RJ Lee Group’s Quality, Validation and Compliance Solutions Highlighted at INTERPHEX 2007


RJ Lee Group, Inc., a leader in pharmaceutical and biotechnology problem solving, showcases its complete range of analytical laboratory and consulting services at INTERPHEX in New York City, April 24-26, 2007.

RJ Lee Group’s Quality, Validation and Compliance Solutions Highlighted at INTERPHEX 2007
Pharmaceutical/Biotechnology/Medical Device Site Expansion Unveiled

 

PITTSBURGH RJ Lee Group, Inc., a leader in pharmaceutical and biotechnology problem solving, showcases its complete range of analytical laboratory and consulting services at INTERPHEX in New York City, April 24-26, 2007. RJ Lee Group will be located at booth #937.

Competitive and technological changes in the pharmaceutical and biotechnology industry are reshaping the business strategies of many companies. RJ Lee Group, an FDA registered laboratory, has learned what services work best in the development process for those that are successful. Mr. Dave Exline is the Director of Pharmaceutical /Biotechnology Services and Mr. Steve Schlaegle is the Director of Biomedical Services. Our scientists are experts in the following laboratory services:

  • Particle Contamination / Source Determination
  • Out of Specification Investigations
  • Defect Analysis
  • High Resolution Particle Imagine (FE-SEM)
  • Automated Particulate Analysis (Raman LPE and SEM/EDS)
  • Medical Device Wear Debris Analysis

RJ Lee Group has the knowledge and capabilities to fit the growing needs of the pharmaceutical industry. Our technical staff has a proven track record of using the latest laboratory techniques to evaluate products and processes. Detailed reporting and adherence to the highest quality standards are core practices to all laboratory and business functions. At our headquarters facility in Monroeville, PA, we specialize in pharmaceutical materials characterization, particulate contamination analysis, particle sizing and high resolution microscopy. Our experts use a variety of instrumental techniques: FE-SEM, SEM/EDS, FTIR, XRD, XRF, ICP-MS, ICP/AES, TEM, GC/MS, HPLC, IC, and other services including Raman Spectroscopy in Pittsburgh, PA.

RJ Lee Group has expanded its pharmaceutical/biotechnology services to its newest facility in Waynesburg, PA. This laboratory includes a Liquid Particle Count System, a Liquid Particle Explorer and a Personal Scanning Electron Microscope, along with a state-of-the-art Class 100 clean room facility. There is an increasing need for clean room technology in the pharmaceutical and biotechnology industries. The focus of concern in the pharmaceutical industry is on contamination, wherein the biological activity of viable particles such as bacteria and viruses may cause the final pharmaceutical product (tablets, capsules, packaged liquids and parenterals) to have unintended side-effects.

Medical devices must be evaluated under intended service conditions to determine their performance. To meet FDA requirements, RJ Lee Group uses its extensive instrumentation and industry experience to develop customized solutions to problems. Medical product evaluation includes:

  • Protocol Development
  • Published Standards Testing
  • ASTM 1877
  • USP 788
  • Design Analysis and Review
  • Element Analysis
  • In-process Test Development
  • Failure Analysis
  • Design Verification

RJ Lee Group is an innovative environmental and materials characterization company that excels in the analysis of materials using chemical and microscopy techniques. Headquartered at an 80,000 sq. ft. facility in Pittsburgh, PA, the Company employs more than 250 people at six locations nationwide. The multi-disciplined technical staff consists of pharmaceutical and materials scientists, forensic experts, geologists, mineralogists, engineers, chemists, physicists, environmental scientists, biologists, computer scientists and information specialists.

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