Requirment Ashwagandha Packaging.pdf

STATEMENT OF REQUIREMENTS

I. BACKGROUND INFORMATION

The Chemical Sciences Division is responsible for chemical measurements in a broad range of areas, including the development of reference materials for the determination of the nutritional content and potential contamination of foods and dietary supplements. Two new candidate reference materials have been acquired for withanolide measurements, Ashwagandha root powder and Ashwagandha extract, which are considered one of the most important herbs used in Ayurvedic (Indian alternative) medicine.

This Statement of Work describes the requirements for packaging these materials for use as new RMs and candidate testing materials for the Health Assessment Measurements Quality Assurance Program

(HAMQAP). These materials will be packaged in polyethylene heat-sealed bags inside heat-sealed Mylar pouches with packets of silica gel. Because the candidate materials will be used for calibration and/or validation of methods determination, cleaning of equipment is critical.

II. SCOPE OF WORK

Each material will be blended and the Ashwaganda root powder will be packaged in 5 g aliquots in 4 mil polyethylene bags under dry nitrogen or argon, the Ashwagandha extract will be packaged in 1.5 g aliquots in 4 mil polyethylene bags under dry nitrogen or argon. This polyethylene package will then be overpackaged in an aluminized packet with a suitable quantity of silica gel (e.g., two packets of SORB-

IT). Blending/homogenizing and packaging equipment must be cleaned. NIST expects to receive nominally 250 packets of the Ashwaganda root powder and 1000 packets of the Ashwagandha extract.

III. SPECIFICATIONS

The Contractor shall package the following material that will be provided by NIST:

a. 1.5 kg of ashwagandha root powder in 5 g units

b. 1.5 kg of ashwagandha root extract in 1.5 g units

Blending and Homogeneity:

• Upon receipt of the materials, each material will be examined for compromises to the contents.

• Once materials are confirmed to be in acceptable conditions, they will be stored in a designated room that is temperature and humidity controlled. The temperature and humidity will be maintained at 20°C to 25°C and 45% to 50% respectively. These parameters will be recorded everyday throughout the course of the packaging project.

• All equipment will be thoroughly cleaned before packaging each material.

• Once the equipment is confirmed clean, the material will then be transferred from the shipping container into a clean blending container and blended for at least six hours.

• Each material will then be tested for homogeneity of elemental composition prior to packaging.

▪ This test will be performed on six randomly selected samples of the blended material.

Each sample is digested in a microwave and then analyzed by inductively coupled plasma optical emission spectroscopy (ICP-OES) for six inorganic analytes. These six analytes will be selected from a list of the following candidate elements – Al, Ca, Fe, K, Li, Mg, Mn, P, S, and Zn. Only six elements with the highest sensitivities need be selected.

Relative standard deviations (RSDs) of less than or equal to 3% for each analyte between the samples confirms that the powder is now homogeneous and can be packaged.

However, before packaging, the contractor will email a report of analysis (ROA) to NIST

TPOC to confirm readiness for packaging. Upon approval by NIST, the contractor will be ready to package the material.

Packaging and Delivery:

• The contractor must acquire aluminized plastic packaging material (GP-48M/25 or equivalent), 4 mil polyethylene, and silica gel packets (SORB-IT or equivalent).

• Polyethylene packets must be flushed with dry nitrogen or argon and filled with either:

▪ 5 g of powdered material for the ashwagandha root powder with an accuracy of 0.1 g (i.e., packets will contain the specified mass ± 0.1 g) or

▪ 1.5 g of powdered material for the ashwagandha extract with an accuracy of 0.1 g (i.e., packets will contain the specified mass ± 0.1 g).

• Material packaging procedures conform to ISO 17034:2016 requirements and verification of the analytical balance calibration is performed at the beginning of each workday.

• Packets must be filled under controlled temperature and humidity conditions (e.g., glove box, controlled-humidity room) at 20 ˚C to 25 ˚C and 45% to 50% relative humidity, respectively.

• Polyethylene packets must be over packaged in the nitrogen- or argon-flushed aluminized plastic packets along with two silica gel packets.

• Upon completion of the packaging, ten random packets from each of the materials will be selected and powder samples from each selected packet will be digested in a microwave and analyzed by

ICP-OES as described in the above section (Blending and Homogeneity) to verify homogeneity between separate packets. Each packaged material must be tested by the contractor for homogeneity of elemental composition after packaging. Tests should be conducted on at least ten samples by inductively coupled plasma optical emission spectroscopy (ICP-OES) for at least six inorganic analytes. Mass fractions must have variability of less than or equal to 3 % relative standard deviation (RSD) between the samples.

• The analysis results of the homogeneity tests will be included on a laboratory report and submitted to NIST prior to shipment. Any issues with the homogeneity will be resolved prior to shipment to

NIST.

• Packets must be transferred, in fill order, to a box that will be filled from back to front. The back and front of each box must be marked, and boxes will be numbered sequentially.

• Boxes must be placed on pallets and delivered to NIST at the contractor’s expense.

IV. PERIOD OF PERFORMANCE

The period of performance shall be 90 days after award of this requirement.

V. PLACE OF PERFORMANCE

All work shall be accomplished at the Contractor’s facility.

VI. GOVERNMENT FURNISHED PROPERTY

NIST will provide the contractor with bulk ashwagandha root powder and ashwagandha root extract to be packaged.

DELIVERABLES

Description Quantity Due Date

5 g packets of Ashwagandha root powder, No later than 90 days after receipt of order or 75 days after receipt of materials from NIST

1.5 g packets of Ashwagandha root extract, 1000 No later than 90 days after receipt of order or 75 days after receipt of materials from NIST

Report documenting the pre-packaging testing of each material

2 Prior to material packaging

Report documenting the post-packaging testing and packet/box fill order

2 No later than 90 days after receipt of order or 75 days after receipt of materials from NIST

Government Acceptance.

Desired Output

Performance

Standard Monitoring Method

On time delivery of packaged materials that meet the performance requirements

Refer to section III in this document

The NIST TPOC will verify that the container(s) are unopened/undamaged and appropriately labeled.

VII. GENERAL INFORMATION

Patent Rights: The Government retains a Government use license to all inventions arising from this work.

Media Inquiries: The Contractor employee shall not respond to any media inquiries. Any inquiries from the media shall be immediately relayed to the TPOC, COR, and/or CO. There shall be no interviews, comments, or any other response without the knowledge and approval of the NIST Director.