FULLY EQUIPPED AND STAFFED BY EXPERIENCED
SCIENTISTS AND TECHNICIANS
One stop problem-solving
As a full-service, objective 3rd party laboratory, AFL provides a complete portfolio of microbiology and chemical analysis on raw and bulk materials, finished products, water and air samples. Our ability to consult, troubleshoot and deliver solutions to our clients in a clear, concise and logical format makes the difference with every test resulting.
Partners in preventative/corrective action
A highly trained team of experts including PhD and Master degreed scientists are dedicated to providing the required specialized knowledge, accreditations and compliance with FDA requirements. AFL is committed to proactive communication with our clients, not just reporting numbers, which means better decision-making.
Quality can be measured!
Our practical approach ensures our clients:
• Research-based testing to deliver credible and accurate results
• Two-way communication through reporting, problem-solving and face-to-face meetings
• Compliance with industry standards and contract specifications
• State-of-the-industry facilities continuously introducing new technologies
Analytical Method Development, Validation and Transfer
Pharmaceutical Testing
Analytical Method Development, Validation and Transfer:
System support to ensure accurate results; new product testing methodology, water system validation (TOC, conductivity, endotoxin)
Microbiological Testing
Safety and pharmacopeia methods including microbial limits testing (USP 61 and 2021), specified microorganisms (USP 62 and 2022), antimicrobial effectiveness (USP 51), bacterial identification (Biolog and Vitek) LAL endotoxin and zone of inhibition. Other methods include FDA BAM and PCTC (CTFA)
Chemistry Testing
Full monograph testing, raw material identification, purity assays on finished products
Stability Studies
Accelerated and real-time results that follow ICH recommendations or customer-specific procedures
Cleaning Validation
Partial or complete studies including swab and rinse, chromatographic techniques or TOC.
State-of-the-art Instrumentation
Provide wide variety of testing capabilities from routine wet analyses to complex instrumental methods. Microbiology: Biolog, Vidas, Chemistry: UHPLC, HPLC, ICP/MS, LC/MS, GC/MS, GC, FTIR, TOC, MARS 6 Microwave Digestor, ANKOM, FOSS, METTLER
Pharmaceutical Testing Services
| Analytical Support | Facility and process validation studies: Chemical Microbiological |
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| Method Development & Validation | Based on your protocol | |
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| Microbial Limits Testing |
USP Aerobic Plate Count
USP E.coli USP Pseudomonas USP S.aureus |
USP Salmonella USP Yeast & Mold Includes validation if required |
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| Preservative Efficacy Testing | USP BP FDA CTFA |
Shelf life studies Mixed inoculums Your specifications |
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| Studies | GC HPLC Stability |
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| Cleaning Validation Analysis | Analytical method development supporting cleaning validation programs | |
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| Other | Raw Materials Analysis Sterility Testing Antimicrobial Testing |
Rate of Kill Studies Zone of Inhibition |
