A Visual Guide to PharMEDium’s
Sterile-to-Sterile Compounding Process

Only FDA-approved* commercially available sterile drugs and medical devices cleared by the FDA are used to produce our ready to use Compounded Sterile Preparations (CSPs).

Step 1

Staging

Batches are generated and batch-specific components are identified and picked from inventory

Step 2

Scanning of Components

All components, and associated small batch documentation and labels are scanned through the Barcode Verification System (BVS) to maintain traceability throughout the compounding process

Step 3

Pass Through

Once components are verified, they are segregated, sanitized and passed into the cleanroom for use in compounding

Step 4

Compounding

FDA-approved* sterile injectable drug products are compounded to the final preparation

Step 5

Filling

Compounded Sterile Preparations (CSPs) are accurately filled into final containers

Step 6

Labeling and Packaging

Filled units are labeled and packaged to fulfill customer orders

Step 7

Laboratory Testing

Samples are pulled from 100% of our CSP batches for sterility, endotoxin and potency testing against the highest USP standards

Step 1 of 7: Staging

ADVANCING THE SCIENCE BEHIND WHAT WE DO.

PharMEDium performs real-time stability verification through independent FDA-registered laboratories who utilize current Good Manufacturing Practices (cGMPs) when testing our final formulations. We maintain a comprehensive set of technical reports and quality compounding reports available 24/7 available within our Customer Resource Center.

Our testing includes:

  • Storage conditions including temperature cycling
  • Homogeneity
  • Particulate matter
  • Active ingredient drug profiles
  • Shifts in pH
  • Specific container and drug manufacturer
  • Packaging and shipping studies
  • Light sensitivity
  • Sterility integrity of each container/closure combination
  • Bactericidal and fungicidal sterility validation testing

 

*List of available admixtures is subject to change. Please visit PharMEDium’s Customer Resource Center for a current list of available services and new product announcements.