TRAINING COURSE PROPOSAL. IAEA TC Project RER/1/011 Introducing and Harmonizing Standardized Procedures for Radiation Technologies
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1 TRAINING COURSE PROPOSAL IAEA TC Project RER/1/011 Introducing and Harmonizing Standardized Procedures for Radiation Technologies Regional Training Course on Microbiological Aspects of Sterilization Validation Process Time Schedule: 2-6 December 2013 Location: Instituto Superior Técnico/ Campus Tecnológico e Nuclear Bobadela, PORTUL Number of participants: ~ 20 (divided by 3 Groups of 6-7) Group A; Group B; Group C (; ; ) Non-local lecturers: András KOVÁCS Miora ALEXANDRU Laura TRANDAFIR Local lecturers/experimental supervisors: Maria Luisa BOTELHO Sandra CABO VERDE Rita MELO Pedro SANTOS Amílcar ANTÓNIO Telma SILVA Joana MADUREIRA Helena MARCOS Estrada Nacional 10 ao km 139, Bobadela LRS Telefone:
2 Theoretical Themes: 1. Basic characteristics and purpose of sterilization validation process - Maria Luisa BOTELHO a. Radiation Sterilization - From the earlier days to nowadays : the concepts evolution from Pharmacopeia up to ISO standards; (L1) 2. Microbiological methods - Miora ALEXANDRU a. Bioburden tests and identification of microorganisms; bacteriostasis/fungistasis tests; microbiota efficiency recovery and optimization of procedures; (L2) b. Sterility test including technical details; reference document; bacteriostasis/fungistasis tests; culture media and incubation (t0). (L3) 3. Dosimetry aspects during sterilization validation András KOVÁCS a. Dosimetric systems, methods, selection criteria; (L4) b. Dosimetry procedures during sterilization validation; dosimetry standards; (L5) 4. Quality control/quality assurance - Laura TRANDAFIR a. Standard methods: description, selection criteria, adequacy of the method for different type of products, SIP establishment and validation; (L6) b. Relevant standards and legal requirements (L7) 5. Monitoring of production and potential sources of contamination Lecturer from a pharmaceutical Industry (L8) (waiting for confirmation) 2
3 Experimental Themes Case study: Establishment of the Sterilization Dose for pharmaceutical tubes using Method 1. I) Microbiological methods: a) Bioburden determination b) Determination of efficiency recovery c) Counting and characterization of microbiota d) Analysis of Results II) Dosimetry: a) Irradiation geometry and samples preparation b) Dose mapping c) Irradiation of samples d) Measurement of absorbed doses e) Determination of Dose Uniformity f) Analysis of Results III) Sterility tests: a) Performance of sterility tests on irradiated samples (Culture and incubation) b) Bacteriostasis/fungistasis tests c) Analysis of Results 3
4 DRAFT AGENDA Day 1: Monday, 02 December 2013 Session 1: Opening 9:00 Welcome & Opening remarks 1. NLO Portugal, Vice-President of IST 2. Local Organizer 9:30 Administrative information 1. Introduction of Participants; 2. Introduction of the program of the training course; 3. Overview of the training course objectives; Mr. Carlos Varandas Mrs. Sandra Cabo Verde Mrs. Sandra Cabo Verde 4. Groups team works versus week planning 10:00 Break 10:30 Country presentations Countries by alphabetical order Session 2: Sterilization validation process concepts and application 14:00 Lecture 1 Mrs. Maria Luisa Botelho 14:45 Lecture 2 Mrs. Mioara Alexandru 15:15 Introduction to the experimental work Mrs. Sandra Cabo Verde 16:00 Experimental work Bioburden,, 17:30 End of day 1 Day 2: Tuesday, 03 December 2013 Session 3: Standard Methods 9:00 Lecture 6 Mrs. Laura Trandafir 9:30 Country presentations (cont.) Countries by alphabetical order 11:00 Country presentations (cont.) Countries by alphabetical order Session 4: Sterility tests and Dosimetric systems 14:00 Lecture 3 Mrs. Mioara Alexandru 14:30 Lecture 4 Mr. András Kovács 15:00 Experimental work Bioburden counts,, 16:00 Technical visit to Co-60 facility - Irradiations,, 17:30 End of day 2 4
5 Day 3: Wednesday, 04 December 2013 Session 5: Dosimetry in Sterilization validation process 9:00 Lecture 5 Mr. András Kovács 9:30 Introduction to the experimental work Local lecturers 11:00 Experimental work,, 14:00 Experimental work,, 16:00 Experimental work,, 17:30 End of day 3 Day 4: Thursday, 05 December 2013 Session 6: Quality control 9:00 Lecture 7 Mrs. Laura Trandafir 9:30 Lecture 8 Lecturer from a pharmaceutical industry 11:00 Experimental work,, 14:00 Results analysis and discussion,, 16:00 Preparation of the oral presentation(per,, group) 17:30 End of day 4 19:00 Closing dinner Day 5: Friday, 06 December 2013 Session 6: Dosimetry in Sterilization validation process 9:00 Oral presentations,, 11:00 Preparation of IAEA Trainning Course Report All (Conclusions and Recommendations) 14:00 Technical Visit to a Hovione Pharmaceutical All Industry 17:30 Closing remarks and end of Training course 5
6 Work schedule Time Monday Time Tuesday Wednesday Thursday Friday 9H00 9H30 9H30 10H00 10H00 10H30 10h30 12h30 12h30-14h00 14h00 14h45 14h45 15H15 15H15 15H30 15h30 16h00 16h00 17h30 Opening Session and Welcome by the President of the Institute Administrative matters Introductory presentations of the participants L1 9H00 9H30 L6 L5 L7 Oral Presentation: 9H30 10H30 10H30-11H00 11H00-12H30 14H00-14H30 L2 14H30 15H00 Introduction to the experimental work Experimental Work - Bioburden,, 15H00 15H30 15h30 16h00 16h00 17h30 Introductory presentations of the participants (cont.) Introductory presentations of the participants (cont.) L3 L4 Experimental Work Bioburden counts (,, ) Visit to Co-60 facility Irradiations (,, ) Introduction to the experimental work Dosimetry Sterility tests Microbiostasis tests Microbiostasis tests LUNCH Dosimetry Sterility tests Sterility tests Microbiostasis tests Dosimetry L8 Experimental work - Results readings,, Results analysis and discussion Oral presentation preparation (per Group) 19:00 Closing Dinner Preparation of IAEA Training Course Report (conclusions and recommendations) Technical Visit to Hovione Pharmaceutical Industry Estrada Nacional 10 ao km 139, Bobadela LRS Telefone:
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