Our compounding pharmacy specializes in sterile compounding and is one of only a very few in Atlanta that is equipped with a state of the art ISO Class 7 sterile room that is required for the production of sterile preparations. We have an ISO-Tech ISO Class 5 laminar flow hood which is located in the ISO Class 7 sterile room in which all sterile preparations are made. This set up exceeds the requirements set by the USP 795, 797, and 1116 guidelines. These ensure that we exceed the highest standards required for sterile production. This level of commitment to our patients centers on their knowledge that our sterile compounds are indeed sterile and safe to inject.
Dunwoody Pharmacy’s laboratory is equipped with a dry heat sterilization oven to sterilize and dehydrogenate all glassware and utensils involved in the compounding process to prevent contamination of bacteria or pyrogens. We also use commercially available sterile and pyrogen free water and saline for injections, vials and filters in all our sterile products to minimize any potential source of contamination.
We have a variety of methods for sterilization available including a dry heat oven, autoclave and various sterile 0.2-micron filters that enables us to sterilize a variety of products, which all require different methods of sterilization. And our Sterile room undergoes daily bactericidal cleaning to maintain a sterile environment. We also monitor the environment by taking air samples to ensure no bacteria are present. We also perform glove fingertip tests to ensure that our compounders have the proper aseptic technique. We also use surface contact plates to sample surfaces weekly that are incubated at the required conditions to ensure the absence of any microbes.
We routinely run our own in-house sterility testing as part of our quality control to ensure our products are sterile. This involves incubating samples in various growth media in an incubator for 14 days to ensure the absence of any microbial growth. We also perform bubble point testing on our sterile filters to validate their integrity which ensures their ability to sterilize heat sensitive mixtures.
All sterile compounding is done by highly trained Pharmacist and Technicians, both of whom have decades of Sterile Compounding experience.
Sterile preparations individually compounded by our laboratory and available with a valid doctor’s prescription include:
- Erectile Dysfunction Injections– TRIMIX, BIMIX, QUADMIX and a range of other injections for the treatment of erectile dysfunction.
- Nasal Sprays – HCG, oxytocin, glutathione, methylcobalamin, lidocaine
- Eye Drops – we make a wide variety of eye drops. Can’t find what you are looking for on the market; contact our pharmacist to see if we can compound what you are looking for
- Nutritional Injections – methylcobalamin, Vitamin C, Vitamin B complex, glutathione, phosphatidylcholine, zinc
- Other – DMSO/lidocaine/heparin/hydrocortisone Bladder irrigations used in urology
Sterile Compounding: Strict Policies and Procedures
These medications are compounded in our specially designed and constructed Clean Room. In this environment, Dunwoody Pharmacy’s skilled pharmacists prepare your medications according to USP 795 and USP 797 guidelines, the regulatory standard for the compounding of sterile pharmaceutical preparations. These procedures include:
- Lab testing of finished products, both in-house and independently
- Monitoring with environmental microbiology sampling
- Monitoring the particle count of the sterile environment
- Proper cleaning and maintenance routines
- Routine outside certification of our laminar flow hood
- Routine testing of our pharmacy staff’s sterile technique
- Proper staff grooming and gowning before entering critical sterile areas
Sterile Compounding: A Measure of Our Commitment
Maintaining a sterile environment requires a constant, ongoing commitment to quality and safety. This is the commitment Dunwoody Pharmacy Compounding Pharmacy makes to you. Please contact us to learn more about Dunwoody Pharmacy sterile compounding services.