Brand_Name_Justification_Redacted_68HERW26P0276_1.pdf

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JUSTIFICATION FOR BRAND NAME COMMERCIAL PRODUCTS/SERVICES OVER THE SIMPLIFIED

ACQUISITION THRESHOLD (SAT) USING SIMPLIFIED PROCEDURES (REVOLUTIONARY FAR

OVERHAUL (RFO))

REFERENCE: SOL 68HERW26R0031, “Beckman Coulter Automated Liquid Handler System (B87585): Biomek i7 Hybrid (MC + Span-8) with a basic warranty, pipefitting, software, customer training and application support options”

1. The Environmental Protection Agency’s Water, Tribal, and Science Division (WTSD) proposes to restrict competition for this commercial acquisition as authorized by RFO 12.102(b).

2. Nature and/or description of the action being approved: New equipment acquisition using commercial procedures.

Purchase of the Beckman Coulter Automated Liquid Handler System (B87585): Biomek i7 Hybrid (MC + Span-8) with a basic warranty, pipefitting, software, customer training and application support options best meets the needs of the government. The government will award a Firm-Fixed-Price (FFP) contract resulting from this combined synopsis/solicitation to the responsible offeror whose offer, conforming to the synopsis/solicitation, will be most advantageous to the government (as determined by the solicitation evaluation criteria).

3. Description of the supplies and/or services required to meet the agency’s needs (including the estimated value): One (1) Beckman Coulter Automated Liquid Handler System (B87585) with a basic warranty, pipefitting, software, customer training and application support options with a total cost of approximately [REDACTED].

Supplies:

Manufacture Item No.

Description Quantity

B87585 Biomek i7 Hybrid (MC + Span-8) with enclosure 1

B87589 Pipetting head, MC96, 5 - 1200 uL 1

B85329 Biomek Method Launcher 1

B87477 ALP, 1x1 static 28

C02867 1X1 TIP LOAD ALP 5

B87483 ALP, Trash 2

C75278 QInstruments Thermal Adapter 2016-1061 for Tubes 24 x 2.0 ml, 15 x 0.5 ml

C85889 Kit, Integration, Bioshake Q1, Deck on i-Series 3 1

D04938 Kit, Integration, Framing Adapter, Bioshake on i-Series 1

B87689 Wash station, MC96 pipette tips 1

B87475 SPAN 8 ACTIVE WASH KIT 1

C67966 Kit, Integration, ColdPlate, Deck on i-Series 2

C05021 Kit, Integration, Deck - ATC on i-Series 1

C05753 Kit, Installation - i-Series Workstation 1 1

D11053 Device Controller PDU 1 1

C82687 Bioshake D30 elm Orbital Shaker Assembly 1

C66351 Qinstruments ColdPlate Heater Cooler 2

C11682 Thermo ATC 96 Well Thermal Cycler, 3m Cable 1

D15216 Welcome Package (WP) includes, in addition to the basic warranty:

▪ Initial Installation ▪ 3 My Beckman Learning Licenses ▪ Priority Onsite response time Software & Engineering updates (MODs I & II) ▪Annual basic operator training ▪ Relocation support (one time)

▪ Unlimited remote technical support ▪ Accidental Damage Coverage (50%)

C02854 On-Site Method Implementation (Tier 3)

Technical Specifications for Automated Liquid Handling System to be used for the generation of transcriptomic data supporting OCSPP chemical risk assessment

BASE INSTRUMENT:

o A work surface that can be configured with a variety of passive holders for microplates, reservoirs and tip boxes. System must also support:

Placement of functional components such as plate heating or shaking.

On-deck and peripheral device integrations to increase capacity for microplate and tip box storage, and add functionality (e.g., heating, cooling, stirring, washing, plate reading).

Framing of work surface for accurate 3-dimensional positioning—including an optical framing tool.

o A grid-based deck for flexible positioning of holders and functional accessories, providing for up to 45 deck positions.

Passive deck positions must be useable to store microplates and tip boxes.

o A Multichannel head and an 8-Channel Dispense head that can work in parallel, sharing most positions on the work surface.

o Two integrated grippers for efficient transportation of microplates, microplate lids and tip boxes. Grippers must:

Rotate 360° for microplate reorientation or for accessing integrated devices with different microplate nest orientations.

Be equipped with downward-pointing offset fingers that maximize accessible deck positions and provide access to peripheral integrated devices. Gripper force must be software controlled and dependent on transported microplate, reservoir, or tip box.

o An integrated front light curtain and safety side shields to protect operator from interfering with the system while pipetting arms are moving.

It must be possible to resume method after tripping light curtain.

o A status light with four different colors and light patterns to indicate stand-by, operation, user intervention required, and error condition.

Status light must be visible from all sides of the instrument.

o An LED-illuminated work surface for optimum visibility when accessing the instrument.

Switch for LED light must be positioned outside of work surface.

o Integrated cameras that enable system monitoring from networked devices.

System cameras must be able to record/store video of unexpected error conditions to support efficient/timely error diagnosis.

o Software and hardware must support stacking of microplates and microplate lids, including support of mixed stacks of different microplates, if possible, by microplate geometry.

o System must be upgradeable to include multiple integrated devices, optional transportation robot, and planning/optimizing/scheduling software.

o System must support remote service by providing a secure infrastructure for desktop and file sharing.

Remote desktop and file access must be configurable and must be granted by the user.

o Vendor must have a qualification program for service and application support personnel accessing the system.

PIPETTING:

o Instrument must have an 8 Channel Dispensing Head with each channel independently controlled, and with Variable Span to process 384-, 96-, 48-, 24- and 6-well plates, and tube sizes ranging from a PCR tube up to a 50 mL bottle.

o 8 Channel Dispensing Head must support:

o Calibration of individual channels to allow for optimization of pipetting performance in low-volume range.

o Individual capacitive liquid level sensing for all channels.

o System must be user configurable to allow for exchange of 96-channel and 384-channel heads. Standard-volume Multichannel head must provide 300 µL working volume and enable use of large-volume filter tips.

o Large-volume Multichannel head must provide for 1200 µL air displacement to effectively enable transfer of 1000 µL with filter tips, and including sufficient blowout volume of >10% target transfer volume.

o Multichannel head must support working with individual tips, columns, rows and patterns to increase flexibility for applications such as tube-to-plate transfer, addition of control reagents, and serial dilution.

o System software must support volume and liquid-level tracking to avoid repeat sensing for known volumes and volume changes.

o Pipetting tips must be:

o Provided in individual tip boxes that separate tips in individual compartments to reduce contamination risk.

o Provided in gripper-transportable tip boxes to move tips from storage positions to tip loading.

o Certified free of DNAse, RNAse, DNA (human and mouse), PCR inhibitors, endotoxins and trace metals.

o Pre-sterile tips must be sterilized with ethylene oxide to avoid use of electron beam irradiation.

o Tip boxes must be color-coded, with colors duplicated in instrument software to reduce user error when loading the system.

SOFTWARE:

o System must operate under the latest version of Microsoft Windows operating system.

o System software must:

o Provide an interface that supports operators with instructions for system setup, selection of desired protocol, monitoring of runs in progress, and performing basic system tasks, as well as protecting validated methods from inadvertently being altered.

o Support remote monitoring of the system from networked devices.

o Provide visual method authoring interface with drag & drop functionality as well as the ability to copy/paste method items, transfer steps, or method sections.

o Offer a set of pre-configured basic pipetting operations such as plate transfer, plate replication, combining plates, and serial dilution. Standard method steps must be user-configurable for method items and pipetting actions. Software should also present plain text summary of settings for pipetting operations.

o Aid method authoring with real-time, step-by-step validation. This includes checking for logical errors, assisting error resolution with plain text instructions, and providing estimated time to completion for the entire methods.

o Enable full control over 3D motion path of tips in wells when moving, dispensing or aspirating. User must be able to define complex pipetting patterns such as X-pattern for aspirating content of a flat-bottom microplate.

o Be able to automatically split volumes that exceed usable pipette tip or pipetting head/probe volumes.

o Support re-use of tips by assigning individual tip boxes to specific reagent reservoirs.

o Include an integrated SQL database for integrity of sample/process data.

o Support recording, tracking, copying and pooling of sample IDs following pipetting procedures.

o Support liquid level tracking to calculate volume changes and well/tube fill heights from initial volumes based on pipetting steps.

o Support using sample data (e.g., sample ID, volume, concentrations, OD readings) for data-driven pipetting operations such as hit picking or normalization.

o Visualize protocols in 3D simulation for faster method development.

o Allow for different user roles to manage operations in a multi-user environment. Access restrictions must be available to limit method development and validation to user-qualified application developers.

o User must be able to easily define new microplate and reservoir definitions based on existing definitions or on actual measurement of the microplate or reservoir.

o Controlled access must provide functions for multiple user access levels, method version control, and system audit trail to support 21 CFR Part 11 requirements for electronic signatures.

CUSTOMER TRAINING AND APPLICATION SUPPORT OPTIONS:

o Basic operation instructions must be provided upon system installation.

o Online training classes must be available to help expedite initial training o Classroom trainings at vendor site must be available for method authoring and method adaptation.

o Optional customer-site training must be available on request.

o Optional on-site field application support must be available to implement required protocols or to assist with customer site method development.

o Pre-defined methods must be available for o Lexogen Quant-seq 3’ FWD v2 w/UDI o Magmax-96 Total RNA Isolation Kit

Performance Requirements

The necessary performance requirements of the system are as follows:

Span 8 pipetting specifications:

Multichannel heads low volume specifications:

Delivery shall be to Cincinnati, OH OCSPP lab 4-6 weeks after award.

Delivery terms — FOB destination

Place of Performance

Address: 26 West Martin Luther King Drive, Cincinnati, Ohio

Postal Code: 45268 Country: United States of America

4. Identification of the statutory authority permitting Brand Name full and open competition.

This will be a full and open competition procurement, subject to a brand name restriction, approved in accordance with RFO FAR 12.102(b) for actions above the SAT but below $9 Million.

5. Demonstration that the proposed contractor’s unique qualifications or nature of the action requires use of the authority cited:

Purchase of the brand name Beckman Coulter Automated Liquid Handler System (B87585) Biomek i7 Hybrid (MC + Span-8) with a basic warranty, pipefitting, software, customer training and application support options is required because the instrument will be integrated into existing workflows, and thus must be compatible in terms of consumables (pipet tips, reservoirs, etc), performance, and use with existing equipment and with existing protocols. As different portions of sample processing are often split among OCSPP laboratories to maximize the efficiency of sample processing and data generation, instrument compatibility is essential to minimize the introduction of location-based inconsistencies that may reduce the quality, dependability, and accuracy of the resultant data, which are intended to be used to guide regulatory decisions. Further, due to the complexity of the workflows, the instrument requires a work surface that can be configured with a variety of passive holders for microplates, reservoirs, and tip boxes, placement of functional components including on-deck heating and plate shaking, on-deck peripheral integration to increase capacity for microplate and tip box storage, and added functionality (stirring, heating, cooling, washing, etc.), a grid-based deck for flexible positioning and at least 45 deck positions, a multichannel head on an 8-channel dispense head, two integrated grippers with the ability to rotate 360° and equipped with downward-pointing offset fingers to maximize deck accessibility, an integrated front light curtain and safety side shields to protect the operator, integrated cameras that enable system monitoring from networked devices, software and hardware capable of supporting stacking of microplates and lids.

Based on the documented market research completed, the brand name Beckman Coulter Biomek i7 is the only instrument available that meets both technical specifications and compatibility requirements.

6. Description of efforts made to ensure offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by RFO 5 and, if not, which exception applies:

Full and open competition is anticipated, and a combined synopsis and solicitation will be posted to the government point of entry to maximize visibility and the opportunity for competition (subject to the brand name requirement).

7. Determination by the CO that the anticipated cost to the government will be fair and reasonable:

The CO determines the anticipated prices will be fair and reasonable as competition is expected and the main equipment components and additional parts are commercially available on the open market.

8. A description of the market research conducted and results, or the reason market research was not conducted.

The contracting office's market research included Google searches and General Services Administration (GSA) findings. From Google searches, [REDACTED] are resellers of refurbished equipment, while [REDACTED] was found to be an affiliate of the manufacturer [REDACTED]. There are two (2) potential GSA suppliers, but all items to meet the Agency needs are not available. The program office/staff scientists met with vendors from other manufacturers to evaluate their liquid handling systems. This allowed direct comparisons of performance and features among instruments. Additionally, product documentation, including manuals, spec sheets, and brochures from various vendors were consulted. The recommended equipment purchase is based on the required equipment capabilities as well as the need for consistency among OCSPP laboratories performing related research.

9. Any other facts supporting using other than full and open competition: N/A

10. A listing of the sources, if any, that expressed in writing an interest in the acquisition: N/A

11. A statement of any actions the agency will take to remove or overcome any future barriers to competition before any subsequent acquisition for the supplies or services required: N/A

12. CO certification: I certify that this justification is accurate and complete to the best of my knowledge and belief. Since this effort does not exceed $900,000.00, this certification serves as approval.

CO’s name/title: Keith T. Pfeffer, Section Manager, Water and OITA Branch

Signature:

Date: 7/14/2026

ALL QUESTIONS REGARDING THIS JUSTIFICATION ARE TO BE REFERRED TO Ella Foster, Contract Specialist, Water and OITA Branch, foster.ella@epa.gov/ 513-569-7970

KEITH PFEFFER Digitally signed by KEITH PFEFFER Date: 2026.07.14 12:42:29 -04'00'