7930--Pharmaceutical Compounded Sterile Preparation Products

Request for Information (RFI): Veterans Health Administration (VHA)

Sterile Cleaning Supplies for Pharmacy Compounding Programs

The Department of Veterans Affairs, Veterans Health Administration (VHA) is conducting a market survey and is seeking information identifying sterile cleaning supplies for pharmacy compounding programs.

Pursuant to VHA Directive 1108.12, Management and Monitoring of Pharmaceutical Compounded Sterile Preparations, VHA Pharmacy Compounding programs are required to apply the standards of the United States Pharmacopeia (USP) Chapters 795, 797, and 800 as well as all other applicable chapters to the practice of compounding sterile and non-sterile preparations. The recent publication of USP 797 (Pharmaceutical Compounding- Sterile Preparations) includes a requirement for the use of sterile cleaning products within the Primary Engineering Control (often referred to as to as the Hood ) for the process of cleaning and disinfecting these units. See USP 797 excerpt below:

7. CLEANING, DISINFECTING, AND APPLYING SPORICIDAL DISINFECTANTS AND STERILE 70% IPA

7.1Â Â Â Â Â Â Â Â Â Agents and Supplies for Cleaning, Disinfecting, and Applying Sporicidal Disinfectants

7.1.1Â Â Â Â Â Agents: Cleaning and disinfecting agents must be selected and used with careful consideration of compatibilities, effectiveness, and user safety. Considerations when selecting and using disinfectants include their antimicrobial activity, inactivation by organic matter, residue, shelf life, preparation requirements of the agent, and suitability for surfaces being disinfected. After the disinfectant or sporicidal disinfectant is applied to the surface, the agent must be allowed to dwell for the minimum contact time specified by the manufacturer.

Cleaning, disinfecting, and sporicidal agents used within the PEC must be sterile. When diluting concentrated cleaning and disinfecting agents for use in the PEC, sterile water must be used. In classified areas outside of the PEC, sterile cleaning and disinfecting agents should be used. When diluting concentrated cleaning and disinfecting agents for use outside of the PEC, sterile water should be used.

7.1.2Â Â Â Â Â Supplies: All cleaning and disinfecting supplies (e.g., wipers, sponges, pads, and mop heads) with the exception of tool handles and holders must be low lint. In addition, cleaning and disinfecting supplies used in the PEC must be sterile with the exception of tool handles and holders, which must be cleaned and disinfected prior to use in a PEC.

Please see ATTACHMENT A for the Draft Statement of Work which defines product description requirements and salient characteristics. The anticipated North American Industry Classification System (NAICS) code is 325612 Polish and Other Sanitation Good Manufacturing.

This RFI is issued for information and planning purposes only. This is not a solicitation or a request for quotes and shall not be construed as an obligation or commitment by the Government. An award will not be made on any offers submitted in response to this notice, and it shall not be implied the Government is committed to providing any solicitation or award following this notice. The Government will not pay for any information received in response to this request, nor will the Government compensate a respondent for any costs incurred in developing the information provided.

This notice is intended strictly for market research. The purpose of this RFI is to determine interest and capability of potential qualified sources of supply and determine the socioeconomic size classification of the supplier and manufacturer of the end items. Do NOT include proprietary, classified, confidential, or sensitive information in responses.

Interested companies shall provide, at a minimum, the following information with their response:

Company Name and Address:

Point of Contact (POC)

Name:

Email Address:

Phone Number:

DUNS Number:

Mark if your firm is eligible for participation in one of the following small business programs. If so, please indicate the program:

[ ] yes [ ] no - Small Business (SB)

[ ] yes [ ] no - HUBZone

[ ] yes [ ] no - Small Business 8(a)

[ ] yes [ ] no - Small Disadvantaged Business (SDB)

[ ] yes [ ] no - Women-Owned (WO) Small Business

[ ] yes [ ] no - Service Disabled Veteran Owned Small Business (SDVOSB)

[ ] yes [ ] no - Veteran Owned Small Business (VOSB)

[ ] yes [ ] no - Large Business

[ ] yes [ ] no - Other (please specify)

In addition, please answer the following questions pertaining to your company:

[ ] yes [ ] no - Does not exceed 500 employees;

[ ] yes [ ] no - Is primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied;

[ ] yes [ ] no - Takes ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice (identify how this occurs); and

[ ] yes [ ] no - Will supply the end item of a small business manufacturer, processor or producer made in the United States.

In addition to providing the information requested above, responding companies are encouraged to include any relevant information (specifications, brochures, capability statements, past experiences, etc.) to confirm the company s ability to meet the requirements outlined in this request.

Responses to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract or agreement. This notice shall not be construed as a commitment by the Government to issue a solicitation, or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued.

Suppliers may submit questions pertaining to the RFI via e-mail only to shannon.mcniel@va.gov by 15:30 PST May 10th, 2024. All questions will be answered and posted via an amendment.

Suppliers may submit responses via e-mail only to shannon.mcniel@va.gov by 15:30 PST May 17th, 2024.