Profile
Eagle is a US Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) registered A2LA ISO 17025 accredited laboratory. With the focus on patient safety Eagle helps facilities/clients mitigate risk by providing USP and CGMP compliance and safety solutions backed by science.
Our expertise extends to the testing of compounded drugs and pharmaceutical products. Eagle ensures the quality and safety of medications through rigorous testing protocols. We employ advanced analytical techniques and cutting-edge technology to verify drugs meet the highest industry standards. In addition to routine analytical chemistry and microbiological testing, Eagle is uniquely positioned to provide services in research and development, facility design, equipment calibration, facility certification, process validation, consulting, and compliance auditing services for pharmaceutical manufacturers, pharmacies, healthcare facilities, medical device companies, and other highly regulated industries.
We are committed to staying up to date with the latest regulations and guidelines in the pharmaceutical industry, ensuring our clients receive cutting-edge solutions that meet the highest standards of quality and compliance. Eagle is equipped with a team of in-house qualified service engineers, enabling a self-sufficient facility without major service disruptions.
Validation services:
- Antimicrobial efficacy testing (USP <51>)
- Stability-indicating method development/ validation/verification
- Stability studies
- Method suitability
- Sterilization and depyrogenation cycle validation
- Container-closure integrity testing
- Cleaning validation
- Disinfectant efficacy testing
- Equipment qualification/calibration
- Cleanroom certification
- USP monograph testing
Finished drug product release testing:
- Potency
- ELISA (enzyme-linked immunosorbent assay) testing
- Rapid sterility testing: ScanRDI®, BacT/Alert®
- Bacterial endotoxin testing (USP <85>)
- Particulate matter (USP <788>/<789>)
- Bioburden testing
- Uniformity of dosage units
Our consulting services include:
- Facility design review
- Quality systems development
- Development and implementation of standard operating procedures
- GAP analysis audit
- Due diligence audit
Eagle provides contamination control expertise and related support services:
- Environmental monitoring program development
- Microbial identification
- Incubation and enumeration of media
- SurfaceShield Wipe Sampling kit for detection of drug residue on surfaces (Title 21 Part 211 CFR requirements)
Eagle’s 50,000 square feet laboratory comprised of segregated specialized laboratories is based in Houston, Texas. Our services extend to clients across the USA and Canada, as well as internationally.
WE TEST
Our team of experts boasts a wealth of knowledge and experience and uses state-of-the-art equipment to ensure accurate and reliable results.
- Laboratory Testing Services, Turnaround Times, and Pricing
- Microbiology
- Chemistry
- Research and Development
WE CONSULT
Eagle’s consultants are adept at identifying challenges, risks, and opportunities for sterile and non-sterile facilities.
- Consulting Services and Compliance Solutions
- Environmental Monitoring Solutions
- GAP Analysis Audit
- USP <800> Compliance Services
WE CERTIFY
Our team of engineers at Eagles can certify that your systems are functioning as intended.
Articles:
Bacterial Endotoxin Test: https://eagleanalytical.com/bacterial-endotoxin-test/
Rapid Sterility Testing, ScanRDI®, 10-year survey https://eagleanalytical.com/wp-content/uploads/2019/04/ScanRDI-System-Performance-A-10-Year-Survey.pdf
Suitability of ScanRDI as a Rapid Sterility Testing Method https://eagleanalytical.com/wp-content/uploads/2019/04/ScanRDI-_Suitability-of-ScanRDI-as-a-Rapid-Sterility-Testing-Method.pdf
Eagle’s approach gives its customers a huge advantage https://www.biomerieux.com/us/en/resource-hub/knowledge/expert-interviews/pharmaceutical-qc-expert-interviews/how-eagles-approach-gives-its-customers-a-huge-advantage.html
Patents:
US patent for the detection of biological contaminants in non-filterable materials. https://uspto.report/patent/grant/10,266,870
Canadian patent for ScanRDI® Oil Method https://www.ic.gc.ca/opic-cipo/cpd/eng/patent/3075267/summary.html?type=number_search&tabs1Index=tabs1_1
