ISO Tech Sterile Compounding Environment
According to the United States Pharmacopoeia, sterile compounding is to take place in a class 100 hood, inside a class 10,000 clean room. Our barrier isolators provide a class 10 environment — exceeding requirements by a factor of 10 fold! We use both positive and negative pressure units from a leader in the barrier isolator field, that gives us redundancy to serve the needs of our clients. Few pharmacies take their sterile compounding to this level of commitment. At O’Brien Pharmacy, anything less is unacceptable.
It’s not good enough to use just an autoclave. The autoclave must have print capabilities for permanent records of medications and equipment that have been sterilized, and must be validated on a regular basis. Another example of the voluntary steps we take to ensure the best product possible.
AT 24,000 revolutions per minute, this homogenizer is used to prepare the ultimate in suspensions and emulsions. Very few pharmacies can justify the cost. Exceptional prescriptions and medications are the only justification we need.
This ointment mill, although expensive, is an absolute requirement for the compounding of effective topical medications. The particle size of active ingredients is greatly reduced, resulting in enhanced penetration and a more cosmetically-appealing product for the patient. Superior emulsions are also produced with an ointment mill. Most pharmacies are unwilling to purchase this piece of equipment, but at O’Brien Pharmacy, it’s just another reason compounded medications are not created equally.
Electronic Mortar and Pestle
Our electronic mixing and dispensing system ensures that your preparation has been uniformly and completely mixed – there are no “pockets” of too little or too much drug. By pushing up the bottom, medication is dispensed in a controlled, hygienic manner that keeps air and oxidation OUT!
Many compounding pharmacies don’t even have one analytical balance, let alone four. This type of balance is extremely accurate and expensive, but it is an absolute must for precise prescription preparation. One such balance has an accuracy that displays to 1/100th of a miligram! That’s 0.00001g! O’Brien Pharmacy uses four of these, producing a permanent record of medications that have been weighed, and this information is stored along with chemical lot numbers and expiration dates.
Negative-Pressure Powder Containment
It’s not required by law, but for years we have protected our work environment and our equipment by manipulating bulk chemicals inside of a Air Clean 6000 powder containment hood that removes chemical dust through HEPA filtration.
Several years ago we began testing all of our sterile products for sterility – not just a random few. We have a total of three in-house incubators for validating the sterility of our products and equipment, and they have out-of-range alarms and daily documentation.