A Year into the Revised USP <797>: The Case for Implementing Viable In-House Air Sampling
It's been one year since the revised United States Pharmacopeia Chapter <797> was implemented. Last November, we published an article covering many of the key changes and provided guidance and compliance solutions for pharmacy teams. However, over the course of the year, we have received feedback that many teams have faced challenges with the increase in environmental monitoring requirements and frustration over how this has affected their facility. Many pharmacies contract with third-party vendors to conduct their air sampling and other environmental monitoring activities; however, handling air sampling in-house offers several advantages that can make it a more practical and efficient solution.
Could conducting in-house active air sampling be a better approach for your facility?
Cost Efficiency
Conducting in-house air sampling can save money, as third-party services often charge for labor, equipment, and travel expenses. Regular sampling can become more affordable when handled internally.
Flexibility and Convenience
In-house sampling allows the pharmacy to schedule the tests at convenient times without coordinating with external vendors. This flexibility can be especially important now that the need for testing is more frequent.
Faster Results
When air sampling is performed in-house, there is no delay associated with scheduling a third party. The pharmacy can conduct tests as needed and send the samples directly to a lab for analysis, resulting in faster detection of environmental excursions.
Better Control Over Procedures
In-house staff can potentially follow the pharmacy's standard operating procedures (SOPs) more closely and consistently. This ensures the sampling process adheres strictly to USP guidelines or the pharmacy's specific requirements with potentially less risk of protocol deviation.
Immediate Response to Issues
If air sampling detects a contamination issue, pharmacy staff can act immediately to correct the problem. Waiting for third-party results could delay response times, increasing the risk to sterile compounding environments and preparations.
Reduced Risk of External Contamination
Conducting air sampling in-house eliminates the risk of a third-party company inadvertently introducing contaminants into the cleanroom during testing, potentially obscuring sampling data or contaminating product.
Enhanced Context and Historical Tracking
Your in-house team can likely provide more comprehensive consults, including behavioral patterns, policy adherence, and cleaning insights, along with historical data and site-specific trends—context a third-party consultant would lack.
In conclusion, while air sampling is just one aspect of a comprehensive microbial environmental monitoring program, it plays a critical role in maintaining the safety and sterility of compounding environments. By considering in-house air sampling, pharmacies can gain greater control, flexibility, and cost savings while responding more swiftly to potential contamination issues.
Hardy Diagnostics offers a complete line of easy-to-use air sampling instruments
Available Formats:
| Aspiration Volume | Additional Specs | Cat. no. |
| 100 liters/min. | 60mm Contact plate, Induction | BAS200K |
| 100 liters/min. | 100mm Standard Petri plate, Induction | BAS201K |
| 200 liters/min. | 60mm Contact plate, Induction | BAS205K |
| 200 liters/min. | 100mm Standard Petri plate, Induction | BAS206K |
| 100 liters/min. | 60mm Contact plate, charging cable | BAS211K |
| 100 liters/min. | 100mm Standard Petri plate, charging cable | BAS212K |
| 200 liters/min. | 60mm Contact plate, charging cable | BAS213K |
| 200 liters/min. | 100mm Standard Petri plate, charging cable | BAS214K |
Available Formats:
| Aspiration Volume | Additional Specs | Cat. no. |
| 100 liters/min. | 60mm Contact plate, Induction | BAS220K |
| 100 liters/min. | 100mm Standard Petri plate, Induction | BAS221K |
| 200 liters/min. | 60mm Contact plate, Induction | BAS225K |
| 200 liters/min. | 100mm Standard Petri plate, Induction | BAS226K |
| 100 liters/min. | 60mm Contact plate, charging cable | BAS222K |
| 100 liters/min. | 100mm Standard Petri plate, charging cable | BAS223K |
| 200 liters/min. | 60mm Contact plate, charging cable | BAS231K |
| 200 liters/min. | 100mm Standard Petri plate, charging cable | BAS232K |
Meet the author
PHARMACEUTICAL PRODUCT MANAGER at HARDY DIAGNOSTICS
Joelle Brackeen, B.S. Marketing
Joelle Brackeen is the Pharmaceutical Product Manager at Hardy Diagnostics and has over a decade of experience in Marketing and Product Management. Before transitioning to the pharma sector, Joelle had the privilege of co-founding and helping to grow a business into a highly profitable, multinational enterprise. Her unique blend of entrepreneurial spirit and product management expertise contributes to her innovative approach and ability to drive successful products and strategic initiatives in the pharmaceutical industry. In her free time, she enjoys playing the piano and spending time at the beach.
