Frequently Asked
Questions
Following are a list of frequently asked questions about our products and
services. If you have questions that are not answered here, please contact
us by phone, fax or email per the information above.
1. How popular is ethylene oxide sterilization?
Approximately half of the medical devices in the USA are sterilized with EO
gas. It is almost 100 year old technology, which has been perfected
through the use of microprocessor technology. No other gas even comes
close to replacing it. It is inconceivable that a government regulation
would ever ban the use of pure ethylene oxide. In doing so, the government
would create a mass health hazard as well as economic crisis. Many devices
simply cannot be sterilized by any other means. The two areas in which the
EO process can be optimized are parametric release and reduced residues.
Mid-infrared spectroscopy allows simultaneous real-time measurement of EO and
water vapor concentrations. This permits product to be release
parametrically. Validating low concentration cycles, better control of
water vapor inside the sterilizer, and post evacuation optimizations can
drastically reduce chemical residues and therefore reduce turnaround times.
2. What is parametric release and how real is it?
Parametric release is the release of product to market following a review of
complete physical processing data rather than the use of incomplete data and
biological monitoring results. All parameters that were directly monitored
before are still monitored. In addition, the user must analyze the
headspace concentrations of water vapor during conditioning, and ethylene oxide
during sterilant dwell. It requires the user to install a gas analysis
system to sample the headspace. The international community first accepted
parametric release in 1994. The requirements for releasing product
parametrically are given in the US recognized ANSI/AAMI/ISO 11135-1994, and in
the European standard EN-550: 1994. Both of these documents are to be
replaced by a single updated ISO 11135.
3. Does the FDA allow parametric release?
The FDA recognizes ANSI/AAMI/ISO 11135-1994 as an acceptable EO sterilization
standard. This standard gives the requirements for parametric
release. In addition, the Association for the Advancement of Medical
Instrumentation (AAMI) formed a Task Group to write a Technical Information
Report (TIR) in 1997 to furnish complete guidance for parametric release. AAMI TIR
20:2001 Parametric Release for Ethylene Oxide Sterilization has been published
and is available by contacting AAMI. Paul J. Sordellini, Vice President of
Quality Assurance & Sterilization Operations at NASP, is a corporate voting
member of the AAMI Industrial Ethylene Oxide Sterilization Working Group. Paul
is also a co-author of the AAMI Parametric Release TIR and can guide clients
through the validation. In TIR 20:2001we attempt to
answer the main questions that industry has and which were not specifically addressed in the
standard. For example, where to sample the gases from, how often to
sample, how to perform the Method A or Method B validations in a pilot vessel
and then use the data to validate industrial size vessels.
4. What are the benefits of parametric release?
Monitoring the headspace concentrations of water vapor and ethylene oxide
allows closer monitoring of a process. Before, using BIs, the user was
notified only of catastrophic failures. A BI cannot indicate even significant
drifts in the process. A gas analyzer can be calibrated to an accuracy of +/-2%
full scale. So even small changes in water vapor and/or ethylene oxide
concentrations are revealed. In addition, the routine use of BIs is
eliminated. There is no need to break down the load, and open master
cartons to place and retrieve BIs. Storage, incubation and documentation
of BIs are also eliminated. By reducing EO chemical residues, through deliberate
decisions during cycle engineering, product can be aerated and immediately
shipped to market. Age-old techniques such as introducing steam during
post-evacuation phases can be employed to eliminate EO from the load and in
doing so, shorten aeration times. The same gas analyzer used for
parametric release is an important tool in designing cycles that are efficient
in removing EO from the product load.
5.
Does NASP have the facilities/capabilities to meet my
packaging/sterilization needs?
Yes, our FDA approved 38,000 sq. ft.
facility in
Franklin, New Jersey is home to some of the most up to date packaging and
die-cutting equipment, meeting a variety of customer needs. All three of our
constantly monitored Ethylene Oxide sterilizers have the ability to continuously
run in order to produce on a large-scale basis. Our production
capabilities also include a seven-day a week, around the clock line, which
virtually never stops. Furthermore, our equipment is subject to stringent
updating and replacement policies that ensure that our customers are provided
with latest and up-to-the-minute technologies that will not only satisfy their
demand, but will also far exceed it.
6.
What unique technologies/processes does NASP employ that could be
beneficial to my company.
One aspect of NASP is that we have the capability of one-stop servicing; we
can do most of the work for your company. NASP sources materials, which are then
processed at our facility into finished products, which are then sterilized
in-house. NASP has also developed and currently manufactures a line of wound
care and dermatological dressings in the form of
HydroGels
and Hydrocolloids. Die cutting and converting services are also offered.
Partnering with a company that manufactures, assembles, packages, and
sterilizes, translates to increased ease and cost efficiency; a savings that can
be passed-on to your customers.
7.
Is the NASP ISO certified? To what standard and registrar?
NASP currently holds standards to ISO 9002:1994/EN 46002:1996 for the
Manufacture of health care and non-health care products to include production,
assembly, packaging and sterilization. KEMA-Registered Quality, Inc., accredited
by The Dutch Council for Accreditation (RvA) and The Registrar Accreditation
Board (RAB), serves as the registrar issuing the certification. NASP is
currently in the process of upgrading our standard to ISO 13485 by the
end of 2003.
8.
What kind of partnership can my company expect with NASP?
Through open and honest communication with our customers, NASP
builds a partnership that transcends the conventional business relationship.
The customer is kept appraised of the strategy to be employed in the manufacture
of the product, operational goals and objectives, and commitments to quality and
customer service. With such a partnership, the integrity of the product is not
only maintained; it is also improved by constant open communication.
9.
What kind of cost improvement program does NASP practice?
Through continuous review, research, and investigation, all process and
materials are evaluated and, when possible, upgraded or replaced to improve
efficiency and costs, never at the expense of quality. By reducing material
costs and efficiency, NASP is able to reduce operating expenses, and then turn
the saving over to our customers.
10.
What kind of packaging has to be used in order to sterilize my product?
With Ethylene Oxide sterilization, Tyvek® to film,
Tyvek® to lid stock, or
medical-grade paper must be used in order for the EO gas to permeate the package
and then aerate for optimal sterilization. NASP's professional team helps
customize packaging designs to equal or exceed our customers' most
stringent packing and sterilization requirements.
Have a question that you would like answered? Please send us an inquiry
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