Statement of Work 032724.docx

Statement of Work

Introduction:

The research effort is to develop and produce a family of affordable, US sourced and manufactured cotton-based advanced wound care products for prolonged field care anti-infectives, burns, slowly healing wounds, and hygienic applications. Eight dressing prototypes prepared and utilized for a hemostatic/antibacterial study are all based on the dressing TACGauze.

Scope/ Objective:

This acquisition of service will provide independent/ impartial testing by an accredited laboratory (contractor) to test the performance and efficacy of the antimicrobial dressing prototypes during/post development. Test methods used are internationally recognized by industry and regulatory outfits to access the textile prototypes efficacy and supply data to support its demonstrated ability, safety and claims. The laboratory will need to be able to test prototypes against non-standard microorganisms. This group includes Enterococcus faecium, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter species. This group of bacteria is chosen because they can evade or “escape” commonly used antibiotics due to their increasing drug resistance.

This service (testing the efficacy of antibacterial activity of submitted samples) will be a recurrent need:- to submit subsequent sample batches for the same tests that will determine direction of research “flowchart” to successful products.

Contractor Requirements:

Technical Requirement/ Tasks:

· Treated cotton non-woven textile samples are to be tested for antibacterial efficacy against the standard and non-standard pathogens using the AATCC 100 Test Method. The standard microorganisms are Staphylococcus aureus and Klebsiella pneumoniae representing gram positive and gram negative. The non-standard microorganisms we require the samples to be tested against are: Acinetobacter baumanii, Pseudomonas aeruginosa, Enterococcus faecium and Enterobacter species.

· The second test needed will be industry standard ASTME 2362, hard surface disinfection test for towelettes or wipe, a carrier test. We would need a preliminary 10 carrier test. Conditions for the test include: non-GLP testing with only one lot per sample submitted; 5 minutes for one contact time (or < 10 minutes) and organic soil load (5% FBS-fetal bovine serum). The samples are tested against the standard microorganisms S. aureus and P. aeruginosa representing gram positive and gram negative.

· The contractor will inform how much of each sample is required to carry out each method asked. A control for each test will be supplied by the contractor. Acknowledgement of receipt of samples and submission form is requested before starting the testing.

· The contractor will be liable for the retesting of samples which do not meet required specifications of the method used.

· The results are reported as the method states it to be reported; this is written and sent by email. The final full report should contain the results of the samples listed on the sample submittal form of the contracted laboratory.

Deliverables / Schedule

· The testing will be performed at the contractor’s laboratory.

· The samples will be sent in batches. Samples will be submitted with required sample submission form specifying which test and microorganism of each sample. After the laboratory’s receipt of the test sample batch, it is anticipated the work will be completed including full report within two weeks. The full report is sent by e-mail to recipients indicated on the submission form, government scientists. If there is an issue, the contracted laboratory needs to contact person indicated on submission form to explain the situation and both parties decide what should be done.

· Initially, 40 tests are expected for AATCC 100 with 36 expected for non-standard microorganisms. Six are to follow with decision for more. Eight test samples are expected for preliminary carrier testing of ASTM E2362.

· The contract is to last to end of September 2024(?)

· Government will be responsible for mailing samples and submission form with information specifying which test and microorganism is requested.