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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