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Introduction to
Antiseptic, Disinfectants
& Insecticides
Hend Al-HussienyHend Al-HussienyBSc. Pharm, MSc.BSc. Pharm, MSc.
Head of the Biocides Vigilance DepartmentHead of the Biocides Vigilance Department
Egyptian Drug Authority (EDA) Egyptian Drug Authority (EDA) Egyptian Pharmaceutical Vigilance Center (EPVEgyptian Pharmaceutical Vigilance Center (EPVC)
Biocides Vigilance Department (BVD)Biocides Vigilance Department (BVD)
Biocidal Product
Active substance and preparations containing one or
more active substances, in the form which are
supplied to the user, intended to destroy, deter,
render harmless, prevent the action of, or
otherwise exert a controlling effect on any
harmful organism by chemical or biological
means.
International Classification of Biocidal Product
According to International Classification the
Biocidal Product is Sub-Divided into:
1- Antiseptic & Disinfectant.
2- Insecticide.
Antiseptic tic
An antiseptic product is considered to be one
that inactivates, reduces, prevents or arrests
growth of microorganisms with the inherent
intent to mitigate or prevent disease. as
bacteria, yeast, fungi, and viruses.
Antiseptic Classification
1. Personal use antiseptics:
1.1 Personal domestic use antiseptics.
1.2. Personal commercial use antiseptics.
2. Professional use antiseptics:
2.1. Food premises antiseptics.
2.2. Professional healthcare use antiseptics.
Personal use antiseptics
1. Personal domestic use antiseptics
Personal domestic (or household) use
antiseptic products are those used by an
individual in a domestic setting to reduce
transient organisms on the skin.
Personal use antiseptics
This includes, but may not be limited to,
consumer-use first aid antiseptics for
application in cleansing minor wounds, self-
administered pre-injection or ear piercing.
Personal use antiseptics
2. Personal commercial use antiseptics
Personal commercial uses products are those
made available to the general public for
occasional use and are intended to reduce
transient organisms on the skin in a
commercial or institutional setting.
2. Professional use antiseptics
1. Food premises use antiseptics
Products for professional food premises are those
which are indicated for use by food handlers to
reduce transient organisms on the skin in a
commercial or institutional setting including
food processing plants, restaurants,
supermarkets, and fast food outlets.
Professional use antiseptics
2. Professional healthcare use antiseptics
Products for professional healthcare use are those which are indicated
for use by individuals to reduce transient and/or resident organisms
on the skin in a healthcare setting (such as hospitals, nursing homes,
clinics and dental offices). Such products are to be used in accordance
with applicable hospital protocols. These products include
professional hygienic hand rub, professional hygienic hand washes,
surgical hand rubs, surgical hand washes and patient preoperative
skin preparations.
2. Disinfectants
• The term "disinfectant" is considered to include
bactericides, fungicides, virucides, mycobactericides,
tuberculocides, sporicides, sterilants, or
combinations of these. A disinfectant without
specific target organisms indicated on the product
label is regarded only as a bactericide.
It applies to all disinfectants and disinfectant
sanitizers within the pharmaceutical frame. This
doesn’t include non-food contact sanitizers which do
not carry disinfectant claims, e.g., sanitizers with a
mission to control plant pathogens such as those used
in greenhouses, odour control sanitizers, and
swimming pool sanitizers
Critical use disinfectants
Present a high risk of infection if they are not
sterile, i.e. contaminated with any organism,
including spores. Routinely penetrate the skin or
mucus membranes into normally sterile areas of
the body (e.g., implants, scalpels, needles, surgical
instruments, laparoscopes), or come into direct
contact with recalculating body fluids, (e.g.,
kidney dialysis tubing and dialyzers, or blood
oxygenators).
2. Semi-critical use disinfectants
Contact with mucous membranes during use
but do not usually penetrate normally sterile
areas of the body, e.g. endoscopes,
anesthesia breathing circuits, respiratory
therapy equipment, dental mirrors, etc…
High-level Disinfectant
A disinfectant that kills all microbial
pathogens, except Large numbers of
bacterial endospores according to
labeling.
3. Non-critical
are those products used for disinfection of
devices or surfaces that contact only intact
skin during routine use, e.g. stethoscopes,
bedpans, areas where animals are housed
…..etc.
Intermediate level disinfectant
A disinfectant that kills all microbial
pathogens, except bacterial endospores,
when used according to labeling
Sanitizer
A product that reduces the level of
microorganisms present by significant
numbers, e.g. 99.9% or more, or to
acceptable levels.
Low-level Disinfectant
A disinfectant that kills pathogenic and
potentially pathogenic microorganisms on
hard non-porous inanimate surfaces or
inanimate objects, when used according to
labeling.
Veterinary Biocide
Veterinary hygiene biocide products are used
for veterinary hygiene purposes including
products used in areas in which animals are
housed, kept or transported.
Disinfectants VS. Sanitizers
• A Disinfectant is a product which completely destroys all
specific test organisms in 10 minutes under conditions of the
American Association of Official Analytical Chemists AOAC Use
Dilution Test.
A Sanitizer is a product which destroys 99.999% of
specified test bacteria in 30 seconds under conditions of the
Official Detergent Sanitizer Test (sometimes called Weber &
Black Test).
Pesticides
A pesticide is a chemical used to prevent, destroy, or repel
pests. Pests can be insects, mice and other animals, weeds,
fungi, or microorganisms such as bacteria and viruses. Some
examples of pests are termites causing damage to our homes,
dandelions in the lawn, and fleas on our dogs and cats.
Pesticides also are used to kill organisms that can cause
diseases.
Pesticides incidents
A pesticide incident is a negative effect to humans, animals
or the environment that can result from being exposed to a
pesticide.
Common types of pesticide incidents include:
• Effects to humans (e.g. skin rash or headache),
• Effects to a pet or a farm animal (e.g. vomiting),
• Effects to the environment (e.g. dead fish or birds), or even
• Problems with pesticide containers
WHO Classification
1. House Hold
Pesticide that is used in or around the house and is
generally available over the counter. They may
include mosquito coils, aerosols spray cans,
insect repellents for personal use, rodent
poisons, cockroach sprays and baits, flea and
tick control products and pet collars.
WHO Classification
2. Public health
Pesticide that is used in the control of pests of public health
significance. They include vector control pesticides,
household pesticides, and professional pest management
pesticides (i.e. pesticides used by pest control operators). For
the purpose of this guideline, public health pesticides do not
include disinfectants
Illegal pesticide
A pesticide that is not registered or
otherwise authorized for a particular
distribution and use, or a pesticide for
which no import authorization has been
given (if applicable).
Substandard pesticide
Substandard pesticide
A pesticide product that does not
comply with National (or International,
where relevant) quality standards.
Most pesticides contain chemicals that can
be harmful to people, animals, or the
environment. For this reason the Biocides
Vigilance Department Programs regulates
pesticides in our country to protect public
health and the environment.
Examples of Pesticide Products
Some examples of pesticide products we use in our
homes
• Cockroach sprays and baits
• Mosquito sprays
• Rat poisons
• Flea and tick sprays, powders, and pet collars.
Types of Incident
There are four types of Pesticides Incidents:
1. Human Health Incident
2. Domestic Animal Incident
3. Environmental Incident
4. Packaging Incident
Applied Tests on Biocidal Product
Common tests applied on biocidal product
before granting registration license
• Safety (NODCAR)
• Efficacy ( NMRI)
• Stability (Stability Study )