Pilot Plant Scale Up Techniques

1. Date
Unit- I
filot Plant Scale up technigues:
for example you areqoing to prepare
Tea tor l00peoplejyou Gr provicded with
t alt neccessary thingsfor
hsssiit:
sh ike Tea powder
Saatht)
Milk, uvater
but lon
you don know how to
prepareit, fhen ifyou
ego aal have addedTeapowde oo
measurement.
itmay happen teawill
Cotain moYetea/suqaroT
water which leads to spoi lage
wastage of al l thìngs teads
to loss.
HbinsPoet o But if you orre hew oT you are
Ndoing something on larqe
1ateScale thentyitfmsmal)
Seale
2bat Preporre teafor I or 2
ipeople
-cCD
ary Sugas without proper

2. Date
you will qet idea about
taste,colowr 2 all
Small Batch
Note procedue tings
then mulHiply with Teguire
quantity, Say for example
l'cup tea will corrtain Ifoaspoon
Sugar2 teathen forlo0 cups
obu you should add 00 teaspoon sugan .
’Big Bateh
Tn Phanaceucticals, Same thi nq will be apphcable
New Derelopments
fistSmall batch Iike pre pare
Definitions:
4339
1000 tablets know prvcedwe, matenals
properiy Cquarity Lquality) successful
dthen mutip'y &
apply same for big batch CI lac)
2pbhdne orthe sl tabletsboy
Plant: Aplace whre
ro pvinike
Saath)
- Successful)
1ifyouare stuted frm sm
to avoid e loss
Money
Mateia
Man
Method
HO Oat Machines
maJ)
SCale
5 mateials/ thìngs
manufactuwing of products.
Brnught toqether
CCO

3. Date
Pilot Plant Port of Pceutical Lndusty
where lab scale formula
viable pnduct
ransformec into
L by
15derelopmetof liable
and practicalprocedure
of manufactue
Gaathi
Before prnduction of Lange Batch likeI Loc
toble ts
Lpilat plomt Small
Do Proctice on smallkscale batch
1ike l000itabletsens
Usingdata
f SuCCessfulthen qo for
Lamge scale
Scale up: Art ofordesigning of prvtoty pe
e obtoined fmm the prlot
plant mode|.
Pilot plant Small batch
310Succéssful
bote down 9uartitnes,fom
pro cedure
Calculations J Btck
JScale up
7 Srnall
forr Big Batchccn

4. 2.
Date
I0 ty the prmce'ss on a model
3.
Objectives
of
prposed plant
before
Comitting large sum of
pnduction unit.
Examination of the fomula
to
deteine ifa ability to
with stan d
av Batch scaleiPrvcess molificartionoP
Evaluation)foY Process
+
Validation
+
bon equipments
4. Tdentify Citical fe atures
of
Prvcess
eq Mixing of oil&water
speed
dlepends upon agrtation
Saathi)
Otherwse waste -Occo

5. 5.
6.
7.
Date
Guidelines
pnduction
ba Prv cess contols
Provide : Master Mfy.fomula
+
wbO Manufactuing prcedure
Avoid : Scale up problems
Steps in Scale up
Step 1 Define prvduct economics
based on prvjected Masket size
bulbrei
Compe titive selling
Saathi
Pvide quidance for
toallowable manufactung
Cost.
Step 2 Conduct Laboatory stucs )
Scaleup planning
at fhe
Same fime.
Step 33 Define key gate contolling steps
J in
proposed process.
@ccD

6. Date
MaJbrigt
focus On
Conduct Preliminamy larqer
Lthan
Laboratomy Studieswith
equipmentto be used
Lin
Decide
ate contol lbng steps
Step S1 Desiqn
Scale up 0
NOT.
28oi in plart desiqn
construct
pilot plant
Step Gi:Svaluate pilot plant results
Product t Process
J including
including prvisionsfor
Pmcess+ env. controls
cleaning +sanrtiging ’ sy stems
packag1ng t waste systems
6 Handling
Meeting/fulfilling
Saathi)
Regulatoy
aqency
regumements
Cquality &vald ate
but pncess economjcs to make
any corections+ decisions
whether o not to pnceed
with fll scale plant derelopmenst.
-OccD

7. Ate
Date
teon
Expt
Scientist+
O Reporting Responsibilities :
topnjost
Pilot plant
General Consideration io points)
R&D9pup
L with
Separvate
staffing
prnvide fonula +
proceduwre for wok
(forrdloctoy )
divile woYk/Responsibilites
Grp
2in
Stale up = Big Botch
eiboeeolett
De pehding uponi prlot plant
womkprocesses opesaionc
, decide team
Traine d
operato3,
Chemist
Phlanacist
ofoTkens
SnaliBateh
How
Oany
grou
2 Perrsonnel Reguimements
:ivacd
Ob Chenist
fomulator : who developed
the prodluct
phannacist
Enginees
Can take into the
pnduction: t povide
Suppoot
LN even after
tsunsition into prcduction
e has'been completed.
Actual
SaathD
+ production
anea
Most paefesableo
wnderstand intent of fomulator
+
perspectire of pduction
personhel.
-@ccp
Scientists with expemence
J,in i

8. Goua should involvebne lettEN
Some personnel with Engireenng knouled¡e
Scale uP
Engineering principles.
O Space Requiyenents:
-Administration + infomation Prncessing
Cdocunpntation)0ffice space
Physical testingaea
cGTesting of Medicines)
StandadGquipmentfoor space
(for actual prnduction of Nedieine)
Sterage area
Cstoring of medeines ter prduction)
Reviewthe fonmula ci
-1horDugh eiew of eachaspect
of
formulation innpartant
Saath
Prpos
Conhibeion Final prduet
MF on
Snmallscale Labeupme
Lunderstood
eech ìngedient

9. Date
- Then effect of scale up
Lusing
-Checking equi pment that may
Reiewing forhnula
5) Raw Matermals !
Storrn ng of
neccess0ry
Tauw mgtenals
Stresses of diff.types
aun deqrees More meadily
be predlicted /
recoghised.
for
futher uses
deending wpon
fomulati on
Onepurpose/ respons1bility
of pilot plant
approval + validation of
active ingredients +
excipients
17aw matemals.
Raw mateials use d
J in
Saath
Small scale poduction
NOT neccessarily
representotire for the
Lasge scale pr duction.
Iotompatibilites Sub)ected the product

10. 6
Date
Gquipments:
Sml Batches
Small eguipnerts
Bio atches
avad wontta ge. Equipment
Bla èoulpmerts
avoid buoste
offiie
Most economical A
Size of the
equipment
in should be Retevant
expeomnental fnals
Sipe of Eqwpments
acc.to
Batch sine
Simplest
4in
Eficient
ppropiate
to
- I f equipment istoo sSmall
Capable of
producing
product
witbin
Proposed
Specifications.
J to be
prncess devreloped
J, will not
Scale p
used.
If equipment is too biq
Prvduction
Saathi
size
batches.
wastage ofexpensire active
ingredients.
-@cco

11. Date
Production Rate:1oebolsz vh
Tupe/size
pduction
2quiprment
Tmmediate + future market
Dheohotrends / Require ments
Mixing
Speed
are considered
while deternsining
S Prcess Evaluaton:
Procuction ate : Speed ?formulating
Time Product
Decice Qaier. basiue
Undenstand/evaluate
Time
Saath
Outcomes of key processes
addof
:MbsgranulesoNiiou
Mixing utRate of Gvanulating Sol-"of
aqents
Heating l
Cooling rates
ophimizing +venfyng
qualitynniatak
dugs
oubrt
in-process +finished procuets.
solvents
Note douwn all prpcesses&quantities of
matenals
-@ccD

12. Date
(9 Master Manufactuingq Prvcedwes': (MMP)
(10
Three important aspects
OWeight
Sheet
cleay idenify
chemicals
mequired in batch
avoid confusion
1n names Nos
Gfor
ingredients used
on batch recods
O
PrcessingManufactwing
dire ctions
accunrate
Understand
able
by
operators
Sinckudes
specifcotjons
e9. MixIng fime,
Speed temp.
Product Stability and Uniforrmity :
Primaryo bj ective of Pilot plant
J deteminahon
physical t chemical Stability
1of
the prvducts.
-Gach pilot batch epres ent
Saath
prvcedues
Stucied for stability.
Specifications
for stoònq
Finished pruduet
Samples
mention
final formulation t MEg procedure
Batch recond
elirectons
-Occo

13. Date
Stability study : camed out in finishad
packages as well.
SMP Consjcerotion:
Eguiprment Qualification:
Crucial process
ensure that eguipment
CORsistetly meetsb
predefinec specifications
Use
aACCOTcling to intended
Maintain documents during
TPilot scale productt on
whentrer Drug Tnspectot
0.sk for pllot plant aale uup
you need to Ghow Sorne
performs documents Cdocurm ents
according to CMPCuidelinec)
New egupnerts
J Pass
Pall Stages of
Cualification
nairtains procluct quality
doneloysuppit
0s appropinatu
id filot plant should follouw
GMP Guidelines
egual fication
after change pi
Saathl)
Change coniro l(5)stage
Perfoomance pualifiuation
Tnstallational pualification
stage
Operational Qualification(8) Staae
stage
Design Qualificafion ) Sfoge
-Qcco

14. Date
2. Process validation :
olutod
1fcdpable of
nehnducible
Porocess validation
Collection 2
+
evaluaion
Goaf
Prrocess Design
of data.
Prncess Qualification,aao
Cortinued process validation
3.Requlory schedule preventire mairtenance:
potecs,Eased veot
Drrelaprert &cal
Trtol botehes hesghiered rormirig
Ongoing routine
Preventire maimtenance
plan for organi3ing
Company resources
i to ensue maintenance
tasks
Saatho
performed accovcing to
spec ific fime ov usage tiggers
PimaryM:to keep accecttin opfirmal
working condition

15. bate
4. Requlasly Prvcoss eview)and revalidatlion d
4
Revalicdation,
b focusecse
on ensuorg that
hub Procluet quality
emains unaffected
changec in the
Process
Machinary
Methods
Scale-ups
Process enviornmert
5. Relevant wntfeniStandad prating Procedues
SOP
Gaathy
o8nsSet of wntfen instructionsishoushA
L that docunents
DUine orequlasty os Tepetitive actvty
followed by3
Ovqanigafions
Povides individuals
erbiinformation
J to peo form
Job prbpesly v
Consistancy in guality &
integvity of
prnduct ßT end esult.

16. 4
Date
The use of competert
Qualified truined employees
ore keys to manufacfure
the good quality product
Every step phármaceutical MEg
Analysis
J should be done
bs the competent person
Allregulatory aqendies
i their quidelines forto) bh
qudlifiedpenons
7 Acleguate Provisions for training of persoD nel :
- in OTde to ensure that
all employèes recieves
appropriate training5
which enhance their
Experience
Skills
Abilityec
behav ior
to execute
notkeotheir appropnate
duties
responsibifies
techrically qualified pernohre|

17. 6
Date
Awell-defined technology toansfes system:
Technology Transfen
Sy stematic prvceduTe
that is followed in
Ordemto pass documerted
knouwledg &expenence
qained dwing derelopment
and/o commencialization.
Goal : to transfer produet ( Prcess
knouwledlqe between
i cleeloprment +Manufactwing
SaathD
Labioutu toachiere prnduetrealigation.
Validated clearming Proceclures .
cleaning Validation
I assuree
Process memores chencals + mjobal esidues
ThegiS b of active +jnactive(detergent
ingredients.
J,of
product rmanufactured inthe
piece of eguiprrent.
cleanig aids utiliged.
-@ccD

18. Date
lo. An oreerly arsangemert of eguipment So as to ease
matemal ftow and pre vet cross Contami naion:
Materal ftow
interlinking of all
operati ons noh
atetac [ elevantD
B So urcing
Processing
taxgolan reatment/t
within specifiedameas.
Of materñals qoods
Prevent cross Gortamination
Saathy
n deCrss cortamination avoided
by taking ppoopriate
measUTes
technica/orgcania ati onalhabn2
irmplereAt shrict hygienee
olossit Saitotion procedwres9
obust cleaning programs
HuuEsblevioUse dedicated eguipent
2 facilifies.
-hpiie distibution S e