EAGLE IS MORE THAN TESTING, LET OUR KNOWLEDGE WORK FOR YOU
GAP ANALYSIS AUDIT | COMPLIANCE SOLUTIONS & CONSULTING | CALIBRATIONS & CERTIFICATIONS | TESTING | & MORE
Hospital Pharmacies Services
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.
GAIN EXPERT KNOWLEDGE: FREE GUIDE
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 about environmental monitoring, beyond-use dating, release testing, and more.
Services and Solutions for Hospital Compounding
Environmental Monitoring
Recommended Products
Cleanroom Certification
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.
Category 3 CSP Beyond-Use Dating Through Stability Studies
Finished Drug Product Release Testing
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.
Consulting Services
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
Smoke Studies
Cleanroom Inspection
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 Services
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
Microbial Identification (subculture isolation and gram staining)
Potency Testing
USP <51> Antimicrobial Effectiveness
USP <71> Sterility Testing
Related Resources:
USP <71> Method Suitability Testing
USP <85> Bacterial Endotoxin Testing
Related Resource:
USP <788> or USP <789> Particulate Count
USP <1207> Container-Closure Integrity Testing
USP <1223> Validation of Alternative Microbiological Methods | ScanRDI® Rapid Microbial Method Sterility Test
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