Pharmaceutical and Cosmetics

FULLY EQUIPPED AND STAFFED BY EXPERIENCED
SCIENTISTS AND TECHNICIANS

Pharma-Tubes

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

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 USP
BP
FDA
CTFA
Shelf life studies
Mixed inoculums
Your specifications

Studies GC
HPLC
Stability
Cleaning Validation Analysis Analytical method development supporting cleaning validation programs

Other Raw Materials Analysis
Sterility Testing
Antimicrobial Testing
Rate of Kill Studies
Zone of Inhibition