Download - Introductory Validation and the Cleanroom
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Introductory Validation and the
Cleanroom
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What we see
FDA regulations require Documentation
These regulations do not provide Guidelines
on how speciically to product the
documentation
It is let up to the speciic companies to
design their own documentation system!
This includes the process o validation
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Validation and "ualiication
Validationcontains premises rom which a
conclusion can #e logically derived
"ualiicationis a condition or circumstance
that must #e met or complied with
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Can anyone give e$amples o
validation%
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Validation organi&ation
As a department validation should cover
'rocess
(quipment
Facilities Computer
Cleaning
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)teps in developing Validation
are
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)etup a validation dep!
Write a validation plan
Write policies* sopsand admin procedures
(sta#lish changecontrol #oard
(sta#lish documentreviewers andapprovers
(sta#lish documentdistri#ution
Identiy equipment tovalidate and ma+e alist
Assign protocols to all
unctions Validate most critical
equipment irst
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Assign equipment
num#ers
Assign protocol num#ers
Assign change control
num#ers
Change protocols
'erorm commissioning atthe original equipment
manuacturer
Write and e$ecute
qualiication protocols
Deiciencies
Deviations
Addendums
Archiving
,equaliiction Internal audits
FDA audits
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"ualiication Testing
Written qualiication protocols are prepared
that speciy the tests to #e conducted and
the data to #e collected!
-#servations are documented!
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What needs to #e tested%
Almost everything needs to #e tested
.ow does one +now%
/-#serve the equipment in operation
/0a1or components are typical!
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What level o testing is required
A standard or equipment testing has not
#een made in the pharmaceutical industry
-#1ect is to gain conidence that the
equipment is operating under a state o
control! )ome include
/0inimum2ma$imum operating ranges
/Worst case
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.ow much testing is (nough%
The num#er o repetitions o a process step
during qualiication should #e #ased on
statistical signiicance!
Conventional wisdom
/-nce is chance
/Twice is nice
/Three times is validation
)orry #ut we need to use )tatistics!
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The Cleanroom
A room that is clean
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I)- standard 3454463
A room in which the concentration o
air#orne particles is controlled* and which is
constructed and used in a manner tominimi&e the introduction* generation* and
retention o particles inside the room and in
which other relevant parameters* e!g!temperature* humidity* and pressure* are
controlled as necessary!
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Who uses clean rooms
(lectronics
)emiconductor
-ptics
7iotechnology
'harmacy
0edical Devices
Food and Drin+
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8 ma1or types o cleanrooms
Tur#ulently ventilated room/9diuses:
/8; changes per hr min
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'articles
.uman .air 93;;um:
Visi#le particle 9>;um:
(! coli 9A #acteria: 3um
'articles we typically measure ;!>um
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)ome ?um#ers o I)- classes
limits 9particles2m@ o air: Class 3 3;
Class 8 3;;
Class @ 3;;;
Class 4 3;*;;;
Class > 3;;*;;;
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Also limits on micro#e contam
Grade Air sample )ettle plates
A 3 3
7 3; >
C 3;; >;
D 8;; >;
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)ome Cleanroom Disciplines
A wal+ing person generates 3*;;;*;;;particles permin 9;!>um:
)ome conditions will preclude wor+ in acleanroom/)+in conditions 9dermatitis:
/,espiratory conditions/0icroloura
/Allergies
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-ther Conditions
Good personal hygiene
Cosmetics
Bewelery
)mo+ers particles and out gassing
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Control o air transer
(nter and e$it through change areas
Do not leave doors open
-pen and close doors quic+ly
Doors usually open inward in production
acilities
,espect the airloc+s
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7ehavior
)itting 3;;+* moving 3mil* wal+ing >mil+
'ositioning so do not drip on product
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(ntry and ($it o 'ersonnel
.ygiene
Cloths* ma+eup and 1ewlery
Wash #eore and ater
Chec+ yoursel and chec+ others
Are you protecting product or yoursel!