Eagle was established two decades ago to meet the regulatory needs and requirements of the pharmaceutical industry. What began as a small lab offering just four tests has evolved into a comprehensive analytical chemistry and microbiological testing laboratory. Over the years, Eagle has expanded its services into consulting including an engineering division that provides a wide range of cleanroom solutions. Eagle continuously adopts advanced technologies to address emerging market demands. Currently, Eagle is the only laboratory offering four different sterility testing options, catering to diverse customer needs. Let’s delve into the subject of sterility testing, its importance, and the various options provided by Eagle.
What is sterility testing?
Sterility testing is a critical quality control process used to ensure that pharmaceutical products and compounded medications are free from viable microorganisms. This process is essential to confirm that products are safe for human use and meet the stringent regulatory standards required in the pharmaceutical industry. Sterility testing is conducted on products such as injectables, ophthalmic solutions, tissue and cell culture products, and other sterile pharmaceuticals.
Who needs to perform sterility testing?
Sterility testing is a mandatory requirement for pharmaceutical manufacturers, compounding pharmacies, and outsourcing facilities. 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).
Compounding pharmacies and regulatory standards
Compounding pharmacies prepare personalised medications tailored to individual patient needs. Hospitals prepare unit doses for patients, many of which are aseptically prepared. Both of these entities 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 which are assigned a beyond-use date (BUD) that requires sterility testing 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.
Sterility testing methods
There are several sterility testing methods available, each with its own strengths and applications. Here, we will discuss four primary methods the Eagle offers: ScanRDI, Celsis, BacT/ALERT, and USP <71>.
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% and offers the fastest option for batch release and moving inventory. Also, it is the perfect option for maximising shelf life for short dated compounded products.
Applications: Ideal for situations where rapid results are necessary through cutting down quarantine hold time, such as short-dated products.
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.
Applications: BacT/ALERT is widely used for sterility testing in blood cultures, tissue derived products, cell-based products, ophthalmic and inhalation products.
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 recognised and accepted by regulatory authorities globally. It provides a standardised approach for sterility testing by a thorough testing process that ensures high reliability.
Applications: It is the sterility test that covers the widest range of products (injectables, medical devices, ophthalmic, inhalation, oil based, water based…)
Conclusion
Sterility testing is a vital component of quality control in the pharmaceutical, compounding pharmacy and hospital pharmacy industries. It ensures that products are free from microbial contamination and safe for patient use. Various methods, including ScanRDI, Celsis, BacT/ALERT, and USP <71>, offer different advantages in terms of speed and product diversity.
Compounding pharmacies, hospital pharmacies, outsourcing facilities, and pharmaceutical manufacturers must choose the appropriate sterility testing method based on their specific needs, regulatory requirements, and production timelines. By implementing robust sterility testing protocols, these entities can ensure the safety and efficacy of their products, ultimately protecting patient health and meeting regulatory standards.
