L Assistant, Left: DPG22FA, P 4.1S, 50 ml, stainless steel Center: G2022, Empty module Right: EWA04, VU 4.1

17. AVS85AH 1.00 pcs 2Port MultiPos Valve V 4.1 Break-free rotor seal w/o drive, 300 bar, SST-DLC 1/16" 10-32 UNF, 0.75 mm bore

18. AY03786 1.00 pcs ASM 2.2L Assistant

Left: DPG22FA, P 4.1S, 50 ml, stainless steel Center: EWA04, VU 4.1 Right: DPG22FA, P 4.1S, 50 ml, stainless steel

19. AZC00 1.00 pcs Eluent Tray E 2.1L

20. V6855 1.00 pcs User Manual EN

AZURA Valve drive VU 4.1

21. V6870 1.00 pcs User Manual DE

AZURA Pump P 2.1S/P 4.1S

22. VOQ-IJM 1.00 pcs VOQ-IJM

Operation Qualification IJM Skid/System

23. WA90801 2.00 pcs Qualification: system

• Qualification of all KNAUER modules in an HPLC system (maximum 8 modules) according to KNAUER quality standards in combination with a functional test

• including test solutions, report and documentation of the measurement results

• Applicative functional tests, spare parts, maintenance or repair work are not included.

• An OQ or PV for third-party devices is not included.

24. M1651 5.00 pcs Power cable, 115V

25. ADA00 1.00 pcs UVD 2.1S

Detector UVD 2.1S with deuterium lamp without flow cell

UVD 2.1SU VD 2.1S

26. A4042 1.00 pcs Flow Cell UV, 3 mm, 2 μl, 1/16", SSt

27. A9854-3 1.00 pcs Mounting bracket AZURA L for valve drive VU 4.1 (both-

28. A0000TD 1.00 flrt Customized Documentation on Compliance of Material of Documentation on compliance of material of wetted parts

• Compliance with the order (EN 10204-2.1)

• Certificate of compliance on material of wetted parts

• Documentation on references (supplier information of material) and wetted parts (certificates such as 2.1)

29. A2682 1.00 pcs PurityChrom 6 GMP version single instrument license

30. A0000SAT 1.00 flrt QUALIFIED SERVICE SAT Site Acceptance Test, 1 System; fixed rate

SAT-standard test protocol of KNAUER is the basis for SAT. Change requests of customer are handled before order confirmation with KNAUER and are documented with the order confirmation.

31. VT002 1.00 pcs Freight & Insurance Total CIP Baltimore Airport

Warranty: 24 months from the date of invoice.

The Warranty does not extend to columns, consumables, thermistor probes, glass breakage, membranes, light sources, gaskets stoppages and lamps.

File details come from the government source that posted it. Updated .