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Top 5 Things to Look for When Choosing a Lab for the Processing of USP <797> Viable Samples Image

Top 5 Things to Look for When Choosing a Lab for the Processing of USP <797> Viable Samples

The requirement for more frequent viable sampling is hopefully coming soon with the release of a new chapter. To prepare for this change, some sterile compounding facilities are planning to collect viable air and surface samples themselves and outsource the incubation and analysis to a contract lab. But what makes a good lab? What should be on your lab “must have” list? To help you through this process, here are Pure Microbiology’s Top 5 things to consider. And we’ve included a checklist to help you assess the labs you are considering!

5. Viable Sampling Expertise

The lab should have knowledge in how to properly collect viable air and surface samples. In the event of an exceeded action level or possible sample contamination, a strong foundation in sample collection allows the lab to assist in cause identification.

4. FDA Registration and ISO Accreditation

Registering with the FDA does not mean the FDA has visited the lab, but it’s a clear indication that the lab is confident in their testing abilities and is willing to be on the FDA’s radar. So, the FDA registration is a “nice to have” but not a must.

An ISO accreditation, specifically to ISO 17025, is strongly recommended. ISO 17025 is titled “General requirements for the competence of testing and calibration laboratories” and is for labs! To become accredited, the lab must have procedures for evaluating competence and ensuring impartiality and it must maintain a consistent operation. The accreditation is performed by a third party. Ask the lab to see their scope of accreditation. It should include viable air and surface sample colony enumeration, done according to USP <797>.

3. Compliance with Industry Relevant Guidance

There is an entire USP chapter devoted to the function of the microbiology lab. USP <1117> Microbiological Best Laboratory Practices defines expectations for aseptic technique, control of media, control of test microorganisms, use and control of equipment, appropriate lab layout, recordkeeping and evaluation of data, and training of laboratory staff. When evaluating a contract lab, consider using USP <1117> as a guide.

CAG-009 Viable Environmental Monitoring for Sterile Compounding Facilities also includes lab expectations. It does cover shipping, incubation, and controls, but the most important aspect defined is the information that must be included in the report. Use section 8.17 Documentation of CAG-009 as a checklist to ensure all necessary information is either captured in your sample collection documentation or in the final report.

2. Access to a Microbiologist

You are not a microbiologist and that’s okay! You are going to need help evaluating the microorganisms recovered. Some labs provide a brief description on the report of the microorganism’s source and pathogenicity. This may not be enough based on the recovery circumstances. Look for a lab that will partner with you and provide microbiology expertise when you need it.

1. USP <797> Viable Sampling Experience and Capabilities

There are a lot of microbiology labs out there. Some do food micro; others specialize in indoor air quality. And there a number that process a variety of different types of samples. This leaves it to you to evaluate the lab. The lab must have staff knowledgeable in USP <797> incubation and analysis. This testing is unique and without USP experience, the testing performed may not comply with the chapter. Be sure the lab can meet the USP <797> incubation times and temperatures and can identify the recovered growth to at least the genus level. As a best practice, consider identifying to the species level. This additional information can make identifying the source of contamination easier.  

Some sterile compounding facilities use their clinical microbiology laboratories. This may be a viable option if they have incubators set at the required temperatures. You must also confirm that they have the capacity to handle your samples and that they are comfortable having your environmental samples mixed in with the patient samples. Remember, their Clinical Laboratory Improvement Amendments (CLIA) certification is for the processing of human specimens. Based on this, the best practice recommendation is to look for a pharmaceutical microbiology lab.

Still not sure how to best evaluate a lab? We’ve compiled a Microbiology Laboratory Assessment Checklist for you to use.

If you still have questions on evaluating labs or are interested in Pure Microbiology auditing a lab for you, contact us!

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