Partner fordisinfection ~ RTTT& Ui@iOi.Rt§§iUl4ilt WSterillium®Alcoholic Rub-in hand Antiseptic (Ready-to-use)For disinfection of hands in sterile sections, manufacturing & packaging areas of oral & injectable formulations.

The hand is the No,1 pathway for germ transmission, because millions of microorganisms feel absolutely at home on the hands.Manufacturing of injectibles, intravenous drugs and life saving compounds need a high degree of asepsis, requiring specialattention to the hand hygiene, of the personnel handling these products,Sugar, a commonly used agent in various formulations, makes the environment susceptible to the growth of micro-organisms,

Hygienic cleaning and disinfection of hands is the most important weapon in breaking the chain of cross contaminationin the clean room environment, production area and packing area. This will ensure quality, purity and sterility of the finalproduct manufactured.

HBVHepatitis B

Virus

HIVAIDS -Virus

H5NI EN 1500Hygienic HandDisinfection

,~~~'

FDA •(TfM)~-~Avian Flu

Staphylococcus aureus, REM-magnification 6,300 fold

Sterillium®Alcoholic rub-in hand antiseptic

Spectrum of Activity :

• 70 different strains of bacteria (g·m+ve + gm-ve)

• 14 antibiotic resistant strains

• 6 types of Mycobacteria

• 7 types of fungi• 16 types of viruses including HCV, Avian Flu, Polyoma,

Adeno & Sars'--.

Bacteria, MycobacteriaS.N.

1 Acinetobacter baumannii

2 Acinetobacter baumannii ATCC 19606

3 Acinetobacter baumannii multidrug-resistant

4 Acinetobacter calcoacetocus

5 Acinetobacter Iwolfii ATCC 15309

6 Bacteroides fragilis ATCC 25285

7 Burkholderia cepacia ATCC 25416

8 Clostridium difficile ATCC 9689;-9Cholera-Vibrionen

--'-·0-·Citrobacter freundii10

11 Enterobacter cloacae ATCC 13048

12 Enterobacter cloacae---:: ....... -=--~----.- -~-" -13 Enterobacter cloacae ATCC 13047

14 Enterococcus faecal is ATCC 29212

15 Enterococcus faecalis vancom ycin-resistant

16 Enterococcus faecium ATCC 19434

17 Enterococcus faecium antibiotic resistant

18 Enterococcus faecium vancomycin-resistant

19 Enterococcus hirae ATCC 10541

20 Eschericha coli ( K 12) NCTC 10538 ----lf-::".,-. ----_._-_._. ._.- .._-21 Eschericha coli ATCC 25922 I

22 Eschericha coli ATCC 10536

23 Eschericha coli ATCC 11229-24 ~hericha coli CNCTC Ec 324/70

25 Eschericha coli EHEC OSM 8579

26 Eschericha coli 0157: H 7 I

27 Eschericha coli multidrug-resistant

28 Haemophilus influenzae ATCC 19418

29 Klebsiella oxytoca ATCC 43165

30 Klebsiella pneumoniae mUltidrug-resistant

31 Klebsiella pneumoniae ATCC 11296._....--

Klebsiella pneumoniae ATCC 435232

33 Klebsiella pneumoniae

34 Listeria monocytogenes

35 Listeria monocytogenes ATCC 7644

36 Micrococcus luteus ATCC 7468 I~ •...-:-;;ATCC 934137 Micrococcus luteus

38 MRSA ATCC 33592

39 Mycobacterium smegmatis CFB 022

40 Mycobacterium terrae ATCC 15755

41 Mycobacterium tuberculosis ATCC 27294

42 Mycobacterium tuberculosis ATCC 25618

43 Mycobacterium tuberculosis multidrug-resistant

44 Mycobacterium tuberculosis H?7RaCIP 103471

45 Proteus mirabilis ATCC 14153--

46 Proteus mirabilis ATCC 7002

47 Proteus vulgaris-48- -=-._-_ ........_ ..._...

ATCC 13315Proteus vulgaris

49 Proteus vulgaris CNCTC PrO 10/52

50 Pseudomonas aeruginosa ATCC 15442

51 Pseudomonas aeruginosa ATCC 27853

~~ Pseudomonas aeruginosa antibiotic resistant I

.__ . ---

53 Pseudomonas aeruginosa

54 Pseudomonas aeruginosa ATCC 15442

55 Pseudomonas aeruginosa CNCTC Ps 79 / 70

56 Pseudomonas aeruginosa HM 116

57 Pseudomonas aeruginosa multidrug -resistant

58 Pseudomonas aeruginosa

59 Pseudomonas aeruginosa

60 Pseudomonas aeruginosa-"*--_.-

61 Pseudomonas aeruginosa

62 Salmonella enteritidis

63 Salmonella enteritidis ATCC 13076

64 Salmonella typhimurium

65 Salmonella typhimurium ATCC 13311

66 Serratia marcescens

67 Serratia marcescens ATCC 14756

68 Serratia marcescens CNCTC Sm 29/ 80

6() Shigella sonnei ATCC 11060

70 Staphylococcus aureus

71 Staphylococcus aureus ATCC 29213

72 Staphylococcus aureus vancomycin -

intermediate-resistant

73 Staphylococcus aureus antibiotic resistant

74 Staphylococcus aureus ATCC 597

75 Staphylococcus au reus ATCC 6538

76 Staphylococcus aureus ATCC 9144

77 Staphylococcus aureus CNCTC Mau 43 /60

78 Staphylococcus epidermis

79 Staphylococcus epidermis ATCC 12228

80 Staphylococcus haemolyticus ATCC 29970

81 Staphylococcus hominis ATCC 27844

82 Staphylococcus saprophytic us ATCC 15305

83 Streptococcus taecalis

84 Streptococcus faecalis ATCC 6057

85 Streptococcus taecalis ATCC 10541

86 Streptococcus pneumoniae

87 Streptococcus pneumoniae ATCC 6303

88 IStreptococcus pneumoniae penicillin-resistant

89 Streptococcus pyogenes

90 Streptococcus pyogenes ATCC 19615

S.N Fungi, Yeast

1 Aspergillus niger ATCC 6275 /70

2 Candida albicans

3 Candida albicans ATCC 10231

4 Candida tropical is STCC 1400

5 Epidermopphyton floccosum

6 Microsporum gypseum

7 Trichophyton mentagrophytes

S.N Viruses

1 Adeno type 5 strain Adenoid 75

2 BVOV Stamm NAOL

3 HBV

4 Herpes simplex type 1 strain HFEM

5 Herpes simplex type 1 strain RR

6 Herpes simplex type 1 MS, ATCC VR-540

7 Herpes simplex type 2 strain 0 316

8 Herpes simplex type 2 Macintyre, ATCC VR 539

9 Herpes simplex type 2 strain DO

10 HIV

11 Influenza A ATCC VR-544

12 Polyoma strain 777

13 Rota strain WA

14 Rota strain RIT 4237

15 Vaccinia strain Elstree

16 H5Ni avian flu

sternnum" passes the EN 1500 norm in 30 seconds for Hygienic Hand Disinfection

Recent Changes :Health care law in Western Europe and North America are becoming more stringent every day. In order to accessthese markets, manufacturing facilities are scrutinized stringently. Therefore complete sterile conditions inmanufacturing units are expected. Minimization of contamination and control of Bio-burden is the norm of the day.

Composition:

Each 1OOgms contains:

• 2-propanol• 1-propanol• ethyl-hexadecyl-dimethyl

ammonium-ethylsulphate(Mecetronium ethylsulphate)

• Skin Protective substances

45 gms30 gms

: 0.2 gms

Spectrum of Activity :

Sterillium is a complete broad spectrummicrobicidal with skin protectors for frequenthand antisepsis.

• Effective kill rate of 99.99% in 30 secsonly!!

• Effective against all fungi includingcandida albicans

• Effective against all gram positivebacteria including Staph. Aureus

• Effective against all gram negativebacteria including E.coli

• Effective against all mycobacteria

• Effective against all Viruses includingHBV, HCV, HIV, Polyoma, Adeno &H5VI

• Effective against all resistant bacteria

• It prevents cross contamination, reducesbio-burden, comes with completevalidation reports, certificate of analysis,MSDS, and comparison charts withother products.

Why only Sterlllium !!

• Practical & -Mo s t Economical• No Soap, water or towel required• One bottle contains 500ml = (gives 170

rubs) 3ml per hand rub.• Very good residual am persistent effect.• Only 3ml rubbed for 30 seconds (press

twice from calibrated dispenser provided).• Non-toxic, skin friendly, can be used

frequently.• Exceptionally good skin tolerability even

with long-term use.

• Excellent skin protection and skin careproperties.

• Sterillium is the most evaluated AlcoholHand Rub in the world with severalInternational Publications.

Please Note :

• Microbicidal and Validation reports,Certificate of Analysis and MSDSavailable on request.

• Registered in 54 countries worldwide including UK & USA.

• 40 years of experience, severalinternational papers published injournals. (Available on request)

• Flagship product of our company,Bode Chemie Germany, recipient ofthe ISO - 9001 Certificate.

Mode of Application:

Hygienic hand disinfection:

• Wash hands to remove coarse organicmatter (if any), and dry.

• Sterillium is to be used with a speciallydesigned elbow dispenser to preventcontamination.

• Rub Sterillium (3m I) well over handsand nail grooves for 30 seconds (presstwice from calibrated dispenser provided).

• Do not rinse or wipe dry after use.

Method of Action :

• Both alcohols combine to give lethalaction on all microorganisms on hand(Transient flora)

• Sterillium penetrates the crypts of theskin into the lower lying horny layersand thereby; forms a defensive barrieragainst microbes contained in secretedsweat, with the result that the germcount on the hands remains low forseveral hours.

• Mecetronium ethyl sulphate goesunderneath the epidermis to behavelike a 'chemical glove' (Mecetronium isnon-toxic and can be washed off withwater)

• Skin protectors provide skin softeningeffect on hand, even on frequent use.

• Alcohol rub in method Vs hand washing:Microbial count reduced to 10 from 10'as compared with hand washing wherereduction was to 10' from 10'

• Sterillium is proven to have a kill rate99.99% on all transient flora and alsoreduces residual flora of hands.(Hand washes with Chlorhexidine orPVP Iodine, reduces transient floraonly by 78% and no effect onresident hand flora).

Alcohols - no acquired resistance

• Alcohols act rapidly and in a non-specificmanner. The alcohol reacts withmembrane proteins of the cell anddiffuses through the cell wall and thecytoplasmic membrane into thecytoplasm.

• The proteins' hydration layer is extractedand the proteins convert into gel(coagulation). Higher alcohol concentrationscause a number of changes to the proteinmolecule (e.g. reactions on the functionalgroup in the side chains, destruction ofdisulphide and hydrogen bridges).Consequently, the bacterial structure isirrevocably destroyed.

• This process, the so-called denaturationprocess, affects both the proteins of the cellwall and the proteins of the cytoplasm.Through such structural changes specificcharacteristics of the proteins dwindle away.For example, proteins that occur asenzymes lose their catalytic effect.

• The result is the destruction of the cellmetabolism and finally a cell lysis. As aconsequence, so far no acquiredresistances against alcohols have beenfound in bacteria.

Usage of Sterillium In

Pharmaceutical Plants :

Sterillium can be used in PharmaceuticalIndustries where the following products aremanufactured and packed:

• Oral Formulations• Injectable Formulations

• Antibiotics

• Vaccines

• Drugs• Medicines• APls (Active Pharmaceutical Ingredients)

• Sterillium is a must for any companydedicated to product Quality Control andQuality Assurance. Specially, those

Pharmaceutical Plants, acquiring andmaintaining the under-mentionedcertifications:* US FDA (approval by U.S.A.)* EDQM (approval by Europe)* WHO GMP (Geneva) / India* REVISED SCHEDULE 'M'

CERTIFICATION

* GMP-Good Manufacturing Practices* FDA-Food and Drug Administration,India

* GLP (Good Laboratory Practices)* ISO 22001 (for drinki ng WATER/Food)

Listing:

• RKI* list of disinfectants inaccordance with § 18 of the InfectiousDiseases Control Law:Effect area A (bacteria, fungi)-30 sec.'Robert Koch - Institute

• Licenced by German Federallnst. of

Drugs & Medical Devices (BfArM)

Shelf Life:

• 3 years

Packing:

• 5 Litre Can• 500ml with dispenser

• 100ml

Carton

2 Jars2050

Sterillium : The unbeatable leader In Alcohol Rubs worldwide I

Sterillium®Alcoholic Rub-in hand antiseptic (Ready-to-use)For disinfection of hands in sterile sections.

A PRODUCT OF GERMAN RESEARCH

Our Customers :

• Abbott India Ltd.• Alembic. Astro Pharrna a Aurobindo Pharrna ja Chiron Behring Vaccines Ltd .• Aventis Pharma Ltd.

• Baxter. Biochem • Biological Evans .• Cadila Health Care Ltd.• Cadila Zydus • Centaur Pharma Ltd.. Cipla Ltd.

• Core Parental • Dr. Reddy's Laboratories. Emcure Biotech. Emcure Pharma • Encube Ethicals Ltd.• F.D.C. Ltd.

• Geno Pharma Ltd.• Gland Pharma • Glenmark • Godrej Food Ltd.• Granules (I) Ltd .• Hetero Drugs • Hotel Taj Exotica

• Indian Immunologicals • Indoco Remedies Ltd.• IPCA Laboratories. JVS Food Pvt Ltd.• Lupin Ltd .• Lyka • Makan Health Care

• Merck Ltd.. Micro Labs Ltd. • Natco Pharma Ltd. • Nicholas Piramal Ltd.• Okasa Ltd.• Ranbaxy Ltd. • Ratio Pharma Ltd.

• Shanta Biotech. Shreya Life Sciences. Sun Pharma • Themis • Troikka Pharma • Tulip Diagnostics (P) Ltd.• UNI Sankyo

• Unichem Lab Ltd .• Wockhardt & others.

Hygienic Hand DisinfectionStandard method according to EN 1500

1st step: Palm to palm. 2nd step: Palm of right hand overback of left hand and palm of lefthand over back of right hand.

3rd step: Palm to palm withfingers interlaced.

6th step: Rotational rubbing,backwards and forwards withclasped fingers of right handin left palm and vice versa.

5

5th step: Rotational rubbing of rightthumb clasped in left palm and vice versa.

4

4th step: Back of fingers to opposingpalms with fingers interlocked.

W1fflfilijji"M~:=:

Our principals BODE CHEMIE was founded in 1924, and since then have achieved excellence in combating microorganisms. They produce hi-tech disinfectants for all areas of applications likehospitals, pharma, food industries, & cosmetic industries, etc. Since 1980, BODE CHEMfE is a subsidiary of the Beiersdorf AG Company worldwide.

All their products are in accordance with German Drug Law, and are approved by the German Society of Hygiene & Microbiotogy (DGHM). In 1995 they were awarded the highest certification, DIN

ISO 9001 conforming excellence in all areas including Manufacturing and Quality Assurance Systems. Now their range of products are registered and approved by Health Departments of 43countries worldwide.

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