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USP <797> Compliance

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Gloved Fingertip Testing (GFT) is performed to demonstrate competency in garbing without contaminating one’s hands with bacteria or fungi. Initial testing of compounding personnel is required three times in a row to both hands, prior to compounding, with zero colony forming units (CFU); six plates total. After the initial GFT, compounding personnel are to GFT each hand every six months as part of the Aseptic Manipulation Competency Demonstration and Garbing and Gloving competency demonstration. 

Results are reported separately as the number of CFU per employee per hand (left hand, right hand).
Standard turnaround time (TAT): 7-10 days. 

Media Fill Testing simulates the most difficult and challenging procedure performed at sterile compounding pharmacies.  Any microbial growth detected results in a failed sample. 

Standard TAT: 14 days. 

Aseptic Manipulation Competency Demonstration involves completing a media filled test (MFT), and immediately after a surface sample (SS) and GFT for each hand every six months for level 1/2 and every three months for level 3.  

The sample includes one petri plate per hand, one plate for the SS, and one media fill test kit. 
Failure if >3 CFU is detected on the combined GFT plates, growth in the MFT or >3 CFU on the SS.
Standard turnaround time is 14-17 days; GFT and SS results can be reported earlier. 

Surface sampling (SS) monitors compounding surfaces for bacteria and fungi. This must be collected upon completion of compounding activities for the shift/day but before cleaning. Take the sample at the conclusion of compounding using a contact plate (size ranges from 24 to 30 cm, standard contact plates that are 25 cm2 ) or swabs (used for irregular surfaces of equipment) in all ISO classified areas. The test is a monthly requirement for level 1/2, every week or day (depending on methods used) for level 3, and as part of the aseptic manipulation /competency demonstrations.  

Results are reported as CFU per plate or swab. Pass/Fail by ISO class: 5= >3; class 7 = >5, and class 8 = > 50.
Standard TAT: 7-10 days. 

Air sampling is used to monitor the air for bacteria and fungi and is required at least every six months in level 1/2, and every month for level 3. Impaction air samples must be collected in each classified area during dynamic operation.  Air Sampling requires that a sufficient volume of air shall be sampled (1,000 liters). 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.
Pass/Fail criteria for ISO class 5 = >1 CFU/m3, class 7 = >10 CFU/m3, and class 8 = >100 CFU/m3.
Standard TAT: 7-10 days.  

Find more information at USP.org
Disclaimer:
This video demonstrates dual-plate method. Sampling can be performed with single plates for both incubation times. We recommend shipping samples with no ice packs to minimize condensation.

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.