Microbiology Services
fULL MICROBIOLOGICAL SUPPORT.
The ability to offer full microbiological support of sterile and non–sterile products, that's the Metrics difference.
THE METRICS DIFFERENCE
• A veteran staff of microbiologists
• Experience working with unique drug products requiring non–traditional handling and testing
• Water testing–filtration method
• Microbial limit testing
• Referree lab testing
• Autoclave validation support
• Water system validation support
MICROBIOLOGY TESTING FOR:
TESTING / ANALYSIS |
USP |
EP |
DETAILS |
Harmonized Microbial Limits |
<61> |
2.6.12 |
Ability to use compendial organisms and specific environmental isolates. Excipients, API and final dosage forms. Method development and validation services. |
Particulate Matter analysis |
<788> |
2.9.19 |
Light obscuration method using the Hiac Royco liquid particle counting system. Microscopy method using the Nikon Eclipse 400. Method development for highly viscous drug products and/or those containing color. Use-time and diluent compatibility studies. |
Bacterial Endotoxin |
<85> |
2.6.14 |
Gel clot method (qualitative method). Turbidimetric method (quantitative method) using the Associates of Cape Cod Pyros Kinetix test system. Method development and validation services. |
Antimicrobial Effectiveness |
<51> |
5.1.3 |
Ability to use compendial organisms and specific environmental isolates. Formulation development support of multi-dose products containing preservative systems. Method development and validation services. |
Sterility |
<71> |
2.6.1 |
Ability to use compendial organisms and specific environmental isolates. Formulation development support of multi-dose products containing preservative systems. Method development and validation services. Utilize the Steritest Equanox test system from Millipore. |
Antibiotic Assay |
<81> |
2.7.72 |
Cylinder plate method. Method development and validation services. |
Custom Water Testing |
Filtration and pour plate methods. Turbidity. Total organic carbon. Total coliform counts. |
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Environmental monitoring |
Incubation and enumeration of settling plates and contact plates. Plating, incubation and enumeration of swab samples. |
AND WHAT IT MEANS FOR YOU
• Your point of contact is a microbiology veteran from whom you’ll receive one-on-one consultation.
• Your project is conducted under complete quality GMP systems.
• You’ll receive timely, accurate results.
Ready to learn more? Click here to request more information, or to be contacted about your specific needs.
