Objetivo SCIENTIFIC AND TECHNICAL BENEFITS WOULD BE EXPECTED FROM THE FOLLOWING PROJECTS: 1. DEVELOPMENT OF STANDARD METHODS FOR THE EVALUATION AND COMPARISON OF AEROBIOLOGICAL MONITORS 2. SELECTION OF AEROBIOLOGICAL MONITORING METHODS THAT WILL ALLOW THE RAPID DETECTION OF LEAKS FROM BIOPROCESS EQUIPMENT AND COMPONENTS. 3. DEVELOPMENT OF METHODS FOR PHYSICAL CONTAINMENT TESTING OF SPECIFIC UNIT OPERATIONS AND COMPONENTS. THE RESEACH IS PARTICULARLY IMPORTANT FOR THE PROMOTION OF INDUSTRIAL SAFETY AND OCCUPATIONAL HYGIENE IN BIOTECHNOLOGICAL PROCESSES IN SUPPORT OF EUROPEAN AND INTERNATIONAL GUIDELINES AND DIRECTIVES.Methods, involving the use of aerobiological samplers and airborne particle counters, have been applied to the containment testing of bioprocess unit operations. Rapid methods of detecting breaches of containment have been developed. Tests carried out during the project have identified difficulties with cell disruptors which release aerosols of viable microorganisms and their products.The application of recombinant deoxyribonucleic acid (DNA) techniques to large scale bioprocessing has raised safety concerns in terms of exposure risk to the operator and the environment. Public perception is preventing a more rapid adoption of recombinant deoxyribonucleic acid (rDNA) bioprocesses. The possible effects on living material are not well understood. The most common form of occupational exposure is via the aerosol route into the lungs. Although the microorganisms used in the majority of biotechnological applications are unlikely to be pathogenic in themselves, the compounds they produce or express may present a risk to health, especially if the microorganism is able to colonize the body after inhalation.Technical information on bioprocessing safety is an integral part of developing a regulatory framework in biotechnology. A review of bioprocessing risks revealed equipment and processing operations where problems might occur. The containment and risk assessment of selected unit operations and components were evaluated using methods developed in the project.The quantification of risks in biotechnology is far more difficult than for the chemical industry, due to the lack of reliability data and gaps in the understanding of fundamental mechanisms underlying the properties of fugitive microorganisms and their products. Methods, involving the use of aerobiological samplers and particle monitors, have been applied to the containment testing of bioprocess unit operations. The need for rapid and sensitive methods to detect breaches of containment was highlighted. Tests carried out during the project have identified difficulties with fermenter off gas filters, cell disrupters and a continuous centrifuge.THE OVERALL PROGRAMME IS DIVIDED EQUALLY BETWEEN WARREN SPRING LABORATORY (WSL, UK) AND THE INSTITUTE FOR APPLIED CHEMISTRY (TNO, NL). THE GENERAL OBJECTIVES OF THE JOINT RESEARCH PROPOSAL ARE: 1. ASSESS AND COMPARE EXISTING METHODS FOR THE DETECTION OF CONTAINMENT BREACH. 2. ASSESS CONTAINMENT OF PROCESS COMPONENTS AND UNIT OPERATIONS. 3. ASSESS FAILURE MODES IN ORDER TO IMPROVE DESIGN. 4. ASSESS THE RELEVANCE OF EXISTING RELIABILITY AND RISK DATA BASES TO BIOPROCESSING. 5. MAKE INFORMATION AVAILABLE SO THAT EQUIPMENT SELECTION CAN BE BASED ON RELIABILITY, CONTAINMENT, ASEPSIS AND SAFETY. THE CONTRACTOR WILL UNDERTAKE TWO RESEARCH ACTIVITIES, SUMMARIZED AS FOLLOWS: ACTIVITY 2 A) CONSTRUCT A STANDARD METHOD FOR COMPARING SAMPLERS AND MONITORS. B) COMPARE THREE IMPACTOR SAMPLERS, THREE IMPINGER SAMPLERS AND THREE AIRBORNE PARTICLE MONITORS AND SELECT THE MOST APPROPRIATE FOR TESTING CONTAINED UNIT OPERATIONS AND COMPONENTS. C) COMPARE THREE METHODS OF ENUMERATING THE AIRBORNE MICRO-ORGANISMS TRAPPED IN A SAMPLER. D. TO EXAMINE THE SUITABILITY OF USING PROCESS MARKERS WITH AEROBIOLOGICAL SAMPLERS AS A MEANS OF RAPIDLY DETECTING CONTAINMENT BREACHES. ACTIVITY 4 A) INVESTIGATE THE MODES AND FREQUENCY OF FAILURE (BREACH OF CONTAINMENT) OF A SPECIFIC UNIT OPERATION (CELL DISRUPTION BY HIGH PRESSURE). STUDY MEASURES TO INCREASE RELIABILITY AND DECREASE OPERATING RISKS. Ámbito científico natural sciencesbiological sciencesgeneticsDNAnatural sciencesbiological sciencesmicrobiology Programa(s) FP1-BAP - Multiannual research action programme (EEC) in the field of biotechnology (BAP), 1985-1989 Tema(s) Data not available Convocatoria de propuestas Data not available Régimen de financiación CSC - Cost-sharing contracts Coordinador Warren Spring Laboratory Aportación de la UE Sin datos Dirección Gunnels Wood Road SG1 2BX Stevenage Reino Unido Ver en el mapa Coste total Sin datos Participantes (1) Ordenar alfabéticamente Ordenar por aportación de la UE Ampliar todo Contraer todo ITC - TNO Países Bajos Aportación de la UE Sin datos Dirección ROUSSEAU I Ver en el mapa Coste total Sin datos
