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Medical devices are one of the largest industries driven by new technologies so that continual innovation and speed to market define success. Our scientists have extensive backgrounds in applications and environmental effects on materials, as well as infection control technologies for reusable medical devices.
Medical Devices & Combination Products
Focused on all aspects of product quality and safety, we can assist with validation in the following areas:
- Microbiology: antimicrobial efficacy and cleaning/disinfection validation
- Chemistry: raw material testing and verification
- Virology: viral clearance, viral inactivation, and viral claim support
- In-vitro Toxicology: bench and clinical studies to ensure the product is safe for human use
Medical Devices & Combination Products
Technical expertise in microbiology, chemistry, toxicology, virology, and molecular biology testing provides full-spectrum, single-source support to accelerate your time to market.
Microbac is ISO 17025-accredited, and GLP- and cGMP-compliant. We work with your company to adhere to the Quality System Regulation (QSR) and fulfill unique needs in medical device testing.
Animal Tissue-Derived Medical Devices
- Viral Inactivation (Viral Clearance) Studies
- Literature reviews
Blood Glucose Monitoring Systems (BGMS) and Other Blood Analyzers
- Viral Inactivation (Disinfectant Efficacy) Studies
- Robustness test
Viral Barrier Test for Condoms and Sheaths
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Face masks
- Antimicrobial and antiviral properties
- Filtration efficiency
Contact lens care products
- Microbes, virus and acanthamoeba
Endoscopes
- High Level Disinfectants for 510(k) submission
- Simulated use and in-use studies
In vitro Toxicology
- Quality Control for In Process and Release of Finished Products and Raw Materials (API and Excipients)
Stability Studies by ICH
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Conditions Available
- 25°C/60% RH
- 40°C/75% RH
- 30°C/65% RH
- 5°C
- -20°C
- Protocol Generation & testing or shipping of samples per timepoint
- Monitored with Alarms 24/7/365
- Automatic Emergency Power Back-up.
Chromatography
- HPLC coupled with DAD, UV, RI, conductivity or fluorescence detection.
- Ion Chromatograph coupled with conductivity detection.
- Gas Chromatography (headspace or direct) coupled with FID, TCD, ECD or FPD detection.
- TLC
Spectroscopy
- GC/MS
- ICP coupled with MS or OES
- AAS & AAGF
- FTIR
- UV/Vis
- Polarimeter
Microbiology
- Bacterial & Yeast Mold Plate Counts
- Antimicrobial Efficacy Testing
- Endotoxin Assay
Physical/Wet Chemistry
- Dissolution/Disintegration
- Kjeldahl Determinations
- Melting Point
- pH
- Refractive Index
- Specific Gravity
- Titrations: Manual, Autotitrator, Karl Fischer (Classical and Coulometric)
- TOC
- Viscosity: Capillary and Rotational
Special Projects
- Method Development & Validation
- Cleaning validation
- Process validation
Contact Us
Have questions or need expert testing solutions? Reach out to Microbac today, and let our team provide you with reliable and accurate testing services tailored to your needs. We’re here to support your business with trusted expertise.