Here at Hartley Medical, quality is paramount. We go above and beyond the mandates of USP to ensure that our products are compounded at the highest level – a level that guarantees patient safety. One of the many ways we do this is through an environmental monitoring method called microbial surface testing.
Surface testing is performed to determine whether a pharmacy’s cleaning, handling, and air quality procedures are properly working to eliminate pathogenic microorganisms such as molds, yeasts, and bacterial spores. This is tested using contact plates, swabs, and paddles; all which are commercially available. USP 797 mandates that surface sampling be conducted biannually to assess the potential bioburdens on carts, counters, walls, floors, and most importantly, the gloved hands of compounding personnel (also known as fingertip assessment). Here at Hartley Medical, we perform surface microbial testing weekly – that’s 50 more tests per year than USP requires.
Hartley Medical utilizes contact plates during the surface testing process. Coated with agar – a type of growth media – these small circular plates contain a convex surface ideal for testing flat surfaces, such as laminar-airflow workbenches (LAFWs), floors, and walls. The plates are aseptically applied to the designated area – gathering any microorganisms that may be present on the surface. After obtaining the sample, the lid is replaced and area sanitized to remove any residue transferred by the contact plate during the process. The plate is then incubated at a controlled temperature that promotes growth of the microorganisms trapped in the agar. After 48 hours, a quality assurance specialist analyzes the growth, and submits a report of findings to the pharmacist in charge.
Surface microbial testing is just a small part of Hartley Medical’s overall environmental monitoring plan – a plan that assesses air cleanliness, temperature, humidity, and personnel compliance to USP mandates. When it comes to assuring the quality of our products, we simply do more. That is the Hartley Standard.
For more information about environmental monitoring, visit Hartley Medical’s Knowledge Center by clicking here.
Or view the article entitled, “The Importance of Environmental Monitoring, Part II: Surface Testing” by Eric S. Kastango, RPh, MBA, FASHP and Kym Faylor by clicking here.