| 09.00 - 10:00 |
BASIC MICROBIOLOGY
Occurrence and size of microorganisms
- Effects caused by microorganisms
- Properties of microorganisms
- Diversity of microorganisms
- Division and growth of
microorganisms
- Structures of microorganisms
(cell walls, LPS, capsules, spores, flagellae)
- Concepts of control of
microorganisms
|
| 10:00 - 10:30 |
CLASSROOM EXERCISE
- Participants work with the
trainer on concepts for control of microorganisms.
|
| 10:30 - 11:00 |
BREAK
|
| 11:00 - 12:00 |
PERSONAL HYGIENE
- Microflora of the human body
- Personal cleanliness
- Illness and health conditions
- Entry into the facility
- Visit of the toilet
- Change and washing of garments
|
| 12:00 - 12:30 |
CLASSROOM EXERCISE
- Participants work with the
trainer on personal hygiene concepts.
|
| 12:30 - 13:30 |
BREAK
|
| 13:30 - 14:30 |
HYGIENE QUESTIONS OF
NON-STERILE FACILITIES
- Sources of microbiological
contamination
- Growth of microorganisms and
hygiene problems
- Entry and flow of personnel and
material
- Zoning and gowning in the
facility
- Behaviour of personnel
- Contamination control in
non-sterile environments
|
| 14:30 - 15:00 |
CLASSROOM EXERCISE
- Work with the trainer on hygiene
and contamination control concepts for non-sterile facilities
|
| 15:00 - 15:30 |
Break
|
| 15:30 - 16:30 |
CLEANING,
DISINFECTION AND SANITISATION
- Cleaning schedules and
techniques
- Classes of disinfectants and
resistance of microorganisms
- Evaluation of effectivity of
disinfectants
- Rotation and sterility of
disinfectants
- Methods of disinfection
- Disinfection plans
|
| 16:30 - 17:00 |
CLASSROOM EXERCISE
- Work on cleaning and
disinfection questions with the trainer.
- Develop cleaning and
disinfection plans
|
| Day 2 |
|
| 9:00 - 10:00 |
BIOBURDEN OF
MATERIALS AND INTERMEDIATES
- Sources of contamination
- Cleanliness of storage areas
- Excipients, intermediates,
packaging materials
- International requirements
- Methods of bioburden monitoring,
pharmacopoeial methods
- Bioburden sampling plans
|
| 10:00 - 10:30 |
CLASSROOM EXERCISE
- Participants propose a list of
actives, excipients and intermediates. Develop a sampling plan.
|
| 10:30 - 11:00 |
BREAK
|
| 11:00 - 12:00 |
WATER AND WATER
SYSTEMS FOR PHARMACEUTICAL USE
- International requirements
- Water system microbiological
considerations
- Water system sanitization
measures
- Pharmacopoeial and alternative
methods for monitoring of water and water systems
- Auditing water - for - injection
systems
|
| 12.00 - 12.30 |
CLASSROOM EXERCISE
- Discuss the status of water
systems based on fictive monitoring results as presented by the
trainer (alternatively monitoring results presented by
participants).
|
| 12:30 - 13:30 |
LUNCH
|
| 13:30 - 14:30 |
Requirements for
Cleanrooms
- Principles of segregation
- Layout of cleanrooms
- European vs. US requirements
- Material and personnel flow
- Cleanroom practices (access,
gowning, comportment)
|
| 14:30 - 15:00 |
CLASSROOM EXERCISE
- Develop approaches to the
solution of cleanroom problems as presented by the trainer.
|
| 15:00 - 15:30 |
BREAK
|
| 15:30 - 16:30 |
ENVIRONMENTAL
MONITORING OF FACILITIES FOR NON-STERILE AND STERILE PHARMACEUTICALS
- International requirements
- Methods of environmental
monitoring
- Sampling plans
- Evaluation and interpretation of
results
- Identification of microorganisms
|
| 16:30 - 17:00 |
CLASSROOM EXERCISE
- Develop reactions and
investigation plans to fictive environmental monitoring results
as presented by the trainer (alternatively monitoring results
presented by participants).
|
