asepco_newsletter_april_2011_online
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2011 ASEPCO Corporation. All rights reserved. 1
In This Issue
Mission-Critical Equipment
Positive Material Identication (PMI):Intepreting Results
Dilbert
Contest
Calendar
CONTEST
Deadleg Killer Valve Name it
and win an iPad 2!
We need a fantastic name for our spiffy
new satallite valve. Come up with the
perfect name, and win an iPad 2! Go
here to enter: http://www.asepco.com/
news/2011/04/killer-app-satellite/
Word of the Month
Repartee
Pronunciation: (rep-er-tee, tey, -ahr-)
Meaning:
(noun) 1. A quick, witty reply.
2. Conversation full of such replies.
3. Skill in making such replies.
Sentence - We engaged in witty repartee
about our Dilbert cartoon.
Does Your Valve Perform Like
a Superhero? Introducing the1/2 Compact Inline Valve.
More info here: http://www.asepco.com/
news/2010/12/killer-app-compact-inline/
Mission-Critical
EquipmentWhat You Should Expect from Your Aseptic
Components
For many of you, the phrase mission-critical components might conjure up animage of the gold foil-covered shields foundon space satellites or the mil spec partsfound in an F-16. But in truth, you are usingmission-critical components in your facilityright now. In our industry, the combinationof product value along with the risk of
product compromise through contaminationdenitely requires a get-it-right-the-rst-time mentality. But is your equipmentdesigned to live up to these demands? Doesit help you meet your quality and productiongoals, or does it get in your way?
ASEPCO denes mission-critical-levelaseptic components as those that provideextremely consistent performance and
delivery of vital functionality in anapplication where downtime and productloss attributable to equipment failure cannotbe tolerated.
So, what should your equipment be ableto do if its designed for mission-criticaluse? We offer the following list of mission-critical characteristics as a measuring stickagainst which to evaluate all your asepticcomponents:
Proper operation is easy to implement.
Dilbert
Continued on page 2
by Paul L. Sturgill, Sturgill Welding & Code
Consulting
In any biopharmaceutical application,material specications are a criticalcomponent to the success of the project.Engineering rms specify the materials thatmust be used based on the process conditionsthose materials will be exposed to during
processing. Vendors like ASEPCO provideproducts that conform to these specications.When the products are received, end usersmust verify that the products conformto the specications. Positive MaterialIdentication (PMI) is one of the non-destructive techniques used verify materialconformance.
At Sturgill Welding & Code Consulting,we nd that PMI results are sometimesmisinterpreted, which can cause projectdelays and other issues. So, we thought it
Positive MaterialIdentication (PMI):
Interpreting Results
Continued on page 3
http://www.asepco.com/news/2011/04/killer-app-satellite/http://www.asepco.com/news/2011/04/killer-app-satellite/http://www.asepco.com/news/2010/12/killer-app-compact-inline/http://www.asepco.com/news/2010/12/killer-app-compact-inline/http://www.asepco.com/news/2010/12/killer-app-compact-inline/http://www.asepco.com/news/2010/12/killer-app-compact-inline/http://www.asepco.com/news/2011/04/killer-app-satellite/http://www.asepco.com/news/2011/04/killer-app-satellite/ -
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2011 ASEPCO Corporation. All rights reserved2
might be useful to briey discuss what PMIis, the equipment that is used to perform PMI,and how to evaluate the results produced bythe testing equipment.
Various techniques are used to determine the
chemical composition of metallic engineeringalloys, ranging from laboratory methods thatcan identify all of the elements (includinginterstitial elements such as carbon andsulfur) to employing portable units that candetermine only a limited number of alloyingelements. Positive Material Identication(PMI) is one of these techniques.
For this discussion, we focus on the portable hand-held units commonly usedin the biopharmaceutical industry for alloyverication. These units can operate in twomodes: They can either provide data as adiscreet list of alloying elements and their
amounts, or they can identify an alloy bycomparing the compositional data obtainedagainst a list of alloys whose partial nominalcompositions are stored in the units memory.This report explains that the most reasonableway to use PMI data is to compare both thediscreet list of alloying elements determined
by PMI and the interstitial elements listedon the MTR with the requirements of thematerial specication to which the materialwas purchased.
Background
The raw data collected by PMI units is theX-ray spectra that plots the intensity of outershell electron decay as a function of thecharacteristic energy level (wavelength) foreach element detected. PMI units convertthese spectra to lists of alloying elementsand their amounts. These units usually have
built-in alloy grade libraries that list partialcomposition ranges for many commercialalloys.
A PMI unit identies an alloy based upon thealloy library in the PMI units memory. Thisdata is based on a wide range of specicationsand sources including American Society forTesting and Materials (ASTM), Society forAutomotive Engineers (SAE), AmericanIron and Steel Institute (AISI), and
trademarked manufacturers such as Haynes,Carpenter, and Allegheny Ludlum (whichmake and patent certain alloys). This datamight be unrelated to the specications towhich the material or equipment in questionwas ordered. In addition, the PMI unit mightidentify a material as a specic alloy if itscomposition is close to that of an alloy in thePMI units library, not because it actuallymeets a set of criteria.
Portable X-ray uorescence (XRF)technology cannot detect elements whoseatomic numbers are less than 22 (whichcorresponds to titanium), so importantelements such as carbon, sulfur, silicon, and
phosphorus cannot be detected. However,material specications that govern materialsof construction for our industry specifyranges for these elements. As a result,PMI data, by denition, cannot be used todetermine an exact match to any ASTM orASME material specication.
For this reason, a PMI units display readingthat an alloy matches a 316 stainless steelcomposition cannot be used as proof thatthe alloy meets a material specicationrequirement. Only the material specication
and alloy grade requirementon the contractdocument is enforceable, not the PMI unitsstatement that an alloy is a match.
Applicable Standards and Specications
Vendors and equipment fabricators buildequipment based on written instructionsfrom engineering rms or end users.These instructions are usually in the formof a purchase order or a bill of materials(BOM), which is included in the drawing
package of requirements for a piece ofequipment. The construction material is
identied by two pieces of information: thematerial specication and the alloy grade ordesignation.
Material Specications
The material specication is one of a numberof common ASTM, ASME, or foreignspecications that list different alloy gradesof a single product form or for a singleintended use. Typical specications include:
A240/SA-240 for plate, sheet, and strip
Positive Material Identication: Interpreting Results
Continued on page 3
Fun and Games
Quote of the Month
If you could choose one characteristic
that would get you through life, choose a
sense of humor.
~Jennifer Jones~
Brain Teaser
Heart of Darkness,
Coat of Grain,
Was once alive,
Now feels no pain,
Never walks, but
Leaves a Trail.
Circle head and pointed tail.
Grows shorter as the day goes on-
Its waistline is a hexagon.
What am I?
Answer on page 4.
Jokes
Job Interview Techniques
Take the prospective employees you are
trying to place and put them in a room
with only a table and two chairs. Leave
them alone for two hours, without any
instruction. At the end of that time, go
back and see what they are doing.
If they have taken the table apart, putthem in Engineering.
If they are counting the butts in theashtray, assign them to Finance.
If they are waving their arms and talk-ing out loud, send them to Consulting.
If they are talking to the chairs, Person-nel is a good spot for them.
If they are wearing green sunglassesand need a haircut, Computer Informa-tion Systems is their niche.
If the room has a sweaty odor, perhapstheyre destined for the Help Desk.
If they mention what a good price wegot for the table and chairs, put theminto Purchasing.
If they mention that hardwood furnitureDOES NOT come from rainforests,Public Relations would suit them well.
If they are sleeping, they are Manage-ment material.
If they are writing up the experience,send them to the Technical Documentsteam.
If they dont even look up when youenter the room, assign them to Security.
If they try to tell you its not as bad asit looks, send them to Marketing.
...continued from page 1
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2011 ASEPCO Corporation. All rights reserved. 3
The Jokes Keep Coming...
Engineering Marketing HypeTranslated
(From: nipperchipper (nipperchipper@
hotmail.com))
ALL NEW: Parts not interchangeablewith previous design.
ADVANCED DESIGN: Nobody
understands it.
YEARS OF DEVELOPMENT: Wenally got one that works.
REVOLUTIONARY: Its differentfrom our competitors.
ALL SOLID-STATE: Heavy as Hell!
UNPRECEDENTED PERFOR-MANCE: Nothing we ever had before
worked THIS way.
You might be an engineer if
... you only get jokes through email.
... Dilbert is your hero.
... you can quote the scenes from any
Monty Python movie.
... you talk about trellis code modulation
at parties.
... your favorite character on Gilligans
Island was The Professor.
... you laugh at jokes about mathemati-
cians.
... the Humane Society has you arrested
because you actually performed the Sch-
rodingers Cat experiment.
... the fun center in your brain hasdeteriorated from lack of use.
Our Last Contest and the Winneris...
In March, everybody was a winner! We
gave away nearly 200 bottles of great
California wine at Interphex and in our
March wine drawing. Cheers!
Smaller, lighter, and easier on
the wallet! ASEPCOs 1.5 Tank
Outlet Valves.
Learn more here: http://www.asepco.
com/news/2011/02/killer-app-new-1-5-
tank-outlet-valve/
It is difcult to make components fail (atASEPCO we call this bomb-proofeddesign).
The basic design requires very littletraining for operation.
Components are easily and quicklyvalidated.
CIP/SIP cycle times are short.
Component manufacturing methodseliminate defects inherent in the production
process (such as the pits and cracks foundin cast valves vs. those manufactured from
bar stock).
All components conform to relevantmanufacturing standards (such as ANSI,ASME, BPE, CE, and CFR).
Traceability is provided (certicates onsteel, ttings, and diaphragms, and heatnumbers on welded sub-components).
Maintenance instructions are simple and
are sent with every order. Delivery is fast, accurate, and on time.
At ASEPCO, we have structured ourmanufacturing processes and designedour components (valves, mixers, vesselconnectors, etc.) to meet these mission-critical component characteristics. And, wehope that by promising to comply with thislist, you will make us your preferred providerof aseptic processing components.
Over the years, youve come to expectthe highest design quality from ASEPCO.Thats why our tank valves are some ofthe most frequently used valves in criticalapplications. Now you can add inline valves,vessel connectors, and magnetic mixers tothat list.
See http://www.asepco.com/news/mission-critical/for the online version of this article.
Mission-Critical Equipment (continued)
Continued on page 4
...continued from page 1
for pressure vessels (heads and shells
of vessels are usually made from plateproducts produced to this specication)
A249/SA-249 for welded austenitic steelheat exchanger tubing
A213/SA-213 for seamless austenitic steelheat exchanger tubing
A484/SA-484 for stainless steel bars,billets, and forgings
A351/SA-351 for stainless steel castingsfor pressure containing parts
A182/SA-182 for forged or rolled alloysteel pipe anges, forged ttings, and
valves and parts for high-temperatureservice
Each of these specications lists a numberof alloy grades. In fact, each has a listing forthe chemical compositional requirements for316L stainless steel. This list of elementsand their compositional ranges is identical insome specications, but might have differentranges for certain elements in others. So, toevaluate any set of PMI readings, both thealloy grade andthe material specication areneeded for every piece tested.
Positive Material Identication: Interpreting Results (continued)
...continued from page 3Alloy Grade/Designation
The alloy grade is an informal description
that can be manufacturer specic, such asHastelloy C276, or it can be more generic,using the Unied Numbering System (UNS)for Alloy 276, UNS N10276. The UNSnumber is the industry standard for alloygrade or designation.
As an example, AL-6XN is a 6% molybdenumalloy manufactured by Allegheny Ludlum.Originally, this alloy was made and patented
by Allegheny Ludlum, and the specic alloyname, AL-6XN, is a registered trademark ofAllegheny Ludlum. The patent on this alloyhas expired and a number of manufacturers
now make this alloy. As a result, the moregeneric name for this alloy is UNS N08367.So, AL-6XN is not an alloy grade; it is atrade name and species UNS N08367 made
by Allegheny Ludlum.
PMI Accuracy
The accuracy of compositional data produced by PMI units must be evaluated prior tocomparing the data to any standard foracceptance. One factor that affects accuracy
mailto:nipperchipper%40hotmail.com?subject=marketing%20hypemailto:nipperchipper%40hotmail.com?subject=marketing%20hypehttp://www.asepco.com/news/2011/02/killer-app-new-1-5-tank-outlet-valve/http://www.asepco.com/news/2011/02/killer-app-new-1-5-tank-outlet-valve/http://www.asepco.com/news/2011/02/killer-app-new-1-5-tank-outlet-valve/http://www.asepco.com/pages/products/valves/valveInline.phphttp://www.asepco.com/pages/products/connectors.phphttp://www.asepco.com/pages/products/mixers/mixers.phphttp://www.asepco.com/news/mission-critical/http://www.asepco.com/news/mission-critical/http://www.asepco.com/pages/products/mixers/mixers.phphttp://www.asepco.com/pages/products/connectors.phphttp://www.asepco.com/pages/products/valves/valveInline.phphttp://www.asepco.com/news/2011/02/killer-app-new-1-5-tank-outlet-valve/http://www.asepco.com/news/2011/02/killer-app-new-1-5-tank-outlet-valve/http://www.asepco.com/news/2011/02/killer-app-new-1-5-tank-outlet-valve/mailto:nipperchipper%40hotmail.com?subject=marketing%20hypemailto:nipperchipper%40hotmail.com?subject=marketing%20hype -
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2011 ASEPCO Corporation. All rights reserved4
Calendar
May 11, 2011
BioTech 2011
Boca Raton, FL
http://www.biospace.com/calendar_
event_details.aspx?CalendarEventEntity
Id=691413
May 30-31, 2011
Interphex Singapore Conference
SUNTEC, Singapore
http://www.interphexasia.com/
June 13-16, 2011
NSTI Nanotech Conference
Boston, MA
http://www.nsti.org/Nanotech2011/
June 27-30, 2011
Bio International Convention
Washington, D.C.
http://convention.bio.org/
August 8-9, 2011
BioProcessing Facilities 2011
San Diego, CA
http://www.tradelineinc.com/conferences/
DDF52B3B-F4CA-1FA4-3D1D00D-
F53A7B347
September 7-9, 2011
BioPharm America 2011
Boston, MAhttp://www.ebdgroup.com/bpa/index.php
October 20-21, 2011
Interphex Puerto Rico
San Juan, Puerto Rico
http://www.interphexpuertorico.com/
Answer to Brain Teaser:
Pencil
Positive Material Identication: Interpreting Results (continued)
Contact Us
355 Pioneer Way,
Mountain View, California 94041
Toll-Free: 800.882.3886
Fax: 650.691.9600
E-mail: [email protected]
Customer Support
http://support.asepco.com
...continued from page 3
is exposure time; that is, the time that thedetector in the PMI unit is receiving energyfrom the decay of the excited electrons in thematerial The typical minimum exposure timefor accurate readings is 30 seconds, and thelonger the exposure time, the more accuratethe reading. Some of the older gamma-ray
source units require the operator to depressand hold the trigger manually for the fullexposure time to keep the shutter open.Inaccurate readings obtained on the olderunits can be due to single pulse depressions ofthe trigger, which result in only momentaryX-ray exposure, and, as a result, incompletedata. The newer units automatically holdthe shutter open for the necessary exposuretime without the operator having to hold thetrigger.
In addition, the data output usually has aheader of Element +/- Prec. This reects
the accuracy tolerance in wt. % of the readingindicated on the display of the PMI unit. Ifthe reading is 58.21 +/- 0.86, the real readingis anywhere between 57.35 and 59.07. Asa result, this precision tolerance must beadded to and subtracted from the displayedvalue to see if the range produced generatesa value within the acceptance range in theappropriate ASTM material specication.
Product Analysis Tolerance
If the PMI unit reports a range outside thecompositional range listed in the appropriatematerial specication, do not automaticallyreject the material. Domestic materialspecications list compositional rangesfor the elements in a given alloy. Thematerial purchaser is allowed to perform a
product analysis to verify the identity of thefurnished material; PMI is a form of this
product analysis. The material specicationlists the tolerance that can be applied to such
product analysis, or states that the producttolerances are found in some other materialspecication, referred to in this report assecondary specications. This is theamount by which the product analysis, when
requested by the purchaser, can be eitherover the maximum or under the minimumlimit and still be acceptable. These tolerancesare a function of the nominal amount of thespecic alloying element in the material andincrease as the amount of the element in thealloy increases. For instance, for nominalspecied molybdenum contents between 7
15 wt. %, the product analysis toleranceis +/- 0.15 wt. % (in some specications).So, for UNS N06022, having a speciedmolybdenum range of 12.5 to 14.5 wt. %, the
product analysis tolerance of +/- 0.15 wt. %results in an acceptable range for PMI datafor molybdenum of 12.35 to 14.65 wt. %.
For product analysis tolerances, ASTMB880 is the secondary specication foundin several ASTM specications for nickel-
based products. ASTM B751 contains the
product analysis tolerances for nickel-basedtubing, including AL-6XN as listed in ASTMB676.
For the purposes of evaluating PMI data,these product analysis tolerances, alongwith the precision tolerance of the PMI unit
being used, must be considered together todetermine acceptability of the PMI data.
Meeting the Molybdenum Range
Bear in mind that the amount of molybdenumpresent in N06022 (or any other molybdenum-bearing alloy) will not be in the middle of the
specication range of 12.5 14.5 wt. % forthis alloy. To minimize the cost of the alloy,the amount added by producers is typicallythe smallest amount required to meet thespecication range (12.50 to 12.70 wt. %).As a result, the PMI data generated on thesehigher alloys can result in some data thatis under the low limit for the importantand expensive alloying elements, such asmolybdenum or nickel. This underscoresthe importance of understanding how touse the product analysis tolerance values inconjunction with PMI precision to evaluatemarginal alloy PMI data. In addition, because
the hand-held PMI units cannot determinecarbon, silicon, sulfur, and phosphorus,PMI data must be used with the data on theMTR to determine compliance to a materialspecication and to the alloy requirements ofthe user specication.
Summary
Sturgill Welding & Code Consultingrecommends that PMI data be used inconjunction with the interstitial elementdata on the MTR to determine materialcompliance to a specication. Thoseoperating the PMI unit must be trainedindividuals who ensure that each reading isthe result of a full exposure cycle. Operatorsmust apply the appropriate product analysistolerance and precision tolerance to eachreading before evaluation. Remeasuringto obtain an acceptable or unacceptableresult is NOT permissible for acquiring andevaluating PMI data.
See http://www.asepco.com/news/pmi-interpreting-results/ for the online versionof this article.
http://www.biospace.com/calendar_event_details.aspx?CalendarEventEntityId=691413http://www.biospace.com/calendar_event_details.aspx?CalendarEventEntityId=691413http://www.biospace.com/calendar_event_details.aspx?CalendarEventEntityId=691413http://www.interphexasia.com/http://www.nsti.org/Nanotech2011/http://convention.bio.org/http://www.tradelineinc.com/conferences/DDF52B3B-F4CA-1FA4-3D1D00DF53A7B347http://www.tradelineinc.com/conferences/DDF52B3B-F4CA-1FA4-3D1D00DF53A7B347http://www.tradelineinc.com/conferences/DDF52B3B-F4CA-1FA4-3D1D00DF53A7B347http://www.ebdgroup.com/bpa/index.phphttp://www.interphexpuertorico.com/mailto:sales%40asepco.com?subject=mailto:info%40asepco.com?subject=http://support.asepco.com/http://www.asepco.com/news/pmi-interpreting-results/http://www.asepco.com/news/pmi-interpreting-results/http://support.asepco.com/mailto:info%40asepco.com?subject=mailto:sales%40asepco.com?subject=http://www.interphexpuertorico.com/http://www.ebdgroup.com/bpa/index.phphttp://www.tradelineinc.com/conferences/DDF52B3B-F4CA-1FA4-3D1D00DF53A7B347http://www.tradelineinc.com/conferences/DDF52B3B-F4CA-1FA4-3D1D00DF53A7B347http://www.tradelineinc.com/conferences/DDF52B3B-F4CA-1FA4-3D1D00DF53A7B347http://convention.bio.org/http://www.nsti.org/Nanotech2011/http://www.interphexasia.com/http://www.biospace.com/calendar_event_details.aspx?CalendarEventEntityId=691413http://www.biospace.com/calendar_event_details.aspx?CalendarEventEntityId=691413http://www.biospace.com/calendar_event_details.aspx?CalendarEventEntityId=691413