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Achieve and Maintain
USP <797> Compliance

Assured Bio provides analytical testing for facilities that compound sterile medications – helping achieve USP <797> compliance.

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USP <797> Sampling Methods

The Aseptic Manipulation Competency Demonstration mandates the completion of a semiannual media fill test (MFT) alongside concurrent surface test (ST) and gloved fingertip test (GFT) for each hand for level 1, 2 and a quarterly frequency for level 3.

Each evaluation comprises one petri plate per hand, one plate for the ST, and a media fill test kit. Failure is determined if more than 3 Colony Forming Units (CFU) are detected on the combined GFT plates, if there is growth in the MFT, or if more than 3 CFU are found on the ST.

The standard turnaround time for results is 14-17 days, with GFT and ST results potentially available earlier.

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 business days.

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

Standard TAT: 14 business days. 

Surface Testing (ST) 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 business days.

Air Testing 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 Testing 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 business days.

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.