Vol. 1, Issue 4  ‣ August 2024

Table of Contents

A 503B compounding facility, also known as an outsourcing facility, is a type of pharmaceutical compounding business that operates under section 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act. The concept of a 503B pharmacy was introduced with the passage of the Drug Quality and Security Act (DQSA) in 2013. These facilities can manufacture bulk pharmaceuticals and are the only pharmacies permitted to provide 

compounded medications in bulk for use in physicians' offices, clinics, and hospitals. Because many of these facilities compound sterile drugs such as injectables, intravenous, and intraocular formulations, sterility testing is a critical regulatory compliance requirement. It is essential to minimize patient harm resulting from potential microbial contamination.

The FDA requires 503B outsourcing facilities to perform sterility testing for all drugs reported as sterile, with additional separate endotoxin testing required for non-pyrogenic products.

Membrane Filtration

The first method is membrane filtration, preferred if the tested drug product is filterable, as defined in USP <797> and USP <71>. This technique involves filtering a test sample through a membrane filter that retains microorganisms that may be present. The filter is then rinsed and incubated in a growth medium to detect the presence of any viable microorganisms. Membrane filtration can be done in an 'open' or 'closed' format.

Direct Inoculation

High-risk or critical applications generally favor “closed” systems as they reduce the risk of test faults by housing the membrane filter within a sealed system, protecting it from environmental exposure and handling errors. Avoiding test faults is crucial as they can lead to false positives, unusable products, or delayed drug release. While closed systems can be more expensive and complex, they minimize the risk of external contamination and provides better assurance of maintaining sterility throughout the process.

To learn more about the critical role of sterility testing in 503B compounding facilities, visit our website to read the full article. Continue reading here.

Discover the ultimate solution for automated sterility testing, designed for contamination prevention, versatile compatibility, and long-term durability.

Sterisart® Universal Pump, Upgraded Version, Stainless Steel,
Cat. no. 16420

Tryptic Soy Broth and Fluid Thioglycollate

Tryptic Soy Broth (TSB), USP, Serum Vial with Needle Port Septum, 100ml, Cat. no. U46

TSB is recommended for use as a general purpose medium for the isolation and cultivation of a wide variety of bacteria and fungi. The U.S. Pharmacopeia National Formulary (USP) describes its use for sterility testing.

Fluid Thioglycollate (FTM) with Indicator, USP, 100ml, Glass Bottle with Needle Port Septum, Cat. no. U84

FTM is recommended by the Food and Drug Administration, National Institute of Health, the National Formulary, and the U.S. Pharmacopeia for sterility testing of clear fluid biologics and other sterile products.

Reference Document: United States Pharmacopeia <797>

Sartorius Sterisart® Operations for sterility testing of liquids by filtration

The Sartorius Sterisart® Universal pump is a peristaltic pump equipped with appropriate devices for attaching a closed sterility test system and a sample container. 

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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