introductory validation and the cleanroom

7/25/2019 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!

introductory validation and the cleanroom

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