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:
System support to ensure accurate results; new product testing methodology, water system validation (TOC, conductivity, endotoxin).
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).
Full monograph testing, raw material identification, purity assays on finished products.
Stability Studies Cleaning Validation
Accelerated and real-time results that follow ICH recommendations or customer-specific procedures.
Partial or complete studies including swab and rinse, chromatographic techniques or TOC.
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
Facility and process validation studies:
Method Development & Validation
Based on your protocol
Microbial Limits Testing
- USP Aerobic Plate Count
- USP E.coli
- USP Pseudomonas
- USP S.aureus
- USP Salmonella
- USP Yeast & Mold
- Includes validation if required
Preservative Efficacy Testing
- CTFA Shelf life studies
- Mixed inoculums
- Your specifications
Cleaning Validation Analysis
Analytical method development supporting cleaning validation programs
- Raw Materials Analysis
- Sterility Testing
- Antimicrobial Testing
- Rate of Kill Studies
- Zone of Inhibition