Sterility testing is a critical quality control measure, that, when coupled with environmental data, proper aseptic technique, and robust process validation, supports that pharmaceutical products and compounded medications are free from viable microorganisms.
Sterility testing is a mandatory requirement for pharmaceutical manufacturers, outsourcing facilities, and many compounding pharmacies. These entities must adhere to strict guidelines to ensure their products are sterile and safe for patient use. Regulatory agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global health authorities mandate sterility testing as part of Good Manufacturing Practices (GMP).
Eagle continuously adopts advanced technologies to meet customers’ demands and address emerging market needs. Currently, Eagle is the only laboratory offering several different sterility testing options, catering to diverse customer needs, and prides itself on being a sterility testing expert. Eagle provides three universally accepted rapid sterility testing options: ScanRDI®, Celsis®, and BacT/ALERT®, in addition to the traditional compendial method USP <71>.
1.ScanRDI®: The Fastest Option
ScanRDI® (Rapid Detection of Indicator) is a cutting-edge technology that offers rapid microbial detection. ScanRDI® is highly sensitive and can detect both viable and non-viable microorganisms. This method uses laser scanning cytometry to detect and quantify microorganisms. With its patent for oil-based products, Eagle can deliver results through ScanRDI® within 1 day. In other words, ScanRDI® cuts your batch quarantine time by over 90% offers the fastest option for batch release, and facilitates a fast-moving inventory. Also, it is the perfect option for maximizing the shelf life of short-dated compounded products.
Key Feature: Ideal for filterable situations only, where rapid results are necessary through cutting down quarantine hold time, such as short-dated products.
2.Celsis®: Automated Rapid Detection
Celsis® is another rapid sterility testing method that utilizes bioluminescence to detect microbial contamination. This method detects the presence of adenosine triphosphate (ATP), a molecule found in all living cells, to identify contamination. Celsis® uses an automated process that reduces the potential for human error. Eagle can deliver results using the Celsis® systems within 5 to 7 days. Even though it might not be as fast as the ScanRDI®, it is still significantly faster when compared to traditional methods, thus cutting quarantine hold times by 50%.
Key Feature: Ideal for products that are not compatible with the ScanRDI® system, yet still justifiable to use a rapid method. Also, it is the best option if microbial identification is necessary per facility procedures while achieving rapid sterility results.
3.BacT/ALERT®: Automated Microbial Detection
BacT/ALERT® is a fully automated microbial detection system that uses colorimetric sensors to detect microbial growth. The system monitors changes in the color of the sensor, indicating the presence of microorganisms. This system is simple to operate and requires minimal manual intervention, offering high sensitivity and specificity for a wide range of microorganisms.
Key Feature: BacT/ALERT® is widely used for sterility testing in blood cultures, tissue-derived products, cell-based products, and ophthalmic and inhalation products.
4.USP <71> : The Compendial Method
USP <71> is the traditional compendial method for sterility testing, as outlined by the United States Pharmacopeia (USP). This method involves membrane filtration, total immersion, fluid path testing, and direct inoculation; followed by incubation of the samples in specific media for 14 days to detect microbial contamination. While it is the gold standard for sterility testing, it is also the most time-consuming. USP <71> is widely recognized and accepted by regulatory authorities globally. It provides a standardized approach for sterility testing by a thorough testing process that ensures high reliability.
Key Feature: It is the sterility test that covers the widest range of products (injectables, medical devices, ophthalmic, inhalation, oil-based, water-based, etc.).
The appropriate sterility testing method must be chosen based on product properties, facility needs, production timelines, and regulatory requirements. Sterility testing is a mandatory requirement for pharmaceutical manufacturers, compounding pharmacies, and outsourcing facilities. Entities preparing personalized medications tailored to individual patient needs and hospitals preparing unit doses for patients, many of which are aseptically prepared, must comply with the United States Pharmacopeia (USP) guidelines, particularly USP <797> for sterile compounding and USP <800> for handling hazardous drugs. Additionally, outsourcing facilities, classified under section 503B of the Federal Food, Drug, and Cosmetic Act, must adhere to current Good Manufacturing Practices (cGMP) to ensure the safety and quality of compounded medications.
USP <797> requires sterility testing for Category 2 CSPs (compounded sterile preparations) which are assigned a beyond-use date (BUD) and all Category 3 CSPs. The FDA on the other hand requires 503B Outsourcing facilities to perform sterility testing for all drugs reported to be sterile and/or non-pyrogenic.
Summary
Sterility testing is a vital component of quality control in the pharmaceutical, compounding pharmacy, and hospital pharmacy industries. It ensures that products are safe for patient use. Various methods, including ScanRDI®, Celsis®, BacT/ALERT®, and USP <71>, offer different advantages in terms of speed and product diversity.
Eagle is recognized for its expertise in sterility testing, offering a range of advanced methods to ensure compliance with stringent regulatory standards. Our dedication to innovation and quality assurance enables us to provide accurate and the fastest turnaround times in the industry, supporting the safety and efficacy of pharmaceutical products worldwide.
About Eagle
Founded two decades ago to meet the regulatory needs of the pharmaceutical industry, Eagle began as a small laboratory offering just four tests. Since then, it has evolved into a comprehensive analytical chemistry and microbiological testing laboratory. Over the years, Eagle has expanded its services to include consulting and an engineering division providing a wide range of cleanroom solutions, reflecting its commitment to expanding its portfolio based on customer needs.
Author Details
Dr. Jacqueline Esqueda, PharmD; and Dr. Ali Mroue, PharmD- Eagle Analytical Services
Dr. Jacqueline Esqueda holds a B.S. in Chemistry and a Doctor of Pharmacy from the Feik School of Pharmacy in San Antonio. Before joining Eagle, she worked as an R&D Scientist for a contract drug manufacturing organization, handling analytical method development, formulation, and process development. As a pharmacist, Jacqueline oversaw the startup and production of a 503B outsourcing facility, including SOPs, formulations, processes, and staff training in both sterile and non-sterile drug production.
Dr. Ali Mroue, PharmD, is an expert in pharmaceutical compounding and manufacturing with over ten years of experience in operations, quality systems, CGMP, and clinical pharmacy. He has primarily worked in the 503B realm, holding various leadership roles and leading cleanroom and facility design projects, process validations, product launches, and regulatory activities. Ali is a Board Certified Specialty Compounding Pharmacist (BCSCP) and holds licenses in 10 states. Before joining Eagle, he provided freelance consulting services both within and outside the USA.
Publication Details
This article appeared in American Pharmaceutical Review: Vol. 27, No. 5 July/Aug 2024Pages: 36-37
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