Experience Matters
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.
Hospital Pharmacies
Consulting & Compliance Services
We are dedicated to equipping your hospital with the necessary tools to operate effectively within the heavily regulated healthcare sector. To support this commitment, Eagle has assembled a team of professionals from the fields of science and pharmaceuticals, including experts in chemistry, microbiology, engineering, CGMP, quality control (QC), quality assurance (QA), and pharmacy.
Sterility Testing
We are dedicated to equipping your hospital with the necessary tools to operate effectively within the heavily regulated healthcare sector. To support this commitment, Eagle has assembled a team of professionals from the fields of science and pharmaceuticals, including experts in chemistry, microbiology, engineering, CGMP, quality control (QC), quality assurance (QA), and pharmacy.
ScanRDI®
- Ideal for aqueous and oil-based, filterable solutions.
- Turnaround time: 1-day results
- Suitable for various product types
- Turnaround time: 5 to 7-day results
- For testing LVP and SVP, ophthalmic, inhalation, cell-based, and tissue-derived products
- Turnaround time: 7-day results
- Filtration
- Immersion
- Fluid Path
- 16 to 18-day results
Finished Drug Product Release Testing
Finished pharmaceutical products are subjected to be tested for their chemical and microbial quality attributes at release to ensure their identity, strength, purity, and efficacy.
Testing Methods
For finished drug product release testing, the chemical analyses include but are not limited to testing for identification, assay/potency, impurities/degradants, physicochemical properties, content uniformity, and dissolution. Microbiology testing includes but is not limited to testing the product for sterility, endotoxins, bioburden, objectionable microorganisms, and antimicrobial effectiveness. The testing may also involve checking physical characteristics such as re-suspendibility, container-closure integrity, and particulate matters. The testing methods used for the above analyses must be accurate, precise, and reproducible.
Laboratory Testing Services and Pricing
Environmental Monitoring Program Development
Environmental monitoring (EM) is fundamental to ensuring that aseptic processing areas are maintained in an adequate state of control. USP <797> revisions, which went into effect on 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 ensuring compounded product quality and personnel safety. Recommended Products
Consulting Services
Our consulting team comprises 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 limit
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 and compounding chapters, effective November 1, 2023, have updated the BUD limits for both sterile and nonsterile compounded preparations. Learn More
Cleanroom Certification
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 the well-being of your staff.
Dedication To Precision
To ensure your cleanroom is operating properly, a full cleanroom inspection is conducted. This inspection includes HEPA Filter Integrity Testing, Differential Pressure Measurement, Air Change Per Hour Measurement and Calculation, and more. Learn More
Smoke Studies
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.
Cleanroom Inspection
Eagle’s smoke studies include a Static Air Visualization study and a Dynamic Air Visualization study with video and report. With Eagle’s engineers performing your smoke study, you and your staff will feel confident that your equipment is operating.
Learn More
Discover The Services Eagle Can Assist You With!
Prioritize patient, personnel, and product safety solutions for hospital compounding pharmacies. Download the catalog below to learn about the services Eagle offers, such as environmental monitoring, beyond-use dating, release testing, and more.
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 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.” —Eagle President and Chief Executive Officer Ross A. Caputo, Ph.D.
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
Pricing Request | Testing Services | Microbiological Department Services
Potency testing measures the concentration of the active ingredient at a specific point in time.
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.
Related Resources:
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 no components of the formulation will interfere with the bacterial endotoxin test and that the testing used is sensitive enough to provide meaningful, accurate data.
Related Resource:
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
Related Resources:
Key:
* 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
System suitability assesses the ability of the test equipment and method to separate analytes and produce accurate results. System suitability tests are based on the concept that the equipment, electronics, analytical operations, and samples to be analyzed constitute an integral system that can be evaluated. Testing is conducted by preparing a solution of API reference standard in a mixture of excipients or placebo preparation at the same active ingredient to excipient ratio as included in the compounded preparation and at the same dilution as would be used for the analysis of the compounded preparation.
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.
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.
Solutions must be essentially free from observable particulate matter. Due to the small amount of material and the heterogenous composition that particulate matter represents, it cannot be quantitated by chemical analysis alone.
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.