Automated Vial Capper Machine and Labeler system with post-warranty service agreement options
Past Recompete Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Not on record
- Estimated value
- $250,000 to $700,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 333993 Packaging Machinery Manufacturing
- Points of contact
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration is procuring an Automated Vial Capper Machine and Labeler system, including installation, onsite qualification, training, and optional annual onsite preventative maintenance service, with an estimated award date of August 1, 2026. The equipment supports the Center for Biologics Evaluation and Research (CBER) Standards Preparation facility in maintaining critical production capabilities for standards used to quantify potency of biological drugs submitted for licensure and regulatory decisions.
The estimated award value ranges from $250,000 to $700,000. The Division of Biological Standards and Quality Control (DBSQC) at FDA will use these standards for manufacturers during product development and production, as well as by international regulatory agencies and FDA for mandatory lot-release testing prior to approving biological drugs for public distribution. Contracting Officer Nick Sartain (nick.sartain@fda.hhs.gov, 301-796-1988) is the point of contact.
Forecast text
Procurement of Automated Vial Capper machine and Labeler system including installation, onsite qualification, training and optional annual onsite preventative maintenance service. This equipment is used for the preparation of Center for Biologics Evaluation and Research (CBER) Standards in support of vaccines and other biological products submitted for licensure and/or other regulatory decisions.
B. Background
Division of Biological Standards and Quality Control (DBSQC) serves as a Standards Preparation facility for CBER. This procurement is for the purchase of a replacement Capper and Labeler system to maintain critical production capabilities. These Standards are essential for quantifying the potency of biological drugs and are used by manufacturers during product development and production, as well as by international regulatory agencies and the FDA for mandatory lot-release testing prior to approving biological drugs for public distribution.
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