TECHNICAL BULLETIN 1.3 WHO Hand-Rub Disinfectant ...Alcohol-based hand disinfectants are the worldwide gold standard for hygienic hand disinfection. , with 75% alcohol, is committed

WHO recommended* Hand-Rub Disinfectant & Sanitizer

Purified Water IP ........................... q.s.

Isopropyl Alcohol IP ............ 75% v/vGlycerol IP .......................... 1.45% v/vHydrogen Peroxide IP .... 0.125% v/v

Product Properties CompositionActive Ingredients

Uniqueness of Ingredients

Most common and widely used disinfectant within pharmaceutics, hospitals, clean rooms, and electronics or medical devices

Propanol:

Serves as an emollient to protect skin against dryness, dermatitis and helps preserve skin moisture

Glycerol:

§ Demonstrates broad-spectrum efficacy against viruses, bacteria, yeasts, and bacterial spores

§ A widely used biocide for disinfection, sterilization, and antisepsis

Hydrogen peroxide:

* Available at https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf.accessed on: 18th March 2020.Ref:

For Domestic

0.2 Micron Filtered

TECHNICAL BULLETIN 1.3

Alcohol-based hand disinfectants are the worldwide gold standard for hygienic hand disinfection. , with 75% alcohol, is committed to making infection control, efficient and convenient.

Sterlo MaxTM

Sterlo MaxTM

RUB-IN-HAND DISINFECTANT & SANITIZER

§ Fast acting

§ Disinfects and kills 99.9% germs

§ liquid hand rub SterloMax

§ Excellent skin tolerability even with long-term use

§ Alcohol based

§ No water required

§ Rapid and effective action against viruses, bacteria and fungi

Sterlo MaxTM

§ Yeasticidal§ Tuberculocidal

§ Bactericidal§ Virucidal against enveloped viruses (incl. HBV, HIV,

HCV) adenovirus, Polyoma, Rota viruses

§ Mycobactericidallong-term use

Ready-to-use alcohol based rub-in product independent of water and wash basin, to prevent infection, in all areas of health care and industry, where hygiene is important. It can also be used in home dialysis and travelling.

Microbiology Areas of application

n Rub 3ml in hands for 30 seconds for Hygienic Hand Disinfection

n Make sure hands are completely covered during application time

n Rub 6ml in hands for 90 seconds for Surgical Hand Disinfection

n Not recommended for infantsn For children under 6, use only under adult supervision

n Please give special attention for finger tips and thumbs

Areas of application

§ 7 types of fungi§ 18 types of viruses including HCV, Avian flu, Swine flu,

Polyoma, Adeno, Sars and Ebola

§ 70 different strains of bacteria (Gm +ve and -ve)

§ 6 types of mycobacteria§ 14 antibiotic resistant strains

The Antimicrobial Spectrum

8 Clostridium difficile

SN Bacteria, Mycobacteria

2 Acinetobacter baumannii 3 Acinetobacter baumannii 4 Acinetobacter calcoacetocus

6 Bacteroides fragilis 7 Burkholderia cepacia

1 Acinetobacter baumannii

5 Acinetobacter lwoffii

9 Cholera-Vibrionen 10 Citrobacter freundii

12 Enterobacter cloacae 11 Enterobacter cloacae

13 Enterobacter cloacae 14 Enterococcus faecalis 15 Enterococcus faecalis 16 Enterococcus faecium 17 Enterococcus faecium 18 Enterococcus faecium 19 Enterococcus hirae 20 Eschericha coli ( K 12) 21 Eschericha coli 22 Eschericha coli

31 Klebsiella pneumoniae

23 Eschericha coli

27 Eschericha coli

30 Klebsiella pneumoniae 29 Klebsiella oxytoca

25 Eschericha coli EHEC24 Eschericha coli

26 Eschericha coli

28 Haemophilus influenzae


ATCC 19418 multidrug-resistant

ATCC 4352 ATCC 11296

ATCC 43165

0157: H 7

multidrug-resistant

multidrug-resistant

ATCC 13047

antibiotic resistant

ATCC 10541

ATCC 25285

ATCC 19606

ATCC 15309

ATCC 25416 ATCC 9689

ATCC 13048

ATCC 29212

vancomycin-resistant ATCC 19434

vancom ycin-resistant

ATCC 25922 ATCC 10536 ATCC 11229 CNCTC Ee 324 / 70

NCTC 10538

DSM 8579

49 Proteus vulgaris 48 Proteus vulgaris

36 Micrococcus luteus

52 Pseudomonas aeruginosa

40 Mycobacterium terrae

43 Mycobacterium tuberculosis


37 Micrococcus luteus 38 MRSA


46 Proteus mirabilis 47 Proteus vulgaris





45 Proteus mirabilis

34 Listeria monocytogenes

39 Mycobacterium smegmatis

35 Listeria monocytogenes


58 Pseudomonas aeruginosa59 Pseudomonas aeruginosa60 Pseudomonas aeruginosa


61 Pseudomonas aeruginosa62 Salmonella enteritidis63 Salmonella enteritidis64 Salmonella typhimurium65 Salmonella typhimurium


57 Pseudomonas aeruginosa56 Pseudomonas aeruginosa

ATCC 7644 ATCC 7468

multidrug -resistant

ATCC 13311

ATCC 14153

ATCC 15755

ATCC 15442

CFB 022

H37Ra CIP 103471

ATCC 25618

CNCTC PrO 10/52

ATCC 9341

ATCC 13076

multidrug-resistant

ATCC 13315

ATCC 15442

ATCC 33592

ATCC 27294

ATCC 7002

ATCC 27853 antibiotic resistant

HM 116 CNCTC Ps 79 / 70

WHO recommended* Hand-Rub Disinfectant & Sanitizer Sterlo MaxTM


saprophyticus83 Streptococcus faecalis

90 Streptococcus pyogenes

84 Streptococcus faecalis

82 Staphylococcus

88 Streptococcus pneumoniae

85 Streptococcus faecalis

81 Staphylococcus hominis

89 Streptococcus pyogenes

87 Streptococcus pneumoniae86 Streptococcus pneumoniae

69 Shigella sonnei

66 Serratia marcescens 67 Serratia marcescens68 Serratia marcescens

70 Staphylococcus aureus71 Staphylococcus aureus72 Staphylococcus aureus

73 Staphylococcus aureus

74 Staphylococcus aureus75 Staphylococcus aureus76 Staphylococcus aureus77 Staphylococcus aureus78 Staphylococcus epidermis79 Staphylococcus epidermis 80 Staphylococcus aemolyticus

intermediate

ATCC 14756 CNCTC Sm 29 / 80ATCC 11060

ATCC 29213vancomycin -

antibiotic resistant (MRSA) ATCC 597 ATCC 6538 ATCC 9144

ATCC 12228 ATCC 29970

resistant (M RSA)

ATCC 27844 ATCC 15305

CNCTC Mau 43 / 60

ATCC 6057

ATCC 6303

ATCC 10541

ATCC 19615

penicillin-resistant

6 Microsporum gypseum7 Trichophyton mentagrophytes

SN Fungi, Yeast 1 Aspergillus niger

3 Candida albicans 2 Candida albicans

4 Candida tropicalis5 Epidermopphyton floccosum

15 Vaccinia

2 BVDV

5 Herpes simplex

7 Herpes simplex

SN Viruses

6 Herpes simplex

1 Adena

8 Herpes simplex

4 Herpes simplex

10 HIV 11 Influenza A

9 Herpes simplex

12 Polyoma

3 HBV

13 Rota 14 Rota

16 H5N1

18 Ebola 17 H1N1

Strain 777

Type 1 strain RR

Swine Flu

Type 2 MacIntyre, ATCC VR 539

Stamm NADL

Type 2 strain D 316

Type 5 strain Adenoid 75

Type 2 strain DD

Strain Elstree

ATCC VR-544

Ebola Haemorrhagic Fever

Type 1 MS, ATCC VR-540

Strain WA

Avian Flu

Strain RIT 4237

Type 1 strain HFEM

EFFICACY EXAMPLES *Broad Spectrum

Bacteria and fungiEN Phase 2 / Step 2

Efficacy according to EN Phase 2 / Step 2 (Practical tests)

Hygienic Hand Disinfection (EN 1500)

30 sec.

Surgical Hand Disinfection (EN 12791)

1.5 min.

EN Phase 2 / Step 1

Appraised efficacy according to EN Phase 2 / Step 1 (suspension tests)

Bactericidal (EN 13727) 15 sec. Yeasticidal (EN 13624) 15 sec.Tuberculocidal (EN 14348) 30 sec. Mycobactericidal (EN 14348)

30 sec.

EN Phase 1

Appraisal according to EN Phase 1 (basic tests / suspension tets) without contamination; does not define the applicability of a product for a specificpurpose

Bactericidal (EN 1040) 15 sec. Yeasticidal (EN 1275) 15 sec.

VAH Certified Application Recommendations for Hygienic Hand Disinfection from the Association for Applied Hygiene (VAH). Based on suspension and practical tests.

Bactericidal / Yeasticidal 30 sec.

Certified Application Recommendations for Surgical Hand Disinfection from the VAH. Based on suspension and practical

Bactericidal / Yeasticidal 1.5 min.


STCC 1400

ATCC 6275 /70

ATCC 10231

Sterlo MaxTM


DGHM Appraised efficacy against bacteria (in accordance with the German Society of Hygiene and Microbiology [DGHM]); within the certified bactericidal efficacy

MRSA / EHEC 30 sec. Listeria / Salmonella 15 sec.

RKI IfSG (Robert Koch-Institut [RKI]) Recognized substance for decontamination according to §18

Area A - vegetative bacteria; incl. mycobacteria (use twice for Tb)

30 sec.

ASTM Appraised efficacy in compliance with American Standard Test Methods (ASTM)

Bactericidal (FDA) 30 sec. Yeasticidal (FDA) 30 sec.

Viruses

EN Phase 2 / Step 1

Efficacy according to EN Phase 2 / Step 1 (suspension tests)

Adenovirus (EN 14476) 1 min.

DVV Efficacy against viruses (German Society for the Control of Viral Diseases [DVV])

Virucidal against enveloped viruses (incl. HBV, HIV, HCV)

15 sec.

DVV Appraised efficacy against enveloped viruses (in accordance with DVV)

Influenza-A-Virus (avian) 15 sec. Influenza-A-Virus (human) 15 sec. Herpes simplex Virus type 1 and 2

15 sec.

SARS-CoV 30 sec.

DVV Appraised efficacy against non-enveloped viruses (DVV)

Adenovirus 1 min. Polyomavirus 5 min.

DVV Appraised efficacy against enveloped viruses (DVV)

Rotavirus 15 sec.

Skin Disinfection

Phase 2 / Step 1 Appraised according to Phase 2/Step1 (suspension tests)

Bactericidal (EN 13727) 15 sec. Yeasticidal (EN 13624) 15 sec.

VAH Certified Application Recommendations for prophylactic skin disinfection from the Association of Applied Hygiene (VAH). Based on suspension and practical tests For skin low and rich insebaceous glands

Bactericidal/Yeasticidal skin low in sebaceous glands prior to injections and punctures

15 sec.

Bactericidal/Yeasticidal skin low in sebaceous glands prior to punctures of joints, body cavitites, hollow organs und before surgical procedures

1 min.

Bactericidal/Yeasticidal skin rich in sebaceous glands before all procedures

10 min.

Stable under normal ambient temperatures

iii. 100 ml x 50 per cartonii. 500 ml x 20 per cartoni. 5 litres x 2 per carton

Stability

Shipping configurations

Shelf Life: 36 Months

Best Before: 12 months after opening container

Fill in

Dispenser Pump Spray

For further information contact:

Manufactured by:Bioplus Life Sciences Pvt. Ltd.S. No. 10-1A, Hoodi Village, Krishnarajapuram Hobli, Bangalore - 560 048.

[email protected]

Mobile: +91 98453 94728, Email: [email protected]

Issued date: 19 March, 2020

Issued by: Merry George

SI-P

DS-

D03

/Mar

202

0

ISO 22000:2005ISO 14001:2015


H E A L T H C A R E

Sterlo MaxTM


Available

Fast acting, Ready-to-use, no water required, for hygiene and surgical hand disinfection, to sanitize hard porous surfaces.

5 Litres 500 ml



100 ml

Available shortly

Sterlo MaxTM Sterlo MaxTM Sterlo MaxTM

Documents

TECHNICAL BULLETIN 1.3 WHO Hand-Rub Disinfectant ...Alcohol-based hand disinfectants are the worldwide gold standard for hygienic hand disinfection. , with 75% alcohol, is committed