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  • 1.
    Ljungqvist, B.
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    Reinmüller, B.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    Monitoring of Airborne Viable Particles2007In: Environmental Monitoring for Cleanrooms and Controlled Environments / [ed] Anne Marie Dixon, New York: Informa Healthcare, 2007Chapter in book (Other academic)
  • 2.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    Reinmüller, Bent
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    Chapter 35: Cleanroom clothing systems - Some calculations2006In: 37th R3-Nordic Contamination Control Symposium / [ed] Wirtanen, G; Salo, S, ESPOO: TECHNICAL RESEARCH CENTRE FINLAND , 2006, Vol. 240, p. 197-206Conference paper (Refereed)
    Abstract [en]

    With the result from the book "Cleanroom Clothing Systems, People as a contamination source" (1), some calculations are given, describing predicted contamination levels in cleanrooms with turbulent mixing air and cleanrooms with vertical unidirectional air flow when people are dressed in modern cleanroom clothing systems which have been used and washed several times.

  • 3.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    A comparison of data acquired from a test chamber during simultaneous measurements by standard DPC, STA-sampler and IMD-A2010In: 41st R³-Nordic Symposium: Dipoli, Espoo, Finland, May 25-26, 2010, Valtion Teknillinen Tutkimuskeskus , 2010, no 266, p. 52-59Conference paper (Refereed)
    Abstract [en]

    A comparison of data acquired from simultaneous measurements by IMD-A, standard OPC and STA-sampler during evaluations in a test chamber will be presented. Pros and cons of different instruments will be discussed.

  • 4.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Air Movements and Airborne Contaminants in Pharmaceutical Cleanrooms2005Conference paper (Other academic)
  • 5.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    Airborne biocontamination in cleanrooms - Some aspects on air samplers2006In: 37th R3-Nordic Contamination Control Symposium / [ed] Wirtanen, G; Salo, S, ESPOO: TECHNICAL RESEARCH CENTRE FINLAND , 2006, Vol. 240, p. 421-428Conference paper (Refereed)
    Abstract [en]

    In cleanrooms the main source of biocontamination is people. The concentration of airborne biocontamination depends upon the number of people present in a cleanroom, their level of activity, and the clothing systems used. There are several methods of measuring the airborne biocontamination and many published reports show that the results - as number of colony forming units per cubic meter (CFU/m3) - depend on the equipment used. The difference in results between microbiological air samplers often depend upon physical parameters of the samplers. These parameters, together with d50 that is the aerodynamic particle diameter where 50% of the particles are collected and 50% are not collected are discussed. In order to evaluate the collection efficiency of impaction air samplers, a simplified mathematical model will be presented and examples given.

  • 6.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    Airborne biocontamination in cleanrooms and controlled environments2007In: Microbial contamination & contamination routes in food industry, Valtion Teknillinen Tutkimuskeskus , 2007, no 248, p. 56-63Conference paper (Refereed)
    Abstract [en]

    To interpret the results from viable air sampling, the user should understand the dynamics of sampling and collection of particles on the collection medium. Results of 0 CFU per cubic meter in manned cleanrooms could indicate that the sampling process, sampling location or the collection media, incubation temperature and time have not been optimized. It is important to be aware of the limitations of each sampling method. Results from one sampling method must not be compared with results obtained by another method without careful investigation. To improve the evaluation of controlled environments based on achieved results, the air sampler used has to be specified. An air sampler should be selected based upon a thorough evaluation of the characteristics of the sampler, the sampling conditions and sampling requirements.

  • 7.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Airborne contamination risks for aseptic manufactured sterile drug products during loading and unloading of freeze-dryers2007Conference paper (Other academic)
  • 8.
    Ljungqvist, Bengt
    et al.
    KTH, Superseded Departments, Civil and Architectural Engineering.
    Reinmüller, Berit
    KTH, Superseded Departments, Civil and Architectural Engineering.
    Airborne particle contamination in food manufacturing2004Conference paper (Refereed)
  • 9.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    An introduction to monitoring of airborne viable particles in clean rooms2006Report (Other academic)
  • 10.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Aseptic Production, Gowning Systems, and Airborne Contaminants2005In: Pharmaceutical Technology, ISSN 1543-2521, Vol. 29, no 5, p. s30-s34Article in journal (Refereed)
    Abstract [en]

    Using a modified dispersal chamber, the authors have studied the protective efficacy of cleanroom clothing systems. Study results show that the state of a cleanroom clothing system-new or much used-influences the protection efficacy of the system. Suitable combinations of cleanroom underwear and cleanroom garments also improve the protection of the clean environment against airborne contaminants from people.

  • 11.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    Chapter 58: Dispersion of airborne contaminants - Basics in R3 technology2006In: 37th R3-Nordic Contamination Control Symposium / [ed] Wirtanen, G; Salo, S, ESPOO: TECHNICAL RESEARCH CENTRE FINLAND , 2006, Vol. 240, p. 417-419Conference paper (Refereed)
    Abstract [en]

    In cleanrooms the main source of biocontamination is people. The concentration of airborne biocontamination depends upon the number of people present in a cleanroom, their level of activity, and the clothing systems used. There are several methods of measuring the airborne biocontamination and many published reports show that the results - as number of colony forming units per cubic meter (CFU/m3) - depend on the equipment used. The difference in results between microbiological air samplers often depend upon physical parameters of the samplers. These parameters, together with d50 that is the aerodynamic particle diameter where 50% of the particles are collected and 50% are not collected are discussed. In order to evaluate the collection efficiency of impaction air samplers, a simplified mathematical model will be presented and examples given.

  • 12.
    Ljungqvist, Bengt
    et al.
    KTH, Superseded Departments, Civil and Architectural Engineering.
    Reinmüller, Berit
    KTH, Superseded Departments, Civil and Architectural Engineering.
    Clean Room Clothing Systems After 1, 25 and 50 Washing/Sterilizing Cycles; Some Calculations on Air Cleanliness2004Conference paper (Refereed)
  • 13.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    Cleanroom clothing systems - Test results2006In: / [ed] Wirtanen, G; Salo, S, ESPOO: TECHNICAL RESEARCH CENTRE FINLAND , 2006, Vol. 240, p. 189-195Conference paper (Refereed)
  • 14.
    Ljungqvist, Bengt
    et al.
    KTH, Superseded Departments, Building Sciences and Engineering.
    Reinmüller, Berit
    KTH, Superseded Departments, Building Sciences and Engineering.
    Cleanroom Clothing Systems: People as a contamination source2004Other (Other academic)
  • 15.
    Ljungqvist, Bengt
    et al.
    KTH, Superseded Departments, Civil and Architectural Engineering.
    Reinmüller, Berit
    KTH, Superseded Departments, Civil and Architectural Engineering.
    Cleanroom dressed people as a contamination source: some calculations2004In: European Journal of Parenteral & Pharmaceutical Sciences, ISSN 1740-6277, Vol. 9, no 3, p. 83-87Article in journal (Refereed)
  • 16.
    Ljungqvist, Bengt
    et al.
    KTH, Superseded Departments, Civil and Architectural Engineering.
    Reinmüller, Berit
    KTH, Superseded Departments, Civil and Architectural Engineering.
    Clothing Systems and Different Air Distribution Systems for Operating Rooms, Some Calculations2004Conference paper (Refereed)
  • 17.
    Ljungqvist, Bengt
    et al.
    KTH, Superseded Departments, Civil and Architectural Engineering.
    Reinmüller, Berit
    KTH, Superseded Departments, Civil and Architectural Engineering.
    Clothing Systems and Different Air Distribution Systems for Operating Rooms: Some Calculations2004In: Renhetsteknik, ISSN 1404-806XArticle in journal (Other academic)
  • 18.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    Clothing systems used in operating rooms - A question of patient safety2010In: 41st R³-Nordic Symposium: Dipoli, Espoo, Finland, May 25-26, 2010, Valtion Teknillinen Tutkimuskeskus , 2010, no 266, p. 142-147Conference paper (Refereed)
    Abstract [en]

    Clothing systems used in operating rooms are compared to clothing systems used in food industry and in pharmaceutical manufacturing. For all these industries the control of the concentration of airborne bacteria-carrying particles are of vital importance. The emission of large particles with regard to clothing system quality is commented. Results from the study can be used to calculate expected concentrations of airborne aerobic colony forming units in the operation room when clothing system and number of people in the room are known. The study shows that the commonly used protective clothing systems need to be upgraded in operation rooms where patients, sensitive to infections undergo operations.

  • 19.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    Dispersion of Airborne Contaminants and Contamination Risks in Cleanrooms2006In: Guide to Microbiological Control in Pharmaceuticals and Medical Devices / [ed] Stephen P . Denyer and Rosamund M . Baird, CRC Press, 2006, 2Chapter in book (Other academic)
  • 20.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Litteraturstudie avseende skyddsventilation: mikrobiologiska säkerhetsbänkar, Klass II2005Report (Other academic)
  • 21.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Loading and unloading of freeze-dryers: Airborne contamination risks for aseptically manufactured sterile drug products2007In: PDA journal of pharmaceutical science and technology, ISSN 1079-7440, E-ISSN 1948-2124, Vol. 61, no 1, p. 44-50Article in journal (Refereed)
    Abstract [en]

    In pharmaceutical manufacturing, freeze-drying processes can be adversely affected by temperature differences relative to the surrounding air. Loading and unloading of freeze-dryers are performed either without or with temperature differences between the cleanroom and the chamber of the freeze-dryer. This operation can cause a flow of room air through the opening, creating a contamination risk, especially when manual handling of material is performed in this area. To minimize this risk, a high-efficiency particulate air (HEPA) filter unit should be installed above the opening to provide clean air and protect the opening. Here the theoretical relationships are discussed and design criteria are presented.

  • 22.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Monitoring efficiency of microbiological impaction air samplers2008In: European Journal of Parenteral & Pharmaceutical Sciences, ISSN 0964-4679, Vol. 13, no 4, p. 93-97Article in journal (Refereed)
  • 23.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE).
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE).
    Monitoring of airborne viable particles2016In: Environmental Monitoring for Cleanrooms and Controlled Environments, CRC Press , 2016, p. 63-70Chapter in book (Other academic)
  • 24.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    People as a contamination source: New results on clean room clothing systems2007Conference paper (Other academic)
  • 25.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering (name changed to Building Service and Energy Systems 2012-03-01).
    Practical Safety Ventilation in Pharmaceutical and Biotech Cleanrooms2006Book (Other academic)
  • 26.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Predicted Contamination Levels in Cleanrooms, when Cleanroom-Dressed People are the Contamination Source2006In: Pharmaceutical Technology, Aseptic ProcessingArticle in journal (Other academic)
  • 27.
    Ljungqvist, Bengt
    et al.
    KTH, Superseded Departments, Civil and Architectural Engineering.
    Reinmüller, Berit
    KTH, Superseded Departments, Civil and Architectural Engineering.
    Studies of Air Movements: The Dispersion of Contaminants with Visual Illustrative Methods in Pharmaceutical Clean Rooms2004Conference paper (Refereed)
  • 28.
    Ljungqvist, Bengt
    et al.
    KTH, Superseded Departments, Building Sciences and Engineering.
    Reinmüller, Berit
    KTH, Superseded Departments, Building Sciences and Engineering.
    The LR Method in Critical Areas: Airflow Patterns and the Design of Aseptic Interventions2004In: Pharmaceutical Technology, ISSN 1543-2521, Vol. 28, no 7, p. 46-54Article in journal (Refereed)
    Abstract [en]

    The authors discuss factual case studies involving the method for the limitation-of-risks (LR) method. This method can be used as an engineering tool in risk assessment work for the identification, minimization, and evaluation of potential airborne risks, and for the identification of adequate monitoring points.

  • 29.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Vägledning: Riktlinjer och mätförfarande gällande mikrobiologiska säkerhetsbänkar, Klass II2005Report (Other academic)
  • 30.
    Ljungqvist, Bengt
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Löfgren, Anders
    Dewhurst, Eric
    Current Practice in the Operation and Validation of Aseptic Blow-Fill-Seal Processes2006In: PDA journal of pharmaceutical science and technology, ISSN 1079-7440, E-ISSN 1948-2124, Vol. 60, no 4, p. 254-258Article in journal (Refereed)
    Abstract [en]

    In order to illustrate current practice in aseptic blow-fill-seal (BFS) technology, a worldwide survey was performed by the BFS International Operators Association. The results are summarized and compared to the media fill data from the Product Quality and Research Institute (PQRI) survey reported in 2003. The survey highlights the differences and shows the robustness of the BFS technology. Compared to the results from the PQRI survey, the BFS survey shows a tenfold lower frequency of contaminated media fills.

  • 31.
    Reinmüller, Berit
    KTH, Superseded Departments, Civil and Architectural Engineering.
    Hygienic Survey of Air in Swedish Cheese Plants2004In: DairyNET - Hygiene control in nordic dairies, Valtion Teknillinen Tutkimuskeskus , 2004Chapter in book (Other academic)
  • 32. Roasto, M.
    et al.
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering.
    Vokk, R.
    Baysal, A. H. D.
    Polanc, J.
    Veskus, T.
    Juhkam, K.
    Terentjeva, M.
    Maékiw, E.
    Bacterial foodborne pathogens of concern2007In: Microbial contamination & contamination routes in food industry, 2007, no 248, p. 116-128Conference paper (Refereed)
  • 33. Sundström, S.
    et al.
    Ljungqvist, B.
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering.
    Particle concentrations in small volume parenterals produced by aseptic blow-fill-seal technology2010In: European Journal of Parenteral and Pharmaceutical Sciences, ISSN 0964-4679, Vol. 15, no 3, p. 87-92Article in journal (Refereed)
    Abstract [en]

    When producing sterile drugs or medicinal products by aseptic processing with blow-fill seal (BFS) technology it is important to achieve an airborne particle cleanliness of ISO Class 5 for particles ≥0.5 micron for US and EU, and ISO Class 4.8 for particles ≥5.0 micron for EU compliance in the critical area, which includes the filling zone. Most BFS machines are equipped with a filling shroud in the filling area, above the ampoules. The shrouds are often pressurised using either HEPA-filtered air or sterile filtered air. This results in a downwards directed airflow, which creates a cleaner environment around the open ampoules during the filling process than the immediate surroundings within the machine region. The clean environment within the shroud also provides protection for the filling mandrel and nozzles. BFS machines which use hot knives for the cutting of plastic parisons are known to generate significant amount of particles and the regulatory requirements can sometimes be difficult to fulfil. These requirements do not take into account the short exposure time for small volume parenterals produced with BFS. This paper describes an experimental study performed on one BFS machine in order to increase the understanding of the relationship between airborne particle concentration and particle concentrations in filled small volume parenterals. The airborne particle concentration in the critical area of the BFS process was increased 1,000 fold (particles ≥0.5 micron) during filling with NaCl fluid. Following the particles challenge, samples of filled ampoules were analysed through light obscuration particle count. The result showed no increase of particles in the filled ampoules. Likely explanations to the result are the short exposure time and small exposure area.

  • 34.
    Sundström, Stefan
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Ljungqvist, Bengt
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Particle conentrations in small volume parenterals produced by aspectic blow-fill-seal technology2010In: European Journal of Parenteral and Pharmaceutical Sciences, ISSN 0964-4679, Vol. 15, no 3, p. 87-92Article in journal (Refereed)
  • 35.
    Sundström, Stefan
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering.
    Ljungqvist, Bengt
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering.
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering.
    Some observations on airborne particles in blow-fill-seal filling rooms2007In: PDA journal of pharmaceutical science and technology, ISSN 1079-7440, E-ISSN 1948-2124, Vol. 61, no 3, p. 147-153Article in journal (Refereed)
    Abstract [en]

    Pharmaceutical products produced by blow-fill-seal (BFS) technology are manufactured in clean rooms of different cleanliness classes. Regulatory authorities set requirements on factors such as the maximum allowed airborne particle concentration in filling rooms with BFS machines. To meet the requirements of the authorities, the supply air is HEPA-filtered. The necessary flow of HEPA-filtered air depends on the particle generations from the BFS machines (source strength). One method of reducing the airborne particle concentration in the filling rooms is to install local exhaust systems in order to remove generated particles. Knowledge of particle dispersion and source strength are necessary to enable correctly dimensioned airflows. In this paper, the dispersion pattern of particles was studied at one filling machine. The partial source strength was determined for four different filling machines. The source strength is the total number of airborne particles per second generated by the BFS machine and the process. The value of the partial source strength will be dependent on the efficiency of the local exhaust system. Partial source strength is defined as the estimated theoretical quantity of particles per second emitted from the filling machine into the filling room. The results show that the partial source strength varies widely between the different filling machines. The source strength levels vary between 102 and 10 7 particles (≥ 0.5 μm) per second. Furthermore, the results show that the efficiency of the local exhausts can be improved by design adjustments.

  • 36.
    Sundström, Stefan
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering.
    Ljungqvist, Bengt
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering.
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering.
    Some observations on airborne particles in the critical areas of a blow-fill-seal machine2009In: PDA journal of pharmaceutical science and technology, ISSN 1079-7440, E-ISSN 1948-2124, Vol. 63, no 1, p. 71-80Article in journal (Refereed)
    Abstract [en]

    Regulatory authorities set requirements on factors such as maximum allowed airborne particle concentrations in critical areas and the surrounded environment. An important issue when producing sterile drugs by aseptic processing with blow-fill-seal technology is to achieve Class 100 (ISO Class 5) in the critical area. To meet these requirements high efficiency particulate air (HEPA)-filtered airflow is used to dilute and remove airborne particles. The required airflow is dependent on the quantity of generated particles. The purpose of this paper is to present the measures taken to reduce airborne particle concentrations at critical areas of a blow-fill-seal machine. The methods being used in the experimental studies are smoke visualization and particle measurements. The results show that particle concentrations can be reduced by minor changes of process variables. By changing the process variables, particle concentrations - number of particles (≥0.5 μm) per cubic foot - in the shroud (filling zone), extrusion zone, and the filling room were approximately reduced as follows: ∼90% in the shroud (filling zone), ∼90% in the extrusion zone, and ∼40-60% in the filling room. It should be noted that the presented results are limited to one type of blow-fill-seal machine and this paper is a continuation of an earlier published paper by the authors in the PDA journal.

  • 37.
    Sundström, Stefan
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Ljungqvist, Bengt
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Stallgård, Mikael
    Applied Mechanics, CTH.
    The use of computational fluid dynamics for the study of particle dispersion routes in the filling area of a blow-fill-seal process2010In: European Journal of Parenteral and Pharmaceutical Sciences, ISSN 0964-4679, Vol. 15, no 1, p. 5-11Article in journal (Refereed)
    Abstract [en]

    An important issue when producing sterile drugs or medicinal products by aseptic processing with blow-fill-seal technology is to achieve an airborne particle cleanliness of ISO Class 5 for particles ≥0.5 micron for US and EU, and ISO Class 4.8 for particles ≥5.0 micron for EU compliance in the critical area, which includes the filling zone. Most blow-fill-seal machines are equipped with a filling shroud in the filling area, above the ampoules. The shrouds are often pressurised using either HEPA-filtered air or sterile filtered air. The pressure inside the shroud results in a downwards directed airflow, which creates a cleaner environment around the open ampoules during the filling process than the immediate surroundings in the bowels of the machine. The clean environment within the shroud also provides protection for the fillingmandrel and nozzles. This paper describes the use of computational fluid dynamics to simulate air velocity magnitudes andmass flow rates as ameans of better understanding particle dispersion routes in the filling area of a blow-fill-seal process and the impact different parameter settings can have on airborne particle concentrations in the filling area. The results show that the movements of the mandrel, together with its nozzles, is the main cause of particles present in the filling shroud during the manufacturing process. The computational fluid dynamics results suggest that particle concentrations can be reduced by changing the mandrel velocity and the mandrel shape. It should be noted that results presented in this paper are limited to one type of BFSmachine.

  • 38.
    Ullman, Catinka
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Ljungqvist, Bengt
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Reinmüller, Berit
    KTH, School of Architecture and the Built Environment (ABE), Civil and Architectural Engineering, Building Services Engineering.
    Design of HEPA-filter units in order to prevent airborne contamination of autoclaves and freeze dryers when doors are open2010In: European journal of parenteral & pharmaceutical sciences, ISSN 0964-4679, Vol. 15, no 2, p. 53-59Article in journal (Refereed)
1 - 38 of 38
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