Quality Assurance

By definition, admixtures are the sum of their parts. One of the keys to safer admixtures, therefore, is the ability to maintain the sterile integrity for both the FDA approved components and the final preparations. At PharMEDium, we only use FDA approved, sterile components that are bar coded and traced throughout the compounding process. We admix according to a defined, ironclad methodology and monitor the process to detect and eliminate even the slightest variances. All of which allows us to achieve a higher quality with accurate and safe compounded sterile preparations.

Traceability

Track FDA approved components all the way to point of care, with 200% verification of all steps in the compounding process, in addition to a sophisticated system of automated checks and verification.

Sterility

Sterility is ensured through a system of process validation and end preparation testing, including sterility container closure testing.

Real-Time Stability

Real-time stability testing specific to drug vial manufacturer, concentration, fill-volume, container and diluents to ensure effective therapy up to the labeled beyond-use date.

Security

Only FDA approved sterile components are used, direct from the manufacturers, to ensure high-quality admixtures compounded from only the best materials available.

Process Control

The use of standard operating procedures (SOPs) ensures controlled and reproducible results.