ISPE Newsletter June 2006

Vol. 3 – June 2006
From The President
By: Ralph Diaz
Welcome to the third edition of the ISPE
Puerto Rico Chapter Newsletter. I would like
to start this message by thanking all the volunteers, RUM Student Chapter Members, committees and Chapter Members that made INTERPHEX Puerto Rico 2006 a great success.
The new Convention Center of Puerto Rico,
with its convenient location and facilities, was
the perfect host for the conference tracks and
exhibits. All participants enjoyed the opportunity to also network with medical device and
supply chain professionals during the conferences. As we all know, this diversity of professionals and its excellence, is making the island
a leader in the industry. Once again, thanks to
all of you for making the participation of ISPE
PR Chapter in this event extremely successful!
During this second half of the year, the Chapter will be focusing on four major areas:
1) Promotion of Educational Programs.
2) Support to the Student Chapter at the
University of PR-Mayaguez
3) Development of Student Chapters: Interamerican University in Bayamon and
Polytechnic University in Hato Rey
4) Strengthen relationships with other
Caribbean and American pharmaceutical communities, by participating in the
VII Dominican Pharmaceutical Conference and by partnering with ISPE Argentina Affiliate.
This is an exciting and dynamic time in the PR
Chapter. We invite all members to participate
in the committees and events to further advance our industry and professionals.
Ralph Diaz
San Juan, Puerto Rico
Trends in the Medical Device Industry in Puerto Rico
The Medical Device Industry in Puerto
Rico ranks third within the US. Puerto
Rico has about 65 manufacturing plants
around the Island according to Puerto
Rico Industrial Development Company
statistics. US based companies like
Guidant, Cordis a Johnson & Johnson
Company, Edwards Lifesciences, Baxter,
Medtronic, Stryker, Becton Dickinson, are
among the largest manufacturing plants
established in PR. Significant investments have been made recently on the Island,
including the expansions of Medtronic, Baxter and Stryker.
In order to seek additional information about the Medical Device Industry and
identify the industry trends, the ISPE PR Chapter Newsletter team interviewed the
members of the Medical Device Cluster. Norma Mejía, President of the Medical
Device (MD) Cluster, allowed us to interview them during their recent MD Cluster
meeting.
We asked them about the MD Industry trends. They pointed out some areas of
the industry that are currently evolving. These include an increase of the integration of electronics and software in the medical device itself, to further enhance
data gathering and patient treatment management and integration of biotech
components. Another trend is the increased introduction of manufacturing automation to enhance productivity goals.
The MD PR Industry, one of the largest high-tech manufacturing centers, is innovative and constantly seeking new applications. The combination of the electronic,
pharmaceutical and biotechnology (“COMBO” devices) has had an impact on the
regulatory compliance emphasis within the industry. In response, the MD Cluster
has created a Regulatory Committee, made up of representatives of member companies and FDA representatives to address this and other regulatory compliance
needs of the industry. The goal is to create a forum where such topics can be addressed in a candid manner to encourage dialogue and increase knowledge in
these areas.
Another initiative of the MD Cluster is the fostering of Clinical Trials on the Island.
They are evaluating strategic alliances with Medical Device manufacturers to establish clinical trails to include surgical procedures possibly through On-Site Operating Rooms, as some manufacturers have already successfully implemented.
These alliances will allow the MD Industries to train doctors on the use and installation of their medical devices. These centers will ease the technology transfer to
the manufacturing plants on the Island and could further foster the establishment
of Research and Development Centers.
The fast changing Medical Device Industry is becoming more innovative and automated. Only those companies willing to transform into high tech industry will
prevail due to the rising operational costs along with global competitiveness. Ongoing challenges in supply chain, operational costs, global competition and government support takes relevance in today’s industry. The MD Cluster is continuously looking for areas to combine synergies and make the operations competitive
for their companies to continue with further investments on the Island, and assisting PRIDCO in attracting new companies to Puerto Rico. To join the Medical Device Cluster and support the initiatives to leverage the Medical Device Industry on
the Island, contact Nelson Perea, Administrator of the Medical Devices Cluster at
njperea@yahoo.com.
By: Yolanda Lassalle & Robert Ramos
Page 1
Vol. 3 – June 2006
Committees In Brief
Marketing Committee
As part of the commitment to the industry, this committee
is expanding the Chapter exposure throughout by participating in some of the most important forums on the Island. With
the goal of developing a campaign to promote and advertise
the Chapter’s initiatives and programs, this marketing scope
will allow the approach on different levels in the industry,
government and educational areas.
PRCHEM 2006 hosted by Colegio de Químicos de Puerto Rico
Westin Rio Mar Hotel at Rio Grande, Puerto Rico
August 15-18, 2006 -Booth 516
3rd Latin American and Caribbean Biotechnology Congress
Mayaguez Resort & Casino at Mayaguez, Puerto Rico
September 21-22, 2006- Booth
If you want to be part of this energetic committee, please
contact Committee Leader Miguel Perez at
mperez@wmapr.com
Vendors Committee
This committee is promoting the next Chapter's events
“Method and Product Transfer Program” and the “5th Annual
Golf Tournament”, with the combination of education and
networking, these events offer the opportunity to interact
with industry personnel and academia. With the new trends
toward Latin community this committee is implementing, in
coordination with ISPE International the initiative to translate
in Spanish the membership applications and the ISPE membership brochure. Be part of the coordination. Volunteers are
welcome! If you want to join this dynamic committee, please
contact Committee Leader Tanyia Miranda at
tmiranda@rubberfab.com
Chapter Program Committee
This committee is presenting the update Chapter Program
2006, which includes the GAMP Puerto Rico Forum on September 2006. The committee is inviting all active members to
participate in these interesting events. If you want to be part
of this dynamic team, please contact Committee Leader Sandra Ortiz ispepr@coqui.net.
San Juan, Puerto Rico
The Medical Device Cluster of Puerto Rico
The ISPE PUERTO RICO CHAPTER is pleased to announce the
development of educative and interesting programs for 2006.
Don’t miss the opportunity to continue your career development!
• 26 August 2006
5th Annual Golf Tournament
Event Leader Ralph Diaz
rdiaz@brendamarreropr.com
Event Co-Leader Jose Torrens
jtorrens@cic-pr.com
• 31 August 2006
Member’s Night
Event Leader Tanyia Miranda
tmiranda@rubberfab.com
Event Co-Leader Jose Garcia
josegarcia@kineticsgroup.com
• 28 September 2006
GAMP Puerto Rico Forum
Event Leader Jose Matos
Jose.matos@bms.com
Event Co Leader David Diaz
ddiaz@isogrouppr.com
Event Co Leader Robert Ramos
rgramos@gap5.com
Please contact Event Leaders for additional details and information about the event.
GAMP-PR Highlights
Welcome to GAMPGAMP-PR Highlights.
Highlights This section will provide a summary of
the events or activities that GAMP-PR is doing or planning
to perform. One time a month, GAMP-PR steering committee meet to
discuss and follow-up the activities established for calendar year 2006.
GAMP-PR is heading two Special Interest Groups (SIG's): System Retirement and Document Translation. System Retirement documents and
deliverables will be part of the GAMP-5. In addition, GAMP-PR is coordinating the GAMP-PR Forum. This event will be programmed for the
fourth (4) quarter 2006. If you are interested to be part of or like to participate in the GAMP-PR activities or events, please contact the steering
committee members at gamp.puertorico@gmail.com or
gamppr.steeringcommittee@gmail.com
Page 2
Vol. 3 – June 2006
Committees In Brief
San Juan, Puerto Rico
Past Chapter Events Update
Membership Committee:
With the initiative of the Student Chapters, the Chapter is
focusing on the development and recruitment of new
members in different membership categories as Academic, Faculty, Government and Students. We are preparing a strategic participation in all our PR Chapter
events and other forum programs where we will be very
active in the promotion of the benefits of the Chapter. In
the past few months we had presentations at some affiliate Universities talking about the Society at different levels. We promoted the interest and sponsorship to different outside Departments as Business Administration and
Natural Sciences. By continuous and direct communication with new candidates from our Pharmaceutical industry, every month we promote our benefits, events and
long term relationship advantages of sharing this professional network society. If you want to be part of this active committee please contact Committee Leader Oscar
Longo at olongo@prent.com
The ISPE Puerto Rico Chapter wants to share the continued success we have achieved in Puerto Rico. The support of the Chapter’s Board Officers and Directors has generated a great dynamic
in the planning for the year’s events and activities.
Web site Committee:
We have compled the change of our Web Site. Feel free
to visit www.ispe.org/puertorico to see the changes and
keep current with the PR Chapter’s events. Upcoming
additions and upgrades will be: photo page of recent
events, awards page, pages for each PR Chapter Committee. The PR Student Chapter at University of Puerto Rico
in Mayaguez Campus proudly invites you to visit their
website at http://www.uprm.edu/ispeprsc/index2.html
To be part of this active committee please contact Committee Leader Tony Bezares tbezares@emgroup.com
On 27April 2006, the Chapter celebrated an event on Commissioning and Qualification. Professionals from the industry got
together with a full day of conferences to learn more about new
trends and step into the future with technologies existing into the
market. Multiple companies collaborated, and participants were
able to identify potential opportunities and showed interest in
continuing their support to ISPE Chapter initiatives.
Student Affairs Committee:
Mayaguez Student Chapter
During the past few months UPR Mayaguez Chapter developed a charity activity that included the student visit
to a geriatric center in Mayaguez. During that activity the
students spent a full day with elderly people doing several entertainment activities and personal items. It was a
wonderful experience to share the most beautiful Puerto
Rican values between generations. In April, the Chapter
performed a Job Fair 2006 at the student center, recruiting new members and collecting resumes from students
near graduation and looking for jobs in the pharmaceutical industry.
The Chapter celebrates the formal initiation at la Cueva
de Tarzan in the campus, where both, Board of Directors
and special members received recognition due to the
efforts developing the Student Chapter. Congratulations!
It has been a very exciting quarter for this Chapter. INTERPHEX
Puerto Rico 2006, in its third year, was again a huge success. This
event, hosted in the new Convention Center with more than 200
booths and more than 3,000 participants during the Exhibits and
Educational Programs, demonstrated its potential for developing
the Island. Thanks to the joint effort of all the organizers and the
ISPE Puerto Rico Chapter, INTERPHEX PR 2007 is already on track,
continuing the tremendous success and beyond.
INTERPHEX PR 2006 Golf Tournament, received more than 160
players. The beautiful greens at Coco Beach Golf Club were the
delights of all the participants that enjoyed a great day with refreshments, goodies, dinner, awards, prizes and good networking.
This Chapter is very proud of its growth In every event we are
receiving new members and professionals that want to be involved the Chapter’s activities. More than ever, approaches have
been received from different universities in Puerto Rico to establish a Student Chapter. ISPE Student Chapter in University of
Puerto Rico, Mayaguez Campus is working with great enthusiasm, preparing for the 2006 Poster Competition to participant in
the finals at the Annual Meeting hosted this year in Orlando, Florida. The new Student Chapter at the Interamerican UniversityBayamon is almost ready to launch. The initiative to establish a
new Chapter at the Polytechnic University is also on schedule.
Working hand in hand with the Student Chapters, we will assure
excellent professionals to the life sciences industry.
For information of upcoming events or how to become a member of our dynamic Chapter, contact Chapter Manager Sandra
Ortiz at ispepr@coqui.net. Chapter President can be reached by email: rdiaz@brendamarreropr.com. Don’t forget to visit our web
site for information about the upcoming events in Puerto Rico,
www.ispe.org/puertorico.
Page 3
Vol. 3 – June 2006
San Juan, Puerto Rico
Chapter Information
About the ISPE Puerto Rico Chapter
The ISPE Puerto Rico Chapter is a not-for-profit organization for technical and manufacturing professionals in the pharmaceutical and bio-processing industries. The Steering Committee was formed in 2001 and the Chapter was officially recognized on 2 April 2002.
The Chapter currently has more than 400 active Members and is located in one of the
most densely populated geographical bio/pharm areas in the world. Elected committees,
consisting of representatives including pharmaceutical industry, engineering and consulting companies and supplier companies, coordinate the different events of the Chapter.
The Committee Members provide a different but real perspective of our local and global
industry. Each year the Chapter establishes a complete program of events consisting of
trainings, plant tours, networking and visitation to Universities to promote the objectives
of ISPE. Monthly Chapter meetings and special events are held. We encourage your participation to the Chapter to further enhance our influence in our industry.
Welcome New Members
January - April 2006
Jesus Alvarado, SSOE
Alessandro Anzalone, Polytechnic University of PR
Mariela Ayala, Lilly del Caribe, Inc
Hector Ayala, Polytechnic Univ of PR
Emmanuel Borreli, University of PR-Mayaguez
Frankie Chervony, University of PR-Mayaguez
Alberto J Cintron, University of PR-Mayaguez
Julio J. Cintron, University of PR-Mayaguez
Gerardo Colon, Schering-Plough
Melvin Colon, VM Validation Consultants
Carlos J. Costas, RCM Technologies Inc
Cesar O. Crespo, Merck Sharp & Dohme
Rey A. Del Valle, Bristol-Myers Squibb
Krizia M. Diaz, University of PR-Mayaguez
Colon Erbel, Pfizer, Inc
Edna Fenollal, Humco Holding Croup Inc
Jose L. Gonzalez, Amgen Manufacturing Ltd
Andres M. Gonzalez, Polytechnic University of PR
Dania B. Gonzalez, Day & Zimmermann
Amir Hedayatnia, Clark Reliance Co
Evelyn Herrero, Food Safety & Security Audits EHR
Jorge I. Irizarry, Siemens
Lynette Liboy, Validation & Engineering Group,Inc.
Michelle Lozada, University of PR-Mayaguez
Ernesto Lugo, VALEANT PR
Giselle D. Marquez, University of PR-Mayaguez
Diana G. Morales, University of PR-Mayaguez
Bernie Morales, Bristol-Myers Squibb
Jesus A. Navas, Siemens Building Technologies
Fernando L. Ortiz, Abbott
Ramon L. Pena, Bristol Myers Squibb
Martin E. Perdomo, Bristol-Myers Squibb Co
Ernie X. Perez, University of PR-Mayaguez
Maruxa Perez, University of PR-Mayaguez
Natalia M. Ramos, University of PR-Mayaguez
Ruben D. Rodiguez, Wyeth Pharmaceutical
Vanessa Rodriguez, University of PR-Mayaguez
Juan B. Rodriguez, University of PR-Mayaguez
Eugenio Roman, Jr., PR Eng Distributions
Mara B. Ruiz-Barreto, Automation Technologies Inc
Orlando Sifre, III, Amgen
Javier O. Tapia, Schering-Plough
Waldemar Tavarez, Moriah Engineering Solutions, Inc.
Sharaim Tirado, Polytechnic University of PR
Pedro Z. Toro, Bristol-Myers Squibb Co
Abdiel Torres, University of PR-Mayaguez
Antonio Veguilla, Siemens Building Technologies
Shawn JA Veguilla, University of PR-Mayaguez
Rafael Velez, Bristol-Myers Squibb Co
Wilfredo Vicente Rodriguez
Myriam Villegas, University of PR-Mayaguez
Luis Westerband, West Validation
Arelys Arriaga, Lilly del Caribe
Dennis Cantellops, FDA
Igxiavel Caraballo, Schering Plough
Christian Cardona, University of PR-Mayaguez
Modesto Centeno, Compliance Systems Solutions
Lyana M. Cintron, BBraun
Jorge Herrera, University of Puerto Rico
Gisela Lopez, VEG
Jomayra Marrero, University of PR-Mayaguez
Liz M. Quezada, University of PR-Mayaguez
Waleska Rios, Integ Consulting Group
Amilcar Rivera, University of PR-Mayaguez
Elisabet M. Rodriguez
Rosivette Santiago, University of PR-Mayaguez
Demiban Martinez, University of PR-Mayaguez
President
Ralph Díaz, Brenda Marrero & Associates
Vice President
Reinaldo Hernandez, Day & Zimmermann
Secretary
José Torrens, Caribbean Industrial Construction
Treasurer
Eugenio Longo, Getinge
Directors
Vangie López, Caribbean Project Management
Braulio Mejía, CSA A/E
Miguel A. Pérez, Water Management
Robert Ramos, Global Automation Partners
Carlos Rivera, Bermúdez & Longo SE
Ricardo Gutiérrez, Holland
José Matos, Bristol Myers Squibb
David Díaz, ISO Group
Frank Rodríguez, Schering Plough
Luis Torres Acosta, T&M
Membership Chairperson
Oscar Longo, Prent
Board Liaison
Andre L. Walker, Biogen Idec Inc.
Chapter Manager
Sandra I. Ortiz
ISPE Puerto Rico Chapter
PMB 721 PO Box 7891
Guaynabo, PR 00970-7891
Our sincere thanks to the Medical Device Cluster Members in collaborating with the articles
of this issue of the ISPE PR Chapter Newsletter.,
especially to Norma Mejias, Tito García, Nelson
Perea and Felipe Morales that helped us coordinate the interview.
Also, we want to recognize the contribution of
Dwight Beal with the article entitled “Parts
Cleanliness Testing for the Medical Device
Industry” and David Diaz and Nelson Perea in
the article “The Medical Device Cluster of
Puerto Rico”.
Our next issue of the ISPE PR Chapter Newsletter will be dedicated to Biotecnology Industry
and Commissioning and Qualification. For
more information, submit articles, advertisement opportunities or simply to give us your
feedback about the newsletter, please contact:
Jose Torrens at jtorrens@cicjtorrens@cic-pr.com
Sandra Ortiz
ispepr@coqui.net
Page 4
Vol. 3 – June 2006
San Juan, Puerto Rico
Student Chapter
As part of the ISPE Student Chapter, we had the opportunity to participate in the 2006 INTERPHEX Convention that was held in February. It let
us promote ISPE and our Student Chapter of Mayagüez, and let them
know who we are in a professional manner, which could not be done by
participating in regular school activities.
As part of our commitment to society, we decided to pay a visit to the
seniors in the Geriatric Center located at the Sánchez Hidalgo building
on our Campus at March 14, 2006. We brought the seniors first necessity
materials as well as things that they could entertain themselves. The AEBI
(Industrial Biotechnology Student Association) joined in and brought
some gifts as well to give to the elderly that won the bingo game that
we played with them, which was a favorite, for both associations.
As part of the events scheduled to educate the student community,
“Process/Piping and Instrumentation Diagram” seminar was held at the
Piñero Building at our campus, from 8:00am to 16:00pm, Saturday,
March 18, 2006. This conference was given by the Ing. Luis Silvestre, P.E.
from LGScott, who kindly offered to do this seminar. After long preparation, we exceeded the participation of student and professional body
when 72 people assisted. It was a successful activity!
We decided to have an initiation event in which we could formally introduce the new members into the organization. This event took place at
19:00pm on April 3, 2006 in the “Cueva de Tarzán”. We decided to dedicate it to our industry advisor, Eugenio Longo, who has always helped
us. Alberto Cintrón and Emmanuel Borreli, did a funny rendition of all
the highlights that the organization did this year. We culminated our
night with some karaoke, where our members and our industry advisor
showed their hidden talents. The activity was a success and our members not only walked away with a certificate, a full stomach, and some
memories, they also walked away with shot glasses with the ISPE organization name written on them as a souvenir of the event.
Our Sponsors
Our Annual Career Fair was held at the Student Center on Thursday,
April 6, 2006. In addition, our industry advisor assisted to help us assemble and welcome our industrial guests. Industries, like Kelly Scientific Resources, Stelex, Day and Zimmerman, Holland Applied Tech, and Fluid
Line Tech/Aquasyn, attended the event in hopes of recruiting students
for job experiences. After a rather slow beginning in the morning period, the students began to arrive, and at least four assisting students
ended up with an interview date.
“Relaying for Life” was held at the “Hermanos Miura” Court in Hormigueros, and it lasted from Saturday, April 22nd to Sunday, April 23rd. Before
going, we had to collect more than $1500 in donation to cancer patients. To ensure out teams success, we united with three associations:
SHPE (Society for Hispanic Professional Engineers), AEBI (Association of
Industrial Biotechnology Students), and CHESS (Common Horizons for
Engineering Science Students) in the group called “Catalysts of Life”.
After arriving there, we each had to take turns in walking. The objective
was to keep walking for the entire day and night without stopping and
to relay each other to give ourselves a small break. When the event was
coming to an end, the event coordinators got up onstage and said that
we surpassed our goal of 300, 000 dollars with 410,000 dollars to treat
cancer patients. The event was a complete success, and even though it
was exhausting, it was worth all the trouble.
Page 5
Vol. 3 – June 2006
San Juan, Puerto Rico
GAMP - Puerto Rico
The Medical Device Cluster of Puerto Rico
GAMP Puerto Rico Chapter was created on March, 2006.
GAMP-Puerto Rico will be part of GAMP-AMERICAS organization. It will have a steering committee with representatives from the pharmaceutical industry, FDA, consulting and services areas. In addition to the steering
committee, some Special Interest Groups (SIG’s) will be
created.
In the spirit of identifying and conveying the message from other
organizations who are also dedicated to the success and education of our Island’s science and technology industrial base, we
spoke with Norma Mejia and Nelson Perea, President and Administrator respectively of the Medical Device Cluster of Puerto Rico.
The GAMPGAMP-P.R. vision is as follows:
To be recognized by the life science and medical device
industries within Latin America and Caribbean, as the
professional organization with the bi-lingual ability to
transmit and expand the GxP technological knowledge,
manufacturing and compliance expertise, to enrich our
Pharmaceutical, Biotechnology, academy and Medical
devices operations.
The Medical Devices Cluster started in 2001 as a local effort to
collaborate on cost reductions for common items like power, security, medical insurance, etc. in the Añasco area, and it has
grown to provide island wide coverage and participation. At this
time, the cluster has over 30 members from industry, academia,
service providers and suppliers that share their interest in advancing Puerto Rico’s competitiveness in the medical device field. The
Executive Committee is comprised by Norma Mejia, Edwards
Lifesciences – Cluster President; Nelson Perea, PRTEC – Cluster
Administrator; Tito Garcia, Stryker – Supply Chain Committee
Chair; Jose Garcia, Cordis – Regulatory Committee Chair; and
Ivonne Cortes, Riquel – Education Committee Chair.
And the GAMPGAMP-PR mission is the following:
To contribute in the development, generation and implementation of the compliance aspects and new technology ideas with cost effective solutions for the life science
and medical devices industries within Latin America, Caribbean, and Worldwide. Leveraging our bi-lingual culture
to effectively transmit and expand this knowledge exchange. Seek alignment with the GAMP Americas Chapter goals and objectives, and to provide technical support
to the Local ISPE Chapter.
The GAMPGAMP-P.R. Steering Committee is organized with the
followings industry and government representatives:
Officers : Chairman: J. E. Matos (BMS), Vice Chairman: W.
Figueroa (FiConelly), Agency Advisor: D. P. Cantellops
(FDA), Secretary: E. Cordoves (C&IS), ISPE Staff Liaison: R.
Ramos, GAP and Steering Committee: F. Rodriguez
(Merck) , J. Vicens (Pfizer), K. Krause (Amgen), L. Santiago
(FiConelly), C. Bruzos (Andrx- USA), E. Plaskett, (JJ), C.
Flores (BMS).
Persons interested in participate or be part of this iniatiative, Please contact to ISPE-PR or contact to GAMP-PR officers: José E. Matos; jem2@engineer.com and/or W. Figueroa; Delmar@prtc.com and/or R. Ramos;
rgramos@gap5.com
The cluster is focused on three main initiatives: improving the supply chain that affects the medical device manufacturers on the
island, improving regulatory compliance and education gaps, and
trying to initiate clinical trials for medical devices in Puerto Rico.
Ms. Mejia stated “we will continue to work on promoting and developing these initiatives since we are convinced that they provide Puerto Rico with the best opportunities and mechanisms to
advance the medical device industry’s competitiveness on a
global level.”
As part of its mission to promote and advance the Island’s medical device’s competitiveness, the cluster directly participated in
the organization of the Medical Device Event which took place
this past February 2006 at the new Puerto Rico Convention Center. This past October the cluster also sent a delegation to participate and represent the local medical device industry at the MEDI
2005 Conference in Hartford, CT. The delegation was comprised
of members from industry, academia, service providers and suppliers who traveled at their companies’ own expense. “It’s commitment like this and consistent follow-up of our measures that
will allow us to implement the strategies that will propel us into a
prosperous industry future”, said Mr. Perea. The Medical Device
Cluster is also working with professors of the University of PR at
Mayaguez to establish a future Medical Device Research, Training
& Manufacturing Center to be located at the Guanajibo Research
& Innovation Park.
Should anyone be interested in supporting the Medical Device
Cluster or wish to know more about its activities, contact Nelson
Perea at 787-834-5700.
By: David Díaz, ISO Group and Nelson Perea, Administrator MD Cluster
Page 6
Vol. 3 – June 2006
Parts Cleanliness Testing for the Medical Device
San Juan, Puerto Rico
Our Sponsors
Part cleanliness in the medical device industry is becoming increasingly important. Patient infections or rejections due to inadequate or improper cleaning
can result in major litigation, and in some cases, business failure. Most contamination-sensitive parts are complex in shape and therefore do not lend
themselves to traditional scanning techniques.
Methods of Extraction
There are three main methods of extraction: high pressure spray, sloshing or
swirling, and ultrasonic. High pressure spray is generally used for larger particle contamination (>50 micron). Cleanliness of both the fluid used and the
collection vessel must be considered when using this method. Sloshing or
swirling is typically used for smaller parts and involves adding the part to a
container of water and sloshing/swirling it about to extract particles. Consistency is difficult in both high pressure spray and sloshing/swirling as it depends very much on the precise effort of the worker. Ultrasonic extraction
involves immersing the part into a bath containing solvent/aqueous cleaning
fluid. The bath has transducers bonded to the surface, which produce ultrasonic energy in the cleaning fluid. Because the extraction force is constant,
more reliable and repeatable particle removal is obtained.
Methods of Sample Analysis
After the particles have been extracted from the part, they must be counted
and sized, and the results must be recorded for analysis. Common methods
are Gravimetric Analysis, optical inspection, or using an optical particle
counter. Gravimetric Analysis involves comparing the weight of a filter before
and after particles are drawn through it. This method does not show the size
of individual particles (just the overall weight of the particles) and is subjected
to additional contamination. Optical inspection involves looking at the particles on a filter through a microscope. Due to the magnification provided by
the microscope, typically only a small region of the filter is inspected, which
can easily result in missing small areas of condensed groups of particles. Use of
an optical particle counter is the most reliable method of analysis. Rather than
counting particles on a filter, it counts extracted particles in a statistically representative sample of the cleaning fluid. It is fast, repeatable, accurate, and eliminates operator error.
Efficiency and Accuracy
All Many of the above methods require time and labor, often involving days or
weeks waiting on laboratory results. This waiting period either dramatically
slows production or allows contaminated parts to move on through the final
stages of manufacturing and even out to the market. New technologies that
combine ultrasonic extraction with the use of a particle counter help maintain
high throughput and make it possible to move testing out of the laboratory
onto the manufacturing floor. This technology incorporates automation that
reduces or eliminates the occurrence of errors inherent in the manual methods described above. Additionally, many advantages are realized by performing the testing right in the manufacturing area, when the parts exit the cleaning system. Foremost, contaminated parts can be prevented from reaching
final stages of manufacturing. An example of this new technology is the Surfex which is very fast (test cycle times of <10 minutes) and provides repeatable
results on the manufacturing floor.
By: Dwight Beal, Particles Measuring Systems
Page 7
Vol. 3 – June 2006
INTERPHEX PR 2006 GOLF TOURNAMENT
San Juan, Puerto Rico
INTERPHEX PR 2006
Our Sponsors
Page 8