Published by the ISPE San Diego Chapter Serving Southern California from San Diego to Orange County Editor: Kimberly Syre Email: [email protected]Information: Phone 1.949.387.9046 and Fax 1.949.266.8461 IN THIS ISSUE H appy New Year! Celebrating the 20 year anniversary of the ISPE San Diego Chapter, our theme for 2012 is: “20 years of Excellence: Building on the Past, While Designing the Future” Building on the Past – At the ISPE Annual Meeting in November, the Annual Awards for Excellence and Innovation were announced. For the 5th consecutive year, the ISPE San Diego Chapter was awarded Platinum First Place Small Chapter Award and for the first time, the Student Chapter of the Year Award for the UCSD Student Chapter. An additional award was received for Innovation for Student Programs 1st Place. The Chapter would like to rec- ognize the tremendous amount of effort given by the students over the past year. At the end of this newsletter, we have included the UCSD Student Chapter 2011 report that was submit- ted for this award. Congratulations to the awesome students at UCSD and to our Chapter Members! NEWSLETTER • Volume 18, No. 1 • www.ispe.org/sandiego President’s Message PAGES 1-2 31 January is 2012 ISPE West Coast Resource Directory Deadline PAGE 3 26 January Temecula Winery Tour PAGES 4-6 2012 Chapter Planning Meeting PAGE 7 Search for ISPE Mentors PAGE 7 Golf Tournament Photos PAGE 8 Vendor Night Overview PAGE 9 23 February Validation Meeting PAGES 10-11 Committee Members Needed PAGE 12 Airborne Particle Cleanliness Article PAGES 13-15 Young Professionals Group Forming PAGE 16 HVAC Class Overview/Photos PAGE 17 Board of Directors List PAGE 18 New Members PAGE 19 ISPE Annual Meeting Report PAGES 20-21 Project Management Class Photos PAGE 22 2012 ISPE Event Calendar PAGE 23 (continued on next page) President’s Message by Christy Pavano of CRB ISPE’s Award Winner for Excellence and Innovation 2007-2011 At the ISPE Annual Meeting in November, the San Diego Chapter was awarded the Platinum First Place for a Small Chapter and also received Student Chapter of the Year for the UCSD Student Chapter. In photo (L-R): Chapter Manager Kimberly Syre, Past President John Lohnes, UCSD Student Chapter Past President Scott Revelli, Chapter President Christy Pavano, Chapter Treasurer Mike Barbera and Communications Chair Nicole Hall. Happy New Year From San Diego!
Transcript
Published by the ISPE San Diego Chapter Serving Southern California from San Diego to Orange County
Happy New Year! Celebrating the 20 year anniversary of the ISPE San Diego Chapter, our theme for 2012 is:
“20 years of Excellence: Building on the Past, While Designing the Future”
Building on the Past – At the ISPE Annual Meeting in November, the Annual Awards for Excellence and Innovation were announced. For the 5th consecutive year, the ISPE San Diego Chapter was awarded Platinum First Place Small Chapter Award and for the first time, the Student Chapter of the Year Award for the UCSD Student Chapter. An additional award was received for Innovation for Student Programs 1st Place. The Chapter would like to rec-ognize the tremendous amount of effort given by the students over the past year. At the end of this newsletter, we have included the UCSD Student Chapter 2011 report that was submit-ted for this award. Congratulations to the awesome students at UCSD and to our Chapter Members!
2012 ISPE Event CalendarPAGE 23 (continued on next page)
President’s Message by Christy Pavano of CRB
ISPE’s Award Winner for Excellence and Innovation 2007-2011
At the ISPE Annual Meeting in November, the San Diego Chapter was awarded the Platinum First Place for a Small Chapter and also received Student Chapter of the Year for the UCSD Student Chapter. In photo (L-R): Chapter Manager Kimberly Syre, Past President John Lohnes, UCSD
Student Chapter Past President Scott Revelli, Chapter President Christy Pavano, Chapter Treasurer Mike Barbera and Communications Chair Nicole Hall.
Designing the Future - San Diego continues to be one of the top Life Science clusters in the U.S. and is now the top hub for Industrial Biotech and Biofuels. As our industry continues to evolve, the ISPE San Diego Chapter will evolve with it and will strive to provide our Members technical programs and educational training classes that are forward thinking. As the landscape changes and we see an increase in demand and collaboration for Industrial Biotechnology we will continue to add programs that educate and inform our Members of the synergis-tic opportunities between Industrial Biotechnology, Biofuels, and the Life Science Industries.
In late 2011, we met with and surveyed our Executive Advisory Council (EAC), made up of Directors of Facilities, Manufacturing and Operations of local biotech and pharmaceutical companies such as Althea, Sangart, Verenium and Advanced Bio Healing to seek feedback and suggestions on programs topics and hot button issues they are facing. We used this information during our annual strategic planning meeting to plan programs that are relevant to the needs of our ISPE San Diego Chapter Members. Thank you to those who took the time to provide feedback, we greatly appreciate it!
For 2012, we have technical programs and educational classes on Operations Management, Critical Utilities and HVAC, Validation, ISPE Guidelines, etc. Be sure to look for our calendar of events in the back of this newsletter.
Wishing you all a Healthy and Prosperous New Year, I look forward to seeing you at our next event.
ISPE Student Chapter at UCSD received the Student Chapter of the Year award! This is the first time a Chapter on the West
Coast has won this award and we are very proud of Scott Revelli, an Associate Engineer at Genentech in South San Francisco (shown here) and Kenneth Ng who were Co-Presidents of the UCSD Student Chapter last year and submitted the awesome report to win this award (see report at the end of the newsletter). The report they prepared is now being shared with other Chapters as a Best Practice for Student Chapters!
Does Your Company Offer Services or Supplies to the
Pharmaceutical or Biotech Industry on the West Coast?
We are Now Taking Submissions for the
2012 ISPE WEST COAST
RESOURCE DIRECTORY
All Ads are 4-Color and distributed in book format to the nearly 2000 ISPE Members on the West
Coast, available on CD at Chapter meetings and posted electronically on Chapter Web sites.
Note to Previous Advertisers: Since a Directory was not published in 2011, all ads previously submitted
will be rolled over to the 2012 edition. Your past submission will be emailed to you allowing you to make any changes before we go to print.
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Join Us on January 26th for a
Temecula Winery Tour
ISPE San Diego and Los Angeles ChapterJoint Social EventJanuary 26, 2012
Your day starts by meeting your limo bus at one of the three pick up spots. One bus will pick up passengers at the Oceanside train station. The other bus will pick up passengers at the Santa Ana train station. One of the buses will make a stop at the Old Town Temecula parking garage to pick up additional guests. Breakfast snacks will be served on the buses.
Our first stop will be Gershon Bachus Vintners for wine tasting and a talk with the wine maker. From there, we head to Oak Mountain Winery for a gourmet pizza lunch and more tastings. Dress warmly as we will be visiting Leoness Cellars for an outdoor vineyard tour and wine tasting in the afternoon.
At the end of the day, we will board the buses and return to Old Town Temecula, Santa Ana and Oceanside enjoying some chocolates and other sweets along the way.
We encourage safe driving. It is recommended that you take the train to either the Santa Ana or Oceanside train station for pick up and drop off. Once at the train station, you can return to the station closest to your home.
Premium Pour Sponsors:
Additional Sponsors:Attention To DetailCommissioning Agents, Inc.CRBDPR ConstructionEwingColeXyntek, Inc
Sponsor the ISPE San Diego and Los Angeles Chapter Joint Social EventJanuary 26, 2012
Premium Pour Sponsor - $500 • Your company logo on signage at wineries and on buses. • Your company logo on all promotional materials prior to the event (on event flyer and email broadcasts). • One Ticket for the event.
Limo Bus Sponsor $400 • Your company logo on signage on each bus. • One Ticket for the event.
Winery Sponsor $325 • Your company logo on signage at wineries. • One Ticket for the event.
Wine Raffle Sponsor $125 • Recognition at Event. • Your business card on each bottle of wine given away.
Goodie Bag Sponsor (Budget for 60-80 guests)Ideas Include: • Your wine related company logo items to give away to the attendees. • Breakfast items on bus. • Snacks on bus. • Drinks on bus.
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REGISTRATION FORMISPE San Diego & Los Angeles Chapter
Temecula Winery ToursJanuary 26, 2012
Please use our Online Registration. If you cannot register online, you can use this form to register.
___ $135 Per Winery Tour Ticket (includes bus transportation to wineries, wine tour, wine tastings, morning snacks on bus, lunch, sweets and waters on the bus)
Please indicate where you will be meeting your bus: ___ Santa Ana Train Station ___ Oceanside Train Station ___ Old Town Temecula Parking Garage Sponsorships
___ Premium Pour Sponsor $500 ___ Limo Bus Sponsor $400 ___ Winery Sponsor $325 ___ Wine Raffle Sponsor $125 ___ Goodie Bag Sponsor (wine items, breakfast, drinks, snacks on bus) Please indicate what you would like to sponsor:
Schedule8:00 - 8:30 amMeet Bus in Santa Ana or Oceanside Train Station (Use Metrolink or Amtrak)
9:30 amBuses Pick Up at Old Town Temecula Parking Structure
10:00 amWine Tasting at Gershon Bachus
11:30 am Oak Mountain Winery for Wine Tasting and Gourmet Pizza Lunch
1:30 pm Vineyard Tour and Wine Tasting at Leoness Cellars
3:00 pm Buses Leave for Old Town Temecula, Oceanside and Santa Ana
5:00 - 5:30 pm Arrive in Santa Ana and Oceanside
Registration InstructionsTo Register and Receive an immediate receipt, use our on-line registration: http://www.atdevents.net/event.php?id=72
If you have an account on our system, please log on and register for the event. If you do not have an account, you can set up a new account using letters (not numbers) as your username.
If you are an ISPE Member in California, you may already be in our system. If you do not know your user name or password, please email Rob Fleming for assistance: [email protected]
Registrations can also be faxed using this form with credit card payment. Fax to 949-266-8461 or 949-387-9047.
If paying by check, please mail check made payable to: ISPE San Diego Chapter, 5319 University Dr., Suite 641, Irvine, CA 92612. ISPE SD Federal Tax ID #33-0551783
Questions? Contact Kimberly Syre [email protected] or call 949-387-9046
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Board of Directors Meet to Establish Game Plan for 2012by Nicole Hall of Commissioning Agents, Inc.
On October 1, the Chapter’s volunteer Board of Directors met at Hera Hub in San Diego for the Annual Strategic Planning Meeting. Using feedback from the Chapter’s Executive Advisory Council (EAC), along with lessons learned from 2011 programs, the Board created a Strategic Plan and the 2012 Chapter calendar (see last page of newsletter for calendar).
We are happy to announce our 20 year anniversary and the theme this year will be “20 Years of Excellence: Building on the Past While Designing the Future”. Carrying this theme through 2012 we’ll be looking at lessons learned and what this means for the future.
2012 topics include Operational Management, Critical Utilities, Validation, Biotech growth in San Diego, Sterile Product Pro-cesses, as well as, some exciting Facility Tours and Network-ing “Socials” including a wine tour in January.
We are here to serve our Members and very much encourage your feedback. Please reach out to your Board Members and participate in Member surveys, so we can help to create the value you deserve in your ISPE SD Chapter.
Preparing to enter the business world can be puzzling. You can help move a college student’s career in the right direction.
UCSD’s ISPE Student Chapter needs mentors to help student members successfully connect their academic experiences with their career aspirations. Volunteer mentors, from all aspects of the pharmaceutical industry, are needed to lend a guiding hand to students trying to fit together the pieces of the career preparation puzzle. Make a difference with just a few hours of your time!
Build a relationship: Become a mentor! Interested? It’s easy. Complete our Mentor Enrollment form at http://ispe.ucsd.edu/
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Golf Tournament Overviewby Christy Pavano of CRB
The Chapter’s Annual Golf Tournament was held the day after Vendor Night at Encini-tas Ranch Golf Course in August. With cool ocean breezes, this tournament was a very refreshing change from the sweltering heat we have experienced in previous
years. Hole sponsors helped liven up the event with food and drinks being served at many of the holes. Thank you to our players, sponsors and the Golf Committee headed by Laura Ellery of Climatec and Albert Marquez of Duhig Stainless.
Congratulations to the winners: 1st Place Open Category with a score of 51 Evans Consulting (See top middle photo (L-R): Chris Syrengelas, Annalisa Evans, Annie Cunningham, Tim Paymaster
1st Place Handicap Category with a score of 60DPR Construction (Carlos Crabtree, Bruce Anderson, Ross Brown, Mike Winstead)
Closest to the Pin: Annalisa Evans, Mike Conroy, Doug Brummett and Juan UvinaLongest Drive: Tim Paymaster and Danette FerrettiGrand Prize Winner of a Flat Screen TV: Christoph Lebl
Thank you to our Sponsors:
Alphabio Inc
Attention To Detail
BNBuilders
CRB
Duhig
Dynalectric
Ellab Inc.
Ferguson Pape Baldwin Architects
Pacific Rim Mechanical
ProcessHQ, Inc.
ProPharma Group
Steriflow Valve
Water Works Inc.
Vendor Night Overviewby Christy Pavano of CRB
The Chapter’s Annual Vendor Night exhibit show was held in August. The event began with a presentation from Jeff Yuen, former FDA Investigator, of Jeff Yuen & Associates with a presentation “Enforcement, Inspections, Top FDA 483s and Warning Letters and
Responding to FDA 483s.” The Casino Night-themed exhibit show followed providing excel-lent networking opportunities for our attendees. Thank you to Jeff Yuen and our Vendor Night Committee headed by Stacy Sutton of Althea Technologies.
Congratulations to Siemens and Eichleay Engineers for best decorated table and to Carl Hulle of Iris Molecular Diagnostics and Claire Lucas of ATMI LifeSciences for best dressed attendees, all winning cash prizes. The grand prize, a trip to Las Vegas, was won by Victor Khachatourians of PaxVax.
Validation Past, Present and Futurethursday, February 23, 2012
5:00 - 7:30 Pm
Location: DPR Construction5010 Shoreham Pl, San Diego CA 92122
Sponsored by:DPR ConstructionEndress + HauserSpeaker:Beth E. Bertelsen-Putirka, President, BB Consulting Services (BBCS) Inc.
Program Manager:Dan Cooper, Instrumentation and Controls/Commissioning Specialist, CRB Consulting Engineers
Schedule:5:00 - 6:30 pm Extended Networking Reception and Registration Dinner and Happy Hour with wine, beer and soft drinks6:30 - 7:30 pm Presentation
Cost: $50 Members / $70 Non-Members / $20 Government or Students / Free to DPR Employees $500 Event Sponsor (includes at display table and two admissions to the meeting)
Synopsis:This presentation covers the evolution of Validation. When, where and why did Validation start? The events and timing around the begin-nings of Validation will be reviewed. The traditional IQ/OQ/PQ Validation approach will be covered. How and why did the traditional Validation approach become so cumbersome? The transition from traditional IQ/OQ/PQ Validation to the current Science and Risk Based Commissioning and Qualification approaches including ICH 8, 9, 10 and ASTM E 2500-07 will be discussed. Where are we headed? What is in store for the future? As science, technology and innovation change, so must the paradigm shift for a fresh approach to Qualification.
Speaker Bio:Ms. Bertelsen has been in the biomedical industry for 18 years. She holds an undergraduate degree in Biology and a Masters of Business Administration. She has held numerous Validation, Quality and Project Management positions in biotech, medical device and pharma-ceutical companies. Her specialty is establishing and implementing Validation Programs and Validation of Biotech, Medical Device, and Pharmaceutical systems and equipment. Currently, she owns and manages BB Consulting Services, Inc. (BBCS) which provides Validation and Quality services, GMP Training and FDA and EU inspection preparation.
Special consideration will be given to those who are unemployed.
ISPE San Diego Chapter 2012“20 Years of Excellence:
Building on the Past, While Designing the Future”
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isPe san diego ChaPter 2012“20 years oF exCellenCe:
building on the Past, While designing the Future”
REGISTRATION FORM:To Register and Receive an immediate receipt, use our on-line registration:
http://www.atdevents.net/ispesandiego.phpIf you have an account on our system, please log on and register. If you do not have an account, you can set one up on the site using letters (not numbers) as your username. If are an ISPE Member in California, you may already be in our system. Your ISPE Member number is your username. If you do not already know your password, please email Rob Fleming to request a new password: [email protected]
Registrations can also be faxed using this form with credit card payment. Fax to 949-266-8461 or 949-387-9047. Mail your check made payable to: ISPE SAN DIEGO CHAPTER, 5319 University Dr., Suite 641, Irvine, CA 92612. Chapter Hotline (800) 869-9621 or (949) 387-9046. Name Badges will be given at the event. ISPE San Diego Chapter Tax ID#33-0551783. Contact Kimberly Syre: [email protected] with any questions.
Cancellations must be received via email to: [email protected] by February 16 for refund. After the cancellation date if you have reserved a space but do not attend, your payment MUST be remitted, however, an alternate person may attend in your place. If the alternate is not a member, they will need to join. Name Badges will be given at the on-site registration desk.
Dinner and Happy Hour Provided
COST ❑ Free For DPr emPloyees (Please Fax this Form or email: [email protected] to Be aDDeD to the list)
❑ $50 isPe memBers ❑ $20 Government/isPe stuDent memBers
❑ $70 non-memBers
❑ $500 meetinG sPonsor
First Name:
Last Name:
Title:
Company:
Address:
City:
State: Zip:
Tel Number:
Fax Number:
E-Mail:
CREDIT CARD PAYMENT
Type of Credit CardCircle One
Name on Card:
Credit Card #:
Exp Date:
Signature:
ISPE Member:
Chapter Affiliation:
Validation Past, Present and FutureThursday, February 23, 2012
5:00 - 7:30 pm
at DPR Construction, 5010 Shoreham Pl, San Diego CA 92122
Speaker: Beth E. Bertelsen-Putirka, President, BB Consulting Services (BBCS) Inc.
Sponsors:DPR ConstructionEndress + Hauser
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Whether You are New to the Industry or a Seasoned Professional...
Your ISPE Membership is portable and goes with you wherever you go in the industry.
...ISPE has something for YOU.
Join today! Visit www.ISPE.org/Join
“Over the years, the body of knowledge that has been developed by ISPE is second to none. If you are looking for answers, this is the place to come and find them.” Andrew A. Signore, CPIP, President, IPS, USA
KnowledgeIncrease your understanding
CommunityMeet like-minded professionals
ProfessionAdvance your career
Whether You are New to the Industry or a Seasoned Professional...
Your ISPE Membership is portable and goes with you wherever you go in the industry.
...ISPE has something for YOU.
Join today! Visit www.ISPE.org/Join
“Over the years, the body of knowledge that has been developed by ISPE is second to none. If you are looking for answers, this is the place to come and find them.” Andrew A. Signore, CPIP, President, IPS, USA
KnowledgeIncrease your understanding
CommunityMeet like-minded professionals
ProfessionAdvance your career
Call for Committee Members!
We need your help. ISPE is a volunteer organization and as such, we need the help of our Members to shape the future of the Chapter. Opportunities to get involved in with ISPE SD
2012 include:
Communications Committee - Quarterly Newsletter Content, Techni-cal Articles, Social Media Guru’s, posting events on the web, creating advertising partnerships, assist Program Chair with organizing full day class around Operation Management. Contact – Nicole Hall, Commissioning [email protected] or 215 237 5127.
Membership Committee - Company Membership Champions for ISPE, Ideas for this year’s Membership Drive, Assist Program Chairs Organiz-ing Full Day Critical Systems Class (i.e. Sponsorships, Speakers, Host Location), Mentors for Students and Incoming Young Professionals. Contact - Jonathan Bradley, Siemens Industry, [email protected] or (858) 880-2043
Young Professionals Committee - Help coordinate Young Profession-als events, recruit new Members, assist with the transition from Stu-dent member to Young Professional. Mentor program assistance, and engaging current and new members to help achieve society goals and education.Contact - Ashlee Ujifusa, BioTek Systems/ProcessHQ, [email protected] or 760-730-9376
Student Affairs Committee - Mentor students looking to enter the bio-tech industry, serve as a judge in the Student Poster Contest, speak at UCSD Student Chapter events, host tours for UCSD Student Members, assist in planning and strategy to expand and improve student pro-grams in San Diego.Contact – Mike Fino, Mira Costa College, [email protected]
Understanding Airborne Particle Cleanliness Requirement Calculations Airborne particle monitoring is a performance qualification activity which measures the quantity of particulates within a controlled cleanroom. These are very fine pollutants which range from 0.1 to 0.5 µm. Cleanliness criteria should be based on particulates inside this size range, often at three different sizes. There are a number of calculations involved in an environmental monitoring qualification; from a qualification development and execution perspective, determining the points for sampling, overall mean of averages, and upper confidence limits are the most frequently used calculations. For other airborne particle calculations refer to ISO 14644-1, Cleanrooms and associated controlled environments. Establishing sample point locations To determine the number of sample sites to be used the following calculation is used:
!! ! ! Where,
NL = Minimum number of samples A= Area of the controlled cleanroom in square meters
Note the number of samples is always rounded up, regardless of the remainder. For example, a cleanroom of 27 m2
is to be qualified. !! ! !"!! 5.19 ! !"!!
It reasons that there may not be 0.19 of a sample location, so 6 sample locations are required. These locations are evenly distributed throughout the cleanroom to give a representative sample. It’s important to remember this value is the minimum required samples; more samples may be taken based on risk analysis. Sampling locations are distributed to represent overall spatial coverage of a room, incorporating those areas of high activity and worst-case areas relative to HVAC design and air flow. Areas of transitional or turbulent airflow and eddies are examples of an area within a cleanroom which would be of a significant concern. The location of high activity may give an aberrant result and requires consideration when making a sampling plan. Understanding results Depending on the size of the cleanroom and the thoroughness of the sampling plan, there are 2 possibilities for calculating sample results.
• A lone sample location requires a minimum of 3 samples at that location. Those samples are averaged together for each particle size.
• Greater than 1 sample and less than 10 samples require calculations of the overall mean of the averages, standard deviation and 95% upper confidence limit (UCL).
Typically, a sample location is tested 3 days consecutively. The average particle concentration for each particle size from the individual locations is calculated for this time period. Consider for each sampling location:
! =!!,! + !!,!+. . .+!!,!
!
Where, x = Average particle at location i, representing any location xi, 1 to xi, n = Particle concentrations of the individual samples n = Number of samples taken at location i. Given arbitrary particle values (in m3) for a 0.5 µm particle sample location:
Over the 3 days of air sampling, there was an average of 2400 particles 0.5 µm particles/m3. Referencing ISO 14644-1 cleanroom standards, this is a satisfactory limit for ISO 5 and higher rooms. This formula may be used for any number of days; the sample values are simply added to the numerator while the denominator reflects the days sampled. The overall mean of averages refers to taking an average from each sample point to give an understanding of the cleanroom as whole. The equation is similar to determining particle concentration for a single sample location.
! = !!,!!!!,!!...!!!,!!
Where, x = overall mean of the location averages x!,! !" x!,! = individual location averages, determined with the previous equation m = number of individual location averages Take site 1, 2400 0.5 µm/m3 the location average for the site calculated above. Assume 2 additional sites are sampled in the room over the same time span giving averages of 600 0.5 µm/m3 and 900 0.5 µm/m3.
! =2400 + 600 + 900
3
1300 =2400 + 600 + 900
3
An event may arise in which a site is sampled more than the other sites within the cleanroom. For example, a risk assessment may determine additional samples are required for a spot with turbulent flow. However, all location averages are equally weighed – no adjustment factors are added for a location which is sampled more frequently. Standard deviation is used to determine the variation from the average. A low standard deviation indicates the data is close the average, whereas the opposite is true of a higher deviation. Figuring out standard deviation requires the overall mean of averages and location averages, as previously obtained.
! = (!!,! − !)! + (!!,! − !)! +. . .+ (!!,! − !)!
(! − 1)
Where, s = Standard deviation of the location averages The equation may appear intimidating, however adding the location averages…
samples are required for a spot with turbulent flow
● ● ●
(continued on next page)14
! = 1,210,000 + 490,000 + 160,000
2
! = 1,210,000 + 490,000 + 160,000
2
! = 964.4, rounded to 964 particles/m!
Ideally, the result produces a lower standard deviation; this is demonstrative of a well function HVAC system and cleaning routines. A higher standard deviation may be influence by a variety of factors including:
• High traffic areas • Personnel Flows • Material/equipment flows • Material storage • HVAC air suction/returns • Cleanroom area
A confidence limit gives indication of how tight the data is to the parametric mean. 95% UCL is used for this statistical analysis.
95% UCL = ! + !!.!"
!!
Where, t0.95 represents the 95th percentile (quantile) of the t distribution, m-1 degrees of freedom. This is known as Student’s t-distribution, which for environmental monitoring purposes, is a variable determined based on the number of individual averages:
Number of individual averages
(m)
2 3 4 5 6 7-9
t 6.3 2.9 2.4 2.1 2.0 1.9 Plainly, if 3 sample locations were used (as in the case of the example), select 2.9 as t0.95.
95% UCL = 1300 + 2.99643
95% UCL = 1300 + 2.99643
95% UCL = 2914 particles/m!
Outlier samples may result in all of the single sample volumes less than a classification limit, yet the 95% UCL outside of the specification. This outlier may be excluded if the calculation is repeated (including all remaining sampling locations) and at least three measurement values remain. Understanding these calculations is a way of limiting the risk associated with only sampling portions of a cleanroom. In this manner, it’s important the results produced are statistically significant. A clean room under sampled may produce a result occurred from chance. In the same right, an over sampled room is an inefficient use of time, money and resources. References:
• ISO 14644-1 Cleanrooms and associated controlled environments • ISPE Good Practice Guide Heating, Ventilation, and Air Conditioning
Geoffrey Brown is a Validation Specialist for Commissioning Agents, Inc. He may be contacted at [email protected].
ISPE Baseline® Guide: Water and Steam Systems Guide (Second Edition)
ISPE Guide Series: (PQLI®) Part 1 – Product Realization using QbD,Concepts and PrinciplesPart 2 – Product Realization using QbD, Illustrative Example
Order today, or view a full catalog of ISPE publications atwww.ISPE.org/Guidance-Documents
ISPE 2012 Training Series
Classroom Training ISPE is offering a variety of Training Courses throughout the year to allow you the opportunity to enhance your career. Each course is taught by ISPE Members who are experts in their fields and face the same daily challenges you do. You will also utilize recently published ISPE Guidance Documents to enhance your expertise.
Upcoming Training Courses:
Sponsorship and Table Top Exhibit Opportunities Available
www.ISPE.org/Training
San Diego, California USA19 – 22 March 2012Biotechnology, C&Q, Facility Project Management (New), GAMP® 5/Part 11 (New), HVAC, and Water (2 New Courses)
Atlanta, Georgia USA23 – 26 April 2012Bio Manufacturing (New), Cleaning, GAMP® 5, HVAC, Oral Solid Dosage, and Water (2 New Courses)
FACILITIES AND OPERATIONS Tampa, Florida USA 27 – 28 February 2012Sterile Product Manufacturing Facilities: Applying the New ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation (T12)- New Course and Guide
FACILITIES AND OPERATIONS Tampa, Florida USA 29 February – 1 MarchManaging the Risk of Cross Contamination: Applying the Risk-MaPP Baseline® Guide (T41)
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Full Day HVAC Class at Beckman Coulter
The Chapter’s full day HVAC class, held in October, started with host Rod Freeman, Validation and Engineering Manager at Beckman Coulter, who presented a session on Clean Room Differential Planning, with an active discussion on cascades and room layout. The second session, Emerging Technologies, was Presented by Frank Shadpour and introduced a num-
ber of new concepts that warrant consideration in new design.
After the morning break, Rod returned with a presentation on Humidity Control, which was followed by the HVAC Troubleshooting and Maintenance session presented by Jordan Parker of BioSPEQ and Juan Uvina of Teva Parenteral Medicines. This case study went into great depth on the establishment and operation of a PM program in a GMP environment, and included real life examples.
After lunch an On-Line Particulate Monitoring session was presented by Scott Hjelmervik of Hach Ultra detailing the technical and compliance aspects of continuous particle monitoring. Matt Smyers from Technical Safety Services followed with a very visual pre-sentation on Execution of Room Smoke Studies, and shared some of his expertise and experience gained from the motion picture industry.
Closing out the day, Frank Shadpour closed the day presenting Smart Building and Demand Response for Pharmaceutical facili-ties. Finally, Stacy Sutton, Director of Filling Operations at Althea Technologies gave an excellent presentation on HEPA Filter Testing and Certification with many pearls of wisdom gained only through real world experience.
Thank you to our speakers and to Rod Freeman and Beckman Coulter for hosting this class.
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Oscar Garcia Technical Sales Representative (323) 252-1110 Cell [email protected]
Director Nicole Hall, Business Liaison, Pacific Region, Commissioning Agents 215-237-5127 [email protected]
Director Dave Stewart, Automation, Genentech 760-231-2473 [email protected]
Director Ashlee Ujifusa, Field Sales Representative, ProcessHQ 760-730-9376 [email protected]
Past President Don Holden, Sr. Electrical Designer, CRB 760-496-3714 [email protected]
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Welcome New Chapter MembersAugust - December 2011
Mary Angelle-CargillTimothy Breier, Jr., Engineer I, Genentech
Ian Brown, Student, Keck Graduate InstituteElisa Buckner, Student, University of California-San Diego
Alexander Burns, Student, San Jose State UniversityChristopher Cantrell, Student, Keck Graduate Institute
Disha Chaubey, Student, University of California San DiegoEmily Chen, Student, University Of California
Tik-Chee Cheng, Student, University of California-San DiegoDong Ha Chung, Student, UC San Diego
Zackery Field, Student, University of California BerkeleyJoel Franklin, Student, University of California-San DiegoVictor Garcia, Project Superintendent, CRB Builders LLC
Sharon Grubner, Student, University of California-San DiegoArthur Jeng, Student, University of California-Berkeley
David Koechlein, Application Scientist, MeissnerKein Lee, Student, Keck Graduate Institute
Stephanie Lum, University of California-San DiegoDebi Marshall, Manager, Process Engineering, Advanced Biohealing
Luis Martinez, FlextronicsBeth McCooey, Manufacturing Supervisor, La Jolla Biologics
Jackie Townsend, CMO, BioSurplus IncAndrew Urazaki, Student, Keck Graduate Institute
Ivaylo Valirov, Student, University of California BerkeleyBehrooz Vazifeh Behnam, Student, Keck Graduate Institute
Andrew Vo, Student, Keck Graduate Institute of Applied SciencesTravis Walsh, District Sales Manager, Asco Numatics
Shelly Wistar, illumina, Inc.Timothy Wong, Student, University of California-San Diego
Edward Yragui, University of California-San Diego
Meeting and Facility Tour Locations NeededIn an attempt to keep meeting prices down for our Members, the Chapter is looking for new companies to host our meetings. If you have a facility that can host a tour or a meeting for 50+ attendees for evening and/or full day classes, we would like to discuss options with you. A benefit of hosting an event is free training for your employees.
Report from ISPE’s Annual Meetingby Kimberly Syre, Chapter Manager
As we say goodbye to Bob Best and wish him well after leading ISPE for the past 27 years, we welcome ISPE’s new CEO, Nancy Berg (announced in December).
Below are bullet points from the various Committee meetings I at-tended at ISPE’s Annual Meeting in Grapevine Texas in Novem-ber:
What is New at ISPE:• A record number of documents were released in 2011 (includ-ing the new Water Guide published in December)• ISPE will be basing new products on research and focus re-sources on the greatest Member needs• Future Visioning Team - ISPE will offer a variety of certificates or similar credentials which allow Members to demonstrate their growing knowledge and competency base. • ISPE will be working with local Chapters to bring more training opportunities to our Members• Collaboration with other organizations to leverage the strengths of all in order to enhance offerings. (Note: this can include another Chapter, Affiliate, Regulatory Agency or Professional Organization)
ISPE Strategic Plan:Five focus areas:1. Optimizing current manufacturing operations2. Developing next generation manufacturing3. Product supply networks4. Enterprise risk management5. Practical solutions to regulatory requirements
Global Leadership:• ISPE will engage in research that focuses on identifying emerg-ing trends. • ISPE will collaborate with global regulatory agencies to deliver information and convene leaders to solve problems. • Where appropriate, ISPE will develop information and training to assist regulators in emerging economies. • ISPE will develop relationships with regulators in every country in which it has an Affiliate. • ISPE will increase its visibility with respect to regulatory affairs both with the regulatory agencies and by providing more timely information and analysis to Members. • ISPE will work to actively engage regulators as Members so that their needs are helping to drive the Society’s agenda.
ISPE focus will tap into the strengths of the Chapters:The Society will evolve to a model in which Affiliates and Chapters are the main points of ISPE’s identity. They deliver – sometimes in partnership with others or with International – the majority of ISPE’s programs. • International will be accountable for central coordination, R&D, brand identity, global strategy, and support services such as database management and web presence. • To do this, ISPE will evolve its business model so that all parts of the Society are adequately resourced.
CPIPTM New and Improved:• Changes have been made to the CPIP process making it more attainable for Members:
- Removed work experience requirement, simplified applica-tion process, removed leadership requirements.- Young Professionals and seasoned professionals can qualify.- ISPE University to offer Seven Knowledge area training.- Chapter study groups. - Encourage Members without knowledge in certain areas to ask for rotational change in job scope so they get the experi-ence and knowledge- Those considering taking the exam can take the practice exam that is posted online.
• Two new CPIPs that have passed are Young Professionals.• CPIP recertification process simplified: can use time on Committees, Board Meetings, Speaking engagements etc.• There are 17 One Hour Webinars that covers all core com-petencies (18th webinar being developed now).• Chapters may conduct CPIP study groups. • Create a business plan and develop content for a CPIP Body of Knowledge guide to be introduced by June 2012.
Membership - Knowledge • Community • Profession• Recruitment of non-Member COP participants to join ISPE.• Increase volunteer base.• Match the skills and expertise of volunteers with the volun-teer needs of ISPE.• Increase number of YP volunteers.• Refer a Friend and Save – One month free Membership to the referral Member (credit given upon next renewal). New Member has to mention who they are being referred by.• Increase Members from small to medium Pharmaceutical companies.• Identify ISPE Ambassadors in companies.
Report from ISPE’s Annual Meetingby Kimberly Syre, Chapter Manager (continued)
ISPE University:• Professional Development Committee working on covering 7 core competencies:1. Product Development2. Facilities and Equipment3. Information Systems4. Supply Chain Management5. Production Systems6. Regulatory Compliance 7. Quality Systems• Will recruit Members with core competencies to help develop curriculum.
Integrated Events with ISPE and Chapters:• Plan and execute 6-12 collaborative events with global Affili-ates and Chapters. • Plans are tailored to current business realities and the local market need. • Create a series of one-day programs suitable for Chapter events that can be easily adapted for that location’s needs.• Choose topics based on demand and new documents.• Use a model that is flexible enough for electronic delivery. • Thoroughly document methodology, agreements and les-sons learned for each event. ISPE DECLARATION OF PRINCIPLESThe culture of ISPE is an important part of the value it provides to its Members and to the global community. The following Declaration of Principles is ISPE’s statement of the values embodied in our commitment to our Members, staff, and stake-holders.
COLLABORATIVE: Members of the entire Society and staff will work together in the achievement of our shared vision and mission. We will strive to draw in and encourage those who wish to participate. In achieving desired results we will not fail to give credit where it is due. Collaboration also embraces working with other organizations to leverage the strengths of all in order to enhance offerings. ETHICAL: We will use honesty in dealing with others and our-selves. We will adhere to individual principles that respect the views of others. We will foster a Society in which our behavior internally toward one another and externally toward the world at large is worthy of trust, respect and admiration. PROFESSIONAL: Professionalism results from behaviors, actions, and communication that are honest, fact-based and politically neutral. ISPE will conduct business with the high-est professional standards and with personal integrity. We will encourage all Members to be considerate, courteous, active listeners, and polite in their dealings with one another. When differences exist, we will work toward solutions and maintain mutual respect. INCLUSIVE: ISPE Members are the number one priority of the Society, and we will strive to see their needs are met. Volun-teer participation will be a reflection of the diversity of our Mem-bership (region, age, ethnic background, experience, etc.). The Society will exist to help Members reach their professional goals and, in so doing, help the industry achieve excellence.
Visit ISPE’s newly-launched Web site for more information: www.ispe.org
§ Leaders in providing precision passivation services for over 45 years.
§ Pioneered the development of high-tech, safe, biodegradable, non-toxic
Chelants for derouging and passivation for the Pharmaceutical Industries.
§ Our passivation operations and documentation meet all cGMP requirements.
§ Services include new system passivation, derouging / passivation
maintenance, system inspection, biofilm removal, and sanitization.
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Photos from Project Management Class at Genentech
Thank you to Genentech for hosting the full day Project Man-agement class in September at their facility in Oceanside. The class was part of the ISPE SD Chapter’s Live, Learn and
Lead series in 2011.
We appreciate the time and effort given by the presenters to help educate our Members:
Carlos Crabtree, Project Executive at DPR ConstructionLaura Cribbons, Director of Program Management, ProPharmaRod Freeman, Validation Manager, Beckman CoulterMarcella Goodnight, Manager, Genentech Frank Jones, Project Executive, DPR Construction
Thank you to our class sponsors:Endress + Hauser Inc.Project Management Advisors, Inc.
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ISPE SAN DIEGOCHAPTER
5319 University Dr., Suite 641 Irvine, CA 92612
Chapter Hot Line:(800) 869-9621 or
(949) 387-9046--------------------
Fax:(949) 387-9047 or
(949) 266-8461
For advertising information:www.ispe.org/SanDiego
_______________________ISPE is a Society of pharmaceutical
professionals who use expert knowledge to create high-quality,
cost-effective GMP solutions.
Join ISPE Today For Great Membership Benefits:
• Member Only Events/Facility Tours• Discounts to Educational Programs and Technical Documents• Subscription to Pharmaceutical Engineering magazine, with access to on-line article archives• Connection to more than 22,000 Members from 90 countries through an on-line Membership Directory
and More!
Event Photos by:Nicole Hall, Commissioning Agents, Inc.
Christy Pavano, CRBKimberly Syre, Attention To Detail
ISPE Event Calendar Celebrating the ISPE San Diego Chapter’s
20th Anniversary in 2012Theme for the Year: “20 Years of Excellence:
Building on the Past, While Designing the Future”
26 January Temecula Winery Tour Joint Social Event with the Los Angeles Chapter
23 February Validation Past, Present and Future 27 Feb - 1 March ISPE Tampa Training
15 March Facility Tour
19-22 March ISPE San Diego Training
26 April Membership Drive and Student Poster Contest
27 April Spring Golf Tournament and Spa Day at La Costa Resort and Spa
1-3 May INTERPHEX, New York
17 May Operations Management and Manufacturing Execution Systems Full Day Class
4-7 June ISPE Washington Conference
14 June Sterile Product Processing
12 July Facility Tour
16 August Vendor Night: “Past, Present and Future of Biotechnology in San Diego” Celebrating the Chapter’s 20th Anniversary
17 August Golf Tournament
September Facilities Reception: Joint Event with BIOCOM and IFMA
25 October Critical Utilities and HVAC Full Day Class
11-14 November ISPE Annual Meeting in San Francisco
All events subject to change due to availability of venue/speakers.
To Register for Any ISPE SD Meetings:http://www.atdevents.net/ispesandiego.php
Chapter Website: www.ispe.org/sandiego
ISPE’s Global Calendar and Additional ISPE Educational Offerings and Publications:
