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Microbiology

Metrics Contract Services’ staff of highly trained microbiologists offers diverse capabilities to support your sterile, non-sterile, and/or preserved product lines:

  • Method development
  • Validation
  • Routine testing capabilities 

The experience to think outside the box.

Metrics Contract Services has extensive experience working with unique drug products requiring non–traditional handling and testing. Whether identifying foreign material to prevent a product recall, or to designing unique bioburden analyses, our staff is prepared to think outside of the box to help solve your problems. 

Compendial analyses

Compendial analyses are our most requested services and include:

  • Pharmaceutical water testing
  • Bacterial endotoxin
  • Sterility
  • Particulate matter
  • Microbial limits
  • Antimicrobial effectiveness
  • Microbiological potency assays 

Microbiology Testing Capabilities

Microbial Limits Testing:

(harmonized USP  <61> & <62>)

  • Quantitative evaluation of sample bio-load including bacterial and fungal organisms
  • Qualitative evaluation for presence/absence of pathogenic organisms
  • Non-sterile dosage forms: solids, liquids, powders, emulsions, and suspensions
  • Non-sterile excipients and empty capsule shells

Antimicrobial Effectiveness Testing:

  • Demonstration of preservative system effectiveness by challenging final products with high levels of bacterial and fungal organisms
  • Sterile and Non-sterile preserved drug products: Nasal sprays, ointments, creams, ophthalmics, otics, injectables, and inhaled products

Particulate Matter Testing:

  • Evaluation of undissolved particles in sterile liquid drug products intended for injection
  • Light Obscuration Method utilizing the Hiac Royco Liquid Particle Counting System
  • Microscopy Method utilizing the Nikon Eclipse Microscope

Bacterial Endotoxin Testing:

  • Detection of endotoxin present in sterile products and excipients intended for sterile products
  • Quantitative Turbidimetric Method utilizing the Pyros Kinetix turbidimetric tube reader
  • Qualitative Gel Clot Method

Other Microbiological Testing includes:

  • Sterility Testing - for ampoules, vials, and intravenous bags utilizing the Millipore Equinox Steritest System
  • Antibiotic Assay - for potency determination of antibiotics and antifungals utilizing the Cylinder Plate Method
  • Water Testing - including total coliform counts, total heterotrophic counts, turbidity, conductivity, and total organic carbon
  • Water System Validation Services - including USP Purified Water Systems, USP Sterile Water Systems, and Deionized Water Systems