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Contract Microbiological and Chemistry Testing

At times, internal capabilities or workload may require a firm to utilize an external GMP/GLP testing laboratory. VAI Labs can assist with compliant testing to support operations, qualify environments, confirm product integrity, and strengthen regulatory confidence.

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Tests to Qualify, Verify, and Release

Tests to Qualify, Verify, and Release

From environmental control to product release, our laboratory services provide data-driven insights to help you make confident decisions.

We work with your team to assure the appropriate protocols, plan and run your tests, manage the program, protect data’s integrity and deliver audit-ready documentation.

What to Expect from Our Laboratory Testing Services

What it is

Comprehensive testing to support GMP-regulated operations, from incoming QC to environmental control to product stability and release.

What we do

We design or follow industry standards and conduct a wide array of tests tailored to your needs.

We manage your testing program directly, pairing you with a study director and technical team to receive updates, uphold timelines, and maintain clear documentation.

Why trust us

Our laboratory capabilities are built on 40+ years of GMP manufacturing and internal testing experience. We understand the pressures of regulatory reviews because we navigate them ourselves. Our goal is the same as your, patient safety.

We operate in alignment with FDA 21 CFR, USP, EP, JP, Annex 1, ISO, WHO, and other global standards.

Every engagement with us includes dedicated support, structured documentation, and secure portal access for full transparency.

Areas of Service

Progress from environmental qualification to product release with our structured tests that support confident decision-making and compliance at every stage.

Full Scale Microbiological and Chemistry Testing

Qualify cleanroom environments, utilities, and cleaning processes with structured validation studies that confirm disinfectant efficacy, sterilization performance, bioburden, presence of organic material, and sustained control of air, surfaces, and water systems.

Tests Offered:

Environmental Monitoring & Utilities

  • EM Plate Reading (Facility / Personnel Monitoring)
  • Full Scale Water Testing (WFI, RO, PW)
  • Process Water Testing
  • Total Organic Carbon (TOC) Testing
  • Conductivity Testing
  • Particulate Matter Testing
  • Particle/Fiber Count Determination
  • Microbial Immersion Studies
  • Bacterial Identification (16S rRNA)
  • Fungal Identification (ITS2)

AET and DET Studies

  • Antimicrobial Effectiveness Testing (AET)
  • Disinfectant Efficacy Testing (DET)
  • Cleaning Effectiveness Studies (CIP/COP Validation)
  • Process Cleaning Effectiveness Studies (CIP/COP Validation)

CIP/COP Validation

  • Process Cleaning Effectiveness Studies (CIP/COP Validation)

Sterilization Validation Support

  • VHPH H₂O₂ D-Value Studies
  • Biological Indicator (BI) Testing
  • Component Sterility (Autoclave/Heat/Gas/Gamma Radiation)

Product Quality & Release Testing

Support batch release and material qualification with coordinated microbiological and chemistry tests that confirm identity, purity, sterility, and specification compliance.

Tests Offered:

Microbiological Release Testing

  • Bioburden Testing
  • Endotoxin Testing
  • Sterility Testing
  • Total Aerobic Counts
  • Microbial Limits Testing
  • Bacterial Identification (16S rRNA)
  • Fungal Identification (ITS2)
  • Growth Promotion Testing

Analytical Chemistry Release Testing

  • High Performance Liquid Chromatography (HPLC)
  • Gas Chromatography (GC)
  • Fourier-Transform Infrared (FTIR)
  • pH Determination
  • Assay Determination (Titration – Burette/Potentiometric)
  • Identification of Inorganic Elements
  • Density and Specific Gravity Determination
  • Color Determination (Spectrophotometric)
  • Non-Volatile Residue Determination
  • Refractive Index Determination
  • Test for Free and Available Chlorine
  • Sorption Capacity Testing

Stability, Method Development, & Reporting

Design and execute stability studies and develop validated methods to support regulatory submissions and ongoing product lifecycle management.

Tests Offered:

  • Product Stability Testing
  • Ingredient / Component Stability Testing
  • Chemical Stability Testing
  • Microbiological Stability Testing
  • Method Development
  • Protocol Writing
  • Final Report Development
  • GAP Analysis Support

Looking for support in a specific area — or beyond what’s listed? Let’s talk.

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Frequently Asked Questions

Validation testing proves that a process consistently delivers the intended result under defined conditions. Release testing, on the other hand, confirms a specific batch meets quality specifications before distribution. Our microbiological testing services cover both, giving you a connected program that supports compliance from process qualification through product release.