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sterilium hand rub didinfectent product
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Partner fordisinfection ~ RTTT& [email protected]§§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.
COPY RIGHTS RESERVED