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ESPOO 2006 VTT SYMPOSIUM 240 R3­Nordic, the Nordic Society of Cleanroom Technology, is a non­profit, VTT SYMPOSIUM 240 37 independent society with a well established network for research, education, product development and production in cleanroom technology and contamination control in the Nordic countries. The venue of the 37th annual symposium is Scandic Hotel Rosendahl in Tampere. The aim of this symposium is to provide knowledge of contamination control and clean room technology dealing with topics in the pharmaceutical, food, and electronics industries as well as hospitals. The topics at the th37 R3­Nordic Contamination Control Symposium are clean room technology and management, clean room clothing, contamination control and cleaning, strategies for process analytical technology, environmental th R 3 monitoring and risk management in production, process design and R 3 technology. We wish that this event will be fruitful in giving background ­NORDIC. Contamination Control Symposium information and new ideas to all participants in the symposium and exhibition as well as readers of the proceedings. 37th R3­NORDIC Contamination Control Symposium Tätä julkaisua myy Denna publikation säljs av This publication is available from VTT VTT VTT PL 1000 PB 1000 P.O. Box 1000 02044 VTT 02044 VTT FI•02044 VTT, Finland Puh. 020 722 4404 Tel. 020 722 4404 Phone internat. +358 20 722 4404 Faksi 020 722 4374 Fax 020 722 4374 Fax +358 20 722 4374 ISBN 951– 38– 6303– 4 (soft back ed.) ISBN 951– 38– 6304– 2 (URL: http://www.vtt.fi/inf/pdf/) ISSN 0357– 9387 (soft back ed.) ISSN 1455– 0873 (URL: http://www.vtt.fi/inf/pdf/) VTT SYMPOSIUM 240 Keywords: contamination control, cleanroom, clean room, air handling, process hygiene, cleaning, disinfection, decontamination, biocontamination, isolators, cleanroom clothing, process design, hygienic integration, monitoring, Process analytical technology, PAT, electrostatic discharge, ESD, R3 technology, food industry, pharmaceutical industry, electronics, hospital, operating theatre, risk assessment, eLearning TH 3 37 R -NORDIC CONTAMINATION CONTROL SYMPOSIUM Tampere, Finland, May 29–31, 2006 Edited by Gun Wirtanen & Satu Salo VTT Programme Committee: Maarit Kaihlanen, Tytti Graeffe, Anne Lintukorpi, Antti Mikkola, Salme Nurmi, Jaakko Paasi, Satu Salo & Gun Wirtanen Organized by R3-Nordic The Nordic Society of Cleanroom Technology ISBN 951–38–6303–4 (soft back ed.) ISSN 0357–9387 (soft back ed.) ISBN 951–38–6304–2 (URL: http://www.vtt.fi/publications/index.jsp) ISSN 1455–0873 (URL: http://www.vtt.fi/publications/index.jsp) Copyright © VTT Technical Research Centre of Finland 2006 JULKAISIJA – UTGIVARE – PUBLISHER VTT, Vuorimiehentie 3, PL 1000, 02044 VTT puh. vaihde 020 722 111, faksi 020 722 4374 VTT, Bergsmansvägen 3, PB 1000, 02044 VTT tel. växel 020 722 111, fax 020 722 4374 VTT Technical Research Centre of Finland Vuorimiehentie 3, P.O.Box 1000, FI-02044 VTT, Finland phone internat. +358 20 722 111, fax + 358 20 722 4374 VTT, Tietotie 2, PL 1000, 02044 VTT puh. vaihde 020 722 111, faksi 020 722 7071 VTT, Datavägen 2, PB 1000, 02044 VTT tel. växel 020 722 111, fax 020 722 7071 VTT Technical Research Centre of Finland, Tietotie 2, P.O. Box 1000, FI-02044 VTT, Finland phone internat. +358 20 722 111, fax +358 20 722 7071 Cover picture Jarkko Laesvirta 2 Otamedia Oy, Espoo 2006 PREFACE R3-Nordic, the Nordic Society of Cleanroom Technology, is a non-profit, independent association for the promotion of new technologies in cleanroom technology and contamination control in the Nordic countries. The venue of the annual symposium is Scandic Hotel Rosendahl in Tampere. The aim of the annual R3-Nordic Symposium is to provide knowledge within the pharmaceutical, food and electronic industries as well as hospitals. The topics at the 37th R3-Nordic Contamination Control Symposium are: – contamination control, – clean room technology and management, – regulations and standards in clean rooms, – clean room clothing, – isolation applications, – R3 technology and air handling, – environmental monitoring in production, – process design, – process hygiene, – cleaning and disinfection, – risk assessment, – process analytical technology and – air quality and hygiene in operating theatres. The persons involved in the Programme Committee are Maarit Kaihlanen, Tytti Graeffe, Anne Lintukorpi, Antti Mikkola, Salme Nurmi, Jaakko Paasi, Satu Salo and Gun Wirtanen. Raimo Pärssinen and Jouko Riihonen have been assisting the programme committee. The editors of the proceedings would like to express their gratitude to the speakers for preparing the abstracts published in the January and April (35 [2006] 1:22–33 & 35 [2006] 2:12–14) issues of the journal Renhetsteknik as well as the full papers or extended abstracts published in these proceedings. We wish that this event will be fruitful in giving new ideas to all participants and exhibitors. Programme Committee Välkommen ! – Tervetuloa ! – Welcome ! 3 4 CONTENTS AND SPEAKERS Preface 3 PLENARY SESSION 11 Chapter 1: The Technology City of Tampere and BioneXt – Keynote 1, 13 Tero Välimaa Chapter 2: Food Safety Research Programming in Europe 15 SAFEFOODERA – Keynote 2, Oddur Gunnarsson Chapter 3: Quality Risk Assessment in the Pharmaceutical Industry – 17 Keynote 3, Camilla Bollner & Petter Gallon PHARMA SESSION 19 Chapter 4: GMP Inspections of the Sterile Manufacturers – Inspection 21 Observations, Hanna-Maija Koponen-Piironen Chapter 5: Raising the Testing Standards through the Cleanroom 23 Testing Certification Board, Neil Stephenson Chapter 6: Implementation and Control of the EU GMP in Russian 31 Pharmaceutical Industry, Alexander Fedotov Chapter 7: Parametric Release of Sterile Products – Requirements, 43 Implementation and Benefits, Didier Meyer Chapter 8: Planning Considerations of a HVAC System for Sterile 49 Pharmaceutical Production, Jouko Miesvirta Chapter 9: Qualification Process of a New Pharmaceutical Facility, 51 Gordon Farquharson 5 Chapter 10: Microbiological Qualification of Pharmaceutical Cleanroom 59 Facilities, Gerry Prout Chapter 11: Cleaning and Disinfection Agents of Pharmaceutical Cleanrooms – Modes of Action, Usage and Requirements, 61 Karen Rossinton Chapter 12: DryFogging as a New Technology to Disinfect Cleanrooms, 65 Dominique Leclercq Chapter 13: Cleaning and Disinfecting of Cleanrooms – A Validation 67 Perspective, Elaine Pears Chapter 14: Optimum Wiper Characteristics for the Cleaning and 69 Disinfection of Pharmaceutical Cleanrooms, Howard Siegerman Chapter 15: Newest Developments in Rapid Microbiology – Practical 83 Aspects and Validation, Frank Panofen Chapter 16: FDA’s Process Analytical Technology (PAT) Strategy and 87 its Implications on Sterile Product Manufacture, Kurt Brorson Chapter 17: Isolator and Containment Solutions, Hans Gath 89 Chapter 18: Practical Issues and Process Solutions to Post SIP and Pre- 93 use Integrity Testing of Sterilizing Grade Filters, Alain Rachon Chapter 19: How Does Rapid Microbiology Meet the Needs of Process 97 Analytical Technology? Peter Ball FOOD SESSION 109 Chapter 20: Risk Management According to Food Safety Standards, 111 Laura Raaska 6 Chapter 21: eLearning as a Tool in Educating Hygiene Aspects in 113 Biotechnology and Food Engineering, Tuija Pirttijärvi Chapter 22: Zoning in Food Processing – Requirements and Examples, 125 Janne Lundén Chapter 23: Cleanroom Technology Application in a Bakery, 129 Petri Uotila Chapter 24: Risk Assessment of and Protective Measures against 133 Microbial Threats, Laura Raaska Chapter 25: Hygienic Integration in Plant Sanitation, Bo B.B. Jensen 137 Chapter 26: Increasing the Level of Hygiene in EU – The EHEDG 143 Training Facilitator and Tool-Box, Bo B. B. Jensen Chapter 27: Computational Fluid Dynamics as a Tool in Planning 151 Cleaning Procedures for the Food Industry, Satu Salo Chapter 28: New Surface Materials for Food Process Applications, 153 Anne-Christine Ritschkoff Chapter 29: Food Hygiene Networking in Europe, Gun Wirtanen 163 Chapter 30: Food Hygiene in Estonia, Raivo Vokk 165 Chapter 31: Lubricants – Are They A Source For Microbial 169 Contamination in the Food Industry? Kaarina Aarnisalo Chapter 32: Food Safety in the European Technology Platform Food 177 for Life, Harmen Hofstra 7 Chapter 33: Comparison of Different Test Methods for Testing Fabrics 179 for Use in High Hygiene Area, Lorenz Michael & Tuija Luoma CLEANROOM CLOTHING SESSION 187 Chapter 34: Cleanroom Clothing Systems – Test Results, 189 Berit Reinmüller Chapter 35: Cleanroom Clothing Systems – Some Calculations, 197 Bengt Ljungqvist Chapter 36: Human as a Particle Source in Cleanroom, Tuija Luoma 207 Chapter 37: Managing Static Electricity and Particles in Cleanrooms 219 and Clean Areas, Johanna Anttila Chapter 38: Care Programme for Cleanroom Clothing, 229 Anna-Leena Hyytiäinen HOSPITAL SESSION 233 Chapter 39: Transmission Modes of Hospital Acquired Infections, 235 Jukka Lumio Chapter 40: Solutions in Preventing Hospital Infection Epidemics – 237 View of Clinician, Janne Laine Chapter 41: Clinical Needs and Current Standards for Operating Room 243 Air, Teija-Kaisa Liljeblad Chapter 42: Airborne Particle Emissions of Textiles during Preparation 255 for Surgical Operation, Salme Nurmi Chapter 43: Particle Emission and Electrostatic Charge in Cardiac 265 Surgery, Anne Lintukorpi 8 Chapter 44: Overview of Standardisation Projects of Hospital Textiles 267 in CEN, Auli Pylsy Chapter 45: Bacterial Adherence, Penetration and Survival on Different 273 Surfaces and Materials, Kirsi Laitinen Chapter 46:
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