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Conducted by Mrs Anagha Conducted from 25 th  May to 24 th  June Shadabjahan Ashraf Qureshi
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Industrial Training at IPCA

Feb 17, 2018

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Page 1: Industrial Training at IPCA

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Conducted by Mrs AnaghaConducted from 25th May to 24th JuneShadabjahan Ashraf Qureshi

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A sincere thanks to Mrs Anagha,Mrs Hema and our beo!ed "rinci"a

maam #r Anubha khae for "ro!iding such a g$$d o""urtunity %

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&abs

'esearch and Anaytica ab

(re"aration of tabets

Shifting

)ranuation

#rying

&ubrication

Com"ression

#issoution by H(&C

*! by assay

+ts a""ication

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or more than -$ years, +"ca has been "artnering heathcare gobay ino!er ..$ countries and in markets as di!erse as Africa, Asia, Austraia,/uro"e and the *S%

+"ca is a fuy0integrated +ndian "harmaceutica com"any manufacturingo!er 15$ formuations and $ A(+s for !arious thera"eutic segments%

3e are one of the ords argest manufacturers and su""iers of o!er ado6en A(+s% 7hese are "roduced right from the basic stage atmanufacturing faciities endorsed by the ords most discerning drugreguatory authorities ike *S0#A, *80MH'A, /#QM0/uro"e, 3H90)ene!a and many more%

+"ca is a thera"y eader in +ndia for anti0maarias ith a market0share ofo!er14: ith a fast e;"anding "resence in the internationa market as e%3e aso ead in #MA'#s <#isease Modifying Anti0'heumatic #rugs=treatment for rheumatoid arthritis% 3e ha!e eading brands in 5thera"eutic areas, ith 4 of our branded formuations being rankedamong the 7o"01$$ +ndian brands by 9')0+MS%

9ur internationa cient roster incudes goba "harmaceutica giants ikeAstra>eneca, )a;oSmith8ine, Merck, 'oche and Sano? A!entis@ most ofhom e ha!e been "artnering o!er the years%

At +"ca, uaity assurance is an attitude of seeking sustainabebetterment in e!ery as"ect of our ork% 7he resuts sho in our?nancias as e as ork ethic% Bet income for the ?nancia year ended1.st March 2$.4 as

's% 1,25-%25 Crores <*S 51 Mn=% Bet "ro?t as 's% 4DD%1D Crores<*S DE Mn=%

3hats more, +"ca as aarded as Among the .$$ Fest Com"anies to3ork in +ndia 2$.$ in a study conducted by )reat (ace to 3orkG 0 +ndiain joint coaboration ith 7he /conomic 7imes%

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 ' and # research and de!eo"ment ab%

A#&0anaytica and de!eo"ment ab%

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 .% Shifting2% )ranuation1% #rying4% &ubrication5% com"ression

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+s the "rocess of "assing the drugs through sie!e% Iarious ty"es ofsie!es are uesd for the same%sie!e -$ is most commony used%

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'%M%) <'a"id mi;ing granuator=0

#ry "oders are ?rst oaded into the 'M) by !acuum or gra!ity

<tota containment=%

'M)s are e;tremey uick and eKcient mi;ers of dry "oders% #ry

mi;ing is the ?rst ste" of the "rocess%

After the "roducts are mi;ed by means of the bottom dri!e rotating

im"eer, a binder is introduced into the "roduct%

 7he binder can be added in dry form or s"rayed in as "art of abinding soution%

S"raying occurs though one or more s"ray no66es and is uicky

dis"ersed into the "roduct by the mi;ing action of the main mi;ing

too <im"eer= and the cho""er bade%

 7he cho""er bade, hich is "ositioned in the highest circumferentia

area of the "roduct aids in de0um"ing%

 7he end "oint of the granuation is detected by ammeter% )ranues

are then easiy and automaticay discharged from a "ort in the

bos side% 7he et granues are generay mied as they come out

of the granuator%

OPERATION

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uidised bed dryer0

uidi6ed bed drying is the o"tima method for controed, gente and

e!en drying of et soids% 7he intensi!e heatLmass e;change of the

uidi6ed bed "roduct makes this method "articuary eNecti!e and time0

sa!ing% 7he technoogy is aso suitabe for "ost0drying of s"ray

granuated or e;truded "roducts ith !ery o residua moisture%

uidi6ed bed drying can be used in the entire "oder "rocessing

industry% +n the "harmaceutica industry, this inno!ati!e method has

re"aced the time0consuming tray drying ong agoO 7he drying "rocess

ith uidi6ed bed drying reduces the drying time in the drying o!en by

a""ro;imatey tenty times% +n addition, uidi6ed bed drying "ro!ides

controed and uniform drying conditions com"ared to the une!en

drying in trays%

uidised bed dryer0

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9ctagona mi;erctagona Fender, due to its octagona sha"e is designed to

"rocess arger !oume of materia% +t occu"ies ess s"ace com"ared to other

simiar benders ike I and #oube Cone%

(oer consum"tion is aso ess% 7he bending takes "ace at o s"eed during

o"eration% +t is e baanced e!en in higher ca"acities% +t is !ery usefu for

"harmaceutica industries herein gente bending of dry granues of "oder is

to be done% +t is a so s"eed bender and has remo!abe ty"e baPes mounted

on a rectanguar she% 7he

im"ortant feature of the machine is easy to ash in "ace% 9ctagona bender is

su""ied ith a bin charging system or can be designed for !acuum charging%

#ust free charging system is aso incor"orated, hich is a com"etey cosed

system for charging and discharging of "oders or granues%

 7he "oer consum"tion is com"arati!ey oer than other simiar ty"e of

benders% 7he machine basicay consists of she eded ith conica 9ctagona

sha"e ends and su""orted ith sturdy su""orts on both side%

 7he right hand side shaft is connected to a standard gearbo; by means of chain

and s"rockets, hich in turn is cou"ed to an eectric motor% 7he hoe dri!e

assemby is co!ered ith S%S% side "ane% 7he inside "ortion of 9cta body is

mirror "oished and the outside surface of 9cta body@ frame guards are matt

"oished% 7he materia to be mi;ed is charged in machine either manuay from

to" or bin charging system or !acuum charging system and then the "ort is

ocked "ositi!ey% 7hen bender is started to "reset bending time% At the end of

"rocess, machine is sto""ed and the "roduct is transferred to "rocess

containers by o"ening the buttery !aue%

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to .$$ by "ressing the C9*Bheck ceaniness of

the eui"ment%

-%.%2 Sitch 9B the instrument, drum i

initiai6e itsef to the oading "osition, the

dis"ay i no sho S7A'7%

-%.%1 3eigh and record the eight of the

tabets%

A% or the tabets ha!ing indi!idua eight u" to

$%-5$ g take 2$ tabets%

F% or the tabets ha!ing indi!idua eight

abo!e $%-5$ g take .$ tabets%

-%.%4 Adjust the counts 7 key fooed by R.,

R$, R$ keys% <Count range . to EEEEE=%

-%.%5 (ress /B7/' to con?rm the reading%

-%.%- 7o see and con?rm the number of counts

"ress C9*B7 key%

-%.%D 9n con?rming the number of counts "ress

'*BLHA&7 key to start, the dis"ay shos the

ea"sed count%

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-%.% B97/O 7est can be "erformed by adjusting R7+M/ simiary as RC9*B7%

-%.%E 3hen test is o!er drum rotates in re!erse direction discharging the tabets

in the tray%

-%.%.$ 7he test o!er is indicated by an audibe bee" and dis"ay shos /B#

-%.%.. 7he drum initiai6es itsef to oading "osition and dis"ay shos S7A'7

indicating the instrument is ready for the ne;t run%

-%.%.2 'emo!e the tabets from the tray%

-%.%.1 #e0 dust and eigh the tabets and note don the eight of the tabets%

Cacuate the "ercentage oss in the eight by using the formua

(ercentage &oss T+nitia 3t ina 3tL+nitia 3t U .$$

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 7he a""aratus consists of a basket0rack

assemby, a .$$$ m&, o0form beaker, .10.-$

mm in height and ha!ing an inside diameter ofED0..5 mm for the immersion uid, a

thermostatic arrangement for heating the uid

beteen 15 VC and 1E VC, and a de!ice for

raising and oering the basket in the immersion

uid at a constant freuency rate beteen 2E

and 12 cyces "er minute, through a distance of

not ess than 51 mm and not more than 5D mm%

 7he !oume of the uid in the !esse is such that

at the highest "oint of the u"ard stroke the ire

mesh remains at east .5 mm beo the surface

of the uid and descends to not ess than 25 mm

from the bottom of the !esse on the donard

stroke% At no time shoud the to" of the basket0

rack assemby become submerged% 7he time

reuired for the u"ard stroke is eua to the

time reuired for the donard stroke and the

change in stroke direction is a smooth transition,

rather than an abru"t re!ersa of motion% 7he

basket0rack assemby mo!es !erticay aong its

a;is% 7here is no a""reciabe hori6onta motion or

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Hardness is

carried out by

 just "acing the

tabet in centre

and the run

button is "ressed

hen there is a

cick sound the

a""aratus shos

the harndness in

B%

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 Schematic re"resentation ofan H(&C unit% <.= So!ent

reser!oirs, <2= So!ent

degasser, <1= )radient !a!e,

<4= Mi;ing !esse for dei!ery

of the mobie "hase, <5= High0

"ressure "um", <-= Sitching

!a!e in Winject "ositionW, <-=

Sitching !a!e in Woad

"ositionW, <D= Sam"e injection

oo", <= (re0coumn <guard

coumn=, <E= Anaytica

coumn, <.$= #etector <i%e% +',

*I=, <..= #ata acuisition,

<.2= 3aste or fraction

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H(&C has been used for medica <e%g% detecting !itamin # e!es in

bood serum=, ega <e%g% detecting "erformance enhancement

drugs in urine=, research <e%g% se"arating the com"onents of a

com"e; bioogica sam"e, or of simiar synthetic chemicas fromeach other=, and manufacturing <e%g% during the "roduction

"rocess of "harmaceutica and bioogica "roducts= "ur"oses%X.Y

Chromatogra"hy  can be described as a mass transfer "rocess

in!o!ingadsor"tion% H(&C reies on "um"s to "ass a "ressuri6ed

iuid and a sam"e mi;ture through a coumn ?ed ith a sorbent,

eading to the se"aration of the sam"e com"onents% 7he acti!e

com"onent of the coumn, the sorbent, is ty"icay a granuar

materia made of soid "artices <e%g% siica, "oymers, etc%=, 25$

micrometers in si6e% 7he com"onents of the sam"e mi;ture are

se"arated from each other due to their diNerent degrees of

interaction ith the sorbent "artices% 7he "ressuri6ed iuid is

ty"icay a mi;ture of so!ents <e%g% ater, acetonitrie andLor

methano= and is referred to as a Wmobie "haseW% +ts com"osition

and tem"erature "ay a major roe in the se"aration "rocess by

inuencing the interactions taking "ace beteen sam"e

com"onents and sorbent% 7hese interactions are "hysica in

nature, such as hydro"hobic <dis"ersi!e=, di"oedi"oe and ionic,

most often a combination%

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(rinci"e of utra!ioet0!isibe absor"tion

Moecues containing Z0eectrons or non0bonding eectrons <n0eectrons=

can absorb the energy in the form of utra!ioet or !isibe ight to e;cite

these eectrons to higher anti0bonding moecuar orbitas%X2Y

 7he moreeasiy e;cited the eectrons <i%e% oer energy ga" beteen the H9M9

and the &*M9=, the onger the a!eength of ight it can absorb%

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*ILIis s"ectrosco"y is routiney used in anaytica chemistry for the

uantitati!e determination of diNerent anaytes, such as transition meta

ions, highy conjugated organic com"ounds, and bioogica

macromoecues% S"ectrosco"ic anaysis is commony carried out in

soutions but soids and gases may aso be studied%

Soutions of transition meta ions can be coored <i%e%, absorb !isibe

ight= because d eectrons ithin the meta atoms can be e;cited from

one eectronic state to another% 7he coour of meta ion soutions is

strongy aNected by the "resence of other s"ecies, such as certain

anions or igands% or instance, the coour of a diute soution of co""er

sufate is a !ery ight bue@ adding ammoniaintensi?es the coour and

changes the a!eength of ma;imum absor"tion <[ma;=%

9rganic com"ounds, es"eciay those ith a high degree of conjugation,

aso absorb ight in the *I or !isibe regions of the eectromagnetic

s"ectrum% 7he so!ents for these determinations are often ater for

ater0soube com"ounds, orethano for organic0soube com"ounds%

<9rganic so!ents may ha!e signi?cant *I absor"tion@ not a so!entsare suitabe for use in *I s"ectrosco"y% /thano absorbs !ery eaky at

most a!eengths%= So!ent "oarity and "H can aNect the absor"tion

s"ectrum of an organic com"ound% 7yrosine, for e;am"e, increases in

absor"tion ma;ima and moar e;tinction coeKcient hen "H increases

from - to .1 or hen so!ent "oarity decreases%

3hie charge transfer com"e;es aso gi!e rise to coours, the coours

are often too intense to be used for uantitati!e measurement%

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 7hrough this training got the "ractica knoedge of the "harmaceutica

industry%

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