Microbiology

Microbiology

We offer a comprehensive range of microbiology services with a strict adherence to cGMP requirements in support of your biopharmaceutical product, including testing of raw materials, cell lines, unprocessed bulk and final filled product.

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 departments 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 ensure contamination-free testing of your products.
  • Our Stability and Raw Materials testing teams work hand-in-hand with our Microbiology group to ensure a smooth transfer of process to downstream services should you choose to use us for supporting services.

Leadership of Group:

 

Mark Kaiser – Director 26 years with Lancaster Laboratories

Mike Yunginger – Manager, Non-Sterile Product Testing24 years with Lancaster Laboratories

Suzanne Williams – Manager, Sterile Product Testing22 years with Lancaster Laboratories

Harolyn Clow – Manager, Facility Validation and Monitoring17 years with Lancaster Laboratories

 

 
 

Testing Available

  • Mycoplasma
  • Sterility
  • Endotoxin
  • Particulate Matter
  • Bioburden

Equipment used:

  • La Calhene soft wall isolator system for sterility testing including two dual half suit workstation isolators, Three 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