metrics now offers microbiology testing
New $18–million facility addition doubles size of company’s footprint
GREENVILLE, N.C. – Metrics Inc. now offers microbiology-testing services to the contract pharmaceutical industry.
The new services stem from the company’s recent $18-million, 47,000-square-foot expansion that doubled its facility size and dramatically grew the company’s service capabilities to clients.
Metrics Inc., headquartered in Greenville, N.C., is one of the fastest-growing contract pharmaceutical development laboratories in the United States. Metrics provides quality pharmaceutical formulation, clinical trial material (Phase I, II and III) and commercial manufacturing, and analytical development/validation services to the pharmaceutical industry.
“Offering our clients all the services they need under one roof has been a long-time goal for us,” said Phil Hodges, president. “We’re glad we can add value to the relationships we’ve developed with our clients, and know these services will make Metrics even more competitive when it comes to attracting new clients.”
As part of its new microbiology laboratory, Metrics has brought antibiotic assay and sterility testing online, enhancing its ability to offer full microbiological support of sterile products. The company routinely performs bacterial endotoxin and particulate matter testing on parenterals.
(For details about the new services, please see the table below.)
Metrics’ facility addition also includes four new fully operational analytical laboratories, validated and ready to handle projects; stability storage with state-of-the-art environmental specialties chambers complete with redundant mechanical systems and strictly limited personnel access; and a dedicated cytotoxic and potent compound laboratory.
TESTING / ANALYSIS |
USP |
EP |
DETAILS |
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. |
||
Environmental monitoring |
Incubation and enumeration of settling plates and contact plates. Plating, incubation and enumeration of swab samples. |
In addition to the above services, Metrics offers specialty services including:
- Expertise working with unique drug products requiring non-traditional handling and testing.
- Referee lab testing.
- Water activity testing.
- Autoclave validation support – incubation of biological indicators and assistance with cycle development.
As part of its expansion, Metrics is increasing staff, adding at least 50 pharmaceutical scientists and technicians. For more information about Metrics, visit www.metricsinc.com
