Gov Requirement .pdf

STATEMENT OF REQUIREMENTS

TITLE: Custom 96-well microplates

I. BACKGROUND

The National Institute of Standards and Technology’s Biosystems and Biomaterials Division (BBD) is focused on developing methods that will assure reliability and confidence in the measurements that underpin research and applications in genomic measurements, biomaterials, protein therapeutics, and cell therapies, cancer diagnostics, nanoparticle safety, and microbial identification and quantification. BBD carries out this work through fundamental research in measurement science and the development of reference materials, reference data, and protocols.

To meet mission requirements, custom 96-well microplates are needed. The custom microplates will ensure that BBD will be able to develop laboratory automation workflows for automated microbial growth and measurement with larger culture volumes than are available in standard 96-well microplates.

II. SCOPE OF WORK

The contractor shall provide 5,000 (five thousand) 96-well microplates that meet the specifications listed below.

III. SPECIFIC REQUIREMENTS

The Government’s requirements have been divided into 4 stages:

Stage 1: Microplate design The contractor shall provide microplate design, which shall include a mechanical drawing with dimensional information to indicate that the microplate design meets the specifications listed in Stage 4.

Stage 2: Custom tooling The contractor shall provide custom tooling required to manufacture the microplates, e.g., the injection mold.

The injection model shall be meet the Class 101 standard as defined by the Plastics Industry Association.

Stage 3: Test pressings The contractor shall provide test pressings from the tooling (i.e., “first articles”) that meet the specific requirements listed in Stage 4.

Stage 4: Microplates The 96-well microplates shall meet the following specifications:

1. Conform to ANSI/SLAS standards for Footprint Dimensions and Well Position (https://www.slas.org/education/ansi-slas-microplate-standards/)

2. The microplates shall have no cut corners (i.e., chamfers or corner notches)

3. 96 wells per plate

a. square wells

b. volume per well of at least 1.0 mL

c. pyramid-shaped well bottoms

4. Raised rims on top of plate around each well to facilitate heat sealing and de-sealing

a. height of raised rim shall be between 0.35 mm and 0.5 mm

5. The total height of the plate (from the base of the skirt to the top of the raised rims) shall be no greater than 20 mm.

6. The microplates shall be made from clear medical grade polystyrene resin

7. The microplates shall be gamma-irradiated for sterilization, and shall be packaged in sealed bags

a. The number of sterilized microplates in each bag shall be between 4 and 12.

https://www.slas.org/education/ansi-slas-microplate-standards/

IV. DELIVERABLES

Government acceptance will occur at each stage before proceeding to the next.

Stage Deliverable Qty Method Due Date 1 Microplate design 2 Images via email Within 30 calendar days after award.

2 Custom tooling 2 Images via email Within 120 calendar days after NIST acceptance of Stage 1.

3 Test pressings 2 Delivery to NIST Gaithersburg

Within 30 calendar days after NIST acceptance of Stage 2.

4 Microplates 5000 Delivery to NIST Gaithersburg

Within 70 calendar days after NIST acceptance of Stage 3.

V. CONTRACTOR’S MINIMUM QUALIFICATIONS

The Contractor shall confirm the microplates shall be manufactured in a class 100K cleanroom facility.