YOUR ONE STOP SHOP FOR COMPLIANCE
Assured Bio provides assistance in complying with the environmental sampling requirements addressed in U.S. Pharmacopeia (USP) <797> Pharmaceutical Compounding—Sterile Preparations. USP <797> applies to health care institutions, pharmacies, physicians practice facilities, and other facilities in which compound sterile preparations (CSP) are prepared, stored, and dispensed. It provides the practice standards to help ensure that compounded sterile preparations are of high quality.
Assured Bio’s One-Stop-Shop for Compliance
Our experienced staff guides you through the sampling process by providing online training, media supply and detailed analysis.
The Assured Bio team provides you with the proper resources to ensure that you receive the help you need. These resources include over the phone consultation, interpretation of your results and an educational YouTube library to teach your staff how to properly collect and store your samples.
Whether you’re a local shop or a large organization with multiple compounding facilities, Assured Bio has the capacity to provide worry free shipping and scheduling of media delivery to help you and your staff save time.
After your staff collects and submits your samples, our analysts perform the sample handling, analysis, evaluation, identification and reporting in accordance with the current USP <797> version, CETA CAG-009, and specific requirements set forth. Our final reports include a comprehensive pass-fail status for your facility based on the industry standard and goes into further detail to calculate a full colony count of total bacteria and total fungi. See below for an example report.
TYPES OF ANALYSIS OFFERED
Air Sampling shall be performed at least every 6 months in all ISO (International Organization for Standardization) Class environments. A sufficient volume of air shall be sampled (400-1,000 liters depending on the ISO Class of the air being sampled). Impaction shall be used for volumetric air sampling counts from air sampling plates. These are reported as estimated colony forming units (CFU) per cubic meter of air using a positive hole correction formula.
Surface sampling shall be performed on a periodic basis at the conclusion of compounding using contact plates (size ranges from 24 to 30 cm2, standard contact plates have an area of 25 cm2) or swabs (used for irregular surfaces of equipment) in all ISO classified areas. Results are reported as CFU per plate or swab.
All compounding personnel shall successfully complete an initial competency evaluation and gloved fingertip/thumb sampling procedure (zero CFU) no less than three times before initially being allowed to compound CSPs for human use. Re-evaluation of all compounding personnel shall occur at least annually for low and medium-risk level CSPs and semiannually for high-risk. Results should be reported separately as number of CFU per employee per hand (left hand, right hand). The CFU action level for gloved hands will be based on the total number of CFU on both gloves, not per hand.
PRICING / TURNAROUND TIME
Pricing for USP <797> analysis is based on number of submitted samples and contract duration. Please complete the form below to be contacted by an expert from Assured Bio, or give us a call at (865) 813-1700.
Depending on the method used, results may be available in as little as five days upon receipt of samples.
OTHER RESOURCES & INFORMATION
Register for USP Healthcare Quality Standards Updates
Frequently Asked Questions: <797> Pharmaceutical Compounding – Sterile Preparations