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GIVE YOUR DEVICE A HEALTHY START

Microbiology and Reusability Validation

Explore everything from reusable device validations, packaging integrity testing and manufacturing support testing to antimicrobial/preservative testing effectiveness, microbial ingress and in-lot release programs.

50+ years of cumulative microbiology experience

In-lot release programs include testing to confirm sterility, the absence of bacterial endotoxin and device bioburden levels

Tailored design for successful global submission

What is microbiology in the medical device industry?

Microbiology testing of medical devices involves identifying the presence and risk of microbial contaminants. If not properly addressed, microbial contamination can cause serious threats to both personal and public health.

When you need to develop an effective microbiological testing strategy, count on our decades of experience. We’ll customize the right microbial assessments for your product that fulfill regulatory requirements. All of our studies are backed by a complete documentation package and are performed with a focus on quality with quick turnaround times.

doctor working in hospital laboratory

Get a full testing strategy tailored to your product’s needs

Our testing portfolio covers reusable device validations, packaging integrity testing, manufacturing support testing, antimicrobial/preservative testing effectiveness, microbial ingress or in-lot release assays including presence of bacterial endotoxin, sterility assurance and bioburden levels. You’ll find Labcorp has the specialized knowledge, resources and capabilities to deliver strategic microbiology testing solutions that move your device or combination product forward.

A team of doctors looking at some lab results together on monitors, in an office at the hospital.

Microbiology and reusability validation services:

  • Customized microbial assessments 
  • Device reusability validation
    • IFU consultation & optimization
    • Pilot reprocessing efficacy studies
    • Manual Cleaning Validation
    • Low / Intermediate / High Level Disinfection Validations
    • Gravity Displacement Steam Sterilization/dry time validation
    • Dynamic Air-removal (pre-vacuum)
    • Sterilization validation / dry time validation
    • Cleaning validations and life cycle conditioning
    • Shelf life/life cycle
  • In-lot release testing
    • Bioburden (aerobic, anaerobic, yeast/molds, spore formers
    • Microbial identification (Gram stain and identification)
    • Bacterial Endotoxin (USP <85> LAL)
    • USP and AAMI Sterility Testing
  • Environmental monitoring
    • Water samples - Heterotrophic plate count (HPC)
    • Surface samples and air settling samples - Environmental Monitoring
  • Packing integrity and validation
  • Ingress testing (microbial, viral, dye)
  • Microscopic particle count testing
  • Sterility Testing and Method Suitability
  • Mycoplasma spp. detection
  • Compendial testing
  • Antimicrobial challenge
  • Antimicrobial testing (preservative effectiveness, microbial limits, time kill, anti-adherence, animal models of infection, zone of inhibition, minimum inhibitory concentration, etc.)
  • Reusable IFU review/generation
Spraying disinfection on surface.

Space

By the Numbers

~6,000

preclinical medical device studies conducted per year
150+

highly experienced preclinical medical device specialists
10+

average years of experience per specialist

Choosing the right test for your prescription drug monitoring needs

We know that your medical device or combination product has the potential to bring greater outcomes to patients in need. That’s why we share your urgency to advance your medical devices and combination products. Whatever your goals and milestones, we’ll help you reach them on time. From developing clear road maps to communicating proactively, we work with speed and efficiency at every turn to keep pace with your important milestones.

You may also be interested in:

Medical professional working on IV fluids

Together, we can give your device a healthy start. Let’s start the conversation.

Contact Us
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Labcorp is a leading global life sciences company that includes contract research and developmental services to the pharmaceutical, medical technology, crop protection and chemical industries.

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