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• Biocides
  • Efficacy test on Biocides/Disinfectants

Efficacy test on Biocides/Disinfectants

The biocides laboratory of Chelab Pharma Division gives assistance to the company for the creation of suitable protocols of performance of biological assay for the evaluation of efficacy in particular of biocides/disinfectants.
Biocides/disinfectants constitute an heterogeneous group of products (it includes the traditional disinfectant, the soap or the antibacterial gel) which has the common property of killing the microorganisms. The Directive concerning biocides requires the verification of the efficacy of biocides/disinfectants introduced on the market. This verification must be carried out in compliance with the use of the product, according to the information reported in the label, by using methods recognized at European level and in authorized laboratories.
Chelab is able to help the producers of biocides/disinfectants in the drawing up and in the fulfilment of specific protocols of different typologies of disinfectants. All the activities are performed in accordance with the GLP and can be formulated in compliance with the requirements of the costumers.
The laboratory is certified by the Ministry of the Health according to the Legislative Decree 120/92 and following updatings. Chelab works in accordance with the Good Laboratory Practise for the verifications mentioned above on biocides/disinfectants with recognized and validated protocols:

 

1. RAW MATERIALS (ACTIVE PRINCIPLES)

2. VETERINARY AREA

3.MEDICAL AREA 

RAW MATERIALS (ACTIVE SUBSTANCES)
EN 1040 basic bactericidal activities
EN 1275 basic fungicidal activities
EN 14347 basic sporicidal activities  
ASTM E1891-97(2002) Standard Guide for Determination of a Survival Curve for Antimicrobial Agents Against Selected Micro-organisms and Calculation of a D-Value and Concentration Coefficient
ASTM E1482-04 Standard Test Method for Neutralization of Virucidal Agents in Virucidal Efficacy Evaluations

ISTITUTIONAL, FOOD AND DOMESTIC AREA (surface and hand disinfection, disinfectant wet wipes, cosmetics and so on)

General methods

EN 1276 suspension test for the evaluation of bactericidal activity (phase 2 step 1)
EN 1650 suspension test for the evaluation of fungicidal activity (phase 2 step 1)
EN 13697 surface test for the evaluation of the bactericidal and fungicidal activity (phase 2 step 2) 
EN 13704 sporicidal activity (phase 2 step 1) 
EN 13610 virucidal activity (Phagi) (phase 2 step 1)
ASTM E1153-03 Standard Test Method for Efficacy of Sanitizers Recommended for Inanimate Non-Food Contact Surfaces
ASTM E2111-05 Standard Quantitative Carrier Test Method to Evaluate the Bactericidal, Fungicidal, Mycobactericidal, and Sporicidal Potencies of Liquid Chemical Microbicides
ASTM E1052-96 Standard Test Method for Efficacy of Antimicrobial Agents Against Viruses in Suspension

Rinse and no rinse disinfection for intact skin

prEN 12054 and EN 1276:2009 suspension test for the evaluation of the bactericidal activities (phase 2 step 1)
(phase 2 step 2) EN 1499 bactericidal activities on volunteers – no rinse
(phase 2 step 2) EN 1500 bactericidal activities on volunteers –  rinse
ASTM E2276-03e1 Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adult Subjects
ASTM E1174-06 Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations
ASTM E1838-02 Standard Test Method for Determining the Virus-Eliminating Effectiveness of Liquid Hygienic Handwash and Handrub Agents Using the Fingerpads of Adult Volunteers

Verification of the persistence action of skin disinfectant

ASTM E1882-05 Standard Test Method for Evaluation of Antimicrobial Formulations by the Agar Patch Technique

Disinfection systems of air and water treatment

Bactericidal activities against Legionella (fase 2 step 1) EN 13623
ASTM E645 Standard Test Method for Efficacy of Microbicides Used in Cooling Water Systems
AOAC965.13 Bactericidal activities for swimming pool

Paper industry disinfection

ASTM E723-07 Standard Test Method for Efficacy of Antimicrobials as Preservatives for Aqueous-Based Products Used in the Paper Industry (Bacterial Spoilage)
ASTM E875-00 Standard Test Method for Efficacy of Fungal Control Agents as Preservatives for Aqueous-Based Products Used in the Paper Industry
ASTM E1839-07 Standard Test Method for Efficacy of Slimicides for the Paper Industry-Bacterial and Fungal Slime
EN 1104 Paper and board intended to come into contact with foodstuffs. Determination of transfer of antimicrobic constituents

Surface disinfection also with wet wipes

ASTM E2362-09 Standard Practice for Evaluation of Pre-saturated or Impregnated Towelettes for Hard Surface Disinfection
ASTM E1153-03 Standard Test Method for Efficacy of Sanitizers Recommended for Inanimate Non-Food Contact Surfaces
ASTM E1053-97(2002) Standard Test Method for Efficacy of Virucidal Agents Intended for Inanimate Environmental Surfaces

Laundry disinfection

ASTM E2406-09 Standard Test Method for Evaluation of Laundry Sanitizers and Disinfectants for Use in High Efficiency Washing Operations
ASTM E2274-09 Standard Test Method for Evaluation of Laundry Sanitizers and Disinfectants

Textile disinfection

AATCC 30 Antifungal activity assessment on textile materials: mildew and rot resistance of textile materials
AATCC 147             Antibacterial activity assessment of textile materials: parallela streak method
JIS L 1902:2008 Testing for antibacterial activity and efficacy on textile products
EN-ISO 20743 Textiles - Determination of antibacterial activity of antibacterial finished products
EN-ISO 20645 Textile fabrics - Determination of antibacterial activity -Agar diffusion plate test
ASTM E2471-05 Standard Test Method for Using Seeded-Agar for the Screening Assessment of Antimicrobial Activity In Carpets

Incorporated disinfectants in plastic and polymeric materials

ASTM E2180-07 Standard Test Method for Determining the Activity of Incorporated Antimicrobial Agent(s) In Polymeric or Hydrophobic Materials
JIS Z 2801:2006 Antimicrobial Surface Test "Test for Antimicrobial Activity and Efficacy"
ISO 22196  Plastics -- Measurement of antibacterial activity on plastics surfaces
ASTM E2149 Standard Test Method for Determining the Antimicrobial Activity of Immobilized Antimicrobial Agents Under Dynamic Contact Conditions
ASTM E2180 Standard Test Method for Determining the Activity of Incorporated Antimicrobial Agent(s) In Polymeric or Hydrophobic Materials

VETERINARY AREA

EN 1656 bactericidal activity  (phase2 step 1)
EN 14349 bactericidal activity  (phase 2 step 2)
EN 14204 micobactericidal activity (phase 2 step 1)
EN 14675 virucidal activities (phase 2 step 1)
ASTM E1327-07 Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions

MEDICAL AREA

Intact skin disinfection also for surgical use

prEN 12054 and EN 1276 bactericidal activities in suspension (phase 2 step 1)
EN 1500 bactericidal activities on volunteers – rinse (phase 2 step 2)
EN 1499 bactericidal activity on volunteer - no rinse (phase 2 step 2)
EN 12791 bactericidal activity on volunteer Surgical handrub and handwash (phase 2 step 2)
EN 14476 virucidal activities (phase 2 step 1)
ASTM E1589-05 Standard Test Method for Evaluation of First Aid Antiseptic Drug Products
ASTM E1115-02 Standard Test Method for Evaluation of Surgical Hand Scrub Formulations
ASTM E1589-05 Standard Test Method for Evaluation of First Aid Antiseptic Drug Products
ASTM E1327-07 Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions

Surface disinfection

EN 14348 mycobactericidal and tubercolicidal activity (phase 2 step 1)
EN 14476 virucidal activity  (phase 2 step 1)

Equipment disinfection

EN 13727 suspension test for the evaluation of the bactericidal activities (phase 2 step 1)
EN 14561 surface bactericidal activities (phase 2 step 2)
EN 13624 suspension test for the evaluation of the fungicidal activity (phase 2 step 1)
EN 14562 surface fungicidal activity (phase 2 step 2)
EN 14348 suspension test for the evaluation of the mycobacterial and tubercolicidal activity (phase 2 step 1)
EN 14563 surface mycobactericidal and tubercolicidal activity (phase 2 step 2)
EN 14476 virucidal activity (phase 2 step 1)
ASTM E2314-03 Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)
ASTM E1766-95 Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
ASTM E1837-96 Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test)
BS EN ISO 15883 Washer-disinfectors. General requirements, terms and definitions and tests

 

 

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