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.

LEARN MORE

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.

TRAINING

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.

SUPPLY

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.

ANALYSIS

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.

USP 797 Example Report

https://assuredbio.com/wp-content/uploads/2020/08/Example-USP-Report-2019-Standards-All-Analyses-1-1.pdf

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
https://www.usp.org/hqs-signup-form

Frequently Asked Questions: <797> Pharmaceutical Compounding – Sterile Preparations
https://www.usp.org/frequently-asked-questions/pharmaceutical-compounding-sterile-preparations

USP Education
https://uspharmacopeia.csod.com/LMS/catalog/Welcome.aspx?tab_page_id=-67&tab_id=20000495

Submission Form:

Contact us about our USP 797 Testing Program. You can also stay up-to-date on USP 797 by receiving notifications regarding our USP 797 Testing Program. Complete this form or call toll-free at 1-866-547-1727.

Frequently Asked Questions

  • What is USP 797?
    • The provisions guarding the preparations for pharmaceutical compounding of sterile medications. It applies to healthcare institutions, pharmacies, physicians practice facilities, and other facilities in which compounded sterile medications are prepared, stored, and dispensed. It provides the practice standards to help ensure that compounded sterile medications are of high quality.
  • What type of samples do I need to collect in order to comply with USP 797 testing requirements?
    • In order to comply with USP 797 guidelines, you will need to collect air, surface and gloved fingertip samples from areas used for compounding sterile medications. Media-fill tests will also be required at least annually to ensure that authorized personnel are performing sterile compounding preparations aseptically.
  • Why choose Assured Bio as your USP 797 testing lab?
    • Assured Bio is accredited by the AIHA (American Industrial Hygienist Association) and has years of experience in processing samples for the purpose of complying with USP 797. We are a one-stop-shop for everything you need to complete your USP 797 testing. Our on-call staff is readily available 8:30am – 5:00pm EST. to assist you with any questions you may have regarding sampling procedures, shipping, or ordering of supplies.
  • What type of media plates do I need to collect USP 797 surface and fingertip samples?
    • Users will collect samples to analyze bacteria with TSA (Tryptic Soy Agar). Some users also collect MEA (Malt Extract Agar) plates for fungal colony counts.
  • How to collect USP 797 air samples?
    • Air sampling shall be performed at least every 6 months in all ISO class environments. A sufficient volume of air shall be sampled (400-1000 liters depending on the ISO Class of the air being sampled).
  • How to collect USP 797 surface samples?
    • Surface sampling is performed on a periodic basis at the conclusion of compounding using contact plates or swabs in all ISO classified areas.
  • How to collect USP 797 gloved fingertip/thumb samples?
    • All compounding personnel shall successfully complete an initial competency evaluation and gloved fingertip/thumb sampling procedure no less than three times before initially being allowed to compound CSPs for human use. A separate sampling device should be used for each hand to collect samples from each gloved fingertip by rolling the finger pads on the surface.
  • How to collect USP 797 media fill samples?
    • A sterile microbial growth medium is used in place of the actual drug solution to test for the presence of microbial contaminants. Presence of microbial contaminants indicates that the aseptic procedures being used for drug production are not adequate.
  • How do I properly send in samples to Assured Bio?
    • Samples must be repackaged in a manner that prevents contamination during transit. Each plate should be securely closed using parafilm, electrical tape, or equivalent. Plates should then be stacked together and placed in a plastic zip-lock bag and packaged in an insulated container along with unused plates for a positive and negative control. Include the filled-out Chain of Custody form in a separate plastic zip-lock bag. Pad the contents using a filling material such as bubble wrap. The package with the samples should be sent overnight to the laboratory with ice packs if the package will be subjected to warm temperatures during transit.

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