Microbial QA.pdf
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- Attached to
- Evaluation of the Microbial Parameters of E-Liquids (ENDS) Federal contract opportunity
- Solicitation number
- 75F4012R00023
About this file
This document outlines a federal solicitation for microbiological testing services of electronic nicotine delivery system e-liquids. The Food and Drug Administration's Center for Tobacco Products requires a contractor to conduct testing of e-liquids over defined time points to determine baseline levels of various microbial and chemical parameters. Testing includes water activity, antimicrobial effectiveness, total aerobic and yeast/mold counts, endotoxin, (1-3)-β-D-glucan, and nitrosamines. The contractor must have the capability to perform validated microbiological methods and analyze laboratory-prepared and commercial e-liquid samples stored at ambient temperature. Samples may be pooled using aseptic techniques to obtain sufficient volumes for all required testing. The contractor must complete all tasks within 18 months of award, including delivery of samples within two months. This solicitation aims to examine the role of e-liquid composition and flavors on antimicrobial properties over a simulated stability period.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| Micro ENDS SOW analyses testing FINAL v1 10.25.21.docx | DOCX document |
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Text version
Evaluation of the Microbial Parameters of E-Liquids (ENDS)
FDA Solicitation 75F40122R00023
Questions and Answers – May 2, 2022
1. Question: Please define the 4 time points (months, weeks, days etc). For example: T1=1 month, T2=2 months etc.
Response: Phase 1 testing on laboratory-prepared e-liquids includes 4 timepoints (0, 7, 14, 28 days) and the following tests: Anti-microbial effectiveness; Water activity; Endotoxin Phase 2 testing on commercial e-liquids includes 3 timepoints (0, 6 and 12 months) and the following tests: TAMC and TYMC; Water activity; Endotoxin; (1→3)-β-D-glucan; TSNAs (NNN, NNK)
2. Question: Are there any preferred storage conditions for the duration of the time points? If not, laboratory work environment conditions will be used.
Response : 25°C ± 2°C/60% RH ± 5% RH. Is this too specific?
If the lab environment is similar to this and consistent throughout storage, this is acceptable.
The contractor shall provide us with the information on the conditions in which the products were stored.
3. Does nicotine need to be analysed at all time points? If not, please define at which time points nicotine needs to be analysed.
Response: If the question pertains to “measuring nicotine,” the nicotine does not need to be measured at any timepoint. During phase 1, the contractor shall prepare e-liquids with specified levels of PG, VG, nicotine and flavors. For Phase 2 testing, contractor shall record and provide the nicotine concentration of the commercial e-liquids along with expiry date, PG/VG levels, and flavor information.
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