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ABSTRACT
INTRODUCTION
TYPES OF SANITIZATION
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Tim Sandle
Room Sanitization
Equipment Sanitization
Glove Sanitization
TYPES OF DISINFECTION
AGENTS
Non-Oxidizing Disinfectants
Oxidizing disinfectants
SANITIZATION REGIME
Cleaning
Cleaning, in the context of pharmaceutical manufacturing, is the process of removing residues and soil (dirt, grease, protein
etc.) from surfaces to the extent that they
are visually clean. This involves clearly defined procedures that often require use of a
detergent or other cleaning agent. Detergents generally work by penetrating the soil
and reducing the surface tension (which
fixes the soil to the surface) to allow its
removal. Hence many of the products are
surfactants (surface active agents).
Cleaning as described above is necessary
for cleanrooms prior to the application of
disinfectant. It is essential that a surface
Disinfection
The critical aspect for disinfectant efficacy is the contact time. The disinfectant
is only effective when left in contact with
the surface for the validated time. This
can be achieved more easily when the disinfectant is applied in overlapping strokes.
When rotation of disinfectants is required,
a water rinse normally employing Water for
Injection (WFI) is employed between the
change-over of disinfectants. This rinse removes traces of disinfectant and detergent
residue such as anions which may reduce
the efficacy of the subsequent disinfectant.
A disinfectant will achieve the desired
effectiveness if it remains on the targeted
surface for an appropriate length of time.
Determining the optimal contact time often means striking a balance between what
is necessary to achieve the desired microbial reduction and what is practical for real-time use in the facility. At minimum, the
manufacturers recommended contact time
should be tested. Additional contact times
may also be evaluated if the manufacturers
recommended time is demonstrated to be
ineffective or if a shorter contact time is desired (12).
Rotation of Disinfectants
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Tim Sandle
EU GMP Guide states that where disinfectants are used, more than one type should
be employed (Annex 1). Nevertheless, the
case for rotation has not been scientifically proven in that there are very few studies
providing empirical evidence. However, it
remains that rotation is often implemented
to satisfy the requirements of regulators.
ASSESSING SANITIZATION
EFFECTIVENESS
QUALIFICATION OF
DISINFECTANTS
SUMMARY
References
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