TRAINING COURSE PROPOSAL IAEA TC Project RER/1/011

IST/CTN - CAMPUS TECNOLÓGICO E NUCLEAR
INSTITUTO SUPERIOR TÉCNICO, UNIVERSIDADE TÉCNICA DE LISBOA
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, PORTUGAL
Number of participants: ~ 20 (divided by 3 Groups of 6-7)
 Group A; Group B; Group C (GA; GB; GC)
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 139,7 – 2695-066 Bobadela LRS – Telefone: + 351 – 219 946 000 – http://www.itn.pt
IST/CTN - CAMPUS TECNOLÓGICO E NUCLEAR
INSTITUTO SUPERIOR TÉCNICO, UNIVERSIDADE TÉCNICA DE LISBOA
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
bacteriostasis/fungistasis tests; culture media and incubation (t0). (L3)
3.
document;
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
IST/CTN - CAMPUS TECNOLÓGICO E NUCLEAR
INSTITUTO SUPERIOR TÉCNICO, UNIVERSIDADE TÉCNICA DE LISBOA
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
IST/CTN - CAMPUS TECNOLÓGICO E NUCLEAR
INSTITUTO SUPERIOR TÉCNICO, UNIVERSIDADE TÉCNICA DE LISBOA
DRAFT AGENDA
9:00
1.
2.
9:30
10:00
10:30
12:30
14:00
14:45
15:15
15:30
16:00
17:30
9:00
9:30
10:30
11:00
12:30
14:00
14:30
15:00
15:30
16:00
17:30
Day 1: Monday, 02 December 2013
Session 1: Opening
Welcome & Opening remarks
NLO Portugal , Vice-President of IST
Mr. Carlos Varandas
Local Organizer
Mrs. Sandra Cabo Verde
Administrative information
Mrs. Sandra Cabo Verde
Introduction of Participants;
Introduction of the program of the training course;
Overview of the training course objectives;
Groups – team works versus week planning
1.
2.
3.
4.
Break
Country presentations
Countries by alphabetical order
Lunch
Session 2: Sterilization validation process – concepts and application
Lecture 1
Mrs. Maria Luisa Botelho
Lecture 2
Mrs. Mioara Alexandru
Introduction to the experimental work
Mrs. Sandra Cabo Verde
Break
Experimental work – Bioburden
GA, GB, GC
End of day 1
Day 2: Tuesday, 03 December 2013
Session 3: Standard Methods
Lecture 6
Mrs. Laura Trandafir
Country presentations (cont.)
Countries by alphabetical order
Break
Country presentations (cont.)
Countries by alphabetical order
Lunch
Session 4: Sterility tests and Dosimetric systems
Lecture 3
Mrs. Mioara Alexandru
Lecture 4
Mr. András Kovács
Experimental work – Bioburden counts
GA, GB, GC
Break
Technical visit to Co-60 facility - Irradiations
GA, GB, GC
End of day 2
4
IST/CTN - CAMPUS TECNOLÓGICO E NUCLEAR
INSTITUTO SUPERIOR TÉCNICO, UNIVERSIDADE TÉCNICA DE LISBOA
9:00
9:30
10:30
11:00
12:30
14:00
15:30
16:00
17:30
9:00
9:30
10:30
11:00
12:30
14:00
15:30
16:00
Day 3: Wednesday, 04 December 2013
Session 5: Dosimetry in Sterilization validation process
Lecture 5
Mr. András Kovács
Introduction to the experimental work
Local lecturers
Break
Experimental work
GA, GB, GC
Lunch
Experimental work
GA, GB, GC
Break
Experimental work
GA, GB, GC
End of day 3
Lecture 7
Day 4: Thursday, 05 December 2013
Session 6: Quality control
Mrs. Laura Trandafir
Lecture 8
Break
Experimental work
Lunch
Results analysis and discussion
Break
Preparation of the oral presentation(per
group)
17:30 End of day 4
19:00 Closing dinner
9:00
10:30
11:00
12:30
14:00
17:30
Lecturer from a pharmaceutical industry –
GA, GB, GC
GA, GB, GC
GA, GB, GC
Day 5: Friday, 06 December 2013
Session 6: Dosimetry in Sterilization validation process
Oral presentations
GA, GB, GC
Break
Preparation of IAEA Trainning Course Report
All
(Conclusions and Recommendations)
Lunch
Technical Visit to a Hovione Pharmaceutical
All
Industry
Closing remarks and end of Training course
5
IST/CTN - CAMPUS TECNOLÓGICO E NUCLEAR
INSTITUTO SUPERIOR TÉCNICO, UNIVERSIDADE TÉCNICA DE LISBOA
Work schedule
Time
Monday
Time
Tuesday
Wednesday
Thursday
Friday
9H00 –
9H30
Opening Session and
Welcome by the
President of the Institute
9H00 –
9H30
L6
L5
L7
Introductory
presentations of the
participants (cont.)
Introduction to the experimental work
L8
Oral Presentation:
GA
GB
GC
Administrative matters
9H30 –
10H30
10H00 –
10H30
BREAK
10H3011H00
10h30 –
12h30
Introductory
presentations of the
participants
9H30 –
10H00
11H0012H30
BREAK
Introductory
presentations of the
participants (cont.)
GA
Dosimetry
12h30 14h00
14h00 –
14h45
14h45 –
15H15
15H15 –
15H30
GB
Microbiostasis
tests
GC
Sterility tests
Experimental work
Preparation of IAEA Training
- Results readings Course Report (conclusions and
GA, GB, GC
recommendations)
LUNCH
L1
L2
Introduction to the
experimental work
15h30 –
16h00
BREAK
16h00 –
17h30
Experimental Work Bioburden
GA, GB, GC
14H0014H30
L3
14H30 –
15H00
L4
GA
Sterility tests
Experimental Work –
15H00 –
Bioburden counts (GA,
15H30
GB, GC)
15h30 –
16h00
GA
16h00 –
Visit to Co-60 facility
Microbiostasis
17h30 Irradiations (GA, GB, GC)
tests
GB
Dosimetry
GC
Microbiostasis
tests
Results analysis
and discussion
Technical Visit to Hovione
Pharmaceutical Industry
BREAK
GB
Sterility tests
GC
Dosimetry
Oral presentation
preparation (per
Group)
19:00
Closing Dinner
Estrada Nacional 10 ao km 139,7 – 2695-066 Bobadela LRS – Telefone: + 351 – 219 946 000 – http://www.itn.pt