IPQC Solid D F

7/26/2019 IPQC Solid D F

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In process quality control tests

For solid dosage forms

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Powerpoint Templates

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'

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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>

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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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IPQC Solid D F