Microbiology Services | Laboratory Testing Services

Microbiology

We offer a comprehensive range of microbiology services in support of both sterile and non-sterile products, as well as facility monitoring and control. Whether you need microbial limits tests on a raw material or sterility testing on your parenteral, our knowledgeable professionals meet your needs with a strict adherence to cGMP requirements and a firm commitment to client service. With our seamless project management, our facilities become an extension of your own in-house laboratory.

Why Lancaster Laboratories?

  • We have been a pioneer in the micro outsourcing industry for over 20 years, offering you experience that includes more than 3,000 product validations and more than 1000 sterility tests performed each year using isolator technology.
  • We have one of the largest Microbiology groups in the industry with more than 40 employees, assuring that you will have the resources necessary to complete your project quickly and effectively.
  • Our state-of-the-art controlled and HEPA filtered microbiology laboratory facilities insure contamination-free testing of your products.
  • We have an outstanding regulatory track record.

Leadership of Group:

 

Mark Kaiser – Director26 years with Lancaster Laboratories

Mike Yunginger – Manager24 years with Lancaster Laboratories

Suzanne Williams – Manager22 years with Lancaster Laboratories

Harolyn Clow – Manager17 years with Lancaster Laboratories

 

 
 

Testing available:

  • Sterility
  • Endotoxin
  • Particulate Matter
  • Microbial Immersion Studies
  • H2O2 D-value Studies
  • AAMII Sterilization Validation
  • Media Fills
  • Microbial Limits
  • Antimicrobial Preservative
  • Effectiveness
  • Bioburden Studies
  • Water Activity
  • Process Water Testing
  • Environmental Monitoring
  • Disinfectant Efficacy Testing
  • Biological Indicator Analysis
  • Organism Identification
    • Fatty Acids Analysis (FAME)
    • Mold Identification
    • Sequence Analysis (MicroSeq®)
    • Ribotyping

Instrumentation used

  • La Calhene soft wall isolator system for sterility testing including 2 dual half suit workstation isolators, 3 transfer isolators and one autoclave interface isolator
  • Millipore Integral Steritest™ systems for membrane filtration sterility testing
  • Steris VHP® 1000 systems for isolator decontamination
  • GC based microbial identification systems (MIS)
  • Qualicon Riboprinter Microbial Identification System
  • MicroSeq Microbial Identification System
  • HIAC Liquid Particle Counting System and PharmSpec software
  • Endoscan V system for kinetic turbidimetric/chromogenic endotoxin testing
  • Aqualab Water Activity Meter
  • 15 Biosafety cabinets – capable of handling biosafety level 2 materials
  • 9000 square foot limited access controlled microbiology laboratories include HEPA filtration and validated cleaning, disinfection and monitoring programs