Microbiology

Microbiology

Test Articles

We offer services in support of these test articles.

 
 

Microbiology

Lancaster Laboratories offers a comprehensive range of microbiology services with a strict adherence to cGMP requirements in support of sterile and nonsterile facility monitoring for biopharmaceuticals, including raw materials, cell lines and unprocessed bulk testing.

Why Choose Lancaster Laboratories?

  • We have been a pioneer in the microbiology outsourcing industry for over 20 years, offering you experience that includes more than 3,000 product validations and more than 1,000 sterility tests performed each year using isolator technology.
  • We have one of the largest Microbiology Departments in the industry, 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 ensure contamination-free testing of your products.

Leadership of Group:

 

Mark Kaiser – Director Nearly 30 years with Lancaster Laboratories

Mike Yunginger – Manager, Non-Sterile Product TestingOver 25 years with Lancaster Laboratories

Suzanne Williams – Manager, Sterile Product TestingNearly 25 years with Lancaster Laboratories

Harolyn Clow – Manager, Facility Validation and MonitoringOver 20 years with Lancaster Laboratories

 

 

Testing Available

  • Mycoplasma
  • 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



    Contact

    Request additional information to start working with us today. Or call one of our Business Development Specialists at 717-656-2300.

Equipment Used

  • MicroSeq® Microbial Identification System
  • Qualicon Riboprinter Microbial Identification System
  • GC-based Microbial Identification Systems
  • La Calhene soft wall isolator system for sterility testing, including three dual half-suit workstation isolators and three transfer isolators, as well as a Skan PSI-M Isolator with Sara-M Airlock
  • Class A/B Cleanroom
  • Millipore Integral Steritest™ systems for membrane filtration sterility testing
  • Steris VHP® 1000 systems for isolator decontamination
  • HIAC Liquid Particle Counting System and PharmSpec software
  • Endoscan V system for Kinetic Turbidimetric/Chromogenic Endotoxin Testing
  • Aqualab water activity meters
  • 15 Biosafety cabinets – capable of handling Biosafety Level 2 materials