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. And we employ industry-leading
real-time stability
testing to ensure admixture effectiveness. 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.