consistent. accurate. timely
TRANSCRIPT
Sterility Assurance and Microbiology Services
Consistent. Accurate.Timely.We’re with you from start to finish.
Single Source Capability and Technical Insights
NAMSA’s testing and consulting capabilities include all areas of microbiological quality control. Our well-equipped facilities include laboratories for microbiology and sterility testing as well as aging chambers. In addition to sterility assurance programs, we perform:
When it comes to lot release and environmental testing, you need accurate results with predictable throughput, every time. NAMSA delivers the highest quality testing to ensure you get the answers you need when you need them - all from one resource.
NAMSA’s MRO™ approach to consulting and testing ensures you have a coordinated team of experts attending to your needs. With our breadth of consulting expertise, we look for ways to save even more time and reduce the overall amount of testing if possible. Our technical specialists partner with you to develop a cost-effective program, applying more than 45 years of experience in medical device safety and regulatory compliance for your benefit.
COMPREHENSIVE STERILITY ASSURANCE PROGRAM
Sterilization Validation
Studies are performed
for all processes, including
radiation sterilization by
either gamma radiation or
electron beam, ethylene
oxide gas sterilization,
hydrogen peroxide
sterilization and thermal
sterilization (both moist
and dry heat).
At NAMSA, we’re known
for our ability to design
custom protocols that not
only meet your testing
budget, but are backed by
a complete documentation
package that fulfills all
necessary regulatory
requirements.
Testing includes:
• Bioburden & Recovery Validation
• Bioburden Characterization
• Dose Verification Experiments
• Biological Indicator Sterility Tests
• Fractional And Half-Cycle Studies
• Pharmacopoeia Sterility Tests
• Bacteriostasis/Fungistasis
• EO Cycle Development
• Growth Promotion
• EO Residual Testing
• Monitor/Notify Of Dose Audits
• Antimicrobial Testing
• Bacterial Endotoxin (LAL)
• Biological Indicator Performance Testing
• Cleaning Efficacy Studies
• Comparative Resistance Studies
• Disinfection Studies
• Immersion Studies
• Microbial Identification
• USP 61 and 62 (Microbial Limits)
• Bioburden
• Reusable Device Studies (cleaning, disinfection, & sterilization)
• Test Development
• Neutralization Validation
• Growth Promotion
• Aseptic Sample Item Portion (SIP) Preparation
• Particulate Testing
• Environmental Monitoring
STERILIZATION MONITORING PRODUCTS
Known for their consistent, reliable performance, NAMSA sterilization monitoring products are used by pharmaceutical and medical device manufacturers, contract sterilizers, and other related industries.
NAMSA's sterilization monitoring product line includes:
• Biological Indicators• Chemical Indicators• Quality Control Organisms/Growth Promotion
To view our complete product catalog, please visit www.namsa.com and search: sterilty assurance products
COMPREHENSIVE STERILITY ASSURANCE PROGRAM
Packaging Validation and Shelf Life Testing
are essential components
of your sterility assurance
program. These tests
ensure that sterility is
maintained when a device
is sealed in a package until
expiration.
We can assist you with
all the testing associated
with materials qualification,
equipment qualification
and process qualification.
Testing includes:
• Accelerated Aging (ASTM F1980)
• Barrier Properties (ASTM F1608)
• Bubble Emission (ASTM D3078)
• Burst Testing (ASTM F1140)
• Dye Penetration (ASTM F1929)
• Gurley Porosity
• Restrained Burst (ASTM F2054)
• Seal Tensile Strength (ASTM F88)
• Sampling Plans
• Shipping Simulation (ASTM F4169)
• Vacuum Leak (ASTM E515)
• Visual Inspection (ASTM F1886)
• Liquid Microbial Immersion
Environmental Monitoring is performed
to meet the requirements
of quality system regulation
when such an environment
can influence the pre-
sterilization bioburden level
or resistance on a device.
Our experts will make sure
that you are conducting
an appropriate amount
of sampling to suit your
Environmental Monitoring
needs. We can provide
you with a protocol, track
your data, and document
results that will be the
underlying support of your
entire sterility assurance
program.
Testing includes:
• Viable Air Sampling
• Microbial Identification
• Airborne Particle Counts
• Surface Sampling
• Water Testing
• Personnel Monitoring
• Bioburden
• Data Handling & Analysis
North American Science Associates, Inc. © 2013; Printed in the USA. 04/13
The MRO™ ApproachRegulatory strategy, testing services and clinical research all support the medical product development process. These services must be available when needed, either individually or collectively depending on the stage of the product development process. With NAMSA’s MRO™ approach to testing and consulting, you maintain project control while gaining the benefit of on-demand external support-whether it’s to extend your in-house capabilities or access specialized expertise at exactly the right time. We’ve assisted numerous companies from around the world in bringing their great ideas to the patients who need them. We know you’re passionate about developing and producing safe, effective and compliant medical products for global markets so we’ve designed our services, trained our people and maintained our facilities to get you there.
You deserve the best knowledge, integrated services and flawless execution in your chosen partner. NAMSA’s ready.
OUR SERVICES
Regulatory and Quality Systems ConsultingResearch and Development SupportNon-Clinical TestingClinical ResearchPost-Market Support
World Headquarters6750 Wales Road Northwood, Ohio 43619 USA
Telephone:+1.866.666.9455 (toll free)+1.419.666.9455 (outside of USA)+1.419.662.4386 (fax)
For more information and a listing of locations worldwide, visit www.namsa.com.
Everything we do must be in our clients’ best interests.”Ted Gorski, NAMSA FounderNAMSA’s commitment
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