Pharmaceutical Facility Validation

Facility Validation

We offer a comprehensive range of microbiology and chemistry capabilities in support of your facility and process validation projects—all performed in strict adherence to cGMP requirements.

Why Lancaster Laboratories?

  • We have completed more than 200 facility validation projects for pharmaceutical manufacturers, biopharmaceutical companies, pilot plants, API manufacturers and tissue processors. You will be working with experts who are experienced in fulfilling the validation needs of your work with the flexibility to handle the specifications that make your project unique.
  • We offer outstanding service and flexible options in sample collection with daily sample courier service in the U.S., pick-up and analysis of samples on weekends (with advance arrangements by the client).
  • Our staff of more than 40 employees is the largest in the industry, and with unmatched laboratory capacity, we are capable of handling multi- and large-volume projects while consistently meeting your needs for rapid results on turnaround time.

Leadership of Group:

 

Mark Kaiser – Director26 years with Lancaster Laboratories

Harolyn Clow – Manager19 years with Lancaster Laboratories

 

 
 

Testing available:

  • Process Water Testing
  • Environmental Monitoring
  • On-site Sample Collection
    • Viable Air Sampling
    • Non-viable Air Sampling
    • Compressed Gas Sampling
    • Process Water Sampling
    • Clean Site Sampling
    • Surface Sampling
  • Cleaning Validation & Consulting
  • Disinfectant Efficacy Testing
  • Biological Indicator Incubation and Enumeration
  • Endotoxin Indicator Preparation and Testing

Instrumentation used

  • 9000 square foot limited access controlled microbiology laboratories include HEPA filtration and validated cleaning, disinfection and monitoring programs
  • GC-based microbial identification system
  • Qualicon Riboprinter Microbial Identification System
  • MicroSeq® Microbial Identification System
  • SMA Portable Viable Air Samplers
  • Met One Laser Non viable Air Samplers