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7/26/2019 IPQC Solid D F
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In process quality control tests
For solid dosage forms
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What Do You Mean By IPQC?
IPQC is concerned with providing accurate
speci!c " de!nite descriptions o# the procedures to$e e%p&oyed #ro% the receipt o# raw %ateria&s tothe re&ease o# the !nished dosage #or%s'
I()P*C+I,(
+*)+I(-
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),.ID D,)/-* 0,1M)
2' +a$&ets3' Capsu&es4' Powders *5ervescent
,ra& Insu6ations Denti#rice Dusting
7' .o8enges
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+/B.*+)
Que9 Is it easyto %anu#acture a ta$&et ?/ns9 (o
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)teps o# +a$&et Manu#acturing
Weighing )creening Mi&&ing Mi:ing -ranu&ation B&ending Co%pression Pac;aging .a$e&ing
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Qua&ity Chec;s DuringManu#acturing
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IPQC Para%eters to $e%easured
I' Physica& Para%eters9 a' te%p
$' ti%ec' partic&e si8e " te:tured' pressure %%
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II' /ttri$utive 0eatures9
a' visi$&e i%purities
$' co&orc' e&eganced' co%p&eteness o# product#' De#ects &i;e
*:cessive powder Pieces o# ta$ /$rasions Crac;s chips swe&&ing
%ott&ing #usion o# ta$''etc'
/ppearance o# crysta&s on ta$or container'
g' *ngravingA*%$ossing &ogoh' .a$e&ing " pac;aging
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Date Time Operation Room
No.
Temp
C
%RH Diff. press
(mm H2O)
signature
Dispensing 23 42 2.0
Sifting 48 1.8
Milling 2.0
len!ing
"ompression
"oating
BM1 #or +a$ M#g Process
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Parameter Limit Obseration
Ma$%ine spee! 20 rpm &15'25 rpm(
)t. of 20 ta*s 12.00g +2 &11.76'12.24g(
T%eoreti$al weig%t,ta* 600mg
-ar!ness 25g &20'30 g(
T%i$/ness &a. of 10ta*s(
4.10mm +0.15mm &3.#5 4.25mm(
engt% 10mm + 0.1 mm .# 10.1 mm(
)i!t% 5 mm + 0.1mm &4.# 5.1 mm(
Disintegration time MT 15 mins
)t. ariation + 3 of . )t.
ria*ilit &10 ta*s( MT 1.0 w,w
Co%pression Para%eters
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Parameter !re"uen#$
Wt. of 20 tabs Every hour by production andevery two hours by QA
Hardness, thickness, length,width
Every hour by production,every two hours by QA
Wt. variation Every half hour by productionand every hour by QA
! Every half hour by production,every hour by QA
IPQC chec;s #reuency during
%#g'
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C/P).*)
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)teps o# Capsu&e Manu#acturing
M#g o# -e&atin )he&&'
Drying o# she&&s in contro&&ed hu%idity'
M#g o# granu&esAspan8u&es'
0i&&ing o# )he&&s'
Pac;aging " .a$e&ing'
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IPQC Chec;s During -e&atin )he&&Manu#acturing
> purity o# ge&atin iscosity o# ge&atin so&ution 3EF7E %i&&ipoise B&oo% strength o# ge&atin so&ution 2EGF3EG g% Iron content (M+ 2E pp%
p< o# ge&atin /HJ BH7'K 0i&% +hic;ness Co&or sur#ace appearance o# e%pty she&&s +e%perature o# hot air #or drying o# she&&s .ength o# Capsu&e " Body o# the she&& Moisture content 23F2E>
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)orting o# de#ective she&&s
/#ter the capsu&es have $een inspected either
e&ectronica&&y or %anua&&y they are sa%p&ed $ythe Q/ inspector " chec;ed #or the de#ects andthen sorted out'
Printing inspection on she&&
. Inspection o# de#ects &i;e9F
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IPQC Chec;s During 0i&&ing o# *%ptyCapsu&e )he&&s
During !&&ing process euip%ent shou&d $e &a$e&edwith 9Fproduct na%e Batch (o +i%e o# starting)ign
During 0i&&ing9 Low property o# granu&es orpowders
Weight ariation 9 0or hard ge& capsF
.i%it (M+ 3 caps shou&d deviate #ro% avg wt'
/- W+ >D*I/+I,( 4GG%g 2G>
N4GG%g or %ore K'E>16
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0or so#t ge& caps9
Wg 2G caps 1e%ove inner content $y cutting with
scissorA$&ade Wash with so&vent " evaporate so&vent at roo%
te%perature #or 4G %in
Wg the e%pty she&&s " ca&cu&ate > deviation
M/C
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/PP*/1/(C*9Inspection o# capsu&es chec;ed with a standard strip
),1+I(- D*0*C+)9*&ectronic auto%ated or %anua& inspection is %adeto sort out " re@ect the de#ected caps'
,verprinting
P1I(+I(- " ./B*.I(-9Inspection o# overprinting &ogo &a$e&ing arechec;ed with the standard shade cards'De#ective ones are sorted out " re@ected'
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.,O*(-*)
QueF /re they di5erent #ro% +a$&ets?/nsFYes''
1#
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)teps 0or Manu#acturing o#.o8enges
Weighing
Mi:ing
)i#ting
-ranu&ation
Mou&dingACo%pression at &ow pressure
Pac;aging " .a$e&ing
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IPQC Chec;s During Manu#acturing
Visual inspection
Shape, size, color
Weight variation
Overprinting logo
Uniformity
Disintegration
Packaging & Laeling
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POWDERS
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!ypes ofPo"#ers
Effervescent powders
Dusting powders
Insufflations (Inhalers)
Dentifrice
Oral powders
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$lo" %hart of Po"#eranufacturing
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IPQC Chec;s During PowderManu#acturing
Partic&e si8e " shape +e:ture Powder Low
0&uness Density 0oreign I%purities Moisture
Pac;aging F sea&ing printing
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2' '(ervescent Po"#ers) sa%p&e powder in 3EG%& o# waterproduces
e5ervescence " disso&ves in 23sec'
*+ Dusting Po"#er)
co&or te:ture density partic&e si8eLow Luness spread a$i&ity
+ -nsu.ations)
Low partic&e si8e density
/+ Dentifrice)a$rasion te:ture partic&e si8e co&or
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Powder 0&ow " +e:ture/na&y8er
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Powder 0&ow /na&y8er used to%easure9
0&ow +e:ture Ca;ing Cohesion
0&ow )peed -ranu&e attrition Co%paction " 1e&a:ation Dusting )ur#ace 0riction
/ggregation /irFentrap%ent -ranu&ation
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Para%eters Measured9
=princip&eFs&icing shearing co%paction
speed o# rotor $&ade $&ade ang&e path o# $&ade resistance in speed and ang&e
a:ia& #orce ti%e distance trave&&ed
Measured $y a sensitive transducer attached to rotor$&ades'
2#
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)u%%ary&
InFprocess contro& not on&y provides a %eans o# contro&&ingproduction it a&so per#or%s a ua&ity assurance #unction'
,ra& )o&id dosage #or%s are so%e o# the %ost popu&ar andconvenient %ethods o# drug de&ivery'
With the high vo&u%e o# products produced in these dosage#or%s it is i%portant that the unit operations #or theirproduction $e thorough&y understood deve&oped andi%p&e%ented'
+his presentation #ocuses on the #unda%enta&s o# eachdiscrete processing step =unit operation with e:tensivediscussions on the current techno&ogies reuired #or the%anu#acturing and pac;aging o# so&id dosage #or%'
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1*0*1*(C*)9
2' W
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