THINK OUTSIDE THE BOX: FILM TYPE CONTAMINATIONS, THEIR IMPACT AND WAYS OF DETECTING AND AVOIDING
||Marcel Kleßen||Cleanliness of surfaces of components is an important property in many industries. Contaminations during production processes cannot always be avoided despite the use of modern technologies. However, sufficient cleanliness is essential for processes which come afterwards, for example mechanical joining or coating. Next to particulate contaminations film type contaminations become more and more the focus and are to discuss in the following.
Film-type ContaminationCleaning SystemsCleanliness Measurement DeviceCleanlinessProcess Chain
A COMPARISON BETWEEN MEASURED VALUES OF AIRBORNE VIABLE PARTICLES AND THEORETICAL CALCULATED VALUES WITH THE DILUTION PRINCIPLE IN OPERATING ROOMS EQUIPPED WITH LOW VELOCITIES UNIDIRECTIONAL AIRFLOW SYSTEMS
||Bengt Ljungqvist , Berit Reinmüller, Pedro Gandra||Many of the recently installed unidirectional air flow systems for operating rooms have low velocities (≤0.3m/s). Measurements of airborne aerobic colony-forming units were performed in such operating rooms during on-going surgery. Results show that, during on-going surgery, calculations with the dilution principle is valid in the surgical zone.
Ultraclean Operating RoomsUnidirectional Air Flow (udf)Dilution PrincipleMicrobiological Air CleanlinessColony-forming Unit (cfu)
CONTAMINATION STUDY OF SPACE SENSITIVE SURFACES BY PACKAGING MATERIALS
||Delphine Faye , David Cheung||The particulate and molecular cleanliness of sensitive components is a priority in the space industry, and in many others as well. In order to keep a surface state in clean conditions during storage and shipment, stringent requirements are necessary for the packaging: protect the sensitive device from the external environment, and not cross contaminate the component as well. This study focuses on the optimisation of conditioning methods, in order to propose some recommendations for the choice of packaging materials, according to the device sensitivity towards particulate and/or molecular contaminations. A methodology has been set up, including the exposure modes of substrate samples in various flexible and rigid packaging materials, and the development of the associated measurement protocols. A benchmark of the packaging materials tested is available, in terms of particulate and molecular contaminations: it will help the user to select the most appropriate materials for his dedicated applications.
CleanlinessPackaging MaterialsParticlesMolecular ContaminationConditioningExposure
d50-VALUE: A CONVENIENT WAY TO COMPARE THE PHYSICAL COLLECTION EFFICIENCY OF MICROBIOLOGICAL AIR SAMPLERS AND A PRACTICAL APPROACH FOR THE VALIDATION
||Hans Zingre, Beat Glauser||The air in pharmaceutical production areas has to be monitored for microorganisms. International Standard ISO 14698-1/2' describes how to check for microbiological contamination and explains the principles and methods regarding these measurements.
In this paper the important parameters for the physical collection efficiency are introduced. With an easy mathematical formula they can be summarized into a single d50 value which can be used to compare different models of impaction based air samplers.
As most of the companies will not have access to a test chamber as required in the ISO 14698 a simplified approach to test the performance of any air sampler is described.
D50-valueImpaction MethodValidationMicrobiological Air SamplersIsolatorsClean Rooms
PRACTICAL EXPERIENCES IN PARTICLE DEPOSITION MONITORING
||Koos Agricola||The rate of particle deposition of particles determines the risk of product contamination and demonstrates the operational quality of a cleanroom. The particle deposition rate depends on the deposition velocity and concentration of particles at a certain location and time. The concentration of particles larger than 10 pm cannot be measured easily; therefore the particle deposition rate of falling particles should be measured. Since the end of 2013 specific particle deposition meters, that measure the particle size distribution and rate of particle deposition, are available. Particle deposition measurements were complicated and expensive in the past. Therefore these were only executed in specific cleanroom applications or to investigate contamination problems. Nowadays it is easy to apply particle deposition measurement in various cleanrooms where operator activities are important. The new instruments make also real time particle deposition measurements possible. Practical experiences with these instruments in various applications are described in this article.
CleanroomCleanroom MonitoringParticle DepositionSurface CleanlinessOperational Quality
CONTROLLED ENVIRONMENT FOR VOC-SENSITIVE MANUFACTURING PROCESSES: FROM MATERIAL CLASSIFICATION TO CONTROLLED IAQ IN CLEANROOMS
||Markus KELLER & Udo GOMMEL||Materials implemented in controlled environments need to be assessed for VOC emissions and classified in order to permit direct comparisons to be made and to select material without any emission of process critical contaminations, such as phthalates, siloxanes and organophosphates. The newly described method uses a holistic approach. First, emission testing is done using a micro chamber and analysis via thermodesorption coupled with gas chromatography and mass spectrometry. The resulting material classification enables a material selection already in the planning phase of a cleanroom. Then a simulation model for cleanroom settings enables the user to estimate the expected VOC-level of the environment to be constructed depending on the selected materials. Two different cleanroom settings (Space technology and research cleanrooms) were planned and built for low VOC concentration using classified materials depending on their outdoor environment. The final VOC concentration is verified to the prior defined specifications.
CleanroomMaterial Emission. VocMicro ChamberAcc: Indoor Air Quality Iaq
A STUDY ON THE ODORANTS EMITTED BY HUMAN BEHAVIORS AS SOURCES OF INDOOR AIR POLLUTION
||Yasuhiro Hashimoto', Atsuo Nozaki, Hoshio Goto, Yuki Yamashita, Yasunori Narita' Tohoku Bunka Gakuen University, Miyagi, Japan, Hashimoto@ait.ac.ip Graduate School of Tohoku Bunka Gakuen University, Miyagi, Japan, email@example.com Life science research laboratory Co. Ltd., Fukushima, Japan, narita@Isrl.biz||In late years, people are becoming increasingly concerned about body odors such as breath odor.
Furthermore, body odor of residents is drawing attention as it has an influence on comfort of indoor space. Main body odor is breath odor, scalp odor, axillary odor, foot odor and excrement odor. By the way, it may include "cigarette smoking" and "alcohol drinking". The present study aims at determining the emission rates of VOCs in the expired air. A human subject was tested for the expiration of target substances following the intake of 500mL of beer. The results showed that ethanol emission rates decreased from 381511[ug/h] to 341603 [ug/h] over 180 minutes after alcohol intakes. Acetone emission rates increased from 349 [ug/h] to 1240 (ugh) over 180 minutes after alcohol intake. Emission rates of acetone and 2-propanol of the cause of breath odor tend to increase with drink liqueur.
Air PollutionHuman Odorants
DYNAMIC MEASUREMENT OF PARTICLE PRODUCTION OF AN OPERATOR WITH DIFFERENT GARMENT ARRANGEMENT IN CLEANROOMS
||Jianhua Huang, Ming Xu, Xiang Shao||There are many possible sources of contamination in the cleanroom environment, including: operators, equipment, structures, and any surface that can generate particles through friction, heat, exhaust, outgassing, and static electricity charge. The operators working in the cleanroom are the major sources that release the most of particles. As cleanroom operators are working, they elucidate millions of particles with every movement. Particles migrate up through the cleanroom garment toward the head and fall down to the legs during cleanroom activities. Specialized textile fabrics have been used in cleanroom garments for many years. The need for this type of fabric has increased mainly due to the increasing need in protecting critical operations in cleanrooms as well as creating comfort for operators and other personnel. Previous studies were limited and only used small number of particles. Previous methods were also poor and unclear. This study covers the general static method of wind-driven and Helmke Drum in regards to the filtration efficiency of cleanroom fabrics and garments. Furthermore, it introduces dynamic method of body box for testing fabrics as well as cleanroom garments. It is more practical and sensitive as being compared to traditional methods and based on a more concise technical approach for the life-time of these products to be examined and controlled, especially when the garments have to be sterilized prior to the use.
Wind-drivenHelmke DrumDispersal ChamberGarment TestingParticle Size DistributionPenetration
RESEARCH OF TEST METHOD FOR CLEANROOM GARMENT AIRBORNE PARTICLE FILTRATION EFFICIENCY
||Jianhua Huang, Ming Xu, Xiang Shao||Filtration efficiency is the key index to evaluate the cleanliness property of cleanroom garment. In this article, the author tries to compare the different test methods from China, United States, Europe, and Japan in terms of it. The author will also try to make a deep research for test principle of textiles filtration efficiency which regulated in Chinese National Standard GB/T 24249-2009 Antistatic Fabric For Cleanroom Garment System.
Airborne Particle Filtration
SPACECRAFT CONTAMINATION CONTROL POLICY THE EUROPEAN APPROACH
||Riccardo Rampini, Delphine Faye||Lessons learned have shown that the risk of damage and performance loss of sensitive surfaces on spacecrafts due to molecular and/or particulate contamination had to be considered as a real concern. Nowadays, more and more stringent constraints of quality and reliability require contamination control at different steps during the development of a satellite. In Europe, to satisfy these specifications a set of normative references has been established in the frame of the European Cooperation on Space Standardization (ECSS) in order to harmonize the rules between the various industrial partners and space agencies at national and international levels. These documents are updated periodically to take into account new needs in the spacecraft contamination control policy. In this paper, we will introduce the joint effort between the different organizations, not only at Europain level, in terms of space standardization. Then, we will focus on the European Cooperation on Space Standardization ECSS-Q-70 branch, related to space product assurance and especially on the last issues of the cleanliness standards for space critical components. Finally, in order to illustrate how these cleanliness standards have to be applied, we will describe the global approach of a spacecraft contamination control programme and remind of some useful guidelines for each development, phase of a spacecrall from design to launch.
Spacecraft Contamination Control
VENTILATION EFFICIENCY IMPROVEMENT IN PHARMACEUTICAL CLEANROOMS FOR ENERGY DEMAND REDUCTION
||P.C.A. Molenaar||Cleanrooms are large energy consuming facilities due to their high air change rates. This research elaborates on three ventilation energy efficient measures for pharmaceutical cleanrooms: Finetuning, Demand Controlled Filtration (DCF) and an optimal airflow pattern. To study the possibilities for finetuning and DCF, two case studies and multiple simulations were performed. Results show that DCF could lead to substantial energy savings of up to 93.6% in the specific case study facilities. Besides this, DCF based on occupancy could be implemented with a negligible effect on the environmental cleanliness. To study how an ideal airflow pattern in the cleanroom can be reached, resulting in a high contaminant removal efficiency, experiments were performed in a demonstration cleanroom. The best results for ACR in the range of 16h-1 - 38h-1, were obtained when air was supplied without a diffuser above the product area and when the work position was located closely to the air extract grilles.
Energy SavingsCleanroom FinetuningOverdesigningDemand Controlled FiltrationContaminant Removal Efficiency
NEW REAL TIME TECHNIQUE FOR VISUALIZATION AND COUNTING OF FINE AIRBORNE PARTICLES
||Gordon Farquharson||This paper explores the potential of a new laser-sheet airborne particle visualization and counting technology that analyses the cleanliness of real space. Historically, visualization of airflow and dissemination of particles has been limited to "smoke pattern" testing and observation. Also, particle counting has been limited to sampling at specific locations, transporting the sample to an instrument for counting. A new technique, has been developed (1) to investigate particle generation, dissemination, and concentration (counting) using a laser light sheet and image visualization and analysis. The technology was
developed initially to observe equipment generated particles in order to prevent damage to products and processes. The technology is now well developed, and can be used to visualize actual contamination events,
visualize airflow using a seeded particle source, and most interestingly count particles in real-time as they pass through a critical process plane. This paper explores the science of this novel technique, discusses
examples of its application, and explores the potential benefits for design and monitoring of critically controlled clean process environments.
CleanroomAirflow VisualizationSmoke PatternsVectorsContamination ControlParticle CountingSimulationIndustrial VentilationOccupational HealthCfdValidationQualificationDetective Work
DEVELOPMENT OF SURFACE PARTICLE COUNTER AND ITS PERFORMANCE
||Yoshihiko Yajima, Katsunori Homma, Goro Nakamura, Tetsuo Momose, Shuji Fujii||Particulate contaminants (Size: ca. 10 – 100 m) can cause quality defects in the products of many
industries, such as optical machine assembly and the coating process in car production. There are some
methods to evaluate such particulate contaminants that have fallen down from the atmosphere. One of them
is exposing a sampling plate and evaluating the surface particle cleanliness (SPC) on it. However, there is no
measurement instrument that can be widely applied for various industries, therefore the development of such
an instrument has been desired with low cost, easy operation, and short measurement time. We developed a
new measurement instrument, Surface Particle Counter which can measure surface particle concentration on
a plate. It can be also applicable to ISO/FDIS 14644-9.
According to our evaluation, the counting efficiency is equivalent to the discrete-particle-counting, light
scattering instrument. The concentration results measured by our new measurement instrument are also
reasonable compared to a conventional microscope method in case the particle concentrations are varied.
The measurement time is about 60 sec which is significantly shorter than the conventional methods. The
operation is also very simple and easy.
Our new measuring instrument can replace the conventional methods for the measurement of such particle
contaminants in electronics and machinery industries.
Particulate ContaminationSurface Particle CleanlinessMeasurement TechnologyMeasuring InstrumentSurface Particle CounterMetrology
ANALYSIS OF RISK FORMING AIRFLOWS FOR CROSS-INFECTION IN AN ISOLATION ROOM
||Ilse Schoenmakers , Wim Zeiler||Hospitals, need a lot of energy for their Heating Ventilation and Air Conditioning therefore it is important to look at possibilities to reduce the energy use. However, this of course has to be done without endangering the primary functions related to the patient’s and staff safety. The HVAC energy consumption in isolation rooms is mainly caused by large volumes of air supply and are continuous supplying to the rooms, regardless the occupancy of the room. Resulting in over conditioned rooms, which leads to excessive energy consumption. It is concluded that the actual energy supply must be aligned to the energy demand. Solutions frequently used for this problem is HVAC setback using time schedules based on occupancy profiles. HVAC set back in isolation rooms require an unconventional approach, others than time schedules. A possible solution is manual HVAC setback for heating, cooling and ventilation. However, an important note to manual HVAC setback in ventilation rate is the increased risk of disease transmission through human failure. The risk of HVAC setback for heating and cooling is expected to be low. This research focusses on the amount of HVAC set back. The manner of setback is not investigated. The amount of HVAC setback
depends on the type of occupancy in the room. For non-airborne infectious patients, a reduction of ACH to the guidance for single bedrooms (100 m3/h per person = 2 ACH) is possible, provided that the comfort requirements are reached with these requirements. The ACH for isolation type of patients is doubtful. For not occupied rooms, the ACH need to be sufficient to maintain the space conditions for the time a patient need to be hospitalized. But also to keep the room at a low positive pressure in order to keep contaminants outside the room. According to the room model results it is concluded that the ACH for isolation patients can be reduced to < 6 ACH, however a more detailed model is needed which provides more certainty. The room model as defined in this research revealed that
transmission of infectious particles through undefined cracks and gaps is most crucial (has most influences on transmission). Additionally, it is concluded that at low ACH the contamination concentrations are higher, however, more evenly distributed.
Isolation RoomCross-infectionValue Of Air Changes Hour
DISTRIBUTION OF MICROBIAL CONTAMINANTS IN OPERATING THEATRES AND HEALTHCARE ENVIRONMENTS
||Hansjörg Rotheudt, Eugen Lichtner, Gerrid Brockmann, Valeria Hofer, Tunc Askan, Anne Hartmann, Benjamin Zielke, Martin Kriegel||Contamination control in healthcare facilities against airborne pathogens is a challenging task to prevent nosocomial infections and the distribution of highly infectious diseases from one patient to another. In different areas and contamination protected areas like operating rooms, isolation wards and intensive care units, similar tasks for the ventilation scheme and knowledge about the distribution of pathogens in the airflow is needed. Most investigations and the standard test cases for acceptance tests consider particulate contaminants of small particle size that is completely airborne without gravitational effects. Most microbial contaminants like respiratory droplets and skin flakes have particle diameters of 1 to 20 μm. These particles are also affected by their gravitational settling and do not perfectly follow the airflow motion. The gravitational forces lead to significant increase of their deposition behaviour. Investigations that consider the microbial particulates as completely airborne have limited validity to predict the surface contamination inside the patient’s wound field or on medical instruments and equipment. However, accurate prediction of the behaviour of the contaminants is fundamental for risk assessment and performance tests of ventilation systems. Numerical simulation models to calculate the particle motion and interaction to the airflow field provide more detailed information about the paths for contamination and infectious diseases. To develop and evaluate contamination control strategies for healthcare environments, the method to simulate the movement of pathogen contaminants has major importance. A CFD simulation is a resource-efficient approach. It provides valuable insights into the three-dimensional and transient behaviour of contaminants. Accumulation zones of contaminants in the air and deposition spots on surfaces can be located and the optimal positions of monitoring devices can be found. The state-of-the-art approaches in particle modelling and simulation as well as their advantages and limitations are presented. Within several research projects in the field of cleanrooms, health care facilities and contamination control, the exposure, distribution, deposition and resuspension of airborne particles ranging from 0.1 to 20 µm are investigated at the Hermann-Rietschel-Institut (HRI). In this range of diameter, the transition zone between airborne particles and particles which are highly affected by gravitation is particularly challenging.
Microbial ContaminationParticle DistributionDeposition Of Airborne BacteriaParticle ModellingOperating RoomsAirborneHealthcareContaminationDesignIsothermal
CONTAMINATION CONTROL IN OPERATING THEATRES
||Remko J.R. Noor MSc||Patient safety is a main topic during surgery. One of the main issues inside operating theatres (OR’s) is the prevention of airborne particles with bacteria that contaminate the wound area and the instruments. The risks and requirements differ for different types of surgery. To minimize the contaminations and improve the patient safety, controlling the quality of the air inside an OR is essential. Several type of air handling systems are available, suitable for different types of surgery. The most used systems are:
• Turbulent Mixed Airflow systems
• Laminar Airflow systems
• Temperature Controlled Airflow systems
The number of colony forming unit is the environment around the patient has an effect on the surgical site infections. When the environment in the OR is clean, the risk of infection will decrease. What is the best ventilation system in an OR in relation to the requirements of surgery, airborne particles and the use of antibiotic prophylaxis? This paper will provide a comparison of different ventilation systems that will support hospital staff to make decisions about the quality of their Operating Theatres. The three systems will be compared both “at rest” and “in operation”.
Performance Of Ventilation Systems In Or’sOperating RoomsAirborneVentilation SystemsContaminationAirflowAt RestIn OperationSurgical Site InfectionsPatient SafetyPoisoning
NEW GUIDELINE ON TESTING OPERATING THEATRES IN THE NETHERLANDS
||Frans W. Saurwalt||Operating theatres in the Netherlands are commonly based upon the use of Uni Directional Airflow in the middle of the room, in order to protect the patient, operating staff and the instrument tables. From the early days on these UDF systems have been qualified on design parameters and were tested only by air cleanliness classification by particles, at rest. As this is method not totally satisfactory, within the VCCN, a project group evaluated various methods of testing and came to a new approach. The test principle based on segregation test is proposed for adoption in the ISO-14644-3. The method has been tested and improved and is proven to be helpful in assessing operating rooms and instrument lay-up rooms. The ultimate test is the cleanliness during actual surgery. A methodology to monitor is currently under development and practical evaluation is on its way.
Operating TheatresInstrument Lay-up RoomSegregation TestMonitoringOperating RoomsHospitalUnidirectional AirflowVccnRoomTestingTest Method
DETECTION OF MICROORGANISMS IN COMPRESSED GASES
||Hans Zingre, R. Meier||The International Standard Norm ISO 14698-1/21 demands the monitoring of bio contamination in
compressed gas systems which are used in pharmaceutical production processes. The norm describes the
detection of bio contamination by sampling and enumerating viable units with appropriate methods.
Two main questions were investigated:
Do microorganisms survive in compressed gas systems?
If they survive, what appropriate method has to be applied in order to sample and enumerate them?
13 different medical relevant species of microorganisms where grown and put under pressure from 10 to 170
bars. Their growth and behaviour under pressure and the effect of decompression has been analysed.
Based on the MAS-100 CG Ex (Microbiological Air Sampler for Compressed Gas) this presentation shows
that microorganisms can be measured and what trapdoors are to be avoided when dealing with colony
forming units under pressure
Microorganisms Under PressureCompressed GasesIso 14698Mas-100 Cg ExNitrogenCarbon-dioxideArgonOxygenPharmaceuticalFood Industry
RISK MANAGEMENT FOR A PROFESSIONAL CLEANROOM CLEANING
||Frank Duvernell||Managing a cleanroom either with microtechnology or microbiology demands needs a professional cleaning
management. How to develop such and how to identify and avoid risks during the insatallation of the
cleaning management is the content of this lecture.
The following lecture is in german language and available also in English.
Cleanroom ManagementRisk ManagementCleanroom CleaningMicrobiologySurfacesContaminationEmployeeClothingRisksPersonel Training
SWEDISH SURVEY AND A SUMMARY OF INVESTIGATIONS IN OPERATING ROOMS
||Bengt Ljungqvist, Johan Nordenadler, Berit Reinmüller||A survey is presented with data from 27 operating rooms in four county councils, where information from
111 ongoing surgical operations was given regarding air volume flows, measured concentration of airborne
viable particles and used clothing systems. With results from the survey the mathematical expression
describing the dilution principle was established to predict the concentration of airborne viable particles
present in the operating room during ongoing surgery. As well supply air system as surgical clothing system
used play here an important role
Operating RoomsOperating TheatresHospital VentilationBacteria-carrying ParticlesSwedish SurveyAirborneFiltrationClothingSupply AirTurbulent Mixing Air
CLOTHING SYSTEMS USED IN OPERATING ROOMS - A QUESTION OF PATIENT SAFETY
||Bengt Ljungqvist, Berit Reinmüller||The number of airborne bacteria carrying particles in the operating room is considered an indicator of the risk of infections to the operating patient. Today when the supply air in the operating room is HEPAfiltered, the main source of airbome microorganisms is people (patient and personnel). The filtration efficacy of the fabric in operating clothing system plays an important role. The design of the clothing system also affects the number of particles generated from people to the air of the operating room. In ultraclean operating rooms, the selection of clothing systems for the operating personnel can no longer be thought of in terms of comfort but in terms of patient safety.
Results from clothing systems evaluated in a body-box test chamber and in operating rooms will be presented. The influence of different clothing systems in the operating room with different air volume flows will be discussed.
HospitalOperating RoomPersonnelClothingGarmentBody-boxMicroorganismAirbornePatient SafetyFiltration
ENHANCED BIOSAFETY BSL3+ FACILITY DESIGN & PERFORMANCE QUALIFICATON
||Conor Murray||This paper deals with biosafety change drivers, biosafety risk assessments, high containment biosafety design, secondary containment barrier design, commissioning & qualification as well as performance & verification testing of enhanced BSL3+ biosafety laboratories which are over and above the minimum requirements of the WHO BSL3 international biosafety standards.
While this paper is not intended to be a complete treatment of biosafety design particular attention is paid to biosafety facility design and construction issues including conflicts between personnel protection (biosafety) vs product protection (cleanroom), the importance of Risk Assessment in choosing the appropriate biosafety level and control measures, the critical linkage between design and a schedule of performance verification tests, common flaws and failures arising during commisioning & qualification and the importance of air leakage measurement in the verification of the Secondary Containment Barrier.
BiosafetyBsl3+Risk AssessmentPersonnel ProductionProduct ProductionLaboratoryBscSecondary Containment BarrierQualificationDesign Principles
VIABLE AND NON VIABLE ENVIROMENTAL MONITORING STRATEGY FOR REAL TIME RELEASE IN PHARMA INDUSTRY
||Gilberto Dalmaso||The scope of this presentation is to show the usefulness and potentialities of this new rapid microbiological technology/method implemented in the pharmaceutical field in viable and non viable environmental monitoring strategy for real time release in pharma industry and in particular applied on the manufacturing process investigation, using the real-time evaluation, to engage the suitable corrective actions and resolute remedy at the right time. This application has been fundamental to solve an important problem in a short time against the microbiological traditional method resolution, regarding the manufacturing process, which allowed discover and identify considerable benefits. Every day the samples have been analysed in real-time and these results provided a useful mapping of all critical points contaminated to allow the specific actions implementation, reconsider the numbers and type of environmental monitoring and re-samples and which type of sanitization carry out to remove the problem. It is important to underline that the new technology has been able to provide economical benefits in terms of "safe-costs" and the "stock-out" risk reduction of the products as well. Moreover the case study reported has also been useful to implement the process understanding evaluation related to the test carried out in the laboratory until now. This means that in a lot of other fields and other type of analyses this rapid microbiology and the correlated technology could be implemented to improve the quality of the process and the risk of management.
MonitoringMicrobiological TestsRapid Microbiological MethodsAnalytical MethodsReal-timeQbdRmmTimely MeasurementsPatRapid Results
A NEWLY DEVELOPED CLEAN HOOD FOR ISOLATION OF PATIENTS THOUGHT TO HAVE AIRBORNE INFECTIOUS DISEASES
||Hidekazu Nishimura, Fumie Kitamura, Soichiro Sakata, Yasushi Kamimura||A new medical clean hood was developed for isolation of patients thought to have airborne diseases, such as pandemic influenza and the like. The hood is intended to be used in a ward where many patients are
treated simultaneously in the same closed airspace such as a dialysis facility, in order to prevent cross infection of other patients by the potentially infected patient. The hood consists of foldaway framework, a
fan High Efficiency Particulate Air Filter (HEPA) unit, and transparent polypropylene curtains. The patient is treated inside the hood, and airborne microbes from coughing or sneezing by the patient are contained
inside the hood, and the air containing microbes finally passes through the fan HEPA unit to be released outside the hood as clean air.
Clean HoodIsolationIsolation RoomInfectiousDiseaseAirborne
AIRBORNE BIOLOGICAL CONTAMINATION: MONITORING AND CONTROL
||Vance Bergeron||Airborne Biological Contamination includes a vast range of particulate and molecular species that present specific challenges for monitoring and control. In particular, the notion of viability places restrictions on
sample collection and analysis. Furthermore, controlling airborne levels of microorganisms requires technologies capable of inactivating and/or chemically eradicating them, as simple capture onto filter media
can lead to proliferation and subsequent release. The advent of new assay capabilities using rapid microbiological methods in combination with effective air sampling techniques holds promise for future
online monitoring systems, while combinations of different technological bricks can be used to tailor air-treatment systems to remove, inactivate and chemically transform particulate, biological, and molecular
CLEANING AND DISINFECTION PROGRAM PART OF THE LIFECYCLE APPROACH: A RISK BASED RATHER ARBITRARILY IMPOSED APPROACH
||Walid El Azab||Is the rotation of more than one disinfectant along with a sporicidal agent mandatory for cGMP compliance? The article will present and analyze the regulatory requirements related to contamination control programs then dive into the requirements for cleaning and disinfection programs, including disinfectant rotation along with a sporicidal agent. the article discusses the process of selection and number of disinfecting agents to be used, the frequency of application, and rotation of (one or more) disinfectants along with a sporicidal agent. Finally, the article reaffirms the importance of periodically reviewing microbial data and auditing practices to confirm the effectiveness of the cleaning and disinfection program including the disinfectant rotation and frequency choice.
CleaningDisinfectionLifecycle ApproachCgmpRisk Based ApproachMicrobiology
INFLUENCE OF EXTERNAL BIOLOGICAL CONTAMINATION ON PARTICULATE BEHAVIOR
||Michel Thibaudonab, Julien Clertantc||Seasonal Biocontamination is frequently observed both inside cleanrooms and in/on the product. When carrying out sampling of the cleanroom environment, it is necessary to also
sample the outside environment. High levels of pollen and fungal spores outdoors in summer and autumn can correlate to detection of such contaminants inside the clean airlock and
even inside the cleanroom, if appropriate non-cultural methods of detection are used for their detection, whereas classic culture methods are ineffective. Monitoring on a daily or weekly
basis with appropriate method, it is easy to correlate outside levels of pollen and fungal spores with impact inside the installation, and identify the principal mode of transmission as
the personnel, the devices, etc. This enables optimization of gowning and cleanroom cleaning practices to maintain effective control in response to the challenge.
REAL TIME MICROBIAL DETECTION BY LASER INDUCED SPECTROSCOPY AND ITS APPLICATION IN CONTAMINATION CONTROL
||J.P.Jiang||A technology based on optical spectroscopy has been developed for real time detection of environmental microbes and continuous monitoring of the environment. This technology utilizes
Mie scattering for airborne particle size measurement in the range of bacterial matters, and the detection of intrinsic UV-induced fluorescence from certain bio-chemicals inside bacterial cells
as a biological marker. The optical instrumentation techniques used to achieve the requisite detection sensitivity and the procedure for its validation test will be presented.
One necessary aspect for applying this technology in contamination control is how to correlate its results to compendial microbiological methods and how to set the new limits based on this new
method. A statistical process control (SPC) approach to the environmental monitoring of bioburden in parenteral aseptic facility is proposed to achieve this goal. This presentation will
cover (1) the procedure of setting new limits using a new instrument, (2) the control chart methodology of utilizing environmental monitoring data to assess the state of control in a
parenteral production environment and to troubleshoot the root cause when a variation from normal trend is detected.
Some application examples will be used to illustrate how to utilize the real time microbial detection features of this technology in the environmental monitoring and contamination control.
Topics of discussion include sensor placement, data analysis, graphic data display, and trend analysis.
Real Time Microbial DetectionEnvironmental MonitoringTrend Analysis
ZERO “0” CONTAMINATION CLEANROOMS
||Dr, Horst Weissieker, Dipl.- Ing. Hannes Rink||From various points of views zero contamination cleanrooms will be necessary in the next 5 years latest. Not only for the coming semiconductor production environments, but also for the nanotechnology and
biotechnology as well as bio-safety new requirements have to be defined. This affects not only cleanroom and clean air but also all other aspects of contamination control from ultrapure media to ultrapure surfaces to the measurements and monitoring of the contaminants and last but not least the control of the contaminations.
PERFORMANCE REQUIRED FOR AIR SHOWER AND EFFECTIVENESS OF PERFORMANCE
||Akihiro Maruyama, Mamoru Okamoto, Toru Kawamata, Han Hyuck Hee||Before entering into cleanroom, people will use Air Shower to clean up the body covered by clean garments. Air Shower is expected to protect cleanroom environment from particle and keep the room pressures. Bu it is saying once in a while, that Air Shower is contaminate cleanroom . We evaluated the expected performances and effectiveness of Air Shower, that was installed between test cleanroom and the owning room as simulation.
NITROGEN PURGING OF FRONT-OPENING UNIFIED POD (FOUP) FOR 450MM WAFER MANUFACTURING
||Chun-Yong Khoo, Chen-Wei Ku, Shih-Cheng Hu||This study aimed to investigate the nitrogen purging of front-opening unified pod (FOUP) with nitrogen for 450 mm wafer which involves stringent cleanliness requirement of water vapor content (RH ≤ 3%)
within the container, besides airborne molecular contamination (AMC). A parametric study was conducted with factors considered to affect the extraction of water vapor content includes the
configuration of plenum injector, purging outlet and FOUP. Computational fluid dynamic (CFD) was employed and Langmuir adsorption models were used to construct physical models of contaminant
concentrations in the FOUP. The results showed that the configuration with nitrogen entering from the rear inlets and the front vent holes and porous ceramics plenum demonstrate favourable water vapor
depletion rate within the gaps formed between the wafers in a fully loaded FOUP. Elaboration of nonlinear fitting was applied to theoretical model and experimental data yields the desorption coefficient
Kd as 0.4 kg/s.
Nitrogen PurgeWaferFoupWafer Manufacturing Airborne Molecular Contamination
A SHORT INTRODUCTION TO CLEANLINESS TECHNOLOGY: MEETING THE FUTURE CHALLENGES
||Udo Gommel, Guido Kreck||For semiconductor components, the demand to improve performance and velocity as well as energy consumption is met through miniaturization. The continuing trend to miniaturize semiconductor structures can be observed since several decades and requires, among other things, sophisticated cleanliness technology. Cleanliness technology in this context is to be understood as the chain of all activities taken to control and reduce all contamination harmful to the product. Because of the very challenging particulate and outgassing contamination levels, semiconductor industry still claims technological and economic leadership in terms of cleanliness technology. But no longer only semiconductor industry is relying on cleanliness technology as the following case studies graphically demonstrate:
In life science industries, mainly microbiological contamination is controlled to prevent users and patients from severe health issues caused by poor hygiene or cleanliness of the highly effective pharmaceuticals or very innovative medical devices.
Space exploration combines nowadays the challenging cleanliness requirements of semiconductor and pharmaceutical industry to be in compliance with the planetary protection program, the guiding principle to preserve planetary and terrestrial conditions for future generations.
And even automotive industry discovered the benefit of cleanliness technology almost ten years ago: Metallic micro sized particles (>50μm) were identified as critical contamination because they can cause malfunctions in fluidic and electronic vehicle systems such as antiblocking systems.
By having a closer look on these three case studies, the increasing importance and on-going diversification of cleanliness technology can be shown and also the challenging future requirements of cleanliness technology over the next few years can be derived.
Cleanliness TechnologyCleanroom TechnologyContamination ControlMedical DevicesPharmaceuticalsSemiconductorsSpace ExplorationFlight HardwareAutomotive
THE CASCADE APPROACH: SEGREGATION BY AIRFLOW DESIGN N STEAD OF BY ROOM PRESSURE
||Ir. Frans W. Saurwalt||Governmental inspection bodies as well as internal quality departments have enforced adherence to monitoring of room pressure as a critical aspect. And because of that, the pharmaceutical and medical
devices and healthcare industry puts a strong emphasis on controlling room pressure itself. As clean room construction becomes better and better, resulting in very limited leakage, active room pressure control
becomes more and more complex. With a narrow focus on room pressure control and monitoring, the broader contamination control perspective and a useful different approach is overlooked. Room pressure
control is only one aspect of the concept of segregation of zones of different classes. The broader view has many benefits. This approach is based on designing on airflow in stead of mere room pressure.
While citing ISO 14644-3, and -4 as well as the EU-GMP-vol 4 Annex 1 it can be demonstrated that there is a basis for designing an overflow / pressure cascade. This cascade approach when compared to various other
systems shows to have many benefits; increased protection of the controlled environment, less complexity, better stability, reduced energy-consumption and reduced costs.
SegregationRoom PressureAirflow/pressure CascadeStabilityWind AttackReduced Energy ConsumptionReduced Costs Of Installation
CLEAN BUILD PROTOCOLS- CONCEPTS AND CONSIDERATIONS
||Andrew D. Watson||A clean build protocol (CBP) is an essential component of a cleanroom
construction project. This paper provides guidance on how to develop and implement a
CBP in order to deliver a cleanroom that can successfully achieve its designated ISO
Cleanroom ConstructionClean Build Protocols (cbp)
MODERN PTFE MEMBRANE BASED HEPA/ULPA FILTERS FOR IMPROVED ENERGY SAVINGS AND RISK REDUCTION
||Marc Schmidt, Ph.D., Sean O'Reilly, Mike Osborne, Ph.D., Jonathan Rajala, Ph.D.||Strict demands are put on HEPA/ULPA filters that are installed as terminal filters in cleanrooms, isolators, workbenches etc. or as last filter stage in air handling units being upstream. They must continuously guarantee safe operation while predefined air quality requirements and energy efficiency are optimized. For that the filter media itself is of major importance.
Standard filter media for HEPA/ULPA filters so far had been fiberglass paper. Being free of boron filter media based on expanded Polytetrafluoroethylene (ePTFE) is used in microelectronics since decades. Based on latest developments in membrane technology, such as PAO compatibility, ePTFE and expanded Fluoro-Resin Membrane (eFRM) based HEPA filters are on their way to replace fiberglass-based filters.
This presentation describes how ePTFE and eFRM membrane media contributes to process safety and low-cost operation.
It sets out structure of modern ePTFE and eFRM membrane media, how these air filters provide significant reduction in energy consumption and risk.
It presents results of several studies on superior stability, durability and performance of ePTFE and eFRM media over traditional fiberglass media. Based on several tests regarding mechanical and chemical resistance as well as soot loading it is demonstrated that ePTFE and eFRM media offer a significant improvement in reducing media failure risk for a retained filter integrity.
Eptfe And Efrm Hepa FiltersRisk ReductionEnergy SavingsMechanical And Chemical Resistance