Civic AI
Civic AI
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Automated Vial Capper Machine and Labeler system with post-warranty service agreement options

Department of Health and Human Services.Food and Drug Administration.75F401
Est. solicitation
Date posted

Description

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.

Planning details

Estimated value
>= $250K and < $700K
Anticipated award
Aug 1, 2026

Classifications

  • NAICS333993
  • PSC333993

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