Statement of Requirement (Final).pdf

STATEMENT OF REQUIREMENTS

TITLE: Ampouling Services: SRM 927g Bovine Serum Albumin

I. BACKGROUND INFORMATION

The National Institute of Standards and Technology (NIST) has a need for Standard Reference

Material (SRM) 927 Bovine Serum Albumin (7% Solution). NIST will provide four (4) kg of lyophilized BSA for the Contractor to prepare, solubilize, filter, fill, seal, and provide documentation of specific characteristics.

II. SPECIFICATIONS

The Contractor shall provide a minimum of 20,000 units of a 7% solution of high purity bovine serum albumin (BSA) in sealed glass ampoules that meets or exceeds the following requirements:

Requirements:

1. A solution of 7 % ± 0.2 % (mass fraction) BSA shall be prepared using a diluent containing 0.02 mol/L sodium chloride. Solution pH shall be 6.5 pH to 6.8 pH using

1.0 mol/L sodium hydroxide or hydrochloric acid to adjust as required. Water used in all solution preparations shall conform to ASTM D1193-91 – Type I. All constituents shall be reagent grade.

2. The BSA solution shall be sterilized by membrane filtration ( 0.2 micron) and tested for post-filling sterility using USP guidelines for sterility testing (USP <71>). Tests shall be performed to detect anaerobic bacteria, aerobic bacteria, and fungi using fluid thioglycolate medium or soybean-casein digest medium as appropriate. A minimum of ten ampoules shall be tested which are to be randomly selected from the fill run.

The contractor shall provide the results of these tests to the NIST Technical Point of

Contact including a statement that these requirements have been met. Transmission of the report via email of a pdf document to the NIST Technical Point of Contact shall occur at least two (2) business days prior to delivery.

3. Ampoules (5 mL size) shall be clear, non-tinted glass, pre-scored, and capable of withstanding refrigeration (2 ºC – 8 ºC) without cracking or breakage.

4. Each ampoule shall contain 2.2 mL BSA solution (filled with an accuracy of 0.1 mL).

5. Ampoules shall be flushed with argon gas prior to filling with BSA solution and shall be sealed immediately before argon gas dissipation from the ampoule. Labels, either provided or approved by NIST, shall be applied to the ampoules.

6. The packaging of the ampoules shall be performed so-as-to preserve the grouping of the fill order of the ampoules within at least hourly increments Boxes shall be numbered sequentially and shall note the time reference for the ampoules inside. The location of the first ampoule in each box shall be noted on each side of the outside corner of the box.

7. Filling and sealing process shall be performed within a single block of time no longer than 16 hours.

8. The concentration of bovine serum albumin shall be determined and reported for 10 vials taken from various times spanning the scope of the filling process.

Concentration to be measured by one of the following methods: biuret test, commercial colorimetric assays or commercial clinical laboratory methods. Other methods may be utilized upon approval of NIST Technical Point of Contact (TPOC).

9. Ampoules received by NIST shall be free of cracks, breakage, discoloration, and foreign particles. Ampoules showing evidence of charring will not be accepted.

10. Boxes of filled ampoules shall be stored under refrigeration (2 ºC – 8 ºC) until overnight cold shipment to NIST. Ampoules shall not be frozen because of potential breakage.

11. Contractor may choose to produce labels internally or accept labels provided by

NIST. Contractor shall notify the NIST Technical Point of Contact within five (5) business days of contract award of which label option is chosen. Contractor produced labels shall be capable of withstanding handling and storage temperatures as stated in requirement #3. NIST approval of the label is required. Contact NIST Technical

Point of Contact for details regarding approval.

12. Contractor shall document and report the following items: total number of vials, number of delivered boxes, BSA concentration and assay type, solution pH, results of sterility testing for each media type used, and duration times and date of filling and sealing process. The report shall be provided to the NIST Technical Point of Contact in electronic (pdf) form via email at least two (2) business days prior to delivery.

13. Delivery of ampoules to NIST shall be within 120 days after receipt of BSA and labels (when supplied by NIST) by the contractor.

III. DELIVERY

Overnight delivery shall be used such that the temperature at all times during transit will be maintained from 2 ºC to 8 ºC. Material to arrive at the NIST facility (addressed as below) only

Monday through Thursday (excluding Federal Holiday) prior to noon. Notice of delivery to be provided to NIST TPOC at least two (2) business days in advance of shipment. Entry onto the

NIST location shall conform to NIST visitor policy detailed in https://www.nist.gov/about-nist/visit/campus-access-and-security.

National Institute of Standards and Technology

100 Bureau Drive

Gaithersburg, MD 20899

Atten: Mr. Mark Cronise, Building 203

IV. DELIVERABLES

Description Quantity Due Date

The Contractor shall notify NIST of label source option.

1 5 business days after award of this requirement

Filled, sealed ampoules of 7% BSA solution

20,000 120 business days after receipt of BSA and NIST-provided labels

Report of the following:

total number of vials, number of delivered boxes, BSA concentration and assay type, solution pH, results of sterility testing for each media type used, duration times and date of filling and sealing process.

1 Report due at least two (2) business days prior to delivery

V. ACCEPTANCE CRITERIA

Acceptance will be met after the NIST TPOC performs a vision inspection and concentration measurements of the materials. The concentration of the vialed ampoules of BSA shall be 7 % ±

0.2 % (mass fraction). The pH of the material shall be within the range of 6.5 pH to 6.8 pH. The sterility tests shall be negative for growth. The vials shall be free of charring or foreign particles.

Acceptance shall also be based upon Contractor’s documentation including all test data or results that demonstrate preparation according to the specifications in this document. The TPOC shall inform the Contractor within 15 business days if the deliverables have been accepted. Invoicing cannot proceed without notification of acceptance from the TPOC.