U.S. Pharmacopeia guidelines 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 use Class 10 barrier isolators located in a Class 10,000 HEPA filtered environment. This is ten times cleaner than required.
In addition, while most compounding pharmacies use technicians for compounding, O’Brien Pharmacy uses only pharmacists who are 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 is making your medicine and can distinguish seemingly identical white powders based on subtle color difference, smell, solubility, and pH.
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. And virtually all compounds are made only on demand, minimizing any question of shelf life or stability.
Comprehensive product testing assures the doctor and patient of the quality of each preparation. Testing includes multi-point sterility testing, endotoxin testing and independent laboratory analysis for potency.
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 temperature and humidity to daily 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. Printers or software are attached to all balances for verification of quantities weighed, and this data is saved with the lot number of each chemical for verification and retrieval – documentation unrivaled by other pharmacies.Click here to see more information