Operating Instructions Validation Tool Kit, ASTM For use with USP
Contents
1. Operating Instructions Validation Tool Kit ASTM For use with USP Apparatus 1 amp 2 PIN VALTOL ASTM Revision 2 0 October 8 2014 Prepared by Quality Lab Accessories LLC 100 Emien Way Suite 108 Telford PA 18969 Table of Contents 10 General iniormaton EE N NE EIE eee 12 Produet Spec ee AT er ee Ve ee EE 3 Produet Desotpton EE 3 Diagram of Validation Toot ASTM el 440 reet Operating stu ne nnn 41 Dipta Vertealty Meter Pat Number Eer 414 Diagram Front at Dipti Veet Neer DEET 413 Key unetan ONOFF ESEG AA Key Function ABSZERO EE 445 Key Function HOLD Aie ett 41 7 Gebuer Accuracy Test 441 8 Collation Recatbratng let 42 Checking Vessel Piate Loveless 43 Sening Pade Basket Het An Checking Paddle State AS Measuring Pace Wobble l At For Hanson and fette A For Vankel Varan Testor AS Measuring Basket Shat Wabeke inia tA AB For Hanan ai tk Tt eA AE Fa Vel Varan Testers eee are 4 7 Measuring Bastet Wobble ad SE At ST A For Vankel Varan Testers eee E Ap Measuring Pac Basket Shaf VEER nnan Een Ap Measuring Vessel Certege T 495 For Teniers wih N iT 492 For Testers wth Two Piece Fre PT ETEA Cet eee A Measuring Vessel Vert ee R 432 Cuesawg Vessel Veal enn 50 Drogen e Waray GEREEN NEER ENE OE Revision History 10 20 General Infrmation Thank you tor purchasing the QLA Validation Tool K ASTM Tis it contains a ary ot unique measur2. Sep 2 Rotate the meter end to end so ne claplay ls taing away rom ou as shown in Figure 4 Make aure 1o postion E ame spot and wa ten seconds Delore hating te reading on the ay NOTE any two readings vary tom ane anamer by mee than 0 1 Gegee he metar MUST be ecabales 41 8 Calbraton risegen Folow tese tve easy staps to recaltate te meter ivu out as entre BED degree range by secroncay cara tw norizortal angles STEP Hy Wh the meter tamed on press and hol the ON OFF key for Si seconds or unt he spay goei Bark STEP N2 Prese the ON OFF key again to enable he recatbraton made nd postion te mater an a iat surtace with tne leer on the ont ht Se up as show i Figure 5 The number wt appear on he iy STEP 5 Press the ABS ZERO key and he il begin rig or ut tour seconds and Pen trange 1a 2 as shown Fire G STEP a Rotate te maar 180 Degrees horizontal so i taces away Van you win he leering igne side up as Shown in Fure 7 STEP 45 Press the ABS ZERO hey an he 2 wl begin rir lor About our seconde and men display a reading The een 1e now completa 42 Checking Vertel Piae Leveiness ei The vessel plate levees can be checked using the Digtal Vertealty oer Pat Number VERTMET MY important d s Tes andor Recatbraton Ot The Data Vertes Meter tus eke Balore Ue To Ensure AE ae ing Ser Secon Ft namo sys 422 Place me Digtal Vertcalty e Gun tester vessel pate at me approximate center ot ne
3. ober me reading EE ET Ed Ee er Baas sabe Eer bee roo 43 Seting Passe Basket Height as The pase or bake ght can be set by placing the 2500 depth gage EE onto fe padas orang baka steer Sy takdir Me support am oro heave nat and making se ep cl z s hing bota pa oe o airg ase LECH DEEN JE e Ed Checking Fase Basket Moon 441 Ater setting the padde or basket height The height can be eck by ng tne Go Na Go Gage as oulinea below 442 Wn the dsoluton dive head lowered os normal operating postion ado lain basket ard the botam ol he vessel Wiehe lager 443 We GO knab does not ft or the NO GO knob doek fe height neede tobe adjusted See Secans 421 423 Measuring Padde Wense 451 For Hanson and Distek Tester 45 1 1 The padi wool can be measured by assembling Pe dal indicator ascemaly smalindesior sha and wabble bracket Sse as shawn Figure 10 45 1 2 Piace the woe meter ario me top athe dissotiton vessel and mave te acs toot nor ut ul te sae s secured 10 he rade oe vesae as sow in Foure 10 45 1 2 the pale shat secured lower and postion the desohsion ive nead so ha he da indicator prabe located about em dv he op ot Pe padde lade and ads he ection othe Idi excel 1 etal a pre oad oft least one evolution a Pe cata dal Tarten the an eens to lack he gage in place See Pige 11 baal 45 14 Setinedsolaion tester to 25 RPMs Start the spindle rotaton ana serve th da cate r
4. 4AL2 Tien the metet on and press the ABS ZERO key unti me ABS icon Appears on he daal delay Pace he meter agana the pande ar Basker anan as shown Figure 16 The meter shouid be positaned wih eV grove against the sha Keep te meer mates tor six cond and man record he value show on me gti py TNS Salue a 1e angular deference rom Tee Horn ven Tocaluate he stat veteally use he example slow Sat he value shown En Ne meier in Degrees FOR 90 Degre Thi new value 1e hat vera Example the va on the meter shows 887 Then 90 Degrees Minus EE Degrees Equals 03 Degrees Shatt Vera The acceptable shati veel value k 90 0 si OS Degrees NOTE An aow located on the ket side af te digtal display as shown in Paure 3 wa indicate whieh decion 1o mave the asso tester to love ue ete The sdusttl teat located on he base lhe ZE ware accompli hs 49 Measuring Vessel Centering vi For Testers wih One Piece Stats 1491 1 Raise he dissolution tester 1o ts hignest positon Remove any sting paddle or basket aran and Tepate E win the nes Shan mi Gage as roun in Pgue 17 49 12 rset the nesta hat into the spindle such hat Be hole on the hl protrudes atout 1inch below the spindle assay 149 13 Atach ne top ot me gage to the banon of the car shahi by tring me kured kot ciocie unt snug Use the anti voton ant insert tu the csr shat Hoi ine gage hardie n Bate anad men tly sen he kuned knon Rase tne sseried gage le he apine
5. NOFF Tas kay is usad to turn the meter an ar a and 1o enale tne recaltyation made See Secton 17 ot In manual or recalbraton nator 414 Key Function eene Thi kay is used to turn he meter on or ot and 1o enale tne recalibration made fee Seton ATA Gi na manda or Ee or aucione 415 Key Function HOLD This key gud ald vai on me cig display while measunng an anga Piace Ine meler agus he padde or pasket ahai aa shawn a Fre Wat su seconds ana ien press E nang the meer in poston fl on cated onthe al desay ta pegin ig for aoud six seconde and Men become sold Once PE ale shown on he dplay wit emai To dsengage Me haki turetan presa fe HOLD key again 41 8 Banery Lte indicator The Digt era Metar ie powered by a 3 Volt Lahn Banery ype GR A new bariery Stout prove about 500 hours at use the Satay iow he batery icon wi be rated on me gla display Feplce wiin a new banery ena 41 7 Calbraton Accuracy Test Peto tn three step test betore using tis meter Also perfor tis test ny ime me meter tas been dropped os usea n an anker Mat aries more than 5 Degrees C am the eavronment in which I was ast STEP Tun the meter on and prese e ABS Zero kay unti ie ABS Teon appears n he ail dps STEP 12 Poston tne meter wih tne splay tacing you on a clean tat ojo surae as shown n Figure 1 The et suace does aal Pave Te be parteci teva Wat Ten seconds unl Yeading has compete Setod and ao he argie on he dy
6. assener and geen he Chuck Assert Chuck series we nat used on Direk Sea 49 14 gedy pressing back on he gage sna to avoid hiting the vessel ran ar centering tog as Shown in Figure 18 Lower the Bean drie head so al the neat en nm above Ihe pol he ET EE pale bushel poston 14915 Sethe solution tester sped to 25 RPMs and place one og MEES EE Dalk 100 sais instruments maybe A LOK doo ina steh at eve gid tan Tee 149 15 San te spindle rotation and observe te eater Wave ott he dl face so a the moma courier mm Ee DEE dE ison on th alto E 48 sop the spe rotation an raise he deve head so hatine Indeator bat is near ihe ape he vesse past below 1e m rd opeat Sectors 47 1510 471 7 492 For Testers wih Two Piece Spin ot Shate 4821 Fotow the nections in Sectan 47 1 with the atoning estas Fave oni ne bee porlon he padle oe asiat Er aom in Pigre 20 sek Testers do not oq the Cette Vessel Centering 1410 1 The actual vestel centering or spot 1o vessel nisstgnment ie ate by ng Me al ea reading or TLR Dy M Example The ciat neater moved vehwse rm 40 to 15 Theat sted easing Sm Thua T Smm Graad By hwo sual tm vane The ciai indicator moved ciocie rm 40 to 25 The oat sted eating is 2 Sm Tus 2 3mm divided by wo equals en Measuring Vesse Vrtalty 4411 For Varkel Varian Hanson or Diek testers the centring gage is also Usad to measure the vessel SE NOTE The Art Raslen Harde may be
7. ave Rotate he dal ace so That he minnum counter chu pointer poston coincides WIT hh mesa Ashe anan eas he painter wl move Shoe 1o a masimum vai Th distance eo ected aang TLR or wobble Each sion he da indicator quali Dine 45 2 For Vankal Varian Testers 4521 Remove te certering rg dissoluton vessel and assemble the linet to he bracket assembly as shown in gure TE 4522 Piace the nesta assembly onto he centering hg guide post as Betten 45 23 Repost Sertons 44 13 8 4414 45 Measuring Basket Sha Wobble 451 For Hanson and Distek Testers EE ET eem TEEN eebe en 4843 Wh the basket shaft secured lower and poston Me soon dv ie op ot me shat nub and ads he location of the Indio excel 1 etblah a pre oad or at least one ER aat Tanien the han acres lo lack he gage in place See Pige 1a 145 14 Sel ne dsolsion tsar ta 25 RPMs Start the spindle rotaton serve th da cto rave Rotate 1e dl ace 20 at he mua counter clockwise pier positon enineides WI T nt nso Ae sah aes he poe wll pove cose 1o a masimum va Th distance eo ected feadag TL or wobble Bach sion he da edeators qual Ota A For Vankal Varian Testers 48 21 Remove te centering ing dasolaon vessel an astonble te lance ote tracket assembly as shown n gute 12 45 22 Place the nesta sembly onto he centering fng guide post as shown in gue 13 45 25 Repou Sectons 451 58 451 4 A7 Measuring Basket Wobble AA For Hanson and Ose Tester
8. ineaed easing st One Ths vessel Passed Example The dal ineator moved counter ciocie fom 40105 The Giplacement or oil EE Ths vessel Faied Qualification and Validation ea shipment te k sessie and inchudes a Cena of Calvaton and Mao The complete k shee retume et once a year hough he measuring ols and gages contained in Wa kt are maiterance ae ae anot aguar any daly eN Ad Be ged eae asch se the ages and toa are tena othe plaste eise case fr store 70 Warranty This pat contained in his are warranted 1o be fe trom detects in materials and Pe under orl isan usa and sanea for a psa ol 1 year Hom Ihe dale of purchase as shonn one purchase order receipt The again of OLA inder a waranty anal be ltd repai or repiacement at our optan ding me waranty period provided ne produet erekered o QLA win transportan charges prepaid Th Haran shal be nal he produet s damaged a a reaut af dtacenent mause Warden destrucien ners in seta umber repai atest or maintenance Serpe ar pary aie an our owr sec acy aud GLA sae
9. ing tol and gages ta provide an accurate reading ol eel plate leveiess padite or basket sha wobble basket webs paddle or Basket ona vericalty paddle ar basket height veast certenng and vessel EE nne new FDA specication ouining be use af an Ze Calton poceaure aban aterat approach 1o curent Apparatus Stab procedure fot Dasouiton Apparat and 2 as descibed in Ne USP General Chapter lt 711 gt Dissalutan The ASTW Hs maintenance te ayo use and hau be tured 1o OLA once a year reer son 12 Product Specticatons See indvidual Carts of Caibraton and Traceabily Unpacking Tha paste storage bor has been designed to minimize any damage iat may occur hing anspor and ean die be used 10 ship ne ASTM KI back 12 OLA ar ecalaton Chec be shaping container Iar any damage dug anspor Unpack the ER ME EE paris tor potable damage Repor ny damage tbe eng shipper ned and om OLA o you laa ee 20 Product Description 34 Sgr Vato To Kt ASTM gies Gage z Dec Tra war age 3 We Bact ser SS D een DIE H WE Bracke Asa SS Go Neco Gage GE ep Set Gage DEPSET 25 Spin ta Apter e APT NA 1 Spr San Apo Varkel 7 eran E in Suna mp D Se ZS 15 al Verity aa D EE ZE 2 St sn A0 installation Operating Instructions 41 Digtal Vrtcalty Meter Pan Number VERTMET AA 44 1 Diagram Front Da Veto Meter 41 2 Dogter Back ot tigtal Vertealiy Meter 413 Key tureton O
10. raved to measure vessel tee STEP 3 Wile gent pressing back on the gage shati 1o sold iting he ventel im certain ing is 1e dasaluton drive head 2o hat he mela bal a postioned out 2rm above The op a Me vessets Drones raaua as Shown Figure Ed paite or basket postion Then de Shaft Cotar onto the el rear Epo te cacao tester as shown In gure 2 NOTE For ante Varian Dissaluton Testers the Shat Colar s nat equred ae he asable Hap acted an te ves gt aus Me pion fhe drive head See Foure 10 STEP 2 Rotate he lace otal the pointer positon coincides wah 40 STEP 13 While gonty pressing back an the gage enat raise tne dissoluton Give nead hgh enough Ta vaert ne apc Bornen Spacer BOR Landaa as shown in Figues 23 and 2a STEP va While gent pressing back on the gage shaft ge sel tin or cemering fg lowe he desolation ve head ul uch he op of he standard ar spacer tase the gage shan and abeere the aang on tha gape Te deri between ie reading at he bation ohe tld he lop ci he versal the dasacemers STEP 5 Rate the gape 90 Degrees and hen repeat steps 2 1hru 4 STEP v6 Repeat stags 2th S tor sach shat neato vi Calculating Vesse Veen A smo seun nas been pertormed to determine tat me mamun EE ma Bape ange sa rat Example The ee moved lene rom 40 1o 5 The displacement or W ert SE Ths vesel Passed Example The dal neater moved counter lchwse trom 4010 50 The Guplacement arial
11. s AF AA The basket obbie can be measured by assemoing me dal Indeatorassomaly smalidesio snart and wobble bracet soem as shon in Figure 10 47 4 2 Piace the wobble gage onto th top ol te dissolution vessel ard move Ie cust Toot e he rate oe vena son Foure 10 4743 Wah ne basket scion shah ower and positon he Vaste ive hea so tthe dal wis roe aching he atom rim af he basket and adit he loan othe ee assent 1o estaban pad oft lent one evolon othe neato cal Tighten the thanb screws a lock he gage in place See Pigre 15 od 47 14 Set 1e dsolsion tsar ia 25 RPMs Start the spindle gen serve tha ca cate ave Rotate te ar ace 3o Ihat he mia outer clockwise pare posion mine es MI O nthe indicator As na anat relates 1e pointer wii move tose 1o a masimum value The tance eo ected feadag TL or wobble Bach dision on he da indicator qual otmen 47 2 For Varkel Varian Testers 147 21 Remave te certering mg dssektan vesse and assemble We ila ha bracket assembly as shown In Foure 12 47 22 Piace the nesta sembly onto te centering ting guide post as shown in gue 13 47 23 Repent Sectons 461 58 481 4 48 Measuring Paddel Basket Shan Vericalty aa The Digtal Vertcalty Mater Pat Number VERTMET M is uted to measure ne pade basket sal vray Important An Accuracy Test andy Seier The Digtal Verica meier Must Ee Peronved Batore Use To Ensire Accurate Badia See Seton oi ha manai Tor Bees tes ad
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