Colony enumeration is the process of counting microbial colonies that appear on environmental monitoring plates (e.g., settle plates, contact plates, or air samples). Under USP <797>, pharmacy staff must demonstrate the ability to accurately count these colonies to monitor cleanroom conditions and ensure patient safety.

State inspectors and internal auditors now require documented competency in colony enumeration as part of USP <797> compliance. Being able to count accurately, and prove it, ensures that your cleanroom monitoring results are reliable.

The Colony Enumeration Proficiency Assessment includes 20 realistic sample plates with colony counts ranging from 0 CFU to 50 CFU. These sample plates are designed to closely mimic actual test conditions, but they do not contain live microorganisms. All colony counts are thoroughly verified for accuracy prior to shipment.

While there is no formal FDA or state board “approval” process for this type of training set, our solution was designed in collaboration with industry microbiologists and aligns with USP <797> expectations for documented colony counting proficiency. This test has been in use since 2024 and is used in pharmacies across the nation.

The included PowerPoint is designed by industry microbiologists and teaches best practices for colony counting, including how to spot overlapping colonies, how to avoid double-counting, and how to identify edge growth and artifacts. It is developed to increase accuracy and confidence before submitting results.

Best practice is to complete proficiency testing annually or during onboarding of new staff. Some pharmacies repeat testing more often based on inspection history or internal quality standards.

No live organisms are used and no incubators or lab supplies are required. We recommend completing the test in a clean space with good lighting and basic magnification, if needed. Our PowerPoint will guide your team through the entire process.

Shipping costs are included in the purchase price of the assessment(s). Please retain the original cardboard box and packing materials for the return shipment. A return label is provided with each shipment for your convenience.

We do! Group discounts begin after the first assessment, and we do also offer reduced rates for retakes and yearly reassessments. For retakes, annual renewals, or orders for more than 10 analysts, please reach out to us directly at orders@pureproficiency.com.

Please complete your analysis and return the proficiency set within 10 business days of receiving it. If your team requires more time to complete the analysis, contact us at orders@pureproficiency.com to request an extension.

You will receive your final reports within one business day after we have received all required data submission forms from your group and return shipping confirmation. Please note that we wait until all analysts’ forms have been submitted before processing results to ensure the integrity of the testing process.

You should order one assessment for each analyst participating in the testing. For example, if you want three analysts to each receive a report, you should order three assessments in total.

No, you do not need a PayPal or Venmo account to purchase the assessments. We accept all major credit cards for payment. When checking out, choose the PayPal option and follow the provided instructions.

While credit card payments are preferred and can be made directly through our website, we understand that this may not be feasible for everyone. If your organization needs to pay by check, please reach out to us at orders@pureproficiency.com for further assistance.

We limit each proficiency set to five analysts to ensure a degree of variability within the organization, enhancing the robustness of the testing process.

We prefer that all forms be completed electronically using the provided PDF form and submitted online. However, if you need to fill out the form by hand, please use a blue or black pen and ensure your handwriting is legible. You can then submit the form by scanning it or taking a clear photo and emailing it to orders@pureproficiency.com.

While our standard sets are used for formal proficiency assessments, we also offer the option to purchase a kit for internal training, onboarding, or other educational purposes. These sets do not include a certificate-based assessment, but are ideal for skill refreshers and practice.
Please note that all training sets are made to order. If you’re interested in purchasing one, contact us at orders@pureproficiency.com for availability, pricing, and turnaround time.