Eagle excels at helping sterile and nonsterile hospital compounding facilities identify risks, challenges, and opportunities by suggesting and helping you implement cost-effective science-based solutions. Our personnel’s experience spans the compounding and pharmaceutical industry with expertise in USP <795> Pharmaceutical Compounding – Nonsterile Preparations, USP <797> Pharmaceutical Compounding – Sterile Preparations, USP <800> Hazardous Drugs – Handling in Healthcare Settings, and Current Good Manufacturing Practices (CGMP).
It is Eagle’s goal to add value to your operation and make compliance convenient and efficient. Choose Eagle as your hospital’s compounding facility support partner and let our experience work for you.
Environmental Monitoring Solutions
Environmental monitoring (EM) is fundamental to assuring that aseptic processing areas are maintained in an adequate state of control. USP <797> revisions, effective November 1, 2023, have increased the monitoring requirements of air and surfaces for microbial contamination. However, environmental monitoring extends beyond that. Revisions to the USP <795> and <797> compounding chapters make USP <800> compendially applicable which introduces environmental wipe sampling for hazardous drug (HD) surface residue. Environmental monitoring for microbial contamination and HD residue is essential for assuring compounded product quality and personnel safety.
SurfaceShield Wipe Sampling and Cleaning Verification Kit
90 mm Tryptic Soy Agar Plates
Our 90 mm TSA (tryptic soy agar) settle plates supplemented with Lecithin and Tween 80 to neutralize the effects of disinfectants are suitable for both active and passive air sampling as well as gloved fingertip sampling. Our plates offer the benefit of room-temperature storage, locking lids, and are triple-wrapped for efficient movement throughout ISO-classified areas. A certificate of growth promotion from the manufacturer is provided with all orders. Eagle performs growth promotion testing on all incoming media and a certificate of our results is available upon request.
65 mm Tryptic Soy Agar Plates
Our 65 mm TSA (tryptic soy agar) contact plates supplemented with Lecithin and Tween 80 to neutralize the effects of disinfectants are suitable for surface, active air, and personnel monitoring. Our plates offer the benefit of room-temperature storage, locking lids, and are triple-wrapped for efficient movement throughout ISO-classified areas. A certificate of growth promotion from the manufacturer is provided with all orders. Eagle performs growth promotion testing on all incoming media and a certificate of our results is available upon request.
Category 3 CSP Beyond-Use Dating Through Stability Studies
A beyond-use date (BUD) is the date, or hour and date, beyond which a compounded preparation, sterile or nonsterile, cannot be used and should be set based on the date, or date and time, of compounding. The revisions to the USP <795> and <797> compounding chapters effective November 1, 2023, have updated the BUD limits for both sterile and nonsterile compounded preparations.
Category 3 CSP
Finished Drug Product Release Testing
Finished pharmaceutical products at release are subjected to testing for their chemical and microbial quality attributes to ensure the identity, strength, purity, and efficacy of the product.
Our consulting team is comprised of professionals spanning the healthcare and pharmaceutical industry with expertise in sterile and nonsterile compounding, current good manufacturing practices (CGMP), chemistry, microbiology, and quality assurance.
Let Our Experience Work For You
Our experts can assist you in all areas related to USP chapters <795> Pharmaceutical Compounding – Nonsterile Preparations, <797> Pharmaceutical Compounding – Sterile Preparations, and <800> Hazardous Drugs – Handling in the Healthcare Setting, including but not limited to:
- Personnel training and qualification including aseptic training
- Development of critical systems including environmental monitoring program, cleaning and disinfection program, and media-fill testing
- Terminal sterilization cycle development and validation
- Building/cleanroom facility design review
- Gap analysis audit
- SOP and quality system review and development
- Regulatory response and remediation
- Development of a hazardous drug wipe sampling program including acceptable surface limits
Eagle knows that you rely on your equipment to perform as expected. These instruments operate as a safeguard for the quality of your products and for the well-being of your staff. With us, you will feel confident that your equipment is operating as intended.
Smoke studies are a key qualification to ensure that your products are free from contamination and that your staff is operating in a safe environment.
Additional Testing Services for Hospital Compounding
The experience and knowledge of our team, outstanding customer service, and state-of-the-equipment make Eagle the best choice for all of your testing needs.
“Our desire, dedication, and discipline to ensure that patient safety is at the forefront of everything we do and our holistic approach to resolving your compliance needs make Eagle a truly unique organization.” — President and CEO, Ross A. Caputo
Media-Fill Testing Services
Media-fill testing should be performed by all sterile compounding facilities to evaluate and/or qualify an operator’s aseptic technique and challenge the aseptic process. The aseptic process is simulated utilizing soybean-casein digest, a liquid media supporting and promoting microbial growth, under worst-case conditions.
Eagle offers the following testing and advisory services to satisfy the USP <797> requirements for media-fill testing:
- Media-fill protocol development
- Incubation and evaluation of media-filled units
- Microbial identification growth in media-filled units
- Post media-fill growth promotion testing
Microbial Identification (subculture isolation and gram staining)
USP <51> Antimicrobial Effectiveness
Sterile articles packaged in multi-dose containers must be free of microorganisms throughout their entire shelf life. Due to the potential for the introduction of microorganisms through the repeated withdrawal of individual doses, sterile products that are packaged in multi-dose containers should contain an antimicrobial preservative. However, the concentration of an added antimicrobial preservative can be kept to a minimum if the ingredients of the compounded formulation possess an intrinsic antimicrobial activity. Antimicrobial effectiveness, whether inherent in the product or as a result of an antimicrobial preservative, must be demonstrated through USP <51> antimicrobial effectiveness testing. Pricing Request | Testing Services
USP <71> Sterility Testing
USP <71> outlines the compendial requirements for sterility testing that must be followed in order to be able to claim that the results of the test provide evidence that the product is sterile. Pricing Request | Testing Services
USP <71> Method Suitability Testing
USP <71> Method Suitability Testing (MST) must be performed prior to being able to claim that the results of a USP <71> sterility test provide evidence of a preparation’s sterility. Method Suitability Testing only needs to be completed once for each compounded formulation, and consists of two parts: i) a suitability test that confirms that the growth media used for sterility testing supports the growth of certain microorganisms and ii) a validation test that demonstrates that no components of the compounded preparation inhibit microbial growth. Pricing Request | Testing Services
USP <85> Bacterial Endotoxin Testing
As bacterial endotoxins can pose health and safety hazards to patients, USP <85> requires bacterial endotoxin testing to detect and quantify the presence of endotoxins from Gram-negative bacteria in sterile compounds. To assure patient safety, the quantity of bacterial endotoxins may not exceed threshold limits defined in USP <85>. For each bacterial endotoxin test, inhibition validation testing is performed. This testing confirms that there are no components of the formulation that will interfere with the bacterial endotoxin test and that the testing used is sensitive enough to provide meaningful, accurate data. Pricing Request | Testing Services
USP <788> or USP <789> Particulate Count
USP <1207> Container-Closure Integrity Testing
Container-closure integrity testing demonstrates the ability of the container-closure system to maintain the integrity of its microbial barrier throughout the entire shelf-life of a product. Eagle utilizes a pressure decay to test container-closure integrity, which is one of the deterministic methods recommended by USP <1207>. As sterility is an event-related occurrence, container-closure integrity testing is performed to support the claim that the sterile containers in which the preparation is packaged are capable of maintaining the sterility of the product throughout its shelf life. Pricing Request | Testing Services
USP <1223> Validation of Alternative Microbiological Methods | ScanRDI® Rapid Microbial Method Sterility Test
ScanRDI fulfills the method suitability requirement as outlined in USP <1223>. The SCANRDI® is a unique alternative technology that enables Eagle to deliver sterility testing results in 2 business days†, allowing sterile compounding facilities to release product faster than when utilizing the compendial USP <71> method. SCANRDI® has revolutionized rapid microbial detection and its combination of speed and sensitivity remains unrivaled to this day(a). Pricing Request | Testing Services
* SCANRDI® is a registered trademark of Biomeriuex.
** Method currently not accepted in some states.
† Standard processing time is 2 business days. 1 business day turnaround time is available through our RUSH service. Please call Eagle customer care for up-to-date scheduling upon sample submission.
(a) Biomeriuex – ScanRDI Rapid Microbial Detection – http://www.biomeriuex-usa.com
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Patient, Personnel, and Product Safety Solutions for Hospital Compounding
Prioritize patient, personnel, and product safety solutions for hospital compounding pharmacy. Download this guide to learn more that environmental monitoring, beyond-use dating, release testing, and more.