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November 27, 2007
Dear Colleague,
Thank you for reading NAMSA's UPDATE
Newsletter!
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Enjoy!
In this Edition
(Click the headline to go directly to the
article):
What Can NAMSA Chemistry Do For
You?
NAMSA Continues to
Expand
Helping Clients Bring New Sterilization Processes to
Market
FDA’s Position on Reporting of Strength, Purity and
Composition
Change Notifications Associated with NAMSA’s
Products
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What Can NAMSA Chemistry do for you?
NAMSA’s Chemistry departments have years of
experience performing testing by well established methods of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), Japanese
Pharmacopoeia, ISO, ASTM and other recognized compendial methods. Utilizing these and other custom designed methods, we have a
rich history in testing a variety of medical devices and pharmaceutical containers and closures. In addition, we are a dynamic
lab, able to adjust and adapt to help solve problems and provide answers.
Package performance testing is one area of
Namsa’s chemistry offerings. Used to evaluate the performance of package materials after exposure to manufacturing and distributing processes,
this testing ensures the sterility and integrity of the package is maintained through the entire process. Utilizing ASTM guidance,
testing can be performed for vacuum leak, bubble emission, dust drum, seal peel and many other methodologies. We also offer
testing of ethylene oxide residuals, including the break down products of ethylene chlorohydrin and ethylene glycol.
Namsa began chemically characterizing materials in the
mid-1990’s, years before ISO 10993-18 was issued. Through the use of extensive extraction techniques, and chromatography
capabilities, we are able to provide detailed information regarding the extractables found in medical device materials. In
addition, this information can be used to develop and validate methods to ICH guidelines specific to your product, and provide leachable data for
submission, or show the equivalency between two materials.
Some of the equipment/techniques available to aid in
problem solving:
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Gas Chromatograph (FID and Mass Spectroscopy)
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High Performance Liquid Chromatography (UV, Refractive
Index and Mass Spectroscopy)
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FTIR Spectrometer
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Inductively Coupled Plasma Optical Emission
Spectroscopy (ICP-OES)
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UV-Vis Spectrophotomer
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Viscometer (Brookfield and Capillary)
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Durometer (Shore A &D)
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Osmometer
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HACH Light Obscuration Particle Analyzer
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Phoenix Dohrman TOC Analyzer
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Refractive Index
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Melting Point
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Instron
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Burst/Creep tester
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Vacuum leak chamber
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Gurley Porosity
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NAMSA Continues to Expand
NAMSA has recently moved our sales office to a permanent location within
a business district, knew as a new technology incubator, in Tokyo, Japan. This new location highlights NAMSA’s growing commitment to the
Japanese market and confirms our presence within this region for our clients.
In 2005, NAMSA began offering the validated test methods required by the Japanese Ministry of Health Labor and Welfare (JMHLW) for regulatory submissions in Japan.
Mr. Fumiyoshi Sayama will be managing the new sales office. Mr. Sayama
joined NAMSA’s direct sales force in 2006 and has extensive experience with NAMSA’s offering and the medical device industry.
With NAMSA’s experience and the excellent sales leadership offered by Mr. Sayama,
we can advise our clients in pre-clinical study design according to JMHLW regulation.
Our new sales office is located at:
NAMSA Japan
Sun-World BLD. 2F,
1-2 Hakozakicho,
Nihonbashi, Chuo-ku, Tokyo 103-0015
Japan
Telephone: 81-3-5642-1741
Fax: 81-3-5642-1742
For more information on our new Japanese location or the JMHLW
requirements and regulations contact NAMSA at info@namsa.com. If located in Japan, please contact Mr. Sayama directly at 81-090-7805-3154 or via email at fumiyoshisayama@gmail.com.
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Helping Clients Bring New Sterilization Processes to Market NAMSA R&D for Hire is in
the unique position to provide guidance and laboratory support to clients who have new sterilization processes that they want to bring to market
either domestically or elsewhere in the world. NAMSA R&D for Hire understands the requirements and can help clients characterize
the safety and efficacy of their process and develop the extensive body of data necessary for regulatory submissions (FDA 510(k), European Notified
Body, Japanese Ministry Health Labor and Welfare, etc.).
NAMSA also has extensive
expertise in the development of biological and chemical indicators (BI & CI) which are critical to the validation and routine monitoring of a
sterilization process. This combination service of helping to develop BIs & CIs along with characterization of the new
sterilization process is not offered by NAMSA contract lab competitors or by other BI or CI manufacturers. Because of how closely
BI & CI development is tied to sterilizer development and characterization, there is significant benefit to working with NAMSA who can do it
all.
NAMSA R&D for Hire can
draw upon resources in NAMSA Advisory Services, as well as upon resources in our internal disciplines of Chemistry, Microbiology and Toxicology (both
in vitro as well as in vivo) to help our clients with their sterilizer development needs.
There are numerous
guidance documents available for reference on the subject of developing new sterilization processes and these documents are constantly undergoing
revision; NAMSA Associates actively participate in the standards development organizations responsible for the revision process so we are up-to-date
on the latest requirements necessary to bring a sterilization process to market.
NAMSA R&D for Hire has
valuable experience helping our clients develop various sterilization technologies and we’re ready to apply our knowledge and experience to
your process to help you get it done correctly and quickly. Please give us a call to discuss your project needs.
Contact Dr. Joel Gorski at 419-662-4395.
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FDA’s position on reporting of Strength, Purity and Composition
A common dilemma when contracting non-clinical GLP studies, is acquiring strength, purity and
composition data for test articles. It is realized that this data is not always readily available. It is further understood that
this data requires strict confidentiality to preserve company trade secrets and proprietary formulations. However, the FDA has
taken a clear stance on the Testing Facility and Study Director’s Responsibilities with respect to this information.
Are Medical Devices subject to the analysis of strength, purity, and composition or is the
standard written for pharmaceuticals?
This was challenged back in 1978 and the FDA communicated that this section of the regulation
does apply to non-clinical device studies. They also clarified that the purpose is to assure that the test or control article being
tested has been thoroughly characterized are defined and that the testing facility has a thorough understanding of what is being tested.
In recent FDA communications, the Department of GLP and Bioequivalence has made it clear if
dosing formulations lack stability, strength and purity data, no determinations on the test article can be made. The FDA has written multiple Warning
Letters, dating back to 2001 through the present, for this issue. Below is an example of a recent citing issued regarding this GLP
requirements.
06/25/2007 Company Name Omitted. The statement in the final report that
purity and composition of the test article were determined by the sponsor is not adequate to satisfy the requirement that the final report contain
the actual characteristics of the test article.
NAMSA requires information related to the strength, purity and composition of every test
article. The purpose in obtaining this information is to assure that the article being tested has been thoroughly characterized or
defined and that the sponsor and the testing facility has a thorough understanding of what is being tested. This provides for
device characterization suited to their identity or uniqueness.
For additional information on the regulations that govern obtaining this information, please
see 21 CFR Part 58, Sec. 58.31 Testing Facility Management, Sec. 58.105 Test and control article characterization and Sec. 58.185 Reporting of
non-clinical laboratory study results.
To obtain a copy of a matrix detailing categories of medical devices and explanations of what
information related to strength, purity, and composition is required, or if you have any questions on this topic, please feel free to contact your
Study Director or Technical Sales and Services at 1-866-666-9455.
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Change
Notifications Associated with NAMSA’s Products
In effort to continuously improve
our Products and expand our offering, NAMSA will make or has made some recent changes to select product configurations. NAMSA will utilize the Update
Newsletter as a tool to more effectively provide notification to our clients when changes are planned or occur. If you have a suggestion for a product
enhancement or expansion to our offering, please let us know through info@namsa.com.
Increased Convenience in Media Growth Promotion Testing
Each of the 12 different organisms
in our Growth Promotion product line is now conveniently available in two configurations: a 100 dose (10 ml) suspension and a new 25 dose (2.5 ml)
suspension. The new smaller volume allows for more efficient use of the suspension within the expiry period for the end user with low or fluctuating
needs for a particular Growth Promotion Test Suspension organism.
In addition to the new smaller
sized configuration, an improved single piece screw cap and septum which allows for access using a syringe or pipette without leakage during shipment
or storage has been validated for both the 10 ml and 2.5 ml configurations.
The ready-to-use microbial
suspensions meet the United States Pharmacopeia (USP) and ISO 11138 requirements for media performance testing. The Growth Promotion Test Suspensions
require no reconstitution or dilution prior to use with the following organisms being offered:
- Aspergillus niger
- Bacillus atrophaeus
- Bacillus subtilis (subspecies spizizenii)
- Candida albicans
- Clostridium sporogenes
- Escherichia Coli
- Geobacillus stearothermophilus
- Kocuria rhizophila (formerly known as Micrococcus luteus)
- Pseudomonas aeruginosa
- Salmonella enterica (subspecies enterica)
- Staphylococcus aureus (subspecies
aureus)
Improved Ethylene Oxide
Chemical Process Indicators
In response to client
feedback, NAMSA will be implementing a change in our EO ink formulation used for production of Chemical Process Indicator product codes CPI-E01,
CPI-E02, CPI-E03 and custom label product codes SP-E01 through SP-E07. Upon receipt of these product codes, no visual difference will be noted as the
ink color transition will remain violet to green.
Modifications to the ink
formulation were made to address concerns related to the signal color of the indicators after exposure when utilized in cycles with lower levels of
humidity. Varying shades of green, tan or gray were being obtained. The ink formulation was adjusted to transition more completely in cycles with
humidity levels less than 50% in response to feedback and cycle parameter information supplied by clients.
The improved indicators are ISO
11140-1:2005 Class 1 compliant. For a sample of the improved EO indicators, please contact Products Customer Service at
1-800-860-1888 or submit a request through productorders@namsa.com .
Reduced
Incubation Period and Elimination of Potential Aseptic Transfer Issues
NAMSA now offers Self-Contained
Biological Indicators (SCBIs) for monitoring Steam and Ethylene Oxide (EO) sterilization processes. While SCBIs are not new to the sterilization
industry, the sturdy construction, easy to read media color transition and reduced incubation period are sure to be a cost effective and convenient
monitoring system for many users.
NAMSA’s SCBIs are similar
in size to those currently available on the market, thus can be used with most existing incubators.
Steam SCBIs are offered in two
convenient population levels, 105 and 106, with an incubation period of 24 hours. EO SCBIs are offered in a 106
spore concentration and incubation period of 48 hours.
Contact Products Customer Service
at 1-800-860-1888 or productorders@namsa.com to request more information on NAMSA’s
SCBIs or to obtain a copy of our Reduced Incubation Time (RIT) Summary Report.
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