Message from the President

Transcription

January 2006 Volume 3, Issue 2
Message from the President
Dear Colleagues,
experience is needed to enjoy our social
events. Watch your email for details and
registration info, and come spend a fun
night socializing with friends and colleagues.
Here we are in
the middle of winter and people
are out walking in
shorts and tee
shirts
enjoying
the warm days
and cool evenings. Our kindly editor has
reminded me to not go golfing, no-no! I
need to let folks know what we’ve been
doing recently in our Chapter. He obviously knows best, so here we are…
INSIDE THIS ISSUE:
ISPE Profile
3
Article Technique
4
Technical Article
7
ISPE Biographie
10
New Members
13
Chapter News
14
Challenger
14
Contact Information
15
As this newsletter goes to publication,
we are still finalizing the details of our
next breakfast seminar. We are expecting
to present on a flu vaccine manufacturing
topic during this seminar. Please note
that we have moved the timing of these
seminars out by one week to avoid a
scheduling conflict with Interphex.
January has been a busy month. Our
first Breakfast seminar in 2006, “Life Cycle Approach for Meeting Building Automation Systems Requirements,” was presented by Irene Miess (Senior Manager
Regulated Industries for Siemens Building Technologies, Inc., North America) on
24 January 2005 in Mississauga and the
25 January 2005 in Montreal. Our first
social event of the year, Billiards at Dave
& Buster’s was held on 26 January 2005.
We had good attendance at all of these
events and many favourable comments
were received from Members.
Looking forward to golf? Our golf tournament will be in Toronto this year, on 1
June 2005 at Glen Eagle GC. Planning is
well underway. Our invitation and registration information for the tournament will
be issued in mid-February.
Keep current with planned events and
dates by:
- Checking the “Upcoming events” section on the Central Canada Chapter
Web site,
- Viewing the global calendar on the
ISPE Web site,
- Reading email communications that
are sent ahead of each event.
Planning is well underway for our next
two social events. An evening of Billiards
and networking will be held at Unison
Billiard & Bar in Saint-Laurent, Montreal
on 16 February 2005. Then, we are setting up a curling night at the Weston Curling club on 13 April 2005. No skill or prior
If you have comments or suggestions
about the Chapter or events, please feel
free to contact any Member of the Board.
You can find email, phone and address
Central Canada Chapter
8000 Decarie Blvd 3rd Floor
Montréal, Quebec H4P 2S4
Ph: 514-735-5651 Ext. 2297
Fx: 514-737-7988
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C en t r al Ca n a da C h ap t e r N e ws
J a n ua ry 2 0 0 6
Vol um e 3, I ssu e 2
contact info on our website, which is at www.ispe.org/
centralcanada.
month of April. The winner will represent Canada during
next years’ ISPE Annual Meeting in Orlando.
We have a thriving Student Chapter at École Polytechnique de Montréal, and are please to see that they will
be holding a Student Poster Competition during the
Kind regards,
Geoff Pilmoor
President,
ISPE, Central Canada Chapter
Message du President
Chers Collègues,
Nous sommes au beau milieu
de l'hiver et voilà que les gens se
promènent dehors en shorts et en
t-shirt en profitant de journées
chaudes et de soirées confortables. Notre amical éditeur m'a
rappelé de ne pas aller jouer au
golf. Mais non, voyons! Il paraît que j'ai la responsabilité
de faire savoir aux amis ce que nous avons récemment
accompli dans notre chapitre. Il le sait sans doute plus
que moi, alors, me voici...
Janvier a été un mois très chargé. Le 24 janvier à Mississauga et le 25 à Montréal, notre premier petitdéjeuner-causerie en 2006, « Life Cycle Approach for
Meeting Building Automation Systems Requirements » (l'approche cycle de vie pour rencontrer les exigences des systèmes de contrôle auto-matique de bâtiments), a été présenté par Irene Miess (cadre supérieure, industries réglementées chez Siemens Building
Technologies, Inc. Amérique du Nord). Notre première
activité sociale de l'année, une soirée de billard chez
Dave & Buster’s, s'est tenue le 26 janvier. La participation à ces événements a été excellente et nous avons
reçu plusieurs commentaires favorables de la part des
membres.
La planification est bien amorcée pour les deux prochains événements à venir. Une soirée de billard et de
réseautage se tiendra le 16 février au Bar & Billard Unison à Saint-Laurent, Montréal. Ensuite, nous sommes à
planifier une soirée de curling au Weston Curling Club le
13 avril. Aucune expérience n'est nécessaire pour participer et s'amuser à nos activités sociales. Surveillez votre courriel pour les détails et les informations sur l'inscription, et venez passer une agréable soirée entre amis
et collègues.
Au moment de la sortie de ce bulletin, nous sommes
toujours à finaliser les détails de notre prochain petit-
déjeuner-causerie. Nous prévoyons présenter un sujet
touchant la fabrication de vaccin antigrippal au cours de
ce séminaire. Veuillez prendre note que nous avons décalé les dates de ces séminaires d'une semaine pour
éviter un conflit d'échéancier avec Interphex.
Vous avez hâte de jouer au golf? Notre tournoi de golf
se déroulera le 1er juin à Toronto cette année au club de
golf Glen Eagle. La planification va bon train. Nos invitations et nos informations sur l'inscription au tournoi seront lancées vers la mi-février.
Restez au courant des événements à venir et des dates en :
- Consultant la section « Événements à venir » du site
Web du chapitre du Canada Central,
- Consultant le calendrier global sur le site Web de
l'ISPE,
- Lisant les communications par courriel envoyées
avant chaque événement.
Si vous avez des commentaires au sujet du chapitre ou
des événements, n'hésitez surtout pas à contacter n'importe quel membre du conseil.
Vous trouverez leurs coordonnées de courriel, téléphone et adresses sur notre site Web à www.ispe.org/
centralcanada.
Nous avons un chapitre étudiant prospère à l'École Polytechnique de Montréal, et il nous fait plaisir d'apprendre qu'il tiendra un concours d'affiches d'étudiants au
cours du mois d'avril. Le ou la gagnant(e) représentera
le Canada à l'assemblée générale de l'ISPE de l'an prochain à Orlando
Bien à vous,
Geoff Pilmoor
Président,
Chapitre du Canada Central de l’ISPE
J a n ua ry 2 0 0 6
Page 3
ISPEProfile
By Rick Hargreaves
Grantek Systems Integration
Sylvie Lachapelle, Marketing Coordinator, SNCLavalin
Our featured ISPE Member this issue is one of our unsung ISPE Chapter heroes. Sylvie Lachapelle has filled
the role of ISPE Central Canada Chapter Manager for
three years now and has been an ISPE Member since
1995.
Sylvie began her working career in 1976 with what was
then Lavalin Inc. in Montreal, and other than a short sabbatical, she has remained with the company, which we
now know as SNC–Lavalin Inc., for the duration. Her
current duties as Marketing Coordinator include marketing research and proposal preparation. It quickly became
clear to us that Sylvie very much enjoys both her work at
SNC-Lavalin Pharma and her role as ISPE Chapter
Manager.
Sylvie’s name is likely familiar to most ISPE Chapter
Members. She handles Chapter communications to
Members such as Breakfast Seminar invitations, AGM
and Golf Tournament invitations, and registration activi-
ties and plays a large role in organization assistance for
all Chapter events.
When Sylvie is not at work she enjoys kayaking (her
newfound love!), cooking, and reading. She speaks
three languages and professes to be an avid biography
reader. Ah, the irony!
Sylvie is also a Montreal Canadiens fan and has a soft
spot in her heart for Guy Lafleur. In fact, she has
amassed quite the scrapbook on the Canadiens hero
and would love to meet him sometime. Sylvie also enjoys music as a Jazz/Blues enthusiast and attends live
performances whenever she can. Her grand plan for her
future is to have a home near water, where she can enjoy her family and the calming affects that being near
water can bring. Sylvie lives in Terrebonne outside of
Montreal with her family.
It was our great pleasure to interview Sylvie and to get
to know her better. On behalf of all of our Membership,
we would like to thank Sylvie for her tireless work on the
Chapter’s behalf and we wish you only the best in for
your future. Thank you, Sylvie, for what you do for all
Chapter Members!
Page 4
J a n ua ry 2 0 0 6
Article Technique
RFID: un nouvel outil de changement
par le Dr Sujeet Chand
Vice-président,
technologie de pointe
Officier en chef de la technologie
Rockwell Automation
Selon la personne à qui vous parlez
ou ce que vous lisez, l'identification
par radio-fréquence ou identification RF va soit révolutionner les pratiques commerciales tout comme Internet
l'a fait, soit simplement devenir une autre technologie de
collecte d'informations intégrée automatiquement au
processus de fabrication. D'une façon ou de l'autre,
pour les fabricants comme pour les distributeurs et les
détaillants, les avancées en technologie d'identification
RF (et leurs conséquences) deviennent de plus en plus
difficiles à ignorer.
Pour certains, les comparaisons entre l'identification
RF et Internet en tant qu'outil révolutionnaire sont un
peu exagérées. En soi, l'identification RF n'est pas révolutionnaire – apposer une étiquette sur une palette et
l'envoyer vers un centre de distribution, ce n'est pas ça
qui va changer la chaîne d'approvisionnement. C'est
uniquement lorsque l'identification RF est utilisée en tandem avec Internet pour accéder et partager de l'information produit que le potentiel « révolutionnaire » de cette
technologie émerge.
Dramatiquement différente de ce qu'était l'identification
RF par les années passées, la technologie d'aujourd'hui
adhère aux normes de l'industrie établies par EPC Global (www.epcglobalinc.org). Ces normes sont la clé permettant le partage d'une quantité beaucoup plus importante d'information via Internet pour une visibilité améliorée et une plus grande efficacité tout au long de la
chaîne d'approvisionnement. En d'autres mots, les données stockées sur les étiquettes individuelles ne sont
plus restreintes aux confins de l'édifice où elles résident.
Les conséquences profondes de l'identification RF ne
se limitent pas au partage de l'information ; le véritable
rendement du capital investi (RCI) survient lorsqu'une
société utilise les données pour modifier et améliorer
ses processus.
Que l'on croie ou non à l'identification RF, on ne peut
nier que celle-ci constitue un catalyseur de changements dramatiques quant à la façon dont les biens sont
fabriqués et distribués. La question est : « Êtes-vous
prêt à adopter l'identification RF et son plein potentiel ? »
Identification RF et fabrication
Sous tous les rapports, le taux d'adoption de la technologie d’identification RF a dépassé les attentes. Néanmoins, ces taux pourraient être même supérieurs si ce
n'était de certains inhibiteurs importants tels que le développement et l'adoption de normes clairement définies, une fiabilité et une lisibilité inférieure des balises et
la difficulté d'obtenir un RCI intéressant. Bien que EPC
Global et les fournisseurs d'étiquettes aient travaillé d'arrache-pied à cerner ces les deux premiers éléments, le
RCI continue d'être un objectif imprécis pour un bon
nombre de gens. Je crois que ceci est largement dû au
fait que plusieurs manufacturiers ont considéré l'identification RF comme un mandat de conformité dicté par
quelques gros détaillants plutôt qu'une occasion d'adopter une technologie permettant l'amélioration des processus.
En considérant l'identification RF comme une simple
question de conformité, les manufacturiers font peu de
cas de l'occasion de puiser à même la mine d'information que cette technologie a à offrir pour prendre des
décisions d'affaires plus précises (et plus rentables).
Recevoir l'information par l'identification RF est une
chose, l'utiliser est autre chose. Les véritables bienfaits
de l'identification RF ne viendront pas de la technologie
elle-même, mais plutôt de la capacité du manufacturier
de filtrer et capitaliser sur les données que celle-ci fournit.
Je crois sincèrement que plus on applique l'identification RF à un objet tôt au cours du processus de production, plus nombreux sont les avantages que l’on obtient
de l'information capturée. De la même façon, plus
l'identification RF est appliquée en amont dans la chaîne
d'approvisionnement aux opérations de fabrication, plus
grande est la valeur que l'on peut obtenir d'une technologie d'identification RF intégrée aux systèmes d'information et d'automatisation existants.
Domaines d'impact au cours de la fabrication
En appliquant la technologie d'identification RF sur le
plancher de l'usine, les manufacturiers sont en mesure
d'intégrer de façon homogène l'information nouvellement
capturée à l'information existante, utilisant l'étiquette RF
comme identifiant unique et minimisant les coûts en capitaux d'équipements et les risques d'investissement.
Sur le plancher de l'usine, l'identification RF offrira le
meilleur impact dans les domaines de la visibilité des
inventaires, l'efficacité du travail ainsi que le pistage et la
généalogie.
J a n ua ry 2 0 0 6
Visibilité de l'inventaire : à mesure que la fabrication en
sous-traitance deviendra de plus en plus courante, assurer la synchronisation de la chaîne d'approvisionnements exigera de plus en plus de visibilité tant pour l'activité des fournisseurs que celle des clients. Plus un
manufacturier sera capable de cueillir, gérer et utiliser
l'information pour la conduite des biens et des processus
de production, plus elle pourra fournir de la visibilité (et
de la valeur) à ses partenaires commerciaux
Efficacité du travail : bon nombre d’activités de code à
barres requièrent une intervention manuelle pour capturer les données. Un des impacts immédiats de la technologie d'identification RF avancée d'aujourd'hui est
d'éliminer ces exigences et de libérer du temps pour effectuer d'autres tâches à valeur ajoutée. Ceci peut avoir
un impact majeur, en particulier sur les opérations de
fabrication à grand volume et à grande vitesse, où la
vitesse, la précision et la rapidité de l'information sont
critiques pour le débit et le rendement.
Pistage et généalogie : les exigences de plus en plus
grandes de la FDA forcent les fabricants de biens de
grande consommation de tous genres à gérer leur information produit de façon plus efficace, y compris le pistage de lots et les données relatives à la qualité tout au
long de la chaîne d'approvisionnement. Advenant le
rappel d'un produit, l'accès à de l'information fiable, précise et en temps réel est absolument critique. L'identification RF peut, en outre, servir de complément aux efforts de pistage de généalogie pour les systèmes d'exécution de la fabrication existants. Par exemple, les informations recueillies par le système d'exécution de la fabrication telles qu'identification du produit, horodateur,
attributs physiques et numéro de lot peuvent être encodées sur une étiquette RF et passée ensuite en aval
dans l'entrepôt au niveau des palettes, puis sortir vers la
chaîne d'approvisionnement. Ceci améliore grandement
la capacité d'un manufacturier de retracer les étapes au
cours d'un rappel de produit.
Commencez MAINTENANT!
En terminant son discours-programme prononcé à la
National Retail Federation au cours de la conférence
Redefining Retail de janvier 2005, la DPI de Wal-Mart
Linda Dillman a déclaré: « Commencez à faire l'essai de
l'identification RF. N'attendez pas ».
À mes collègues qui sont dans la fabrication, je fais
écho à son sentiment – n'attendez pas ! Commencez un
programme pilote aussitôt que possible. À l'instar de
toute nouvelle technologie, je recommande de commencer à petite échelle et d'apprivoiser la technologie en
termes de ce qu'elle peut faire et ne pas faire pour votre
organisation. Outre sa capacité d'aider à identifier les
processus qui en subiront l'impact, les programmes pilotes peuvent fournir un aperçu précieux du rendement sur
Page 5
le capital investi de leur investissement potentiel en
technologie d'identification RF. Cette capacité de faire
un 'essai sur route' du déploiement de l'identification RF
aide à réduire le risque d'investissement et à améliorer
le rendement commercial à travers toute l'organisation.
Bon nombre de manufacturiers sont dépassés par le
volume d'information disponible par le biais de la technologie d'identification RF et ne savent pas par où commencer. L'information peut être déroutante – quelles
étiquettes utiliser, quel type de lecteur, quelle infrastructure, quelles imprimantes – mais la bonne nouvelle, c'est
qu'on peut obtenir de l'aide de fournisseurs de technologie compétents tels que Rockwell Automation et d'autres
qui aideront les sociétés à se frayer un chemin à travers
le labyrinthe d'information et leur fourniront des conseils
pratiques du monde réel.
Par dessus tout, n'y allez pas seul. Trouvez un partenaire qui comprenne à la fois votre société et la façon
d'utiliser l'identification RF pour obtenir un changement
positif. Avec la bonne approche et la bonne mise à exécution, les coûts à court terme de l'identification RF seront facilement éclipsés par les avantages à long terme
qu'offre cette technologie.
Pour plus de renseignements à propos de l'identification RF dans le processus de fabrication et les services
offerts par Rockwell Automation, visitez:
www.rockwellautomation.com/rfid.
Sujeet Chand est responsable de la stratégie technologique, du développement des technologies de pointe et
des normes globales et du commerce chez Rockwell
Automation. M. Chand a publié plus de 150 fiches techniques dans des journaux consacrés à la recherche et
au cours de conférences, et il détient quatre brevets d'invention. Il représente les États-Unis à la tête de la délégation à Intelligent Manufacturing Systems, un consortium mondial sur la technologie de la fabrication.
M. Chand détient un doctorat en philosophie en génie
électrique et en génie informatique.
Page 6
J a n ua ry 2 0 0 6
Hire an Engineering Student!
Embauchez un stagiaire!
Embauchez un stagiaire!
Engineering students: what a deal!
Les étudiants d’aujourd’hui sont les décideurs de demain. Nous avons besoin de leur énergie et ce sont eux
qui plus tard prendront en charge l’industrie pharmaceutique (et paieront notre rente de vieillesse!). Mais ils ont
aujourd’hui besoin d’un coup de pouce de la part des
industries, des fournisseurs d’équipement et des firmes
d’ingénierie pour obtenir un stage rémunéré de 4 ou 8
mois pendant leurs études.
They are young, bright and will work very hard in the
future so we can play golf more often. Now however,
they need a little help from us. If you are a drug manufacturer, an engineering firm or an equipment supplier
we would like to encourage you to hire a student intern
for 4 or 8 months.
Depuis quelques années déjà, le Gouvernement du
Québec offre un crédit d’impôt de $150 par semaine par
stagiaire. Le programme devrait continuer en 2006 mais
cela n’a pas encore été annoncé officiellement. Voyez
tous les détails au site Web suivant: http://
www.revenu.gouv.qc.ca/fr/entreprise/impot/credits/
creation/stage.asp
For the last few years, the Government of Quebec has
given a tax credit of $150 per week per student. The program should continue in 2006, although it has not yet
been officially announced. Details are available at: http://
www.revenu.gouv.qc.ca/eng/entreprise/impot/credits/
creation/stage.asp
In the next newsletter, we will provide details about a
similar program in Ontario and other provinces.
Au prochain bulletin, nous vous donnerons plus de détails sur les programmes similaires en Ontario et dans
les autres provinces.
Hiring a student is dead easy (I have successfully done
it myself)…just call the University of your choice and
they will make it happen for you!
Pour embaucher un étudiant, il n’y a rien de plus simple : vous appelez au service de placement de votre université préférée et ils vous donneront tous les détails. La
démarche est très simple, même moi j’ai réussi à y parvenir!
That said, we encourage you to consider Members of
ISPE Student Chapter of École Polytechnique de Montréal. This Student Chapter is a dynamic chapter with 27
members. Most are studying chemical engineering and
have already attended classes including cellular and molecular biology, biochemistry, validation and industrial
processes. Contact Mario Jolicoeur, Supervising professor for the Chapter, at: [email protected].
Encouragez les membres du nouveau Chapitre Étudiant ISPE de l’École Polytechnique de Montréal : ce
Chapitre très dynamique compte déjà 27 membres, la
plupart en génie chimique ayant suivi des cours de biologie cellulaire et moléculaire, de biochimie, de validation
et de procédés industriels. Contactez Mario Jolicoeur,
professeur supervisant ce Chapitre, à l’adresse suivante:
[email protected].
This Student Chapter has a student who is looking for a
Ph.D. thesis topic within the pharmaceutical industry.
Un étudiant est aussi à la recherche d’une thèse de
doctorat qu’il pourrait faire en milieu pharmaceutique.
[email protected]
Merci d’avance!
Daniel Laporte
[email protected]
Many thanks!
Daniel Laporte
Page 7
J a n ua ry 2 0 0 6
Technical Article
Purdue Pharma gets down to the item
By Mark Roberti
Republished with permission from RFID Journal
www.rfidjournal.com
On Nov. 29, 2004, a small team of packaging, IT and
security experts at Purdue Pharma made history. At a
production facility in Wilson, NC, the group went live with
the world’s first system for tagging large numbers of
unique items with EPC tags. Just as the Wright brothers’
first flight at nearby Kitty Hawk ushered in the era of
manned flight, the Purdue tagging project marks the
dawn of a new era of smart products.
Founded in 1892, Purdue Pharma, a privately held
pharmaceutical company based in Stamford, CT, is best
known for making over-the-counter medicines such as
Betadine antiseptics and Senokot laxatives. The company also makes prescription drugs, including Schedule
II narcotics MS Contin and OxyContin. It was the need to
track these painkillers that led to the company’s interest
in RFID.
In November 2003, Wal-Mart announced that it would
require its suppliers of Schedule II narcotics to tag individual bottles with RFID tags, beginning in 2004. The
suppliers were invited to Wal-Mart’s Bentonville, Ark.,
headquarters to be briefed on what was expected of
them. Purdue sent a small team of executives, including
David Richiger, executive director of package design
and development, and Chuck Nardi, executive director of
supply chain and corporate systems.
Senior executives at Purdue felt RFID was the wave of
the future and would eventually deliver benefits throughout the pharmaceutical supply chain by reducing counterfeiting and improving patient safety. They made the
bold decision not just to comply with the Wal-Mart mandate but to integrate RFID into Purdue’s OxyContin production line. By doing this, they could capture data as
the product moved from its packaging area to “the
vault”—a super secure storage area—and then to the
shipping area.
“From the start, we decided we didn’t want to take a
slap-and-ship approach,” says Richiger. “We wanted an
automated way to integrate RFID tagging into our current packaging line, and we wanted to integrate the data
into our IT systems.”
A Cross-Functional Team
Richiger and Nardi quickly formed a cross-functional
RFID project team, which included Jeff Zerillo, executive
director, supply chain management; Mike Celentano,
associate director of supply chain and RFID systems;
Sajan Idicula, systems analyst, logistics; Kevin Leggett,
electronics and implementation specialist; Harry Ramsey, senior package development engineer; John Fox,
assistant director, materials management; and Aaron
Graham, VP and chief security officer.
The team traveled to Arkansas in December 2003 to
attend a gathering of suppliers and technology vendors
at a hotel near Wal-Mart’s headquarters in Bentonville.
One of the first tasks was to identify companies that
could deliver RFID tags based on the Class 1 and Class
0 Electronic Product Code specifications that Wal-Mart
wanted to use. Alien Technology and Matrics (now
owned by Symbol Technologies) were, at that time, the
only companies that could deliver EPC tags. Matrics had
a 1-inch by 1-inch tag that was perfect for the small pill
bottles (roughly 4 inches high by 2 inches wide by 1 inch
deep) that Purdue was using to ship OxyContin in, so
Purdue quickly settled on Matrics as its RFID technology
provider.
In January 2004, Matrics sent a team to Purdue’s Wilson facility to survey the site and begin fleshing out a
plan for a pilot. Later that month, Purdue invited executives from SAP to the Wilson facility. Purdue uses SAP’s
R3 enterprise resource planning (ERP) software, as well
as its supply chain management (SCM) application, and
wanted to learn how the data captured by the RFID system could be integrated with these IT systems.
Matrics worked with SAP to develop a prototype system
that integrated Matrics readers with SAP’s supply chain
management application. In April, Purdue’s RFID team
gathered in a conference room at SAP’s US headquarters in Newtown Square, PA. A Matrics reader was able
to read every serial number on 48 individually tagged
bottles that were packed in a carton that was more than
10 feet from the reader antenna. The numbers were captured by a prototype middleware SAP had been develop
ping, called Auto-ID Infrastructure (AII) , and then transmitted to SAP’s SCM application, both running on servers at SAP world headquarters in Walldorf, Germany.
The captured data was presented back to the system in
Newtown Square nearly instantaneously. The team realized then that they had just achieved a major proof-ofconcept milestone.
Convinced that Matrics and SAP could deliver what
Purdue needed, the decision was made to move ahead
with the project. Leggett began working with NJM/CLI
J a n ua ry 2 0 0 6
Packaging Systems International, a Lebanon, NH based
company that made the packaging and labelling equipment on the Purdue line. They spent the summer figuring out exactly where RFID antennas would be placed
on the packaging line and how the RFID readers would
interact with the programmable logic controller (PLC)
that monitors and controls the line. Richiger worked with
label providers to find a way to integrate the RFID tag
into the product label and ensure that every tag was
functioning before and after it was applied to a bottle.
And Celentano worked with Matrics and SAP on ways to
capture and store the RFID data. The Purdue team
members met weekly through the spring and summer to
keep each other informed about their progress. They
also held weekly teleconferences with Matrics and SAP
to make sure the project stayed on track.
Checking the Label
There were challenges to overcome each step of the
way. One involved integrating the RFID tag into the
product label. There wasn’t a lot of room in the packaging area at the Wilson facility, so Purdue couldn’t install
new equipment that would “marry” a tag to the label or
affix the tag to the bottle before the label was applied on
the packaging line. The tag had to be integrated into the
label off-site so that the label could be applied normally.
Richiger talked with Purdue’s label providers, but none
had the capability to marry labels to RFID tags. At the
same time, Purdue was talking with Guilford Gravure, a
unit of George Schmitt & Co., a label maker based in
Guilford, CT, about a label that would have special antic
counterfeiting features. Guilford Gravure said it could
design a system to integrate RFID tags into labels before
shipping the labels to Purdue.
Another big concern was how to deal with defective
RFID labels. Not all tags work when they’re manufactured, and they can be damaged during the process of
integrating them into a label. If defective tags were applied to the bottles, the cost of removing them would be
significant (the bottles would have to get kicked off the
line, the labels would have to be removed manually, and
then the bottles would have to be reintroduced into the
Page 8
line to get new labels).
Purdue worked with
Matrics to find ways to
reduce the defect rate.
(Matrics has since developed
an
automated
process for checking
tags before delivering
them.) When the RFID
tags were delivered to
Guilford Gravure, the
label maker used its own
patented method
of
making sure that all tags
could be read at a minimum distance set by Purdue and removing those that
didn’t respond to the reader. After the tags and labels
were married, the label maker interrogated each tag
again to make sure that it was not damaged during the
production process. Defective tags were rejected.
Guilford Gravure also developed a method of integrating the RFID tag into the label’s anti-counterfeiting features, for added security. “We have one overt and several covert anti-counterfeiting features built into our label,” says Richiger. “I can’t disclose them, but we have
the capability to link those with the RFID tag. We see
RFID as an integral part of our layered anti counterfeiting
solution.”
In fact, the anti-counterfeiting possibilities offered by
RFID are a key driver behind Purdue’s desire to expand
its RFID initiative. “Our objective in implementing these
security features is to deter counterfeiting, reduce diversion and help ensure the authenticity, safety and integrity of our products,” says Graham.
Purdue has a quality assurance (QA) department that
checks random samples of bar code labels to ensure
they meet all requirements. The company added QA
tests for a sampling of RFID labels. Inspectors read the
tag using a handheld reader and check to see if the tag
is precisely located in middle of the label. If the tag is off-
Page 9
J a n ua ry 2 0 0 6
center, the label has to be discarded because the tag
could be damaged when the expiration data is hotstamped onto the label during packaging.
if that would enable the tags to be read, but that solution
was impractical. In the end, Purdue decided to switch to
a case that holds 48 bottles.
Purdue also had to ensure
that the tags wouldn’t be dam“We operated under a aged in transit. So Ramsey
strict internal directive put RFID labels on bottles of
to ensure that RFID placebos and then put them
enabling the packaging through a series of shock and
line didn’t negatively vibration tests. The bottles
impact cycle times.” were frozen and then thawed
repeatedly, subjected to tem- Chuck Nardi
peratures as high as 130 deExecutive Director of supply
chain & corporate systems grees Fahrenheit (54 degrees
Celsius) and as low as minus
4 degrees Fahrenheit (minus 20 degrees Celsius), and
dropped repeatedly. The tagged bottles were put
through the shrink-wrap machine 15 times to determine if
the heat used during the process would damage the
tags. After all these tests were completed, six cases of
the test placebos were shipped to Wal-Mart, which was
able to read every tag. “That was the end of the tests for
us,” Richiger says. “We were satisfied that the tags were
durable.”
The biggest challenge was finding a way to integrate
RFID into the packaging line without slowing down the
process. That was tough, because the tags had to be
read after they were applied to the bottles. The system
had to reject any bottle with a tag that was defective, had
a duplicate EPC or had an EPC for a different type of
product. Purdue makes 10-, 20-, 40- and 80-milligram
versions of the pills, each with its own stock-keeping unit
(SKU), and the system had to ensure that an EPC for
10-mg pills was not mistakenly put on a bottle containing
20-mg pills. There wouldn’t be much time to check the
database and then kick out a bottle with a bad tag.
Putting RFID on the Packaging Line
Wal-Mart’s requirement was that 100 percent of all tags
on bottles be readable while the bottles were still in the
case. Purdue also wanted to be able to read all the bottles in the cases for its own tracking purposes. To
achieve 100 percent readability, Purdue needed to do
extensive testing.
Leggett worked with Matrics on how many antennas to
use on the packaging line and how to position them to
ensure that the tags could be read. Originally, Purdue
planned to use a case that held 72 bottles, but Leggett
found that no matter how he positioned the antennas,
many tags couldn’t be read within five seconds—the
amount of time the bottles would be in the read field on
the line—and often the tags on bottles in the middle of
the case couldn’t be read at all. He and Ramsey discussed spiralling the cases through the read zone to see
Leggett worked out a solution with Matrics and NJM/
CLI. In the first week of August, they spent two days installing the new equipment on the line. It took two more
days to refine the timing of the systems so any bottle
with a problem could be rejected. “The easiest part was
connecting the PLC to the RFID reader,” says Leggett.
“The hard part was working out the software and timing
issues, so the bottle could be kicked out if the tag was
bad.”
Here’s how the system works: The first half of the packaging line operates as before. A machine feeds exactly
100 pills into each bottle. The bottles travel down a conveyor and are sealed and capped. As the bottles enter
the area of the line where the labels are affixed, they trip
an electric eye that activates an RFID reader installed in
a standardized metal box (known as a NEMA enclosure)
next to the line. A reader antenna (about the size of a
paperback book) installed on the rail alongside the conveyor reads the RFID tag. If the reader is unable to pick
up the tag’s EPC number before the bottle passes a second electronic eye, installed right after the reader antenna, a tube installed along the conveyor emits a burst
of air that blows the bottle off the line into a small hopper.
If the tag is read, the reader passes that information to
J a n ua ry 2 0 0 6
a computer in the NEMA enclosure. The computer,
which has a touch screen that allows a supervisor to enter information about the product on the line, checks to
make sure the EPC number on the RFID tag has the
right product identifier for the type of OxyContin being
packaged (10-, 20-, 40- or 80-mg pills).
It takes about half a second to read the RFID tag,
check the tag to make sure it has an appropriate EPC for
the SKU on the line, and then send a message to the
PLC to kick the bottle off the line if the tag contains the
wrong type of EPC. “As it turns out, that’s about all the
time we had, given the speed of the line, which is 120 to
140 bottles per minute,” says Richiger.
After the tags are read, the bottles continue down the
narrow conveyor and are organized into lots of six, which
are shrink-wrapped and placed by hand into small cases
that hold a total of 48 bottles each. Purdue could have
tested the tags at this point but decided against it because finding a bad tag would have disrupted the packaging process. “We operated under a strict internal directive to ensure that RFID-enabling the packaging line did
not negatively impact packaging cycle times,” says
Nardi. “We had to aim high.”
After eight lots of six bottles are put into a case, the
case is sealed with special tamper-proof tape. Then it
moves along a U-shaped conveyor and passes another
electric eye, which fires up an RFID reader powering
three antennas installed like a tunnel over the conveyor.
The reader has five seconds to read all 48 bottles in the
case. The serial numbers on the tags are then compared
with the serial numbers on bottles that have already
been tagged and captured in the AII database, to make
sure there are no duplicate numbers being used. If there
is a duplicate, or if fewer than 48 tags are read, a command is sent to the PLC that automatically stops the line
so that a supervisor can investigate the problem. If all 48
numbers are unique, they are added to the AII database.
Next, 100 cases are stacked on a pallet and taken to a
conveyor with a reader that has been set up near the
secure storage area of the facility. The cases are taken
Page 10
off the pallet and sent down the conveyor one by one.
The bottles in each case are read before the cases are
put into the vault. This enables the company to know
exactly which bottles are in storage. When they are removed from storage, the cases are sent down another
conveyor with a reader and read again before they are
shipped to Wal-Mart’s pharmaceutical warehouse in
Bentonville. This allows Purdue to track exactly which
bottles are sent to Wal-Mart. The information could eventually be put in an advance shipping notice that would
alert the retailer to what’s coming.
Data Collection
Celentano and Idicula set-up Windows 2000 servers in
the Wilson facility, and SAP helped to install its AII middleware on the servers to pass data between the readers and the supply chain management software. WalMart didn’t require pharmaceutical companies to share
RFID data, but Purdue decided from the start that it
wanted to use the RFID data to help confirm that the
product had moved from the packing line to the vault and
then to the shipping area. If Wal-Mart later required Purdue to send an advance shipping notice with the EPCs
of all products in a delivery, Purdue would have the data
available.
One issue was how to differentiate tagged products
from the regular products, since both versions would
need to coexist. Celentano considered creating new
SKUs for the four types of OxyContin that would have
RFID tags. But that introduced too much complexity into
the system, and it went against the company’s vision of
ultimately blending RFID into Purdue’s operations.
Instead, the company chose to assign an RFID attribute value of either “yes” or “no” to each batch of OxyContin produced. One advantage of this approach is that
workers in the warehouse do not have to put tagged
products in a special area or worry about managing two
types of inventory. Today, when pills are bottled, Purdue
stores the date of manufacture, SKU, batch number and
other information in the company’s SAP software. When
the product is put in the vault, the shelf location is stored
in the application.
Page 11
When an order is received, the system determines
which product to pick from the vault based on a number
of criteria— product type, date of manufacture and so
on—and then creates a pick order that tells warehouse
personnel which shelf to take the product from. If the
order comes in from Wal-Mart, the computer system
knows that the RFID indicator has to be “yes” and creates a pick order that indicates the location in the warehouse where the tagged product has been stored. “We
can easily scale the system to add another customer,
another SKU or another product line,” says Celentano.
J a n ua ry 2 0 0 6
supply chain.
Now that it has begun satisfying Wal-Mart’s RFID requirement, Purdue doesn’t plan to rest on its laurels. It’s
installing the same type of RFID system at a packaging
facility in Totowa, NJ. Depending on tag availability, the
company plans to tag all bottles of OxyContin and Palladone, another Schedule II narcotic that Purdue manufactures. Purdue is also considering tagging cases as well
as individual bottles.
The RFID equipment added to the test line went
through a number of qualifications before the system
could go live. The final qualification involved packaging a
batch of each SKU. In early November, the first batch of
20,000 tagged bottles went through successfully. There
were only two defective tags, and both were successfully
kicked off the line. The qualification process was finished
later that month, and on November 29, the line went live,
with the first shipment to Wal-Mart.
Wal-Mart didn’t ask Purdue to put tags on cases, because both companies want to identify each bottle in a
case individually as the product moves through the supply chain. But the RFID team at Purdue believes tagging
cases would enable the company to locate a specific
bottle more precisely (today, a bottle is identified only as
being part of a batch, which means it could be one of
12,000 bottles made during a certain period). Also, tagging cases of other products could provide some efficiencies in the supply chain.
Moving Forward
Purdue has invested significant time and money integrating RFID technology with its packaging line and IT
systems. The company doesn’t expect to see a return on
investment in the near term, at least for tagging OxyContin, but this year Purdue will look at the potential benefits
of using RFID in its supply chain.
“This was a very exciting project,” says Richiger. “We
put together a multidisciplinary team, and each person
took ownership of their part of it. This is cutting edge
technology. There aren’t a lot of times in your career
where you get to work on first-time-out issues. We all felt
that we may never get another opportunity like this.” Not
many people, after all, get to make history.
“Long-term, we think RFID is the right approach for
product authentication and creation of an electronic
pedigree throughout the supply chain,” says Richiger.
“There are significant benefits in our industry to identifying product from the point of manufacture to the retail
pharmacy. And we’re very interested in working with the
wholesalers and retailers to make the information visible
up and down the supply chain.”
An electronic pedigree is a secure file that stores data
about each move a product makes through the supply
chain. If FDA inspectors have any questions about a
product, they can go back to the manufacturer and get a
full accounting of how that product moved through the
J a n ua ry 2 0 0 6
Page 12
ISPE Biographie
par Rick Hargreaves,
Grantek Systems Integration
Grace Chin, vice-présidente
exécutive, science et technologie chez SNC-Lavalin
Pharma
Notre membre de l'ISPE en vedette dans ce numéro
est Grace Chin, vice-présidente exécutive, science et
technologie chez SNC-Lavalin Pharma, (SLP). Grace et
sa famille ont émigré au Canada à partir de la Jamaïque
alors qu'elle était au début de l'adolescence. Elle a fait
ses études supérieures à Ryerson où elle a obtenu un
diplôme en génie chimique.
En sortant de Ryerson, Grace s'est jointe à BristolMeyers dans le département de l'assurance de la qualité. Elle est passée ensuite chez Sandoz (devenue par
la suite Novartis) où elle a occupé des postes en production/opérations, ingénierie de projets et gestion et validation de projets. Il y a huit ans de cela, Grace déménageait chez Pellemon, qui est devenue par la suite SLP,
la division pharmaceutique/biotechnologique de SNCLavallin.
Grace a été l'un des deux ingénieurs chargés de l'ouverture d'un bureau à Toronto, Ontario pour SLP ; elle a
ensuite été promue à la validation au niveau de la société en janvier 2005 pour assumer son rôle actuel où elle
supervise quatre groupes d'entreprise sur le plan global
– processus, automatisation, validation et conformité.
Grace est un membre actif de l'ISPE depuis près de 17
ans et elle apprécie énormément d'y participer. « Mon
statut de membre de l'ISPE me donne l'occasion de me
réseauter avec d'autres membres de l'industrie, et les
avantages pour chacun sont immenses », a répondu
Grace quand on lui a demandé si elle voyait un avantage majeur à être membre.
Grace continue de redonner à l'ISPE de nombreuses
façons. Elle a été membre du conseil d'administration
durant deux ans pendant lesquels elle présidait le comité
d'éducation de notre chapitre à organiser nos événements de petits-déjeuners-causeries. Elle est actuellement sur le comité international d'éducation de l'ISPE est
elle est directrice du comité de l'AGA de notre chapitre
du Canada central. Elle adore les occasions d'encadrement que lui offre son affiliation à l'ISPE et apprécie le
contact de ses confrères. « J'aime aider les autres
quand ma compétence ou mon emploi du temps me le
permettent », affirme Grace. « C'est vraiment une petite
industrie et lorsque nous pouvons aider les autres, on se
fait aider soi-même. » Pas besoin de dire que Grace est
très engagée à l'égard de l'ISPE et que ses efforts sont
grandement appréciés de tous.
Grace répond rapidement à notre question au sujet des
passe-temps. « Mon travail est mon passe-temps favori », répond-elle, et si vous avez jamais eu l'occasion de
rencontrer Grace, cela se voit facilement. Grace est
passionnée par son travail et par notre industrie et elle
travaille sans relâche à promouvoir l'ISPE et l'industrie
des sciences de la vie. Nous ne doutons nullement que
Grace continuera d'avoir du succès dans ses entreprises.
Grace vit présentement à Markham et est la fière maman de deux filles. Bonne chance pour la suite des choses, Grace, et sache que nous apprécions ton soutien
indéfectible envers l'ISPE et de notre chapitre du Canada Central en particulier.
Page 13
J a n ua ry 2 0 0 6
New Members Welcome
NAME
TITLE
COMPANY
Bill Abou
Khursh Ahmed
Cyril Boucher
Paul Bovos
Alain Cabana
Jose Chvaicer
Caroline Durand
Farhad Esmaeilzadeh Azar
Marie-Pierre Fafard
Rachel Falcon
Rene E. Fitzpatrick
Michael K. Foster
Karl Fournier
Francesca Gougeon
Jonathan Gougeon
Genevieve Gravel
Ping He
Azadeh Kermanshahipour
Jean-Philippe Laviolette
Marie-Christine Leblond
Fay Y. Low
Effie Manziaris
Catherine Marcoux
Pierre Martineau
Tony Mesec
Tim Morrison
Charles-Andre Munger
Nisha R. Patel
Mario Perez
Frederic Poulin
Liliana P. Ramirez
Francois Reney
Adrien Reymond
Troy W. Selley
Amir Sepehrdad
Shetal Shah
Quoc-Hoa Tran
Tan-Dat Tran
Melanie Turcotte
Anne Weber
R. Drew Wilson
QA Manager
QA Manager
Student
Purchasing/Project Mngr
Vita Health Products
Population Health Research Institute
Ecole Polytechnique De Montreal
O'Hara Technologies
Opep Pharma Inc
Taro Pharmaceutical Industries Ltd
Wyeth Organics
OBK Technology Ltd
Confab Laboratories
Cheme Engineering Inc.
Cheme Engineering Inc.
Nucryst Phama
Pharmascience
QLT Inc.
Sanofi Pasteur Ltd
GSK Biologics
Environmental Systems Corporation
ATS Compliant Solutions
Preston Phipps
Patheon
Galax Inc
AstraZeneca Canada Inc
Cangene Corp
GE Water & Process Technologies
Genpharm Inc.
ATS Test Systems
Associate Director Validation
Student
Student
Student
Student
Project Engineer
Sr Eng Technologist
Validation Engineer
Student
Process Engineer
Student
Student
Validation Supervisor
Operating Sys Analyst
Student
Senior Consultant
Engineer
Jr Project Engineer
Chemical Engineer
Student
QA Svcs., Manager
Student
Student
Validation Manager
District Account Representative
Project Specialist
Student
Student
Student
Student
Director Of Technology
J a n ua ry 2 0 0 6
Page 14
Chapter News
Upcoming Breakfast Seminar
Our next Breakfast Seminar entitled Successful Implementation of an EPCMV Project in Only 9 Months, is
scheduled for 28 March 2005 in Montreal at the Schering-Plough facility and repeated on 29 March 2005 in
Toronto at the GSK facility. Also note to schedule your
calendars for the final Breakfast Seminar scheduled for
16 May in Toronto and 17 May in Montreal.
We continue to strive to provide you, our Membership,
with the best possible seminars we can. If you have
feedback for us, and perhaps an idea of what you might
like to see in future seminars, please let us know. We
would enjoy hearing your thoughts! Please forward your
comments to: [email protected].
SNC-Lavalin Acquires BHA
SNC-Lavalin is pleased to announce that BHA has
joined its Pharmaceutical & Biotechnology Division,
SNC-Lavalin Pharma (SLP). Through this acquisition,
SLP’s Toronto office can provide additional expertise in
process and automation services, through a team of
highly experienced and dedicated process and automation specialists, fully versed in cGMP regulatory requirements. This team supplements SNC-Lavalin’s 1,375 engineers and advanced technology specialists, based out
of its Toronto offices.
Since 1996, BHA has been combining bioprocess and
automation expertise for many of the local and international pharmaceutical and biotechnology leaders. This
dynamic team specializes in providing design, installation supervision, commissioning and validation of clean
utility systems (WFI, PS, PW), waste neutralization systems, bioprocess engineering systems, as well as sterile
and liquid process systems. Their approach encourages
synergy between engineering design, process design,
automation, commissioning and validation requirements.
This experienced team has nurtured innumerable process projects throughout their life cycles, from conception
to completion. Their philosophy continues to be actively
listening to the Users and thus have a clear understanding of their present and evolving needs and objectives.
We are excited about the growth of our Pharmaceutical
& Biotechnology Division. For further information, please
contact: [email protected] or visit:
www.snclavalin.com/pharma.
Technical Articles Wanted
Do you have an article or the idea for one? We are
looking for technical articles that would be relevant to the
pharmaceutical industry and ISPE Central Canada
Chapter Members. The newsletter is published electronically five times a year and posted on:
http://www.ispe.org/centralcanada/newsletters.htm.
All articles of a non-promotional nature will be considered. To submit, please send your information to the
newsletter committee: [email protected].
Central Canada Challenger
Now here’s an interesting puzzle to solve. This quiz
contest closes 3 March 2005at 12:00 pm at which time
all correct answers will be entered into our draw for a
mystery prize. The correct answer and winner’s name
will be published in the next newsletter
issue. So, good luck, have fun and
here is the quiz…
A cylinder 60 cm high has a circumference of 20 cm. A string makes exactly 4 complete turns round the cylinder while its two ends touch the cylinder's top and bottom. How long, in cm,
is the string?
Good Luck to all! Please send your answers to:
[email protected].
CONTACT INFORMATION
ISPE Central Canada Chapter
8000 Decarie Boulevard., 3rd Floor Montreal, Quebec, H4P 2S4
Bus: 514-735-5651 ext. 2297, Fax:514-737-7988
Geoff A. Pilmoor
President
[email protected]
Richard Poulin
Vice-President
[email protected]
Rudy W. Dietrich
Treasurer
[email protected]
Raymond F. Marcoux
Secretary
[email protected]
Cassie Kelly
Director
[email protected]
Ken McKay
Director
[email protected]
Rick Hargreaves
Director
[email protected]
Daniel Laporte
Director
[email protected]
Iva Sola
Director
[email protected]
David Barrett
Director
[email protected]
Mark Butterworth
Past President
[email protected]
Sylvie Lachapelle
Chapter Manager
[email protected]
Sims Moelich Associates Ltd.
277 Lakeshore Road East, Suite 408
Oakville, Ontario
Tel: 905.849.1833 ext. 413 Fax: 905.849.9734
SNC-Lavalin Pharma
8000 Decarie Boulevard, 3rd floor
Montreal, Quebec
Tel: 514.735.5651 ext . 2439 Fax: 514.737.7988
Sanofi Pasteur Limited
1755 Steeles Avenue East
Toronto, Ontario
Tel: 416.667.2766 Fax: 416.667.2720
SNC-Lavalin Pharma Inc.
Montreal, Quebec
Tel: 514.735.5651 ext . 2496 Fax: 514.737.7988
AMEC Americas Limited, Industrial & Pharmachem Division
2020 Winston Park Drive, Suite 700
Oakville, Ontario
Tel: 905.403.5046 Fax: 905.403.5026
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
Tel: 905.803.5767 Fax: 905.275.0706
Grantek Systems Integration Inc.
4480 Harvester Road
Burlington, Ontario
Tel: 905.634.0844 x270 Fax: 905.634.9548
Laporte Engineering
5250 rue Ferrier, suite 517
Montréal, Québec
Tel: 514.733.1073 Fax: 514.733.6114
Taro Pharmaceuticals Inc
130 East Drive
Brampton, Ontario
Tel: 905.789.2742
Siemens Building Technologies Inc.
2 Kenview Boulevard
Brampton, Ontario
Tel: 905.602.1959 Fax: 905.602.1910
GlaxoSmithKline Inc.
7333 Mississauga Road North
Mississauga, Ontario
Tel: 905.819.3254 Fax: 905.819.7099
ISPE Central Canada Chapter
Montreal, Quebec H4P 2S4
Tel: 514.735.5651 ext . 2297 Fax: 514.737.7988

Message from the President

Transcription

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