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).

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 Cleaning Validation

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

Our 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


  • GC
  • HPLC
  • Stability

Cleaning Vali­da­tion Analysis

Analyt­ical method devel­op­ment supporting cleaning vali­da­tion programs


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