Clean Room Activities

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  • Topic: Cleanroom, Contamination control, ISO 14698
  • Pages : 10 (2570 words )
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  • Published : October 20, 2012
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Mikhail Kitain

CLEANROOMS IN PHARMACEUTICAL PRODUCTION
Bachelor’s thesis Building Services March 2010

DESCRIPTION
Date of the bachelor's thesis

14.03.2010

Author(s)

Degree programme and option

Mikhail Kitain
Name of the bachelor's thesis

Building Services Engineering

Cleanrooms In Pharmaceutical Production

Abstract

The subject of this thesis was studying how cleanrooms are designed, controlled and maintained. During process of studying cleanroom technology I firstly met different requirements and regulations for a certain industry. Each of them has their definite property and purpose. So every cleanroom for every industrial field should be designed according to their own manufacturing characteristics. In this thesis was shown detailed rules of designing cleanrooms for pharmaceutical production. Here was also described a proper behavior of personnel, their clothing that protect both a product and a human.

Subject headings, (keywords)

pharmaceutical, cleanroom, clothing, designing, cleaning, particles, contamination control Pages Language URN

36
Remarks, notes on appendices

English

Tutor

Employer of the bachelor's thesis

Marianna Luoma, Heikki Salomaa

CONTENTS 1. INTRODUCTION......................................................................................................1 2. CONTAMINATION SOURCES AND REGULATING STANDARDS .................2 2.1 Contamination sources .........................................................................................2 2.2 International Standards.........................................................................................3 2.3 General conditions................................................................................................5 2.4 Cleanroom zoning ................................................................................................6 2.5 Cleanroom classification ......................................................................................6 2.5 Prevention of contamination ................................................................................9 2.5.1 Isolating technology ....................................................................................13 2.5.2 Blowing-filling-hermetic sealing technology..............................................13 2.6 Personnel ............................................................................................................14 3. DESIGNING & IMPLEMENTING PHARMACEUTICAL CLEANROOMS ......15 3.1 Purpose and strategy of design...........................................................................16 3.2 Layout of cleanroom suite..................................................................................17 3.3 Changing room ...................................................................................................19 3.4 Material distribution technology ........................................................................20 3.4.1 Air supply....................................................................................................21 3.4.2 Air distribution ............................................................................................23 3.4.3 Filtration and supply air ..............................................................................26 3.4.4 Materials of construction.............................................................................28 3.4.5 Operating procedures ..................................................................................30 4. CONTROL AND MAINTENANCE OF CLEANROOM AREAS ........................30 4.1 Cleanroom Clothing ...........................................................................................32 4.2 Cleaning instructions..........................................................................................33 4.3 General cleanroom regulations...........................................................................33 4.4 Measurement...
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