Our 7 Steps to Quality Assurance

PharMEDium sets the industry standard for quality assurance through our innovative sterile to sterile 7-step process.

Step 1

Staging

Batch specific sterile drugs and components are identified and picked from inventory.

Step 2

Scanning of Components

All components and associated batch documentation and labels are scanned through our Bar Code Verification System (BVS) to maintain traceability throughout the compounding process.

Step 3

Passthrough

Sanitized batch components are passed into the clean room for use in compounding.

Step 4

Compounding

FDA-approved sterile injectable drugs are compounded with diluent to the final concentration.

Step 5

Filling

Compounded sterile preparations are accurately filled into final containers.

Step 6

Labeling & Packaging

Filled units are labeled and packages to fulfill customer orders.

Step 7

Laboratory Testing

Samples are pulled for chemical and sterility testing to ensure quality assurance.

Step 1 of 8: Staging

Advancing the science behind what we do.

PharMEDium performs real-time stability verification through independent FDA-registered laboratories who utilize current 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