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3V 4 APPENDIX III Removal of Asbestos Fibers by Pall 0.2 Micro meter Absolute (AR) and Coarser ______ U l t i p o r W Membranes_______ Summary % The ability of the Pall 0.2 um* (AR), 3 urn (AP), and 10 um (AY) absolute filter membranes to remove asbestos was tested. The suspension of asbestos was prepared by homogenizing and soni cating asbestos fibers removed from a commercial pyrogen removal grade asbestos filter. This suspension was passed through the test membrane and all filtrate particles were collected downstream on 0.2 and 0.1 um absolute analysis membranes. The analysis membrane was then examined for the presence of asbestos. In no case were asbestos fibers detected downstream from the 0.2 um (AR) or 3 um (AP) absolute membranes. Asbestos fibers were however detected downstream from the 10 um absolute membranes. A theory accounting for the unexpectedly high removal efficiency of the 3 um absolute' membrane is presented. Materials and Methods ; 1) Asbestos: Asbestos was removed from Ertel EO filters and placed in deionized water. The suspension was dispersed at 5000 RPM * um = micrometer 2 for 4 hours with a Gifford-Wood model FL6806 homogenizer comprising a close clearance rotor and stator. This was followed by sonication (using a high energy level Bendix 20 KC magnetostrictive unit) for 5 minutes and filtration through coarse wire mesh. The final suspension contained approximately 10 million fibers/ml, 0.1 to 0.5 urn in dia meter and 0.2 to 5.0 urn in length. 2) Asbestos Removal Test Set Up: 3) Test Procdure: The test membrane and set up (without the analysis membrane installed) were flushed with pre-filtered tap water flowing 3 at 3 liters/min. for 2 hours. An analysis membrane was installed and a blank taken with 250 ml of deionized water run through test set up shown above. The analysis membrane holder was disconnected and opened in a laminar flow HEPA filter fitted hood and the membrane was placed in a plastic petri dish. The set-up was reassembled with the membrane to be tested in place, and with a new analysis membrane, and 500 ml of asbestos slurry was run through the test set up at the same flow rate. The analysis membrane was then removed as described above. Flow rate used throughout the tests is 15 ml/min/cm2 , which is several times higher than flow rates typically used in actual filtration service. 4) Methods of Detection: a) Optical. The method used was that published in "Criteria for a Recommended Standard - Occupational Exposure to Asbestos", Report of Review Committee, National Institute for Occupational Safety & Health, Publication No. HSM 72 10257 (1972). b) Scanning Electron Microscope. A JEOL Model JSM-2 SEM was used, Resolution 150 8 (.015 um) c) X-Ray Dispersion. An EDAX 707A energy dispersion analyzer system was used, which provides qualitative, semi-quantita- 4 tive and quantitative information about the composition of the specimen.* Results ; 1) Optical Method s : Three separate tests were run using 0.2 urn Pall membranes as the test membranes. The HSM 72-10257 method was used to scan 30% of the area of analysis membranes. In each case the blanks and the tests showed no fisible asbestos fibers. *The following is a capsule explanation of an X-ray energy dis persive analyzer system whose acronym XREDAS and other variations have been widely used. When added to the SEM electron column it provides chemical analysis "in situ" without destroying the speci men, When a specimen in the SEM receives energy from the electron beam it must release an equivalent amount of energy in some form. One way that it achieves this conservation of energy is by emitting X-rays, each of which has a particular energy that is determined by the structure of the atom from which it comes. Since all elements in the periodic table differ in atomic structure, it is possible to identify the elements present in the specimen by simply identifying the energies of the X-rays emitted. When an X-ray strikes the lithium drifted, silicon detector, it is converted to an electronic pulse whose heights is proportional to the energy of the X-ray, The pulse is then amplified and shaped by a preamp and amplifier before being counted and analyzed by a multichannel pulse height analyzer (MCA). The energy processing of each X-ray is completed in less than one microsecond, permitting sufficient data for multi elemental analysis to be obtained in minutes. The pulses are counted and sorted according to their height by a special purpose hard-wired computer called a multichannel analyzer. The data output is in the form of a spectrum showing the number of X-rays that have b e e n .counted in each of the four hundred channels comprising the X-ray energy range. Interpretation of this spectrum provides qualitative, semi-quantitative and quantitative information about the multielemental composition of the specimen, an X-ray energy analysis system can be used to map the distribution of one or more selected elements or to perform a line scan showing how the concentration of a selected element changes from one region of the specimen to another. 5 2) SEM: Table I shows the results we obtained using the Scanning Electron Microscope to examine the analysis membranes. Between 1.5 and 3 hours was spent in examining each analysis membrane. No asbestos fiber was detected downstream from either the 0.2 or 3.0 um absolute Pall membranes (tests 1 - 5 ) . Asbestos was, however, detected downstream when coarser pore size membranes were us e d ; in test 6 we used a 10 um pore size membrane and were able to count asbestos fibers downstream? this grade of membrane removed more than 99.9% of the influent asbestos. 3) X-Ray Dispersion: X-ray dispersion was used to identify all particles observed during scanning. This tool was extremely valuable since relying only on visual identification is often inconclusive and innaccurate. Discussion s It will have been noted that the 3 um absolute element quantitatively removed asbestos fibers as fine as 0.1 um in dia meter and 0.2 um in length. Normally, the 3 um graded filter re moves over 90 to 99% of particles over about 1 um, but is not at all effective at 0.2 um. The reason for the effectiveness of this 6 filter in removing such fine asbestos particles is believed to be the following: Asbestos (Chrysotile)is strongly positively charged in aqueous suspension. The fibers of which the filter is composed are strongly negatively charged. Removal efficiency is greatly enhanced by the opposing charges. This theory is supported by the observations that when separately suspended in water, both asbestos fibers and the filter medium fibers are well dispersed with little or no floccutation. If the two suspensions are mixed, heavy flocculation occurs - indicating strong interparticulate attraction. TABLE I ASBESTO S FIBER REM OVAL EFFIC IEN C Y OF P A L L ULTIPOR M EM BRANES T est M embrane A nalysis M em brane Used 0. 1 u m M illipore 0. 2 um N u clep o re 0. 22 jam M illip o re 1. P a ll AR (0. 2 ,um) T e s t M em b ran e 1 % A rea of A nalysis M em brane Scanned M agnification R esults 0 .4 10, 000 No A sbestos 0 .4 10,000 No asb esto s 2. P a ll AR (0. 2 ,um) T e s t M em b ran e 2 % A rea of A nalysis M em brane Scanned M agnification R esults 2. 9 10,000 No asb esto s 2 .9 10,000 No A sbestos 3. P a ll AR (0. 2 /um) T e s t M em b ran e 3 % A rea of A nalysis M em brane Scanned M agnification R esults 0. 1 8,000 No A sbestos 4. P a ll AR (0. 2 Aim) T e s t M e m b ra n e 4 % A rea of A nalysis M em brane Scanned M agnification R esults 0. 1 8, 000 No A sbestos 5. P a ll U P (3. 0 yum) T e s t M e m b ra n e 1 % A rea of A nalysis M em brane Scanned M agnifi c ati on R esults 0. 1 8,000 No A sbestos 6. P a l l 10 u m T e s t M e m b ra n e % A rea of A nalysis M em brane Scanned M agnification R esults Random 10, 000 A pprox. 5, 000 a sb e sto s fib e rs on the a n a ly sis m em bran e. Note that the efficien cy of filtratio n i s g r e a t e r th an 9 9 . 9% ( *. h eM ^ p / o r r l "y m m - m - y.y c-pv t m 'MMP ? * -'MPS < - '- - .* - * < ' e - t - - < ' v & **..' . 4i ` r. * ' 'M -- - r4 3 ? ' A ,; r f ` F p V ' A i l A ` i' x,? ^ ,, * * ' V- /. ' ] i j . Q H e . 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F o r p r o p a .v a t .io t i o f d r u g s ?..nd c l e a n i n g B i o l o g i e s ; Serum and se r b a f r a c t i o n s , p lasm a vac.n in e s, c u ltu re m edia EPICAL jytVXCE s 'Water i;or kidf-mg m ach in e s, u r o l o g i c a l e x a m in a tio n devices etc. rooky MU... P r o d u c t F i l t r a t i o n ; Alcoholic ( b e e r , g i n , e t c . ) and so ait d r i n k s , sy ru p Air s S t e r i l e v e n t f i l t e r s f o r ste e rag e t a n k s COSMETICS Water, l o t i o n s , perfumes, e t c ' Coti AU! Abbott Lobs A1.1e r c an r h a r m. h 3.c o n Tshor. a t o r i g v McGav; i r - ; Armour ph^rm As t r a Pherr, Avar;:;. L ab s B a x te r itabo Perchan- m o F u a g ill B r 5.a t o l t o b a Cu tito:,: I m o C ib a Pbarnw Dow Ho f f man ~L alto eh e Johnson & Johnson S c h e rin g E li L illy P fizer Elkxn Sinn Endo Labs F . F o u g sra & Co,, Ho3lan d llan to s 3ol n 1)o y1.. i n s (b \ i o XsC-tt u ro n -* 17, Ch.'j o a o o , 1 1 1 . S a n ta Annin C a lif , Irn't W oitn, Texas 1L?I&tOu r s? Gn an t a l e f C a l i f Si C h io s >;e, 1 1 1 . forcesl-K ' f Hiss,R o u se s Pi:,, Lev; York tl n St Heir t o n G r o v e , 13.1, IS ,5i : ; p h o ry , t o , ? J o m a y 13 t ;y r Dcr o ;r,. Pen; o; 1 !! :,ex.KQ;C r y , c a i x i . I S u m m it, NCW J :1 C0'r Y io n ev i11e , Ind ian a 23 S3 H u t le y , New J e r s e y New B r u n s w i c k , Nev? J e r s e y It It Ken i I w o r t h , Nev J e r s e y 19 I n d i an a p o 1 1 s , I n d . l Groton, Conn. 23 C h e r r y H i l l , New J e r s e y ft G ard en C i t y , New Y o rk f! H i c k s v i l l e , New Y ork IS IPi SCd'C iu-WcIV"&> jSI('vt1 tTOi'L*s &y Be It-iifto re , Mo. ss l N ,,X ci. J.'30TTcCJ 1.1 T`TjC>*, Mcu:a J o i n asc-d & Co t. V}airs o r L a m b e r t Wa r n e r Ci? I Xc o v 1; K 11 so n Pha?'m, & Ccvu Co j.p . Mi l e a LnV>, K n o ll Pbancu S ,,B c P e n i c i b Ce ,, R i i e.y bn.be, T e e Upjohn Co, E . R . qu i b b b S o n s Richardson M e rrill Wyeth L a b s G eigy F i son s Phcrra, I .C 1 . PLarnc Calm ic (div,, o f Wellcome) G laxo E lid a Gibbo 1.OCXT I (17 hetnonia, ^ Pearl R iver, N il, ov .in n v j . X s j,,.m!, L itity , Pa, Mor r i s P1 an i & Chicago, 111, F l k 'h c t r t , I n cl , C lifto n , M ,J, O.C ' '?. - 1 - ~ I'i , t^ , Rr;:ci:1?,; j d g e , Ca.I. i :' Knlomao o o , M ich, llatboro, Pa. W estch ester, Pa. Ma c c l e s f i e l d Ho1mes Chapo1 Mac c 1e s f i e l d Crewe U lverston SI JOT 3 S 5! IS 1. SI 1? IS ft u IS It UJ n n a IS i? COMP r orj>-'.rPvor'T Sandor U ivcr s ton 3ji (B ih ar L ab s) ]X - C5 t( .. : '- -1 X t'iX V of E li L illy ) D yl -Ce E v a n & J`celi ce il E e E. e S q u i b b C o lga La Palino l i ve A l l 3ed rrev/oti ec L iv e rp o o l li S! n Bcrehvn:;-; Flo\>: L ib i Irvin a tl Kochc produci,;.; (Pie i, 3m n X-e]''o o.-.1e. ) S3 . C J . A griculb uta]. di v v W inthrop Labs R iliingham U G laxo I C . I . Gr a n g e m o u t h Bernard C astle 1! Vario u s brewer i e s i n c l u d i n g Vau x , Tennants, S c o ttish & N ew castle & Coca-Cola If Beecharo W orthing R ou ssel Swindon C an cer Ile s e e r d i In s t it u t o London t<_ ? IV u II 1? tl II J? 13 II II fi li 13 Si II fi ? COKPp\yi h is t e 3n s x.i ivo.t.c A i '' u:' 3 V i >",?s R e s e c r c 'h I r a i i invio G laxo Sm ith & hepliev; Merck Sharpa c- Dohroc iicrob:' e lo g ic a l Re ,i;,a o v, di E;ai: < WelIcome round a t io i : rrixev j e ,3 L a -mora;: Boechama S o ft D rink a Schveppes Showorings Coates r i d e r G ordo n 8s Giri Bootli Gin t , t- , t - . T'^l. c4ti3 31 CjJ 0 ibD ODd k am lord Ecalde sdo.e r o r ben P.irhr ig lit Sandwich co d 20 Chneh au\ B : on i i o r o fi Som erset ii I.ondon e. 52 1! ii t! SI f: H 15 r l u II 31 li ccpahy T/'.f' (JF. COUNTRY Dr * TlO'.'iyc- Gmbh Farbv.'s rice H o e c h st k G 72 3 B l l ; o r a oh P o sti?e h 720 6 2 3 1 ?: a ni? :,u: t / i v Ilo e eli s t POb t 3 Ci! G en e aviy U B i o c h e m i e GmbH 2b blindi A u s t r i i D e i 't c c l i e U elcorno GmbH K a l i ** Crit n i . ,, 3(i0 G j . o s s b v r g v o l s i Im la n g e n F e l c e 3C37 N e u sta d t a Rubaviergo Gerraany li B a o i 13 o 11 \K<; i k Dr ; B o d e v Co. 2 0 0 0 Uam.ier.cj Sd ite? n n c h t L o n s t u noe 27 1. Ch orni re h o r o b o 3k vom H e y don 84 Jh'Cjon bur-.'i TM- ? Doriuustrr i eroti: . 378 F a r b v s r k e H o e c h s t AG (32 3 F r ank f u r.t . / b Hoe cl i s t }?o s t f k i eh M a r b e r t GmbH 4 Du s s e lei o r f 16 Borni e r S t i c 155 E au cia C o lo g n e 5 Kln ~ Lliren ieldfc P ostfach 4711 MI GmbH 8 Mnchen 75 Xrupie r str, 18 E u r o c l i n i c , S chu ck u . Co 8 Mnchen 55 S a u e rb r u c h s t r e s se 10 W ebeck e u , C o . GmbH 2407 Bad~Schwarta u N uhlens t r a s s e 38 Stiefenhofer KG 8 Mnchen 12 P o s t f a c h 79 DMB ' Apparatebau 62 W iesbaden Saarbrcker Alle 3 i{ H 19 !! fl II 1! II COilPAWY Hi i e Ka 1 i -C)i emi g E . M erck Iw cm K o c n .a ti)'r. GmbH Kocibn. Gaioli Farl'V /crke H o e c h s t hfl Bayer C i b s - Oei gy hG Solidem EG blochooi e Technik sh Im p o rt B iogal R u d o lf M Iler u Co . S c h e r i n g AG F r enk enbr unn en H u f n a g e l oHG Teutoburger M ineral~ hrunnen G atzw eiler s A ltB r a u e r e i oi-JG Rudolf Rieder JX lh e F .P / 3 0 V ri x BfIo .. g 6 ) P nx IV's t ?.d t 2 P o s t f a c h 4 3 1P CO51 E c u f s h r :,! 61 Ua x"iogt;cid L Mb j,'u x.` ot,T fe. 42 623 Frankfrt-/.<I--Pcochst P o stfach 503 Levc-rkn een CB-4 0 0 2 B a s e l Po ? t:vc: cm CIl--- 00 2 F r s e i L i f t i l s t z e s s e 3 .j Iv-6/5 isvmdl Moskau-Q 200 S mo 1 en sk a j 3. p 1, 6301 W atzenborn-Steiuberg G .iessen er S t r a s s e 75 4619 Bergkamen P o stfach 8532 Bad Windshcim 13.1er sh eiraer S t r a s se 4 8 1 2 Ummeln B r o ck h a g en e r S t ?: a s s e 4000 D nsseldorf--O berkassel P o stfach 128 Getrnk e f abr ik c tion 8 4 4 W5r t.h/Don a u __COUFTFY Cor reBiiy 1? n a V Sveif zoxf. n Aus tri c Hvt s i. a Hangary Germsny II (3 IS IS ii  />(: -a TPP F e r 1neeicke Kc>e oh s '1. AG 6 2 ? F r u r k i urt/l-P'Hoechnh Po s t f a r u Baya.c AG Sh) lup p er in.? Placr' f o tri A r t s - Werl: a 4 81 y EracJoveclo Pen; t f a c h 109 P f i z e r Gmbh 75 ivaxlnri a Po a t f a c h COiS Saiico- AG P^ j. J' 1l . :r"'i Do r traun o c x Un i on ' . .o" traun cl S c b u l t l i o i o s - B r a u e r e i Ar:f vu r i e c h 9 65 H am su AVL>-Brauexe 1 4 1 5 5 "~i 1 J ' ch Po.; arxoh 80 E a a h e r o c h hcj / P T i,,c Gra n s n s t r a s c s 60 Ster n E r a u er e i , Ca r1 Funke AG 4,3 K o se n D ellJaighauaer S tr a s s e 1 Lovenbrau AG SO00 Mnchen 40 C i e men sstras.e 83 go-u p t ' Gorma' An s i t ' Ge xnuo ! 5! 1! n u ii XV 1 . JiruiaX Vi.-} -co ci, I 9 7 2 - 1 S V 3 , 2 , L i s t. o P.. 13. I ; : t ' V t s ,, 3, List, of cy.btomers in the pharmaceutical and reated 1ndustries.