PENGUJIAN ANTISEPTIK

DAN DESINFEKTAN
MOHAMMAD KHOTIB
 CONTROL OF MICROBIAL GROWTH

• Sterilizing Agents-- kill everything (e.g. heat, radiation)

• Disinfectants-- kill most things. Too strong for living tissues (e.g. lysol, NH3)
• Antiseptics-- milder in action. Can be used topically, but not ingested. (e.g. alcohol, iodine)
• Chemotherapeutics-- can be ingested (e.g. penicillin, sulfa drugs)

Aktivitas antimikroba:
1 – non-selective antimicrobial agents, causes most destructive effect on the majority of
microorganisms (antiseptics and disinfectants).
2 - selective antimicrobial drugs (chemotherapeutic agents).
 DEFINISI

 Antiseptik atau germisida adalah senyawa kimia yang digunakan untuk

membunuh atau menghambat pertumbuhn mikroorganisme pada jaringan yang
hidup seperti pada permukaan kulit dan membran mukosa.
 Disinfektan digunakan untuk membunuh mikroorganisme pada benda mati

 Sterilizing Agents-- kill everything (e.g. heat, radiation)

 Disinfectants-- kill most things. Too strong for living tissues (e.g. lysol, NH3)
 Antiseptics-- milder in action. Can be used topically, but not ingested. (e.g. alcohol,
iodine)
 Chemotherapeutics-- can be ingested (e.g. penicillin, sulfa drugs)
Orthocresol
Triclosan
Orthophenylphenol Hexachlorophene

Bisphenolics
 REQUIREMENTS FOR ANTISEPTICS
AND DISINFECTANTS.
• Must have a broad spectrum of action;
• Rapid onset of action;
• Should have a small latency period;
• Should have a high activity;
• Must be chemically resistant;
• High availability and low cost;
• Lack of local irritant or allergic effects on tissues;
• Minimal absorption from the place of their application;
• Low toxicity.
 CLASSIFICATION OF ANTISEPTICS AND DISINFECTANTS
(ACCORDING CHEMICAL STRUCTURE)
I. Inorganic substances 2. Oxidizing agents:
1. Halogens: • Hydrogen peroxide
• Iodine (2%, 3%, 5% alcochol • Potassium permanganate
solution) 3. Acids and alkalis:
• Iodinolum • Boric acid
• Ioddicerinum • Salicylic acid
• Solution of ammonia
• Povidon-Iod (Betadinum)
4. Metallic salts:
• Iodophorm • Hydrargyri dichloridum
• Lugol’s solution • Hydrargyri amidochloridum
• Chloramine B • Silver nitrate
• Copper sulfate
• Chlorhexidine bigluconate
• Zinc sulfate
• Pantocidum (Halazone) • Zinc oxide
II. Organic substances
1. Aldehydes: 5. Detergents:
• Formaldehyde (Formalinum)
• Aethonium
• Glutaraldehide
• Decamethoxin
• Hexamethylentetraminum (Methenamine)
2. Alcochols: • Roccal
• Spiritus aethylicus (Ethyl alcohol) • Dimexid
3. Phenol derivatives: 6.Tar, resins, products of petroleum:
• Phenol (Phenolum purum, • Pix liquida Betulae (Birch tar)
Carbolic acid) • Ichthyolum
• Cresol (Tricresolum)
• Liniment by Vishnevsky
• Resorcinol
• Thymol 7. Nitrofuran derivatives:
• Benzylbenzoat • Nitrofurasone (Furacilinum)
4. Dyes: 8. Antiseptics from medicinal
• Methylenum blue plants:
• Brilliant green (Viride nitens) • Chlorophyliptum
• Etacridin lactate • Novoimaninum
 PEDOMAN PENANDAAN ALAT KESEHATAN
DAN PERBEKALAN KESEHATAN RUMAH TANGGA
(PKRT)
Gunamenghindariterjadinyakesalahanpadapenggunaan, maka pada penandaan harus
mencantumkan tambahan informasi sebagai berikut
1.Jenis produk dan varian;
2.Nama dan kadar/persentase bahan aktif;
3.Bahan aktif ditulis sesuai dengan nama resmi dan sebelum penulisan nama bahan/zat aktif
harus tercantum ”bahan aktif” atau ”zat aktif”;
4.Tanda peringatan atau efek samping kecuali PKRT kelas I;
5.Tanggal kedaluwarsa untuk produk yang memiliki batas kedaluwarsa.

Pada penandaan tidak diperbolehkan menggunakan kata-kata berikut :

1.Penulisan persentase untuk menyatakan tingkat mutu dan efektivitas

produk, misalnya 100%, 99%.
 PERATURAN MENTERI KESEHATAN REPUBLIK INDONESIA
NOMOR 27 TAHUN 2017
TENTANG
PEDOMAN PENCEGAHAN DAN PENGENDALIAN INFEKSI
DI FASILITAS PELAYANAN KESEHATA
Kriteria memilih antiseptik:
- Memiliki efek yang luas, menghambat atau merusak mikroorganisme secara luas (gram
positif dan gram negative,virus lipofilik,bacillus dan tuberkulosis,fungiserta endospore)
- Efektifitas
- Kecepatan efektifitas awal
- Efek residu, aksi yang lama setelah pemakaian untuk meredam pertumbuhan
- Tidak menyebabkan iritasi kulit
- Tidak menyebabkan alergi

Fasilitas pelayanan kesehatan harus mempunyai disinfektan yang sesuai standar untuk
mengurangi kemungkinan penyebaran kontaminasi.
Contoh :Natrium hipoklorit 0,05-0,5%, H2O2(H2O2) 0,5-1,4% untuk ruangan rawat dan
2% untuk permukaan kamar operasi, sedangkan 5-35% (dry mist) untuk udara.
METODE UJI
 Classification based on the objective

 Basic test
– To evaluate the intrinsic qualities of a disinfectants
– Bactericidal, fungicidal, sporicidal or virucidal tests

 Application test
– To determine the best conditions of application
– Common and specified strains in a defined procedure
– Concentration, exposure time and temperature

 In‐use and field test

– To evaluate the result of a disinfectant
– To verify the efficacy in a defined procedure
EN 1040
bactericidal activity – Phase 1 / Step 1. Suspension test in 5 minutes (or 1, 15, 30 and 60 minutes), at
20°C (or others with 10°C interval) – Microbial reduction >105.

EN 13727
bactericidal activity – Phase 2 / Step 1. Medical. Quantitative suspension test in 60 minutes (or 5, 15
and 30 minutes), at +20°C (or others with 10°C interval), in the presence of interfering substances (CC:
0.3 g/L albumin + 30°f hard water; DC: 3g/L albumin + 3ml/L erythrocytes + 30°f hard water; or others)
– Microbial reduction > 105.
EN 1276
bactericidal activity – Phase 2 / Step 1 – Industry. Quantitative suspension test in 5 minutes (or
other additional), at +20°C (or others with 10°C interval), in the presence of interfering substances
(CC: 0.3 g/L albumin + 30°f hard water; DC: 3g/L albumin + 30°f hard water; or others) – Microbial
reduction > 105
EN 13697
bactericidal activity - Phase 2 / Step 2 – Medical. Quantitative carrier test by immersion in 60
minutes (or 5, 15 and 30 minutes), at +20°C (or others with 10°C interval), in the presence of
interfering sub- stances (CC: 0.3 g/L albumin +30°f hard water; DC: 3 g/L albumin + 3 ml/L
erythrocytes + 30°f hard water; or others) – Microbial reducation > 104.
EN 14561
bactericidal activity – Phase 2 / Step 2 – Medical. Quantitative carrier test by immersion in 60
minutes (or 5, 15 and 30 minutes), at +20°C (or others with 10°C interval), in the presence of
interfering sub- stances (CC: 0.3 g/L albumin + 30°f hard water; DC: 3 g/L albumin + 3 ml/L
erythrocytes + 30°f hard water; or others) – Microbial reduction > 105.
EN 13697
fungicidal / yeasticidal activity – Phase 2 / Step 2. Industry. Quantitative carrier test in 15 minutes (or
1, 5, 30 60 minutes), at +20°C (or +4, +10 and +40°C), in the presence of interfering substances (CC:
0.3 g/L albumin + 30°f hard water; DC:3 g/L albumin + 30°f hard water; or others) – Microbial reduction
> 103.
EN 14348
mycobactericidal / tuberculocidal activity – Phase 2 / Step 1 – Medical. Quantitative suspension
test in 60 minutes (5, 15 and 30 minutes), at +20°C (or others with 10°C interval), in the presence of
interfer- ing substances (CC: 0.3 g/L albumin + 30°f hard water; DC: 3 g/L albumin + 3 ml/L
erythrocytes + 30°f hard water; or others ) – Microbial reduction > 104.
EN 14563
mycobactericidal / tuberculocidal activity - Phase 2 / Step 1 – Medical. Quantitative suspension
test in 60 minutes (5, 15 and 30 minutes), at +20°C (or others with 10°C interval), in the presence of
interfer- ing substances (CC: 0.3 g/L albumin + 30°f hard water; DC: 3 g/L albumin + 3 ml/L
erythrocytes + 30°f hard water; or others ) – Microbial reduction > 104.
Bactericidal activity - Phase 2 / Step 2
EN 13697
This European Standard specifies a test method (phase 2/step 2) and the minimum requirements for bactericidal
and/or fungicidal or yeasticidal activity of chemical disinfectants :
 that form a homogeneous physically stable preparation in hard water or - in the case of ready-to-use products -
with water in food, industrial, domestic and institutional areas, excluding areas and situations where disinfection
is medically indicated and excluding products used on living tissues.

The scope of this European Standard applies at least to

the following:
2) Food of vegetable origin:
a) Processing, distribution and retailing of:
i) beverages;
1) Food of animal origin:
ii) fruits, vegetables and derivatives (including sugar
i) milk and milk products;
distillery);
ii) meat and meat products;
iii) flour, milling and backing;
iii) fish, seafood and products;
iv) animal feeds;
iv) eggs and egg products;
v) etc.
v) animal feeds;
vi) etc.
Bactericidal activity - Phase 2 / Step 2
EN 13697
b) Institutional and domestic areas: c) Other industrial areas:
1) catering establishments; 1) packaging material;
2) public areas; 2) biotechnology (yeast, proteins, enzymes...);
3) public transports; 3) pharmaceutical;
4) schools; 4) cosmetics and toiletries;
5) nurseries; 5) textiles;
6) shops; 6) space industry, computer industry;
7) sports rooms; 7) etc.
8) waste container (bins);
9) hotels;
10) dwellings;
11) clinically non sensitive areas of hospitals;
12) offices;
13) etc.
Bactericidal activity - Phase 2 / Step 2
HAND ANTISEPTIK/DISINFECTANT
EN 1499 EN1500: Hygienic Hand Rub
Surface test for hygienic handwashes Challenge organism: E. coli Single product
 12 – 15 volunteers; hands immersed in cross-over design:
E. coli K12 broth  Each volunteer uses test product and an
 Reference Product vs Test Product internal reference product
 Reference non-antimicrobial soft soap, 5  Product application for defined volume,
ml for contact time
 60 seconds  Typical: 3 ml for 30 sec
 Log10 Reduction Factors calculated (RF)  Must show non-inferiority to internal
 Traditional superiority test, 𝑝𝑝 = 0.01 reference
 2 x 3 ml of 60% isopropyl alcohol ◦ 60 second
total rub time
 Non-inferiority test, 𝑝𝑝 = 0.025
TEST AND REFERENCE PRODUCTS
EN 1499 - Soft soap
EN 1500 - Propan-2-ol 60% (v/v) EN 12791 – Propan-1-ol 60% (v/v)
The effectiveness of reference and test products are assessed