Sterile Compounding
Sterile compounding involves the preparation of medications in a controlled, cleanroom environment to help ensure they meet strict quality and sterility standards. At Valor Compounding, sterile preparations are compounded in accordance with applicable state and federal regulations and USP <797> standards.
What is Sterile Compounding?
Sterile compounding refers to the preparation of medications that must be free from viable microorganisms, endotoxins, and particulate contamination. These preparations are typically administered through routes that require sterility, such as, ophthalmic solutions, injectables, intravenous (IV) preparations, or intrathecal preparations.
However, Valor's sterile compounding services are currently limited to five (5) different strengths of atropine sulfate ophthalmic solution. Valor works with several California-based Optometrists and Ophthalmologists specializing in myopia. Learn more by clicking below.
We DO NOT compound sterile injectable medications, intravenous preparations, or GLP1's.
Atropine Sulfate Ophthalmic Solution
Valor Compounding focuses sterile compounding services exclusively on the preparation of atropine sulfate ophthalmic solution, compounded pursuant to a valid prescription.
This sterile ophthalmic preparation is compounded in a controlled cleanroom environment and is intended for ophthalmic administration as directed by a licensed healthcare provider. Because ophthalmic solutions must meet strict sterility standards, compounding is performed using validated aseptic techniques and regulated processes designed to minimize contamination risk.
Cleanroom Standards
We maintain controlled sterile compounding environments consisting of ISO Class 5 primary engineering controls within ISO Class 7 buffer rooms and ISO Class 7/8 anterooms. Classified spaces are routinely and continually certified to meet USP <797> cleanroom standards through environmental and personnel monitoring.
Environmental Monitoring
We perform air particle testing and surface sampling throughout the cleanroom suites. We continuously monitor the room temperature, humidity, and pressure differentials of our cleanrooms and storage locations. Sampling is an integral component of our staff procedures and is also verified by external certified cleanroom vendors.
Staff Training
All staff are required to receive thorough didactic and hands-on training in hygiene, gowning, cleaning, and aseptic technique before compounding any sterile compounded preparations. Staff must successfully complete regular gloved fingertip and thumb sampling and pass routine media‑fill and process verification assessments to confirm the sterility of their technique. Compounding only occurs under the supervision of licensed and registered pharmacists.
Quality Assurance
All testing materials must meet strict quality standards and come with documentation confirming their safety and accuracy. We source from reputable manufacturers with FDA registration and ISO-certified quality systems. Our compliance team documents, investigates, and promptly corrects all concerns or unusual findings.
Beyond-use Dating
Assigning safe and appropriate beyond-use dates (BUDs) protects patients by ensuring each preparation maintains its stability and sterility. BUDs are set by carefully reviewing factors that directly affect the chemical integrity of a formula and follow the limits and regulations set by USP <797> and the California State Board of Pharmacy.
Learn more about compounded Atropine for California Patients
Valor Compounding Pharmacy is licensed as a 503A sterile compounding pharmacy in California only.
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