Cell Bank Vialing Instrument SoR v4.pdf

STATEMENT OF REQUIREMENTS

Cell Bank Vialing Automation Instrument

I. BACKGROUND

Title 3 Section 3036 of the 21st Century Cures Act (Cures Act; Public Law 114–255;

the Act), enacted in 2016 directs the U.S. Department of Health and Human Services (HHS), in consultation with the National Institute of Standards and Technology (NIST) and stakeholders to “facilitate an effort to coordinate and prioritize the development of standards and consensus definitions of terms, through a public process, to support, through regulatory predictability, the development, evaluation, and review of regenerative medicine therapies and regenerative advanced therapies, including with respect to the manufacturing processes and controls of such products.” For purposes herein, regenerative medicine therapies include, in accordance with the U.S. Food and Drug Administration’s (FDA) definitions and guidance documents, cell therapies, gene therapies, therapeutic tissue engineering products and other regenerative therapies.

Pursuant to the Act, the NIST Biosystems and Biomaterials Division (BBD) of the Material Measurement Laboratory (MML) performs research and standards activities in the fields of regenerative medicine and advanced therapies (RMAT), precision medicine, and biomanufacturing. BBD develops test materials, candidate reference materials, measurement methods and measurement assurance strategies. BBD also coordinates and/or participates in interlaboratory studies of materials and methods under development.

Due to these activities, BBD requires a laboratory-scale mammalian cell bank vialing automation instrument that can rapidly fill hundreds of automation-compatible 1 to 2 milliliter (mL) cryovials while operating within a general-purpose biological safety cabinet (BSC) defined here as:

• A class II, type A2 biological safety cabinet

• Maximum sash opening of 24 inches or less for automation instrument placement

• Maximum interior workspace load capacity of 175 lbs or less

• Maximum interior workspace usable dimensions o 54” or less width (perpendicular to operator) o 24” or less depth o 30” or less height

To meet the government's need, the instrument shall fit inside pre-existing BSCs in use by BBD and shall include core capabilities for (1) accepting pre-sterilized, pre-formatted 1 to 2 mL nominal volume cryovials in 48-vial racks, (2) integrated and automated capping/decapping of all 48 vials at once while maintaining caps under aseptic conditions, (3) volumetrically-accurate peristaltic pump-driven multi-channel dispensing of cell culture material into decapped vials at a pre-set dispensing volume, and (4) integrated and automated movement of the vial rack among loading position, cap/decap position, and filling position according to a pre-defined automation workflow.

II. CELL BANK VIALING AUTOMATION INSTRUMENT MINIMUM

SPECIFICATIONS

• The instrument shall be new and not refurbished.

• The instrument shall be compatible with 110 V / 60 Hz electrical supply.

• The instrument shall be configured as a 48-way filling system dispensing to six vials simultaneously and accepting 1.4 to 2.0 mL nominal volume cryovials in pre-formatted 48-vial racks.

• The instrument shall dispense in settable volumes in the range of at least

0.5 mL to 2.0 mL and with settable increments of 0.005 mL or less and with per vial dispense accuracy of at least 0.1 mL.

• The instrument shall complete one 48-vial filling cycle, defined as rack loading, decapping, dispensing, recapping, and all necessary motion within 3 minutes or less.

• The instrument shall be supplied with o one (1) reusable, steam sterilizable, large dispensing reservoir having a usable volume of at least 750 mL o one (1) reusable, steam sterilizable, small dispensing reservoir having a usable volume of at least 250 mL o one (1) reusable, steam sterilizable priming vessel allowing simultaneous priming of all six filling channels and dispense volume calibration o one (1) mini-stacker trolley or other instrument-specific device(s) for end-user transfer of the instrument into and out of the BSC o all pump tube sets or other original equipment manufacturer (OEM) instrument startup consumables necessary for completing instrument installation, demonstration of specifications, and user training

• The Contractor shall provide copies, in either electronic or hardcopy format, of manuals for user operation and user maintenance of the instrument.

• The instrument shall include a one (1) yr. warranty.

INSTALLATION:

The Contractor shall install the instrument in Building 227, Room A220, at NIST’s Gaithersburg, MD facility. Installation shall include, at a minimum, uncrating/unpacking of all equipment, set-up and assembly, hook-up of all equipment, start-up, demonstration of all required minimum specifications, and removal of all trash.

Contractor authorized personnel shall install the instrument and perform all activities necessary to ensure the instrument is fully functional and meets all required minimum specifications.

The instrument shall operate to OEM specifications upon completion of installation.

The installation shall occur during regular business hours, between 8:30AM and 5:00PM ET M-F except for Federal Holidays and shall be coordinated with the NIST Contracting Officer’s Representative (COR) or Subject Matter Expert (SME). Installation is to occur within 30 calendar days of delivery.

WARRANTY:

The Contractor shall warrant that the instrument will operate within OEM specifications and be free from defects in material and workmanship for at a minimum, a period of one (1) year.

The warranty shall cover all parts, labor and travel and shall commence upon successful completion of delivery, inspection, installation, training, and a demonstration that all required minimum specifications have been satisfied.

TRAINING:

The Contractor shall conduct training at NIST’s Gaithersburg, MD facility for up to four (4) NIST personnel covering normal operation, basic troubleshooting, and routine maintenance procedures. Training shall be provided during regular business hours, between 8:30AM and 5:00PM ET M-F except Federal Holidays and shall be coordinated with the NIST COR or SME to ensure maximum availability of NIST personnel. Training may be mutually scheduled to occur within 10 business days of installation. Alternatively, training may be conducted on-site at NIST’s Gaithersburg, MD facility immediately after installation and demonstration of specifications.

III. SERVICE LEVEL AGREEMENT

Option Yr. 1: beginning the day following expiration of the 1-yr. warranty through 365 days

Option Yr. 2: beginning the day following expiration of Option Yr. 1 through 365 days

The Contractor shall provide the Essential Service Level Agreement (SLA) for the Cell Bank Vialing Automation Instrument, that shall include:

• One (1) annual preventative maintenance (PM) instance

• PM associated labor and travel expenses

• Performance verification

• SW updates

• Replacement/exchange of parts subject to wear

Response time shall be no later than (NLT) next business day (NBD) for technical helpdesk support and priority on-site response for the PM instance.

The Contractor shall provide one (1) planned maintenance (PM) visit during the term of the Essential SLA. The PM shall include replacing and/or cleaning all necessary parts in order for the instrument to meet the Original Equipment Manufacturers (OEM) specifications.

Scheduling of the PM shall be consistent with the maintenance requirements of the instrument as detailed in the operations and maintenance manual for the instrument and in accordance with the most recent service practices and maintenance protocols.

The PM shall occur during regular business hours of 8:30AM-5:00PM ET M-F, excluding Federal holidays. The Contractor shall contact the NIST COR or SME to schedule a mutually acceptable date and time to conduct the PM. The visit shall be scheduled in advance with the NIST COR or SME.

Service Conditions

The annual PM shall be performed by factory trained and certified personnel who are fluent in the operation of the covered Cell Bank Vialing Automation Instrument.

All parts shall be approved for use with the Cell Bank Vialing Automation Instrument by the OEM. The Contractor shall only employ tools, equipment, instruments, software, test apparatus, methodologies, techniques, and practices approved for use with the Cell Bank Vialing Automation Instrument by the OEM. The service protocols and equipment specifications shall be adhered to at all times.

The Essential SLA shall include correcting, repairing and/or replacing, as applicable, a non-conforming or defective Cell Bank Vialing Automation Instrument component, as determined by the Contractor at its sole discretion.

NBD Helpdesk Technical Support

The Contractor shall provide telephone/e-mail helpdesk technical support during normal business hours M-F, 8:30AM to 5PM EST except for Federal holidays.

Telephone/e-mail technical support shall include responses to questions about operating practices, applications use, and service issues that can be diagnosed and resolved over the telephone.

IV. DELIVERY

Delivery shall be FOB Destination (or equivalent terms, such as INCOTERMS Delivered Duties Paid) and shall occur not later than (NLT) 90 calendar days

ARO.

FOB Destination means: The Contractor shall pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for any loss of and/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the purchase order; and pay all charges to the specified point of delivery. The Contractor shall deliver to:

National Institute of Standards and Technology 100 Bureau Drive Building 301, Shipping and Receiving Gaithersburg, MD 20899

V. DELIVERABLES

Description Quantity Due Date Cell Bank Vialing Automation Instrument

One (1) NLT 90 calendar days after award of this requirement.

Accessories including dispensing and priming reservoirs, trolley/transfer device(s), and instrument startup consumables

One (1) set NLT 90 calendar days after award of this requirement.

On-Site Installation Once NLT 30 calendar days after delivery.

Operations and Maintenance Manuals, in electronic or hardcopy format

One (1) set NLT 90 calendar days after award of this requirement

On-Site Training Once NLT 10 business days after installation.

VI. INSPECTION AND ACCEPTANCE CRITERIA

In addition to the inspection and acceptance terms articulated in FAR 52.212-4, a visual inspection of the instrument will be performed by the NIST COR or SME to identify surface defects or any form of indication that the instrument was damaged during transport to NIST. The Government shall have the sole discretion to require repair or replacement of damaged and/or nonconforming componentry at no cost to the Government. The Government at any time prior to acceptance may reject the instrument due to defects and/or nonconformance.

To verify the instrument conforms to all technical specifications, during installation, the Contractor shall, for the purpose of confirming the instrument is fully operational,

• Demonstrate transferring the instrument into a BSC using the trolley or other transfer device(s): satisfactory if transfer can be completed without using any additional lifting aids.

• Power on the instrument and initialize, if necessary: satisfactory if instrument powers on and becomes ready for normal operation.

• Demonstrate installation of filling reservoir and pump tubing and priming of pump tubing (or other liquid-handling consumables): satisfactory if connections are liquid-tight and all air in tubing is expelled during priming.

• Demonstrate calibration of pump tubing or other liquid-handling consumables for dispensing volume: satisfactory if calibration can be completed according to pre-programmed routine or an OEM documented standard operating procedure (SOP).

• Demonstrate loading of a 48-way rack of vials: satisfactory if rack properly seats into instrument.

• Demonstrate decapping of one rack of vials: satisfactory if all vial caps are unscrewed and lifted away from the vials.

• Demonstrate filling of one rack of vials with sterile water at a 1 mL setpoint: satisfactory if all vials appear filled to 1 mL by visual inspection and at least three (3) randomly sampled dispensed volumes are measured, by mass, to contain 1.0 mL ± 0.1 mL

• Demonstrate recapping of one rack of vials: successful if all vial caps are lowered to vials and screwed onto vials.

• Demonstrate automated movement of rack of vials without manual intervention to perform all steps and while maintaining aseptic conditions:

satisfactory if (1) the rack fill does not need interruption from rack loading to completion of recapping, (2) liquid does not splash outside the open vials or otherwise drip onto the instrument, consumables or BSC, and (3) no contact occurs between aseptic and non-aseptic surfaces.

• Power down the instrument or place in standby: satisfactory if instrument powers down or stands by.

NIST staff will remain present during operations to observe results. Instrument acceptance is contingent on the demonstrated results.

Final acceptance by the Government will be granted after confirmation that the instrument meets all minimum technical specifications defined in the SoR, including satisfactory test results achieved, and installation and training successfully completed. The warranty shall not commence until final acceptance has been granted by the Government.

VII. GOVERNMENT RESPONSIBILITIES

The Government will provide access to the NIST facility for the purpose of instrument installation, training, and Essential SLA PMs.

The Government will also provide access to an operating BSC, sterile water, and consumable cryovials for purposes of installation and training.

VIII. PLACE OF PERFORMANCE

Installation of the instrument, training, and Essential SLA PM instances shall be accomplished at the NIST, Gaithersburg, MD facility. Normal duty hours are M-F 8:30AM to 5:00PM except for Federal holidays.

IX. PAYMENT

Advanced payments are not authorized.

The Contractor shall invoice in one lump sum after all required items and services (i.e., installation and training) have been received and accepted by the Government.

Partial payments are authorized for the Essential SLA for which the Contractor shall invoice quarterly in arrears.

X. GENERAL INFORMATION

Safety: The Contractor shall be responsible for knowing and complying with commercial installation safety prevention regulations. Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal.

Security: NIST is a restricted campus. An identification badge is required for entry into buildings and also is shown to the armed Security Police when entering the campus.

Identification Badges: The Contractor shall comply with NIST identification and access requirements. The Contractor shall provide the name and citizenship information of employees for on-site visits to the NIST COR or SME prior to arrival. The NIST COR or SME will submit the name(s) (first/middle/last) and citizenship information to the NIST Office of Security in order for a given Contractor employee to enter the NIST campus. Each Contractor employee shall wear a visible identification badge provided by the NIST Security Office. The Contractor employee shall surrender the NIST identification badge to the NIST COR or SME upon conclusion of any services rendered.