Facility Validation

Facility Validation

Facility Validation

Lancaster Laboratories offers 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 Choose 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. and pickup and analysis of samples on weekends (with advance arrangements by the client), as well as development validation services, utilizing various equipment dependant upon project needs.
  • Our Facility Validation Team 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 turnaround time and results.

Leadership of Group:

 

Mark Kaiser
DirectorNearly 30 years with Lancaster Laboratories

Harolyn Clow
ManagerOver 20 years with Lancaster Laboratories

 

 
 

Testing Available

  • Process Water Testing (EP/USP/JP/BP)
    • Total Aerobic Microbial Count (membrane filtration or pour plate)
    • Endotoxin Testing
    • Total Organic Carbon Testing
    • Conductivity Testing
    • Nitrate Testing
    • Heavy Metals Testing
    • EU Directive Testing on Drinking Water
    • Total Coliform/Fecal Coliform Testing (source water)
  • Environmental Monitoring
  • On-site Sample Collection
    • Viable Air Sampling
    • Non-viable Air Sampling
    • Compressed Gas Sampling
    • Process Water Sampling
    • Clean Steam Sampling
    • Surface Sampling
  • Cleaning Validation & Consulting
  • Disinfectant Efficacy Testing
  • Biological Indicator Incubation & Enumeration
  • Endotoxin Indicator Preparation & Testing
  • Method Development & Validation

Contact

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

Instrumentation Used

  • MicroSeq® Microbial Identification System
  • Qualicon Riboprinter Microbial Identification System
  • GC-based microbial identification system
  • 18,000-square-foot, limited-access-controlled microbiology laboratories include HEPA filtration and validated cleaning, disinfection & monitoring programs
  • SMA Portable Viable Air Samplers
  • Met One Laser Non-viable Air Samplers
  • HPLC, GC, TOC, ICP-OES, NVR for testing swab & rinse samples for residual product, raw material, or cleaning agents.