Documente Academic
Documente Profesional
Documente Cultură
Module Outline
Scope
Regulatory Requirements
Aseptic Processing
Microcontamination
Types of Contamination
Source of Contamination
Personnel
Module Outline
Equipment and Facilities
Production Material and Processes
Improper Work Practices
Controlled Environmental Concepts
◦ Contamination Pathway
◦ Cleanroom Parameters
ModuleOutline
Personnel and Contamination Work
Practices
Cleaning the Cleanroom
◦ Housekeeping
Microbiology Laboratory
- Aseptic Techniques
◦ General Principles that should be
observed
CGMP’S Part 211
Subpart C – Building and
Facilities
Subpart D – Equipment
Subpart F - Production Controls
and Manufacturing
Subpart I – Laboratory Controls
Regulatory Requirements:
◦ <1211> Sterilization and
Sterility Assurance of
Compendial Articles
Provides a review of the principles
involved in producing aseptically
processed products with a minimal
risk of microbial contamination in
the finished lot of final dosage
forms.
Regulatory Requirements
◦ Chapter USP <1211>
◦ The areas of critical concern are the
immediate microbial environment
where these pre sterilized
components are exposed during
assembly to produce the finished
dosage form and the aseptic filling
operation.
Regulatory Requirements
Chapter USP <1211>
6, 7 and 8.
Acritical area is one in which
the sterilized drug product,
containers and closures are
exposed to environmental
conditions that must be
designed to maintain product
sterility (211.42(c)(10)
This area is critical because an exposed
product is vulnerable to contamination and
will not be subsequently sterilized in its
immediate container.
To maintain product sterility, it is essential