Presentation on theme: "Biocidal Product Active substance and preparations containing one or more active substances, in the form which are supplied to the user, intended to destroy,"— Presentation transcript:
0Introduction to Antiseptic, Disinfectants & Insecticides Hend Al-Hussieny Head of Biocides Vigilance DepartmentEgyptian Drug Authority (EDA)Egyptian Pharmaceutical Vigilance Center (EPVC)Biocides Vigilance Department (BVD)Introduction to Antiseptic, Disinfectants & InsecticidesHend Al-HussienyBSc. Pharm, MSc.Head of the Biocides Vigilance Department
1Biocidal ProductActive 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.
2Biocides Uses of Biocides Hend Al-Hussieny Head of Biocides Vigilance DepartmentUses of BiocidesMedicineAgricultureIndustryBiocides
3International Classification of Biocidal Product According to International Classification the Biocidal Product is Sub-Divided into: 1- Antiseptic & Disinfectant. 2- Insecticide.
6Antiseptic ticAn 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.
7Antiseptic 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.
8Personal use antiseptics Personal domestic use antisepticsPersonal domestic (or household) use antiseptic products are those used by an individual in a domestic setting to reduce transient organisms on the skin.
9Personal 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.
10Personal use antiseptics 2. Personal commercial use antisepticsPersonal 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.
112. Professional use antiseptics Food premises use antisepticsProducts 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.
12Professional use antiseptics 2. Professional healthcare use antisepticsProducts 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.
142. DisinfectantsThe 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.
15It 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
16Classification of Disinfectants CriticalSemi-CriticalNon-CriticalDisinfectants
17Critical 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).
18N.B.Gaseous sterilant, and critical device sporicide, also referred to as critical sporicide
192. 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…
20High-level Disinfectant A disinfectant that kills all microbial pathogens, except Large numbers of bacterial endospores according to labeling.
213. Non-criticalare 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.
22Intermediate level disinfectant A disinfectant that kills all microbial pathogens, except bacterial endospores, when used according to labeling
23SanitizerA product that reduces the level of microorganisms present by significant numbers, e.g. 99.9% or more, or to acceptable levels.
24Low-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.
25Veterinary BiocideVeterinary hygiene biocide products are used for veterinary hygiene purposes including products used in areas in which animals are housed, kept or transported.
26Disinfectants 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 % of specified test bacteria in 30 seconds under conditions of the Official Detergent Sanitizer Test (sometimes called Weber & Black Test).
27Hend Al-Hussieny Head of Biocides Vigilance Department Pesticides
28PesticidesA 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.
29Pesticides incidentsA 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
31WHO Classification 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.
32WHO Classification2. 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
33Illegal pesticideA 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).
34Substandard pesticide Substandard pesticide A pesticide product that does not comply with National (or International, where relevant) quality standards.
35Most 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.
36Examples of Pesticide Products Some examples of pesticide products we use in our homesCockroach sprays and baitsMosquito spraysRat poisonsFlea and tick sprays, powders, and pet collars.
37There are four types of Pesticides Incidents: Types of IncidentThere are four types of Pesticides Incidents:1. Human Health Incident2. Domestic Animal Incident3. Environmental Incident4. Packaging Incident
38Applied Tests on Biocidal Product Common tests applied on biocidal product before granting registration licenseSafety (NODCAR)Efficacy ( NMRI)Stability (Stability Study )
39Hend Al-Hussieny Head of Biocides Vigilance Department Thank You