Testing for Microbials
Intrathecal medications are a sophisticated way to treat chronic pain, and quality medications are paramount. Have you asked yourself these questions: How clean is my pharmacy’s clean room? Am I familiar with its environmental monitoring program? Remember: Not all compounding pharmacies are the same!
Hartley Medical has devoted tremendous efforts toward developing facilities and best practices that deliver confidence and peace of mind, for both our pain physicians and our patients. One such best practice is surface testing for microbials.
Surface testing determines whether a pharmacy’s cleaning, disinfection, and air quality procedures are effectively eliminating pathogenic microorganisms such as molds, yeasts, and bacterial spores. Assessing these potential bioburdens on equipment and staff is critical because of the delicate nature of intraspinal medications.
There are several ways to perform surface testing, including contact plates, swabs, and paddles; all of which are commercially available. Hartley Medical uses contact plates. These plates are coated with agar to promote growth and have a convex profile that is ideal for testing flat surfaces, such as laminar-airflow workbenches (LAFWs), floors, and walls. Using aseptic technique, we apply these contact plates to various critical areas in order to gather microorganisms that may be present. The lid is then replaced, and the area is sanitized to remove any residue, and the plate is incubated at a controlled temperature that promotes growth of the microorganisms trapped in the agar. After 48 hours, our quality assurance specialist analyzes the growth and submits a report of findings to our pharmacist-in-charge.
The Hartley Standard
Industry standards require surface testing biannually. At Hartley Medical, we conduct surface microbial testing daily. That’s over 250 more tests per year than what is required! We do this in order to apply stricter controls over our clean room. To augment this, we employ lower alert and action levels than industry averages.
Surface testing is only one facet of Hartley Medical’s overall environmental monitoring program, but it’s essential. A clean room must exhibit pristine conditions for sterile compounding. At Hartley Medical, when it comes to assuring the integrity of our products, we strive for only the highest quality. Because, it isn’t the industry standard that we’re after; it’s the Hartley Standard.