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Sterile
Compounding
United States Pharmacopeia regulations classify sterile compounding
from non-sterile ingredients as the highest risk category, and recommend,
among other things, procedures to take place in a class 100 cabinet
inside a class 10,000 clean room.
O'Brien Pharmacy is serious about sterile compounding. That is why
we received the prestigious seal of PCAB Accreditation, achieving the highest standards set for compounded medications.
In addition, while most compounding pharmacies use technicians for
compounding, O'Brien Pharmacy relies upon pharmacists specifically
trained and experienced in aseptic compounding. Technicians do not
possess the knowledge base in pharmacology, dosing and calculations
necessary for consistently accurate compounding. Confidence comes
from knowing an experienced pharmacist can distinguish seemingly identical
white powders based on subtle differences of color, smell, solubility,
pH and other factors.
In fact, our entire sterile compounding environment and related chemicals
are isolated from all other compounding and pharmacy activities.
This greatly reduces the possibility of the wrong medication being
used or unauthorized activity in the lab. Compounds are made
on demand with documented Beyond Use Dates, minimizing any question of shelf life or stability.
It has been said, "If it isn't documented, it didn't happen." The
heart of our 150-page policy and procedure manual is documentation.
Everything from daily temperature and humidity to calibration of our
balances is documented. In addition, compounding software in the lab
facilitates documentation of all formulas, procedures, chemicals,
lot numbers and expiration dates. Analytical
balances are connected to software and printers for verification of quantities weighed, and this data is saved along
with the lot number of each chemical for verification and retrieval. |
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