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Greetings ISPE CaSA Chapter! As 2015 comes to an end, it’s the perfect time to reflect on the past years’ accomplishments for our Chapter. Lookingback, we have had many inspiring moments! Thanks to the hard work anddedication of our Board of Directors andCommittee members, the CaSA Chapterhosted two Education events in Atlanta.Plans are in the works for more events in

Atlanta, and a new reach into the Tampa market. This is a hugeaccomplishment for our Chapter and it is exciting to see ourgrowth throughout the Southeast!!

RTP happenings remain solid! The 2015-16 Annual PlanningSession…a.k.a. “Oktoberfest” had record-breaking attendancewith 150 attendees. Oktoberfest was designed to re-engage current members and motivate new industry friends to get involved and join ISPE. The Networking Committee did an amazing job organizing the event. This is just the beginning ofwhat’s to come in 2016!

The ISPE Annual Meeting was held November 8-11 in Philadelphia with over 1800 industry professionals and studentsin attendance. The CaSA Chapter was well represented by ourmembership, as well as our Student Chapters. Each year, theChapter sponsors a group of Student Chapter representatives to attend the Annual Meeting. This year, we proudly sponsored 12 students from North Carolina State University, North CarolinaCentral University, East Carolina University and Campbell University. These 12 students have been dedicated to servingtheir University Chapters. Engaging the future generations ofleaders is a key initiative for CaSA and the value our Chapterbrings to the industry.

Looking ahead to 2016, I am honored to be working with such a strong Board of Directors and Committees who have embraced my vision to re-engage our members, recharge ourevents and grow the CaSA Chapter by hosting great educationand networking events! Meaningful education events show thevalue that ISPE brings to our membership and the Life Sciences industry. And, we like to have fun too! So, don’t forget about the networking opportunities the Chapter has to offer!!

Of course, the Chapter’s successes would not be possible without you! We hope that you will join us at our upcomingevents! Keep an eye on your email for registration and sponsorship opportunities.

See next page for a list of what’s coming up. See you soon!!

Lisa Kerner

President’s Message

CaSA NewsVolume 22 • Number 6 December 2015

Connecting a World ofPharmaceutical Knowledge

Carolina-SouthAtlantic Chapter

Lisa KernerPresident, ISPE CaSA ChapterRe-Engage. Recharge. Grow.

January 28, 2016RTP Therapeutic Thursday at Blackfinn Ameripub Morrisville, NC

February 27, 2016Gala at the North Carolina Museum of ArtRaleigh, NC

March 31, 201623rd Annual Technology ConferenceRaleigh, NC

April 2016ATL and RTP Education Events

May 16, 201622nd Annual Golf Tournament at Prestonwood Country Club Cary, NC

INSIDE THIS ISSUE

2

President’s Message.................................................................1

2015-2016 Board of Directors..................................................2

Education Committee...............................................................3

CaSA Committees.....................................................................3

Networking Committee............................................................4

Welcome New CaSA Members.................................................5

Member Spotlight....................................................................6

Student Affairs..........................................................................7

Technology Conference............................................................7

Technology Corner....................................................................9

2015 Advertising and Sponsorship Opportunities..................13

Electronic Media.....................................................................14

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OfficersLisa Kerner, PresidentBruce Craven, Vice PresidentWendy Haines, TreasurerMike Putnam, SecretaryHeather Denny, Past President

DirectorsAndy FerrellChip ChappellWes Robbins

Committee ChairsMarisol Patino, Student Affairs Jim Hubbard, EducationJustin Rothwell, IT/Social Media Eric Mayer, NetworkingTerence Morrison, Membership Development Jamie Sigmon, Young ProfessionalsAmy Lineberry, Technology Conference Rich Stanfield, Newsletter

Carolina-SouthAtlantic Chapter

Board of Directors 2015-2016

3

Membership Corner

January 11, 2016 - Education Committee’s “Call for Partners”(most spots were filled in 72 hours this year)

March 31, 2016 - Education sessions at the 2016 Tech Conference in Raleigh

April 13, 2016 - Education/Networking event in Atlanta (newmarket)

April 14, 2016 - Education/Networking event in Raleigh

June 23, 2016 - Education/Networking event in Tampa, FL(new market)

How can you participate in growing Education in our industry?• Attend an event! • Submit an abstract for the Tech Conference.• Become an Education partner (there are many benefits for

your company).• Volunteer as a member of the committee.• Volunteer as a SME to speak at events.• Offer suggestions for ideas or improvements.

Please call me to discuss how you can get involved in yourlocal ISPE-CaSA Chapter.

Jim Hubbard, Education Chair, 240-344-1109√

By Jim Hubbard, Education CommitteeEducation Committee

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Student AffairsMarisol Patino

EducationJim Hubbard

NetworkingEric Mayer

Membership DevelopmentTerence Morrison

Young ProfessionalsJamie Sigmon

IT/Social MediaJustin Rothwell

Technology ConferenceAmy Lineberry

NewsletterRich Stanfield

CaSA COMMITTEES 2015-2016

Thanks to all the ISPE-CaSA team for supporting Oktober-fest 2016! We had 18 great sponsors to insure the event wasa huge success. Thanks so much CRB, CAI, Watson-Marlow,PCI, Hipp, STI, EMD, PEG, RGD, Avid, Bray, EHS, IPS, Hydro,FLW Southeast, Statesville Process, Mettler Toledo, and Steris.

NNE Pharmaplan put on a great Therapeutic Thursday on

19 November at the Carolina Ale House. Save the date of 16May for the ISPE-CaSA Golf Tournament at PrestonwoodCountry Club. Sponsorship opportunities will be publishedsoon.

See below, upcoming networking events. √

Membership CornerBy Eric V. Mayer, Networking Committee

Networking Committee

4

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Get involved with your regional Affiliate or Chapter to meet industry leaders in your area, contribute your expertise to industry-advancing initiatives at the local level and share best practices with like-minded professionals.

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Connecting a World of Pharmaceutical Knowledge

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5

Membership Corner

$40 DISCOUNT NOW AVAILABLE FOR NEW INDUSTRY MEMBERSHIPS! Applications can be made online atwww.ispe.org/join, click on “Join Now” under Industry Membership, and enter CASA2015 in the promotion code box.

Please remember ISPE’s Refer-A-Friend Program! Earn one freemonth of membership for every friend you refer. All the detailsare available at: http://www.ispe.org/membership-referral-program

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7

Q: What is your full name? A: Mariessa Rose-Lorraine Blunt .

Q: Birth Place?A: Tucson, Arizona.

Q: College?A: Campbell University, Buies Creek, North Carolina for both B.S.and M.S. in Pharmaceutical Sciences.

Q: What is your present position? What do youdo at your job?A: Campbell University, Buies Creek, North Carolina for both B.S.and M.S. in Pharmaceutical Sciences.

Q: Tell me a little about your personal life. A: I was born and raised in Southern Arizona and have only beenin North Carolina for almost 3 years. I have a 6 year old Cockapoodog named Daisy and 3 Siberian cats named R2D2, Skywalker, andJar Jar Binks. I am a frequent concert goer and big Star Wars fan.

Q: What is your present position? What do youdo at your job? A: I am currently a second-year graduate student in the Masters of Science in Pharmaceutical Sciences program. My studies primarily focus on biotechnology/bioprocessing and pharmacology. I am the current ISPE Campbell University StudentChapter President.

Q: How long have you been with your current employer? A: This is my third year at Campbell University.

Q: Tell me how you ended up where you aretoday. A: I initially wanted to be a mathematician but since moving toNorth Carolina I have discovered a passion for the pharmaceuticalindustry and the role pharmaceutical scientists play in healthcare. Iwould like to pursue a career in upstream process development.

Q: What is your favorite part of your job? A: My favorite part about being a student is the opportunities Ihave had to hold various officer’s positions in the ISPE CampbellUniversity Student Chapter. I truly enjoy being able to lead our Stu-dent Chapter to various community events and raise awareness ofthe pharmaceutical sciences.

Q: How long have you been a member ofISPE/when did you first join ISPE?A: I joined the ISPE Campbell University Student Chapter in thebeginning of 2014. I have since been the 2014-2015 secretary and the current President of our Chapter.

Q: What benefits have you realized from beinga member of ISPE?A: The most important benefit I have gained from being a member in ISPE is being able to network with people from all

aspects of the pharmaceutical industry that I normally would nothave been able to interact with. Also, being an active member ofmy Student Chapter has helped me build my leadership and organizational skills.

Q: Why are you still involved with ISPE?A: ISPE provides multiple opportunities to network and continuemy education on current topics and trends that are happening inindustry. It is also enjoyable to be around like-minded, goal oriented people.

Q: Any Mentors/Role Models that have helpedto shape your life? A:I have met many great and kind people while being involvedwith ISPE; however, Dr. Daniel Shin, Jamie Sigmon, and Dr. WendyHaines have been generous with their time and have given advicethat has been invaluable to me.

Q: If you weren’t involved in pharma/ biotech,what business do you think you’d be in? A: I have a strong passion for the arts and helping people, so Icould see myself doing Art Therapy with children.

Q: What is one skill you wish you had that youdon’t? A: I wish I had better cooking skills.

Q: Any hobbies? What are they? A: I have many hobbies that all revolve around creating art. I love getting lost in any sort of art project, whether it is oil painting, graphite sketching or sculpting.

Q: Do you collect anything?A: I collect Star Wars memorabilia.

Q: Finish this sentence – “I need more….” A: I need more laughter in my day. Sometimes, I often get caughtup in the stresses of upcoming exams, planning events, or my research project. I need to remind myself more frequently to stopand smile for a moment.

Q: Favorite Food? A: My favorite food is sushi.

Q: What is something that people would besurprised to learn about you? A: Despite being born and raised in Arizona, I have never been to the Grand Canyon.

Q: Last movie you saw?A: Jurassic World

Q: For those in the early stage of their ca-reers, what advice would you give them?A: I would say start networking as soon as possible. Even if you areunsure of what you would like to do in the industry, get yourselfout there and take every opportunity you can to learn and grow.

CaSA Member Spotlight: Mariessa Rose-Lorraine BluntMembership Corner

6

√

This month several of our ISPE student members attendedthe 2015 Annual Meeting. We had a large group attend withabout 14 students representing 4 university student chapters.

Students were able to get a better understanding of all theroles within the pharmaceutical industry:

“The annual meeting really broadened my knowledgeabout the career paths available after graduation. Our depart-ment at school really encourages us to go into manufacturing,but our students aren’t limited to that. They can just as easilygo into something like consulting or validation or supplying.”

They were inspired by the educational sessions:“The Office of Manufacturing Quality talk made me more

interested in FDA policies and regulations. This talk revealed ahuge gap in my knowledge, and I got an idea about having anacronym list for students, readily downloadable during thetalk.”

“Interacting with people at the exhibit was my favorite activity. Whether it was asking about what they look for intheir new recruits or asking them about their instruments and

understanding the variety of latest technology used in Phar-maceutical sciences.”

They learned how to expand their network:"I bought a GoPro and took selfies with everyone I saw to

help break the ice. I was open about how it was my first ISPEAnnual meeting and the professionals were so willing to openup and educate.

“After the conference, I feel more confidence about talkingwith industrial professionals and networking.”

Some of the highlights for the students included a bowlingsocial with other students and young professionals, meetingthe local CaSA chapter executive board, and meeting JohnBournas, CEO of ISPE globally (they got a selfie with him!).

Next, the students will be encouraged to begin working onposters to enter the poster competition in March at the ISPE-CaSA Technology Conference. The winners earn an all-expenses paid trip to the 2016 Annual Meeting in Atlantaand a chance to compete nationally. √

7

Membership Corner

Technology Conference 2016 Is Right Around the Corner By Amy Lineberry, CPIP, Technology Conference Committee

We are happy to announce exhibitor registration openedon December 8, 2015 for the 23rd Annual ISPE-CaSA Life Sciences Technology Conference. Be sure to visit www.ispe-casa.org/2016 to reserve your table or boothtoday, as they are sure to sell fast! Be sure to keep an eye onyour email for more announcements about the TechnologyConference. This should be the best conference yet, with

more tables and great education sessions. We are also working to secure a great Keynote with more informationabout new things happening in the CaSA region. Attendeeregistration will open in January. We hope to see everyone on March 31, 2016 at the Raleigh Convention Center.

Exhibitor Registration NOW OPEN!!! √

Student AffairsBy Marisol Patiño, Student Affairs Committee

9

Technology Corner

PURPOSEThe purpose of this white paper is to provide a High-Leveloverview and road map to plan and execute of the following aspects of H2O2 decontamination cycle development.• A process overview of the Vapor Hydrogen Peroxide (H2O2)decontamination cycle.• The planning and pre-requisite activities that must be com-pleted prior to the execution of the H2O2 decontamination cycledevelopment.• Execution of the H2O2 decontamination cycle development.• Performance Qualification (PQ) of the H2O2 decontaminationcycle development.

H2O2 DECONTAMINATION CYCLE PHASESThe typical decontamination cycle consists of four separate anddistinct phases: Pre- Conditioning, Conditioning, Decontamina-tion and Aeration.1. Pre-Conditioning

a. The initial physical conditions of temperature, humidity andair velocity inside the isolator are established. Additionally, the vaporizing plates are heated to a set-point temperature and the liquid H2O2 is delivered to the vaporizing plates. Typically the control system of the isolator will determine if a sufficient amount of liquid H2O2 is available to complete the decontamination cycle. H2O2 is not injected into the isolator during this phase. This phase only establishes the proper

condition to successfully and repeatedly execute the H2O2 decontamination.

2. Conditioninga. During the conditioning phase, vapor phase hydrogen peroxide is introduced into the isolator chamber and preparesthe isolator environment for the desired decontamination effect.

3. Decontaminationa. Decontamination is the process step where the desired decontamination effect is achieved.

4. Aerationa. Aeration is the final process step that removes the residual

H2O2 from the Isolator to a specified set point.

Figure 1

The cycle development approach described in this document is fairly universal and should not be dependent on individual isolator systems. The terminology used may be slightly different depending on the technology, but the general principles, process descriptions, andprocess and execution steps can still beapplied across various isolator systems.

By Kevin Debbs Senior Pharmaceutical Specialist – CRB

101. Preconditioning2. Conditioning3. Decontamination4. Aeration

H2O2 DECONTAMINATION CYCLE DEVELOPMENT PREREQUISITESPrior to initiating cycle development, there are items that shouldbe completed. Each of these items will affect the cycle develop-ment for the H2O2 cycle. As testing is completed and compiled,keep in mind that the end goal is to have an effective and efficientH2O2 cycle.

1. Execute FATa. Factory acceptance testing should be completed prior to executing H2O2 cycle development. A popular approach recently is to perform as much of the installation verification (IV) and functional testing as possible during the Factory Acceptance Test (FAT) and then leverage all this testing going forward. This leveraged approach enables testing to begin earlyin the Commissioning/ Qualification/ Validation (CQV) process that can help to save time on the overall project schedule and save significant money. Testing is only executed once and is referenced or leveraged in subsequent CQV documentation. This also provides early confidence the system was fabricated and assembled in accordance with the design documentation and functions as intended. Problems that are identified during the FAT can be fixed in the vendor’s shop prior to shipment.

2. Perform Airflow Pattern Testinga. Airflow pattern testing to visualize the airflow patterns insidethe isolator should be performed during the FAT and then repeated after installation once the isolator is installed on the filler. This testing can be used to select the worst case positions.

3. Perform High Efficiency Particulate Air (HEPA) Filter Certificationa. The upstream side of the filters is challenged with an Emory 3004 aerosol and then the filter faces are scanned with photometers to determine overall leakage.

4. Loop Checks and Calibration of Instruments for Critical Process Parametersa. Prior to or during the FAT, instrument loop checks should be performed for all digital and analog inputs and outputs. This will provide evidence that the instruments are wired correctly, the proper signals being exchanged and displayed on the HMI and the instruments are measuring within the proven acceptable range.b. Instruments that measure and monitor critical process parameters must be calibrated to ensure the instruments are accurate and precise within proven acceptable ranges, therebyallowing the H2O2 decontamination process to be properly characterized and defined.

5. Determine the Isolator Load Patterna. Isolator Load Pattern should be defined with the worst case load of items inside the isolator to challenge the decontamination cycle. The items loaded into the isolator will affect the airflow, the decontamination time, and the duration of aeration.b. The exact quantity and location of each items needs to be defined and documented so the load pattern can be

consistently repeated without variation which would then help to ensure that the decontamination cycle can be successfully re-qualified without deviations.

6. Perform Manual Cleaninga. The internal surfaces of the isolator including the inside and outside of each glove, the filler and the ancillary equipment should be thoroughly cleaned manually with 70% IPA or an approved cleaning solution. The H2O2 decontamination process is a surface decontamination process and will not penetrate into cracks, crevices and other occluded surfaces if the isolator is not properly cleaned. Therefore, the H2O2 decontamination process is only as good as the cleaning process.b. This initial cleaning could be combined with a bio- burden reduction study to evaluate the bioburden post cleaning.

7. Qualify the Room Environmenta. The background room environment must be commissioned and qualified to provide a controlled and stable environment with respect to differential pressure control, temperature and humidity, so the isolator and the decontamination cycle can be qualified.b. The Environmental Monitoring Performance Qualification (EMPQ) does not necessarily need to be completed prior to executing cycle development.

8. Determine the Process Sequencinga. Cleaning and Coolingi. The cool zone sterilization of the depyrogenation tunnel (if applicable), the CIP / SIP of the filling equipment and the H2O2 decontamination cycle should be sequenced in such a way to avoid hot surfaces during the decontamination cycle. Hot surfaces present a worst case situation to achieve the desired killing effect and should be avoided during the decontamination cycle. Optimizing the sequence of operations can reduce the overall cycle time between lots / batches.ii. The optimal way to sequence these activities is to initiate a cool zone sterilization of the dry heat tunnel (if applicable) and a CIP cycle concurrently. These two activities can also be sequenced in series (one after the other) if cycle time is not important.iii. Once the surfaces inside the isolator that were exposed to elevated temperature cool to < 40°C, the H2O2 the decontamination cycle can be initiated.iv. When the decontamination cycle progresses to the aeration phase and is approximately < 10ppm, the SIP cycle can be initiated. Otherwise the SIP can be started once the aeration phase is complete and the residual H2O2 acceptance criteria levels have been achieved. Starting the SIP of the filling loop during aeration is a way to shave some time off of the entire cycle time if aeration is a long process.

9. Glove Integrity Testinga. Both physical and visual glove integrity testing should be performed prior to each H2O2 decontamination cycle. Physical tests usually involve one of three methods: a flow test, a pressure decay test or a trace gas sensing method to detect leaks. Each physical test method has their advantages and disadvantages; therefore, each method must be properly evaluated. Visual inspection should also be paired with physicaltesting to check for gross defects. Furthermore, visual inspection of isolator gloves should be performed during each isolator intervention.b. Following the glove integrity testing, glove extenders or

11glove holders should be used to extend the gloves inside the isolator to eliminate folds and creases that prevent the gloves and sleeves from being fully exposed to H2O2. Depending on the isolator design, it may be necessary to extend the isolator glove on the outside of the isolator to execute the glove integrity testing on select gloves. In this situation, a negative pressure chamber can be used to extend the gloves outside the isolator.c. Glove integrity testing and insertion of the glove extenders or glove holders are typically the last pre- requisite operation performed in the isolator prior to initiating the H2O2 decontamination cycle.

10.Determine the Biological Indicator (BI) vendor and qualify the lot of BIs.a. The BI vendor and the individual lots of BIs must be qualifiedprior to cycle development to understand the BI performance with respect to D-value. Too often cycle development is executed without knowing the D-value of the BI and how it performs within a specific isolator with a specific process.b. The BI also needs to be evaluated for identification and population.c. The gold standard BI for H2O2 Decontamination Cycle Development is Geobacillus stearothermophilus with a population of 1 x 106 spores per carrier on a stainless steel coupon as represented by ATCC 12980 from Apex Labs.

H2O2 CYCLE DEVELOPMENT EXECUTIONThe cycle development of the H2O2 bio-decontamination can beexecuted in a progressive manner. BI qualification and Chemicaland temperature mapping must occur prior to developing a worstcase study.1. BI Qualification

a. D-value: The resistance of a BI against a defined inactivation method is expressed by decimal reduction per unit of time (min).b. The D-value describes the time unit it takes to reduce the test organism population 90%.c. Conduct a series of D-values studies to understand the response of the BI (relative resistance and behavior) and the killing effect of the corresponding cycle development parameters that created the conditions in the target isolator environment by use of a Fractional-Negative method.d. The D-value studies are executed by exposing pre- determined groups of BIs with multiple BIs per group to H2O2 vapor.e. At pre-defined intervals, each group of BIs are removed fromthe isolator environment and evaluated using a growth promotion test.f. The goal of the fractional negative method is to achieve a total-kill of the test organism via growth tests and then determine the D-value and survival/kill window.g. The D-values studies are executed in a location inside the isolator that will provide the best exposure conditions to the vaporized H2O2. This will generally be a location immediately below the HEPA filter where the H2O2 vapor is being generated or being injected. There should also be no airflow obstructions above or around the BIs used in these studies.h. The calculation of the D-value mean is the average of three D-value evaluations plus a 25% safety factor.i. Use the D-value mean to design the length of the decontamination portion of the decontamination cycle.

2. Temperature, Humidity and Chemical Indicator (CI) Mappinga. Thermocouples and / or temperature and humidity sensors are used to map the temperature and humidity conditions on various surfaces inside the isolator.b. High temperature and low humidity would be indicative of a worst case location for the killing effect of H2O2.c. These locations should be included and challenged with BIs as part of the cycle development worst case study.d. A chemical indicator is used to demonstrate H2O2 distribution within the isolator system.e. The chemical Indicator challenge can be executed as an independent test or executed in conjunction with temperature and humidity mapping. If the chemical indicator challenge is executed independently, the CIs with the worst color change should be included and challenged with the BIs in those locations as part of the cycle development worst case study.

3. Worst Case Biological Indicator (BI) Studya. The worst case study is accomplished by first selecting the challenge locations inside the isolator. These challenge locations should be selected based on the results of the preceding tests that were executed as well as some geometric locations.b. The worst case study is executed with three (3) BIs per location. The worst case study can easily have between 100 – 150 BI Challenge locations depending on the size and complexity of the filling and isolator systems. Finally, it is critical that Engineering and C&Q are aligned with the Quality group on the identification and selection of the worst case locations. This agreement should be formalized by having Quality review and approve the H2O2 Cycle Development protocol. c. Locations to be considered / selected and included in the worst case study:i. The worst case airflow pattern locations can be locations where there is not turbulent flow or locations that are under equipment, devices, instruments, motors, conveyors, under windows, corners, etc. Direct observation and / or video analysis of the airflow patterns will allow you to easily visualize the problem areas that may present challenges to achieve the desired decontamination effect.ii. The temperature and humidity mapping locations that demonstrated elevated temperatures and lower humidity should be included in the worst case study. These temperature and humidity locations may present more difficulty in achieving the desired killing effect.iii. The chemical indicator mapping locations that had the worst color change should be included in the worst case study.iv. Occluded Surfaces are all hard to reach locations where the airflow of the isolator system may have trouble delivering the vaporized hydrogen peroxide to achieve the desired killing effect.v. Critical Zones are areas within the filling and isolator systems where there is manipulation of product contact parts including isolator gloves and sleeves. Additional locations should be selected to properly challenge the isolator system to consistently and effectively achieve the desired decontamination effect.vi. The E-Beam tunnel (if present) is typically part of the surface area that is decontaminated with the isolator system. The E-Beam should be included in all of the appropriate testing to

evaluate the system during H2O2 cycle development.vii. Entrances and Exits to the isolator system need to be included in the worst case location study to properly evaluate the isolator system. This should include all transfer locations such as Rapid Transfer Ports (RTPs), transfer isolator locations and piping connections.viii. BIs should also be placed on gloves and sleeves. Typically, BIs are placed in two general positions: The first on the sleeve in the most challenging position as the gloves are extended into the isolator and secondly on the fingers of the gloves. To determine the final sleeve position(s), each glove extender length needs to be determined, fixed and consistently replicated for each decontamination cycle.ix. Consult the quality group to see if there are locations insidethe isolator they want to see challenged as part of the worst case BI study. This strategy may eliminate second guessing and questions as the CQV activities proceed and the protocols and summary reports are approved.

4. Aeration StudyThe aeration study is executed by running the final cycle that was determined through the cycle development studies. This final cycle is then initiated.a. When the cycle transitions to the aeration phase, use a Draeger hand pump and Draeger tubes to evaluate the residualH2O2 levels at various time points.b. When two consecutive residual H2O2 readings are in the same Draeger Tube range, the aeration endpoint is established.However, the endpoint can only be established if the minimum

required H2O2 level has been achieved in accordance with the residual ppm level defined in the User Requirements Specification (URS).Note: The URS endpoint is either established as an Operator Exposure Level (OEL) requirement of ≤ 1ppm or a product specific requirement to prevent oxidation and degradation of the drug product being filled within the isolator environment.

5. Performance QualificationThe PQ for the H2O2 decontamination cycle shall be performed by running three consecutive decontamination cycles with three BIs per location. The PQ runs will use the parameters and conditions that were established during the cycle development work. If the filling system requires CIP and SIP, these activities should be included in the PQ test plan and protocols. An alter native approach is to use a reduced decontamination phase of vthe decontamination cycle to execute the PQ for a more challenging qualification.1. The number of BIs locations used in the PQ can be reduced vs. the total number exposed during the worst case study.2. The reduced number of BIs can be based off the findings andresults for each of the individual tests during cycle development.For example, the number of BIs for the PQ Study can be deter-

mined from the worst case locations identified during Temperature and Humidity Mapping, chemical indicator study and from the airflow pattern testing. Once this strategy is definedand the number of BIs is determined, this should be applied to the periodic requalification procedure.

About the AuthorKevin Debbs, CPIPKevin Debbs is a Senior Pharmaceutical Specialist at CRB with over 23 years of aseptic manufacturing experience in the pharmaceutical and biologics industries. He has designed, constructed and qualified new facilities, equipment systems and manufacturing processes. He has successfully launched new products and line extensions, while continuously improving product quality, patient safety and value to the organization. Kevin has also led teams in the design, construction, commissioning and qualification of manufacturing plants, laborites and support services.

His expertise includes aseptic and sterile manufacturing processes, including isolation technology and lyophilization. He is skilled at preparing and executing protocols, designing experiments, statistical process control, performing risk analysis and engineering evaluations to ensure designs and processes meet quality and performance standards. He has developed User Requirement Specifications (URS), Design Qualifications (DQ), System & Component Impact Assessments,Validation Plans and IQ/ OQ protocols. In additions, Kevin is able to perform job safety analysis to identify and mitigate operationalhazards to minimize or eliminate costs related to health, safety and ergonomic injuries.

Contact Kevin at kevin.debbs@crbusa.com or 919-852-5494.

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Advertising Opportunities in ISPE-CaSA 2016 Electronic Newsletter

The ISPE CaSA Chapter produces six e-newsletters per year. ISPE CaSA sends out the newsletters via e-mail and via Web link to all of our Chapter Members throughout the Southeastern U.S., which reach top-notchpharmaceutical, biotechnology, and bio-science professionals and managers. These newsletters are alsoposted on our Web site so your ad can be accessed by interested visitors to our site.

The cost for a full color business-card-sized ad is $750 per year. There is also the ability of positioning yourad on the front page of the newsletter for an additional $750 per year for six issues. Space limits the numberof front page to only four, and is offered to the first four paid advertisers on a first-come, first-served basis.

Also, if you would you like to have your targeted customers go directly to your website by simply clicking onyour ad; a hot-link can be added to your submitted ad file for an additional $500.00 for the entire year.

You may choose one of the special offers below:

$1,500 Full-color ad for six issues on the front page of each newsletter ($250/issue) $1,500 Full-color double-sized ad for two issues ($250/issue) $750 Full-color ad for two issues ($125/issue) $200 Full-color ad in 1 newsletter of your choice ($200) $500 Add a hot link for directing customers to your website by a simple click ($500)

We hope you will take advantage of these opportunities and advertise in the 2015 ISPE CaSA e-newsletter.

To reserve a placement of your ad for 2015 please contact the ISPE-CaSA Headquarters at 919-573-5442 orvia e-mail at info@ispecasa.org. Deadline for 2016 advertisers to be in the February 2016 issue is January 22.

You will be notified via e-mail or telephone when your advertisement has been accepted by the ISPE-CASANewsletter Committee and asked to submit your advertisement digitally. Full-color business card-sized ads (3.5” x 2”) may contain your logo or other artwork. Artwork should be sent

directly to newsletter@ispecasa.org.

We ask that your text be no smaller than 12 pt so that the text is easily readable in the electronic format.PDF, JPEG, or TIF formats, are easiest for us to work with. Space is limited, sign up today!

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15ISPE CaSA Chapter E-Newsletter AdsNewsletter Ads Work for Your Business!

Our Chapter produces six e-newsletters per year, and we dependon the support of our advertisers.We send out the newsletters via e-mail and via web link to all of our

Chapter Members throughout the Southeastern U.S.That means you get targeted access to top-notch

pharma, biotech, and bio-science professionals and managers. These newsletters are also posted on our website so your ad can be accessed by interested visitorsto our site.

Best of all, the cost is only $750 for your full color, business-card-sized ad for six insertions. That’s only $750for targeted advertising in full color for an entire year!

Ask About HOT LINKS!!

Would you like to have targeted customers simply clickon your ad and get right to your website?

A hot-link can be added to your ad, connecting readersdirectly to your company website for an additional$500.00 for a whole year.

If you are interested in advertising with the ISPE CaSA e-newsletter, please contact our Chapter headquarters at:

ISPE-CaSA1500 Sunday DriveSuite 102Raleigh, NC 27607919-573-5442info@ispeCaSA.org

ISPE Carolina-South Atlantic Chapter Newsletter

1500 Sunday Drive, Suite 102, Raleigh, NC 27607Tel: 1-919/573-5442 • Fax: 1-919/787-4916

rich.stanfield@cagents.com

A word to the ISPE CaSA Newsletter advertisers:

Thank you all for your continued support. Without it we

could not have the wonderful support staff to get our ISPE

CaSA Members the news in such a timely and professional

fashion. If you have updates to your advertisements or

find any other error, please contact us so that we can serve

you better.

Would you, or someone you know,like to publish your technical

content in these pages?Please submit any and all technical content to

info@ispecasa.org or send directly to our Newsletter

Chair at rich.stanfield@cagents.com.

EDITORIAL POLICY

Articles should be written for technical

professionals in the pharmaceutical, biotechnology,

and medical device industries. The author is

responsible for the accuracy and correctness of all

statements contained in the manuscript (ISPE

Carolina-South Atlantic Chapter assumes no liability.)

Manuscripts should be submitted with a brief, three

to four sentence synopsis of the article, as well as a

brief biographical statement about the author that

includes educational background, title and job

affiliation, job responsibilities and major areas of

accomplishment.

You will be notified via e-mail or telephone when youradvertisement has been accepted by the ISPE CaSANewsletter Committee and asked to submit youradvertisement digitally.

Full-color business card-sized ads (3.5” x 2”) maycontain your logo or other artwork. Artwork shouldbe sent directly to info@ispeCaSA.org.We ask that your text be no smaller than 12 pt so that the text is easily readable in the electronic format.PDF, JPEG or TIF formats are easiest for us to workwith. Space is limited, sign up today!