Pavilion Compounding Pharmacy is pleased to announce the evolution of the bio-identical hormone pellet to our patients and providers. With our newest innovation, we offer E-Beam processing of our SteriPellets®. Our processing facility is able to provide many advantages to be able to compound advanced pellet technology.
When ordering hormone pellets, make sure the pharmacy is preforming all of these important processes:
Sterilization: E-beam irradiation is currently the best method for sterilization. Autoclaving does not comply with USP Chapter <797> in regards to sterilization of this dosage form. E-beam irradiation is the only validated method to penetrate and sterilize the entire pellet. E- Beam irradiation is less harsh to the pellets, provides an environmentally friendly technique using on-off technology, faster turn-around time for timely delivery to our patients, and is less stressful to the active drugs.
Dose Map Verification: This report establishes the E-beam dose that is required to ensure pellet sterility and integrity.
Dose Audits: Dose audits are performed to ensure that pellets are sterilized at the minimum dose established in the Verification protocol and that the inherent product bio-burden has not changed. Bio-burden testing is preformed with each dose audit to ensure that the conditions in which the pellets are made meet the required regulations. Dose Audits are preformed quarterly.
Sterility Reports: These reports are generated by third party labs to ensure each batch of pellets are sterile.
Method Suitability: This important test is to ensure that false negatives do not occur with sterility testing. The suitability test verifies that microorganisms will grow in the test media if they are present in the preparation using the specified testing method process.
USP Quality: The highest quality pellets only contain USP grade hormone powder (testosterone or estradiol) and USP stearic acid. Fillers such as PVP should be avoided as they may cause local irritation.
Have questions or concerns? Contact Pavilion Compounding Pharmacy today and one of our pharmacists will be happy to discuss. Ask us for our reports and documentation on all of the above items listed.
Pavilion Compounding Pharmacy is located in Atlanta, GA. We have over 20 years of experience compounding hormone pellets.
Contact us by phone: 404-350-5780