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Hygiene Training Course

	Content Day 1
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

	Content 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).

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