1. Partner for
disinfection ~& RTTT Ui@iOi.Rt§§iUl4ilt W Sterillium®
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 special
attention 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 contamination
in the clean room environment, production area and packing area. This will ensure quality, purity and sterility of the final
product manufactured.
HBV
Hepatitis B
Virus
HIV
AIDS -Virus
H5NI EN 1500
Hygienic Hand
Avian Flu ~(TfM-) ~
Disinfection
,~~~
FDA •
'
Staphylococcus aureus, REM-magnification 6,300 fold
3. 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 access
these markets, manufacturing facilities are scrutinized stringently. Therefore complete sterile conditions in
manufacturing 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 gms
30 gms
: 0.2 gms
Spectrum of Activity :
Sterillium is a complete broad spectrum
microbicidal with skin protectors for frequent
hand antisepsis.
• Effective kill rate of 99.99% in 30 secs
only!!
• Effective against all fungi including
candida albicans
• Effective against all gram positive
bacteria including Staph. Aureus
• Effective against all gram negative
bacteria including E.coli
• Effective against all mycobacteria
• Effective against all Viruses including
HBV, HCV, HIV, Polyoma, Adeno &
H5VI
• Effective against all resistant bacteria
• It prevents cross contamination, reduces
bio-burden, comes with complete
validation reports, certificate of analysis,
MSDS, and comparison charts with
other 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 care
properties.
• Sterillium is the most evaluated Alcohol
Hand Rub in the world with several
International Publications.
Please Note :
• Microbicidal and Validation reports,
Certificate of Analysis and MSDS
available on request.
• Registered in 54 countries world
wide including UK & USA.
• 40 years of experience, several
international papers published in
journals. (Available on request)
• Flagship product of our company,
Bode Chemie Germany, recipient of
the ISO - 9001 Certificate.
Mode of Application:
Hygienic hand disinfection:
• Wash hands to remove coarse organic
matter (if any), and dry.
• Sterillium is to be used with a specially
designed elbow dispenser to prevent
contamination.
• Rub Sterillium (3m I) well over hands
and nail grooves for 30 seconds (press
twice from calibrated dispenser provided).
• Do not rinse or wipe dry after use.
Method of Action :
• Both alcohols combine to give lethal
action on all microorganisms on hand
(Transient flora)
• Sterillium penetrates the crypts of the
skin into the lower lying horny layers
and thereby; forms a defensive barrier
against microbes contained in secreted
sweat, with the result that the germ
count on the hands remains low for
several hours.
• Mecetronium ethyl sulphate goes
underneath the epidermis to behave
like a 'chemical glove' (Mecetronium is
non-toxic and can be washed off with
water)
• Skin protectors provide skin softening
effect 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 where
reduction was to 10' from 10'
• Sterillium is proven to have a kill rate
99.99% on all transient flora and also
reduces residual flora of hands.
(Hand washes with Chlorhexidine or
PVP Iodine, reduces transient flora
only by 78% and no effect on
resident hand flora).
Alcohols - no acquired resistance
• Alcohols act rapidly and in a non-specific
manner. The alcohol reacts with
membrane proteins of the cell and
diffuses through the cell wall and the
cytoplasmic membrane into the
cytoplasm.
• The proteins' hydration layer is extracted
and the proteins convert into gel
(coagulation). Higher alcohol concentrations
cause a number of changes to the protein
molecule (e.g. reactions on the functional
group in the side chains, destruction of
disulphide and hydrogen bridges).
Consequently, the bacterial structure is
irrevocably destroyed.
• This process, the so-called denaturation
process, affects both the proteins of the cell
wall and the proteins of the cytoplasm.
Through such structural changes specific
characteristics of the proteins dwindle away.
For example, proteins that occur as
enzymes lose their catalytic effect.
• The result is the destruction of the cell
metabolism and finally a cell lysis. As a
consequence, so far no acquired
resistances against alcohols have been
found in bacteria.
Usage of Sterillium In
Pharmaceutical Plants :
Sterillium can be used in Pharmaceutical
Industries where the following products are
manufactured and packed:
• Oral Formulations
• Injectable Formulations
• Antibiotics
• Vaccines
• Drugs
• Medicines
• APls (Active Pharmaceutical Ingredients)
• Sterillium is a must for any company
dedicated to product Quality Control and
Quality Assurance. Specially, those
Pharmaceutical Plants, acquiring and
maintaining the under-mentioned
certifications: * 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 in
accordance with § 18 of the Infectious
Diseases 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 Jars
20
50
Sterillium : The unbeatable leader In Alcohol Rubs worldwide I
4. 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 Disinfection
Standard method according to EN 1500
1st step: Palm to palm. 2nd step: Palm of right hand over
back of left hand and palm of left
hand over back of right hand.
3rd step: Palm to palm with
fingers interlaced.
6th step: Rotational rubbing,
backwards and forwards with
clasped fingers of right hand
in left palm and vice versa.
5
5th step: Rotational rubbing of right
thumb clasped in left palm and vice versa.
4
4th step: Back of fingers to opposing
palms 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 like
hospitals, 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 43
countries worldwide.
COPY RIGHTS RESERVED