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INTRODUCTION TOPHARMACEUTICAL CLEAN

ROOM

Presented by: Kiran Kumar

M. Pharm irst !em."#.A.T.$

R%&& n%. '()

Padm . Dr. D. *. Pati& Institute O+Pharma,euti,a& !,ien,es And

Resear,h Pim-ri Pune/01

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ONTENTS

Purpose of clean protocol

Introduction

Classification

Types of contamination Contamination sources

Contamination control

Clean room enviroment monitoring

Conclusion

Refrences

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PURPO!EO CLEAN PROTOCOL

Promote Successful Cleanroom Operations

Ensure Safety in the Clean Environment

Provide Operational Conditions that Meet Process

& User eeds

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2HAT I! A CLEAN ROOM3

! clean environment designed to reduce thecontamination of processes and materials" This is

accomplished #y removing or reducing contamination

sources"

$%ederal Standard '(E) defines a clean room as aroom in *hich the concentration of air#orne particles

is controlled to specified limits"

$+ritish Standard) defines a clean room as a room

*ith control of particulate contamination, constructedand used in such a *ay as to minimi-e the

introduction, generation and retention of particles

inside the room and in *hich the temperature,

humidity, airflo* patterns, air motion and pressure are

controlled"

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CLA!!IICATION O CLEANROOM

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I!O !TANDARD!

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CLA!!IICATION O AIR 5 MICRO/OR6ANI!M A! PER 2HO 6UIDELINE!


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CLA!!IICATION A! PER EU C6MP

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!CHEDULE M

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11

Sr. no U.S.

Federal 209

E

MHRA/TGA ISO

Standards

1 Class 100 A & !

2 Class 10"000 C #

$ Class

1"00"000

%

C%m-aris%n %+ 7ari%us 8radesdes,ribed in 7ari%us 8uide&ines


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T*PE! O CONTAMINATION

Particulate7ust, s8in, hair, ma8eup9

ChemicalOil, grease, metal ions, perfume9

+iological+acteria, fungi, rodents:::

RadiationUltraviolet light9

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CONTAMINATION !OURCE!

People ;1


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PER!ONAL H*6IENE

Sho*er each day #efore entry

Control 7ermatitis & 7andruff

7o not smo8e #efore or after entry

o che*ing gum or to#acco o Cosmetics , e*ellery or *rist *atches should #e

*orn

6eave all personal items in changing room

.*allets,8eys,com# etc"0!void coughing and snee-ing if unavoida#le leave the

clean room

7o not move vigorously.+ris8 movements shed large

particles from #ody movement0

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6O2NIN6

Proper go*ning order/air cover/ood

Shoe coversCoverallAloves%ace mas8

Safety Alasses Cotton garments shed

fi#ers" /ence, not used15

Decron (polyster)


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HVAC SYSTEM

AIR HANDLING SYSTEM:

Re?uirements D

Temp should #e >''" Relative humidity G


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HEPA 5 UEPA

High efficiency particulate air (HEPA:

They are #oB type depth filters used for air filtration"

These filters are made up of glass fi#ers"

Efficiency of /EP! filters are (("(12 against '"4 5m

particles" Testing for /EP! filtersH

/ot 7OP test .efficiency testing0, Cold 7OP test

.integrity testing0 , !ir flo* resistance test

!ltra l"# penetrati"n air (!LPA: Most U6P! filters are replacea#le eBtended media dry

filters that have a minimum particle collection efficiency

of (("(((1 2 efficient for particles greater than or

e?ual to '">micron in si-e"

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ENTR* 5 EIT

Enter and eBit ?uic8ly" Only one person may enter at a time"

Each user must use their o*n access card"

Pass from the go*ning area to the clean area slo*ly

to reduce migration of particles #et*een areas"

Restricted no" of people in aseptic area"

7rug sensitivity tests should #e carried out for

employees *or8ing in critical area"

Medical chec8ups of people *or8s in critical area

should #e more fre?uent than other employees"

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!%me s-e,i;, re


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CLEAN ROOM EN4IRONMENT MONITORIN6

Test %re?uency

I" Particle Monitoring in airJ monthly

II" /EP! %ilter Integrity TestingKearly

III" !ir Changes Rate CalculationJ Monthly

I=" !ir Pressure 7ifferentials7aily

=" Temperature and /umidity7aily

=I" Micro#iological monitoring #y7aily, and at

decreased

settle plates and L or s*a#s in fre?uency in other

aseptic areas areas21


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CONCLU!ION

The main purpose of #uilding a cleanroom suite is

to provide a vital element in the assurance of

product ?ualityaccording to *hole concept of good

pharmaceutical manufacturing operation"

The resultant facility should prevent contamination

of the product, and should #e seen to #e doing so

#y the incorporation of effective monitoring devices"

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REERENCE!

Current Aood Manufacturing %or pharmaceuticalsManohar !" Potdar Page noH1'14"

Pharmaceutical uality !ssurance, Manohar !"

Potdar , irali Pra8ashan Page noH>4">>4">'

Comparison of uality Re?uirements for Sterile

Product Manufacture as Per Indian AMP and US%7!

Kogita P, =ishal Aupta, atasha S, !sh*ini

ageen 6, R Sudeendra +hat Research ournal of

Pharmaceutical, +iological and Chemical Sciencesan '> volume 4.>0H


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24THANK *OU

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