Vol. 1, Issue 7  ‣ November/December 2024

Table of Contents

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.

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. 

Read on to explore essential steps for maintaining
cleanroom safety by following USP <797> guidance ...

The American Society of Hospital Pharmacists' (ASHP) sterile compounding page provides resources and guidelines to ensure safety and compliance in sterile compounding practices. It includes standards, training, and policy documents, with a focus on maintaining high-quality compounding practices in pharmacy settings. The resources cover areas like USP <797> updates, training programs, and tools for managing sterile compounding risks. For more information, you can view the full page here.

Hardy Diagnostics offers a complete line of
easy-to-use air sampling instruments

Available Formats

Available Formats

We’ll be at ASHP – New Orleans.
Come see us at Booth 1854 • December 8th - 12th

Ensure the highest standards of safety and cleanliness in your compounded sterile preparations with our detailed brochure. Designed for microbiologists, it provides comprehensive insights into our diagnostic and testing solutions for detecting microbiological impurities and maintaining contaminant-free workspaces. Download now to enhance your quality control processes and safeguard your products.

Joelle Brackeen

PHARMACEUTICAL PRODUCT MANAGER

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.

Do you have a suggestion, comment, or question? Please contact Joelle here.

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