NOL CH OG E Y T • • R E E C S N E E A I 168 R C C S H • S H N I G O I H S L I I V G • H S T 45th R3Nordic Symposium Cleanroom technology, contamination control and cleaning VTT TECHNOLOGY 168 Keywords: Contamination control, clean room, cleanroom, air, water, hygiene, cleaning, disinfection, cleanroom clothing, body-box test, airborne contamination, airborne particles, particle measuring techniques, hospital infections, microbiological methods, hygienic design, pharmaceutical industry, hospital, hospital pharmacy 45th R3Nordic Symposium Cleanroom Technology, Contamination Control and Cleaning Naantali Spa, Naantali, Finland, May 19–20, 2014 Edited by Gun Wirtanen & Satu Salo Program committee: Satu Salo, Kari Leonsaari, Leila Kakko, Sirkka Malmioja, Antti Mikkola, Raimo Pärssinen & Gun Wirtanen Organised by R3Nordic – Nordiska föreningen för Renhetsteknik och Rena Rum ISBN 978-951-38-8142-9 (USB flash drive) ISBN 978-951-38-8253-2 (URL: http://www.vtt.fi/publications/index.jsp) VTT Technology 168 ISSN-L 2242-1211 ISSN 2242-122X (Online) JULKAISIJA – UTGIVARE – PUBLISHER VTT PL 1000 (Tekniikantie 4 A, Espoo) 02044 VTT Puh. 020 722 111, faksi 020 722 7001 VTT PB 1000 (Teknikvägen 4 A, Esbo) FI-02044 VTT Tfn +358 20 722 111, telefax +358 20 722 7001 VTT Technical Research Centre of Finland P.O. Box 1000 (Tekniikantie 4 A, Espoo) FI-02044 VTT, Finland Tel. +358 20 722 111, fax + 358 20 722 7001 Cover photos: Naantali Tourist Information. Cover logo: Antti Huovinen. Preface R3Nordic, the Nordic Society of Cleanroom Technology, is a non-profit, independent association for the promotion of new technologies in cleanroom technology and contami- nation control in the Nordic countries. The aim of the annual R3Nordic Symposium is to provide knowledge within the pharmaceutical, food and electronic industries as well as hospitals and hospital pharmacies. This year the sessions at the 45th R3Nordic Symposi- um are Pharma, Hospital and General Sessions and the presentations deal with construc- tion and design, planning, auditing, contamination control, cleanroom technology and management, sterilization techniques, cleaning of clean rooms, protective clothing, moni- toring techniques, rapid test methods and regulations in clean and controlled rooms. The venue of the annual symposium 2014 is Naantali Spa in Naantali. The Programme Committee 2014 (PK14) is lead by Satu Salo and other persons in- volved are Kari Leonsaari, Sirkka Malmioja, Antti Mikkola, Leila Kakko, Raimo Pärssinen and Gun Wirtanen. The editors of the proceedings would like to express their gratitude to the speakers for preparing the abstracts published in the journal Renhetsteknik 1/14 as well as the extended abstracts or full papers published in these electronic proceedings. We wish that this event will be fruitful in giving new ideas to all participants and exhibitors. 3 Contents Preface 3 PLENARY SESSIONS 7 Risk Analysis: Myths, Confusions and Real Sense 9 Alexander Fedotov Safety in Health Care Business 19 Tom Ståhlberg Energy Saving in Cleanrooms 23 Alexander Fedotov PHARMA SESSION 31 Cleanroom Consumable Selection: Making the Right Choice 33 Rob Tomlinson Biotrak a new instrument for Real time Viable Particle Detection 39 Thomas Lööf & Patrik Bengtsson New Air Purification Concept for Significant Improvement in Control of Indoor Air Particle Concentration 41 Hannu Salmela, Kimmo Heinonen, Tapio Kalliohaka, Matti Lehtimäki, Matti Niemeläinen & Seppo Enbom Safety Cabinets in Cleanroom Environment 49 Jyri-Pekka Multanen How to Get New Micro Method Started! 53 Fredrik Alexandersson The i.v.Room of the Future 59 Bastiaan Moulart Barrier Technology 61 James Drinkwater Vaporized Hydrogen Peroxide Room Decontamination in Cleanrooms 63 Nicolas Toulze PHSS Biocontamination Technical Monograph 20 65 James Drinkwater 4 HOSPITAL SESSION 67 Performance of Single-use Surgical Clothing Systems in On-going Surgery 69 Bengt Ljungqvist & Berit Reinmüller Evaluation of Clothing Systems – Results from Dispersal Chamber Tests 79 Bengt Ljungqvist & Berit Reinmüller Rapid and Sensitive Detection of Antibodies against Norovirus using VLP-functionalized Biolayer Interferometry Biosensor 85 Sanna Auer, Tiia Koho, Vesna Blazevic, Hanni Uusi-Kerttula, Timo Vesikari & Vesa P. Hytönen Compounding of Pediatric Oral Formulations 91 Minna Helin-Tanninen Testing of Hand Hygiene of the Personnel in an Internal Medicine Ward using Automatic Non-Touch Dosing Devices in Comparison with Hand-Operated Dispensers 95 Gun Wirtanen, Päivi Godden, Satu Salo & Hannu Salmela Effect of Door Opening in Hospital Isolation Room 99 Petri Kalliomäki, Pekka Saarinen & Hannu Koskela Modern Concepts of Environmental Monitoring: QbD for Aseptic Processes 105 Gilberto Dalmaso Cleanroom Classification Studies and Airborne Bioburden Particles in Operating Theatres 107 Hannu Salmela, Seppo Enblom, Satu Salo, Tuomas Attila, Jukka Vasara & Gun Wirtanen Cleanroom Design of Hospital Pharmacies 117 Jukka Vasara New Classification of Operating Theatres 121 Dennis Andersen 5 GENERAL SESSION 123 Modular Manufacturing System Compared to the Conventional Clean Room Construction 125 Esa Högel Cleanroom Standardization: Where Does It Go? 127 Alexander Fedotov Hygiene Survey in Food Plants 139 Satu Salo Particle Deposition Monitoring, the Missing Link in Contamination Control 143 Koos Agricola Selection and Use of Cleaning Agents and Disinfectants 155 Jennie von Fielitz Basics Regarding Clean Room Ventilation and Biosafety Contamination Control 159 Conny Lindqvist & Kari S. Aune Basics Regarding Cleanroom Clothing – Why, What and How 163 Heidi Tuomi How to Bring Zones of Ozone Closer to Everyone's Everyday Life 167 Juhana Haukioja Indoor Air Quality Research in Laboratory Environment 173 Vuokko Lappalainen, Elina Sohlberg, Helena Järnström, Jarmo Laamanen, Hannu Viitanen & Pertti Pasanen Modelling Bioaerosol Dispersion in Manned Spacecraft 177 Ilpo Kulmala, Eero Kokkonen, Tapio Kalliohaka & Matti Lehtimäki 6 PLENARY SESSIONS PLENARY SESSIONS 7 Risk Analysis: Myths, Confusions and Real Sense Risk Analysis: Myths, Confusions and Real Sense Alexander Fedotov Invar Project, Moscow, Russia Abstract Methods of risk analysis are been actively propagated for pharmaceutical manufacturing for more than ten years and plants are pressed to apply them. What is the sense of these methods, their area of application and real value? Risk means the possibility of danger- ous or unwanted event to occur. There may be financial, insurance, traffic risks as well as concerned with faults of equipment, safety of nuclear power stations, etc. People estimate or analyse risk for ages and every day, protecting themselves against unwanted events. The purpose of risk analysis is to understand Reasons – Consequences chain to find proper protection. Any new method should be supported with demonstration of its cor- rectness and practicality with explaining what new it gives. Healthcare has specific fea- ture that can shortly be stated as: No risk for medicinal products is permitted! What is risk analysis? Methods of risk analysis are been actively propagated for pharmaceutical manufacturing for more than ten years and plants are pressed to apply them. What is the sense of these methods, their area of application and real value? Risk means the possibility of dangerous or unwanted event to occur. There may be fi- nancial, insurance, traffic risks as well as concerned with faults of equipment, safety of nuclear power stations, etc. People estimate or analyze risk for ages and every day, protecting themselves against unwanted events. The purpose of risk analysis is to understand the Reasons – Consequences chain to find proper protection. Any new method should be supported with demonstration of its correctness and practicality with explaining what new it gives. Healthcare has specific feature that can shortly be stated as: No risk for medical products is permitted! 9 Risk Analysis: Myths, Confusions and Real Sense EU GMP and ICH Q9 promises In 2010 ICH Q9 “Quality Risk Management” document was included in Part III of EU GMP Guideline. In the introduction to the EU GMP it says: “The aim of Part III is to clarify regu- latory expectations and it should be viewed as a source of information on best current practices”. The ICH Q9 Guide states: “Quality risk management supports a scientific and practical approach to decision-making”. These are responsible and promising statements. But are they true or just cover misleading myths? Methods of risk managements are separated into general and others. The general methods include Flow charts, Check sheets, Cause and Effect diagram (Fishbone or Ishikawa diagram) and others. The Fishbone diagram has the same sense as any other Reason – Consequence chain but it is presented as a fish bone (Figure 1). Why a fish bone structure? Probably because sea food products are the most part of Japanese menu. Science is not included in this at all. Fish bone picture is only one ex- ample from numerous variants e.g. tables, schemes and graphs that we all use for ages. This is a simplest logic analysis that can be carried by anyone. Other methods include e.g. Failure Mode Effect Analysis (FMEA), Failure Modes, Ef- fects and Criticality Analysis (FMECA) and Hazard Analysis and Critical Control Points (HACCP). Here below follows a closer presentation of FMEA. Other methods have the similar sense. Figure 1. Example of fishbone diagram. 10 Risk Analysis: Myths, Confusions and Real Sense FMEA method: comparisons of incomparable It is stated that FMEA gives “Quantity