Sterillium (Alcohol-Based Hand Rub)
Propanol-based cutaneous solution for surgical and hygienic hand disinfection
Quick Facts: Sterillium
Key Takeaways
- Broad-spectrum antiseptic: Sterillium kills bacteria, mycobacteria, fungi, and enveloped viruses (including SARS-CoV-2, influenza, HIV, hepatitis B and C) within seconds, and has documented activity against certain non-enveloped viruses when contact time is extended
- Two indications: Hygienic hand disinfection (30 seconds contact time) and surgical hand disinfection (1.5 minutes contact time) – the correct contact time is essential for efficacy
- Long-acting residual effect: Mecetronium etilsulfate remains active on the skin after the alcohol has evaporated, providing a longer duration of reduced microbial counts than alcohol alone
- Skin-friendly for frequent use: Formulated with skin-conditioning agents to support repeated daily use by healthcare professionals, though it is not intended for broken or inflamed skin
- External use only: Sterillium is flammable, for topical use on intact skin of the hands only, and must never be swallowed, inhaled deliberately, or applied to wounds or mucous membranes
What Is Sterillium and What Is It Used For?
Sterillium is a ready-to-use alcohol-based hand rub containing 45% propan-2-ol, 30% propan-1-ol and 0.2% mecetronium etilsulfate. It is used for hygienic hand disinfection in everyday healthcare situations and for pre-operative surgical hand disinfection, reducing the number of microorganisms on the hands of healthcare workers and carers to help prevent healthcare-associated infections.
Sterillium is one of the most widely used alcohol-based hand rubs in healthcare worldwide. First introduced in 1965, it was the first commercial alcohol-based hand antiseptic designed specifically for routine clinical hand hygiene. The product has since become an international reference in infection prevention and control, and it is manufactured by BODE Chemie GmbH, part of the HARTMANN Group, with distribution in more than 80 countries.
The product is classified as a topical antiseptic and falls under the Anatomical Therapeutic Chemical (ATC) classification group D08AX – Other antiseptics and disinfectants. In the European Union, Sterillium is typically registered as a biocidal product under Regulation (EU) No 528/2012 (Biocidal Products Regulation, Product Type 1 – human hygiene), and in some countries as a medicinal product. In the United States, similar alcohol-based hand rubs are regulated by the FDA as over-the-counter (OTC) topical antiseptic drug products subject to a specific monograph.
Hand hygiene is widely recognised as the single most effective measure for preventing healthcare-associated infections (HAIs), which affect an estimated 7% of hospital patients in high-income countries and up to 15% in low- and middle-income countries according to the World Health Organization (WHO). Alcohol-based hand rubs such as Sterillium are recommended by the WHO as the standard of care for hand hygiene in healthcare settings because they are faster, more effective, and better tolerated by the skin than traditional soap-and-water washing when hands are not visibly soiled.
Primary Clinical Indications
Sterillium is indicated for two distinct applications, each with its own technique and minimum contact time:
- Hygienic hand disinfection: The rapid reduction of transient microorganisms on the skin of the hands, performed at the five "moments" defined by the WHO – before touching a patient, before an aseptic task, after exposure to body fluids, after touching a patient, and after touching patient surroundings. Typical contact time is at least 30 seconds.
- Surgical hand disinfection: A more thorough procedure performed before surgical interventions with the aim of reducing both transient and resident skin flora to the lowest possible level. Hands and forearms are kept continuously wet with the product for 1.5 minutes (or as specified by the local protocol). This indication has been validated under European Norm EN 12791.
- Hygienic hand antisepsis in non-clinical settings: Care homes, dental practices, ambulance services, laboratories, food handling environments, and community outbreak situations.
Mechanism of Action
Sterillium achieves its antimicrobial effect through a combination of mechanisms. The two alcohols – propan-2-ol (isopropyl alcohol) and propan-1-ol (n-propanol) – denature microbial proteins and disrupt cell membranes within seconds of contact. This causes rapid, broad-spectrum bactericidal, tuberculocidal, fungicidal, and virucidal activity against enveloped viruses. The combination of the two alcohols is more effective at lower total concentrations than either alcohol alone, and the presence of water in the formulation is essential for the denaturing effect.
The third active ingredient, mecetronium etilsulfate, is a quaternary ammonium compound present at only 0.2%. It is not a significant antimicrobial agent in its own right at this concentration, but it adheres to the skin after the alcohols evaporate and provides a measurable residual effect that prolongs the reduction in microbial counts for several hours. This property is particularly valuable during long surgical procedures where gloves may be breached and on hands that frequently come into contact with patients.
Antimicrobial Spectrum
The documented antimicrobial spectrum of Sterillium includes, at the manufacturer's validated contact times:
- Bacteria: Including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae, and extended-spectrum beta-lactamase (ESBL) producing organisms
- Mycobacteria: Including Mycobacterium tuberculosis and Mycobacterium terrae (tuberculocidal)
- Fungi and yeasts: Including Candida albicans and Aspergillus brasiliensis
- Enveloped viruses: Influenza A (including H1N1 and H5N1), SARS-CoV-2, HIV, hepatitis B and C viruses, herpesviruses, respiratory syncytial virus (RSV), Ebola virus, and vaccinia virus
- Non-enveloped viruses: Activity against rotavirus, adenovirus, and norovirus (murine norovirus model) at extended contact times
Alcohol-based hand rubs are listed by the World Health Organization as essential medicines for infection prevention. The WHO provides two formulations (WHO Formulations I and II) that can be produced locally when commercial products such as Sterillium are unavailable. Sterillium's commercial formulation offers superior skin tolerance compared to the basic WHO formulations, making it better suited to very frequent daily use.
What Should You Know Before Using Sterillium?
Sterillium is for external use on intact skin of the hands only. Do not use on open wounds, inflamed skin, or mucous membranes. It is flammable and must be kept away from naked flames. It is not suitable for newborns, and it should not be swallowed. Hands that are visibly soiled must first be washed with soap and water before Sterillium is applied.
Because Sterillium is a frequently used product, often dozens of times per day by healthcare workers, it is important to understand its limitations, contraindications, and situations in which it should not be used. The following precautions apply to all users.
Contraindications
Sterillium should not be used in the following circumstances:
- Known hypersensitivity: Do not use if you have a documented allergy or hypersensitivity to any of the active ingredients (propan-2-ol, propan-1-ol, mecetronium etilsulfate) or any of the excipients.
- Broken, inflamed, or damaged skin: Sterillium must not be applied to cuts, abrasions, burns, eczematous or other inflamed skin, or to any area where the skin barrier is compromised. This will cause significant burning pain and may delay healing.
- Mucous membranes and eyes: Do not apply to or near the eyes, mouth, nose, genitals, or any mucous surface. Accidental contact with eyes causes intense irritation and temporary visual disturbance.
- Newborn infants (neonates): The skin of newborns is not fully developed and is more permeable to alcohol. Sterillium is not intended for application to the skin of newborns.
- Internal use: Sterillium must never be swallowed. Ingestion of alcohol-based hand rubs can cause severe intoxication, hypoglycaemia, and, in large quantities, life-threatening poisoning.
Warnings and Precautions
The following warnings should be observed by all users of Sterillium:
- Flammable product: Sterillium contains approximately 75% alcohol by weight and is classified as a flammable liquid. Do not use it near naked flames, sparks, hot surfaces, electrosurgical equipment, lasers, or any other ignition source. Allow hands to dry fully (approximately 30 seconds) before handling flammable materials or operating electrical medical devices, including surgical diathermy.
- Visibly soiled hands: Alcohol-based hand rubs are not a substitute for soap-and-water hand washing when hands are visibly soiled with dirt, blood, or other body fluids. In those situations, wash first with soap and running water, dry thoroughly, and then apply Sterillium.
- Presence of spores: Standard alcohol-based hand rubs have limited activity against bacterial spores (for example Clostridioides difficile). In situations involving confirmed or suspected C. difficile infection, soap-and-water washing is recommended to physically remove spores from the skin.
- Norovirus outbreaks: Although Sterillium has some activity against non-enveloped viruses, soap-and-water hand washing is generally preferred during norovirus outbreaks because of the physical removal of viral particles.
- Skin reactions: Repeated use may cause dryness or mild irritation, particularly in cold, dry weather. Regular use of a compatible hand cream after clinical shifts is recommended.
- Children: Keep Sterillium out of the reach of children. Children must not apply the product unsupervised, and dispensers in homes with small children should be positioned out of reach.
- Dispenser hygiene: Use only from intact, sealed bottles or validated dispensers. Do not top up partially empty dispensers, as this increases the risk of microbial contamination.
Several cases of operating-theatre fires have been reported in the literature when alcohol-based skin antiseptics – including hand rubs – were used in close proximity to surgical diathermy before the alcohol had fully evaporated. Always wait until hands and any treated skin area are completely dry before using any ignition source. Do not pour Sterillium onto large surfaces; use it only as intended for hand rubbing.
Pregnancy and Breastfeeding
Sterillium can be used during pregnancy and breastfeeding when applied as directed. When used correctly on the skin of the hands, systemic absorption of propanols and mecetronium etilsulfate is very low, and exposure is considered negligible. Regulatory agencies, including the European Chemicals Agency (ECHA), have assessed the safety profile of alcohol-based hand rubs for reproductive toxicity and have not identified clinically relevant concerns at recommended usage.
Pregnant and breastfeeding healthcare workers should, however, avoid using very large volumes over long periods in poorly ventilated spaces, as prolonged inhalation of alcohol vapours may rarely cause transient headache or irritation of the airways. Breastfeeding parents should ensure that the product has fully dried on their skin before direct contact with the infant, particularly during feeding, to avoid transfer of alcohol residue.
Driving and Operating Machinery
When used correctly, Sterillium has no known effect on the ability to drive or operate machinery. Systemic alcohol absorption through intact skin is very low and does not produce clinically detectable blood alcohol levels. However, transient dizziness or mild headache has occasionally been reported when large volumes are used in confined, poorly ventilated spaces due to inhalation of alcohol vapours. Ensure adequate ventilation during prolonged use.
How Does Sterillium Interact with Other Products?
Because Sterillium is applied topically and has very low systemic absorption, it has no clinically significant drug-drug interactions in the traditional pharmacological sense. The most relevant interactions are with other topical products applied to the hands and with disulfiram therapy, where frequent inhalation or ingestion of alcohol-based products should be avoided.
Sterillium is a topical antiseptic with minimal systemic absorption when used as directed. Because the product is applied to intact skin and the alcohols evaporate rapidly, it does not share the metabolic interactions that are associated with oral or parenteral medications. Nevertheless, several practical interactions with other topical products, chemicals, and rare systemic situations deserve attention.
Interactions with Other Topical Products
The efficacy, skin tolerance, or safety of Sterillium may be affected by concurrent use of other topical agents:
| Product / Situation | Nature of Interaction | Practical Recommendation |
|---|---|---|
| Hand creams and moisturisers | Oil-rich creams applied before Sterillium may reduce contact of the antiseptic with the skin surface and impair efficacy | Apply hand cream after, not before, disinfection, ideally during breaks or at the end of a shift |
| Soap-and-water washing | Applying Sterillium to wet hands dilutes the product and significantly reduces antimicrobial activity | Dry hands thoroughly after washing before applying Sterillium |
| Other hand antiseptics | Repeated alternation between chlorhexidine and alcohol-based products generally does not cause incompatibility but may increase skin irritation | Standardise hand hygiene protocols within an institution rather than mixing multiple products |
| Gloves | Applying Sterillium to wet gloves may weaken some glove materials and cause skin occlusion | Apply Sterillium only to bare hands, allow to dry completely, then don gloves |
| Pre-surgical skin antiseptics | Accumulation of alcohol in drapes or on skin folds may increase fire risk during electrosurgery | Ensure full drying and removal of pooled solution before draping and diathermy |
Relevant Systemic Considerations
Although routine topical use of Sterillium does not produce clinically significant systemic exposure, a small number of uncommon scenarios should be considered:
- Disulfiram therapy: Patients taking disulfiram for alcohol dependence experience severe reactions even with small amounts of systemic alcohol. Although transdermal absorption from Sterillium is minimal, patients and carers on disulfiram should avoid prolonged, heavy use in poorly ventilated spaces. Ingestion is strictly contraindicated.
- Metronidazole: A small theoretical risk of an alcohol-metronidazole interaction has been described historically, but clinical significance with topical hand rubs is considered negligible.
- Concurrent use of cosmetic products containing fragrance or dyes: Alcohol can enhance absorption of some co-applied compounds, potentially increasing the risk of contact dermatitis. Use a consistent range of products to reduce this risk.
Successful hand hygiene programmes combine appropriate product choice with dispenser availability, staff training, and feedback. The WHO Multimodal Hand Hygiene Improvement Strategy has been associated with relative reductions in healthcare-associated infections of 20–40% in well-implemented programmes. Sterillium and similar products are effective only when applied at the right moment, for the correct contact time, and using the correct technique.
What Is the Correct Way to Apply Sterillium?
For hygienic hand disinfection, apply approximately 3 ml (two to three pump strokes) to dry, clean hands and rub all surfaces for at least 30 seconds until fully dry. For surgical hand disinfection, apply enough product to keep hands and forearms continuously wet for 1.5 minutes using the manufacturer's validated technique. Never rinse with water afterwards – allow the alcohol to evaporate naturally.
The effectiveness of Sterillium – and of any alcohol-based hand rub – depends on three critical factors: the volume applied (enough to cover all surfaces), the contact time (maintained until fully dry), and the technique (all hand surfaces must be treated). Failure to meet any of these criteria can substantially reduce antimicrobial efficacy and leave areas of the hands inadequately disinfected, in particular the fingertips, thumb bases, and skin under rings or nail folds.
Adults and Adolescents
Hygienic Hand Disinfection (routine use)
Volume: Approximately 3 ml (or at least enough to fill a cupped palm – typically two to three pump strokes from a standard wall dispenser).
Contact time: At least 30 seconds. The product must remain visible on the skin throughout this period.
Technique: Follow the WHO six-step technique: (1) palm to palm; (2) right palm over left dorsum with interlaced fingers and vice versa; (3) palm to palm with fingers interlaced; (4) backs of fingers to opposing palms with fingers interlocked; (5) rotational rubbing of the thumbs; (6) rotational rubbing of the fingertips in the opposing palm. Continue until hands are completely dry.
Surgical Hand Disinfection (pre-operative)
Volume: Apply enough product to keep hands and forearms up to the elbows continuously wet for the entire duration of the procedure. Typical total volume is 6–10 ml applied in multiple portions of 3 ml.
Contact time: 1.5 minutes, or as specified by local protocol based on validated EN 12791 testing.
Technique: Before the first procedure of the day, wash hands and forearms with soap and water and clean fingernails. Dry completely. Apply the first portion to the hands and work upwards over the forearms, keeping the product uniformly distributed. Re-apply sufficient portions to maintain wetness throughout the full contact time. Keep elbows below hand level until the product has fully evaporated. Do not rinse, towel-dry, or fan-dry.
Community and Non-Clinical Settings
Volume: Approximately 3 ml.
Contact time: At least 30 seconds.
Technique: Same six-step technique as hygienic hand disinfection. Use at key moments such as before preparing food, after public transport, when caring for vulnerable individuals, during infectious disease outbreaks, and whenever hand washing facilities are unavailable.
Children
Sterillium can be used for hand disinfection in children aged 3 years and above, under adult supervision. Because the product is flammable and contains a high concentration of alcohol that is toxic if swallowed, young children must not use it unattended. For infants and toddlers under the age of 3, soap-and-water hand washing with a child-appropriate soap is usually preferred in everyday settings. In healthcare environments, local protocols and paediatric infection prevention guidance should be followed.
When Sterillium is used in children, an adult should apply the appropriate volume to the child's palms (typically 1–2 ml for small hands), demonstrate the rubbing technique, and ensure hands are dry before the child touches their face or other surfaces. Dispensers should be mounted out of reach of small children to prevent accidental spraying into the eyes or ingestion.
Elderly Users and Individuals with Fragile Skin
Older adults and individuals with thin, fragile, or aged skin can use Sterillium, but they may be more susceptible to skin dryness and irritation with frequent use. A compatible hand cream should be applied regularly to support skin barrier function. If significant dryness, cracking, or redness develops, reduce frequency of use where possible and consider alternative hand hygiene approaches such as soap-and-water washing combined with emollient-rich moisturisers.
Healthcare Workers with Hand Dermatitis
Healthcare workers who develop occupational hand dermatitis should, paradoxically, often continue using alcohol-based hand rubs rather than switching to repeated soap-and-water washing, which is more damaging to the skin barrier. Sterillium is generally better tolerated than detergents during daily use. Additional measures include consistent use of an emollient, avoidance of hot water, and in severe cases, referral to an occupational health physician or dermatologist for topical corticosteroid therapy and glove strategy review.
Missed Application
Because Sterillium is used on demand at specific "moments" of hand hygiene rather than on a fixed schedule, the concept of a missed dose does not apply. Each hand hygiene opportunity should be treated as it arises. If hand hygiene was not performed at a required moment, perform it as soon as the omission is recognised, and do not touch patients, patient-care equipment, or susceptible surfaces until decontamination has been carried out.
Overuse, Accidental Ingestion and Overdose
Excessive topical use typically causes only local effects such as dryness, cracking, or irritation. However, accidental or deliberate ingestion of Sterillium represents a medical emergency, particularly for children. Swallowing alcohol-based hand rubs can cause rapid intoxication, severe hypoglycaemia (especially in children), metabolic acidosis, central nervous system depression, seizures, and respiratory failure. Large ingestions may be fatal.
In the case of ingestion or eye exposure, the following steps should be taken:
- Ingestion: Do not induce vomiting. Contact your national poisons information service or emergency services immediately. Provide information on the amount ingested, time of ingestion, patient age, weight, and symptoms. Keep the bottle for reference.
- Eye contact: Rinse eyes copiously with lukewarm water for at least 15 minutes, keeping the eyelids open. Seek medical attention if irritation or visual disturbance persists.
- Skin reaction: Stop use. Wash with water. Seek medical advice if a rash, blistering, or severe irritation develops.
- Inhalation: Move to fresh air. Seek medical attention if symptoms persist.
What Are the Side Effects of Sterillium?
Sterillium is very well tolerated by most users. The most common side effects are mild skin dryness, transient stinging on damaged skin, and, rarely, allergic contact dermatitis. Serious systemic effects are extremely rare with topical use on intact skin, but can occur after accidental ingestion, large-scale inhalation, or eye exposure.
Clinical trials and decades of post-marketing surveillance have established a very favourable safety profile for Sterillium when used as directed. In studies comparing alcohol-based hand rubs with traditional soap-and-water washing, the alcohol-based products consistently demonstrated fewer and less severe skin reactions than repeated detergent exposure. The table below classifies the frequency of side effects using standard Medical Dictionary for Regulatory Activities (MedDRA) convention, based on the summary of product characteristics and pharmacovigilance data.
Common Side Effects
- Skin dryness, particularly of the dorsal surfaces of the hands and fingers
- Mild transient stinging or tingling sensation, especially if the skin is already dry or damaged
- Feeling of tightness or roughness of the skin after repeated use
- Temporary whitening of the nails or cuticles
Uncommon Side Effects
- Irritant contact dermatitis (redness, scaling, small cracks)
- Itching or burning sensation without visible skin changes
- Transient redness of the treated areas
- Temporary exacerbation of pre-existing eczema
Rare Side Effects
- Allergic contact dermatitis (type IV hypersensitivity to an ingredient or fragrance)
- Immediate contact urticaria (localised wheals and itching shortly after application)
- Small cracks or fissures on the fingers with bleeding in very heavy users
- Accidental eye contact causing transient burning and conjunctival irritation
Very Rare or Misuse-Related Effects
- Anaphylactic reactions (extremely rare)
- Systemic alcohol intoxication after accidental ingestion (especially in children)
- Hypoglycaemia and metabolic acidosis in children who ingest the product
- Chemical burns of the cornea following direct eye exposure
- Respiratory irritation from prolonged inhalation of vapours in poorly ventilated spaces
- Operating-theatre fires if applied near electrosurgical devices before full drying
Suspected adverse reactions to Sterillium or any other medicinal or biocidal product should be reported to your local pharmacovigilance authority. In the European Union, this is typically done through national agencies coordinated by the European Medicines Agency (EMA); in the United Kingdom via the MHRA Yellow Card Scheme; in the United States via the FDA MedWatch programme. Reporting helps regulators and manufacturers continuously monitor safety and improve product information.
Managing Skin Reactions
Mild skin dryness and irritation can usually be managed by simple measures:
- Apply a fragrance-free, hypoallergenic hand cream several times daily, particularly at the end of a shift and before bed
- Avoid hot water and harsh soaps when hands are washed; use lukewarm water and mild cleansers
- Pat hands dry rather than rubbing vigorously with paper towels
- Remove rings during clinical work to avoid trapping alcohol and moisture under the band
- If cracks or bleeding develop, cover with a thin hydrocolloid dressing overnight
- In persistent or severe dermatitis, seek advice from an occupational health service or dermatologist; patch testing may be indicated to rule out allergic contact dermatitis
How Should Sterillium Be Stored?
Store Sterillium in its original container at room temperature (below 25°C / 77°F), tightly closed, upright, away from direct sunlight, heat and naked flames. Keep out of reach of children. Do not use after the expiry date printed on the label. Once opened, most bottles are stable until the expiry date provided the cap is replaced after each use.
Correct storage of Sterillium is important both for product stability and for fire safety. The product is classified as a flammable liquid under the European Regulation (EC) No 1272/2008 (CLP) and must be handled, stored, and transported in accordance with the applicable safety data sheet.
Storage Conditions
- Temperature: Store below 25°C / 77°F. Avoid sustained high temperatures that could increase internal bottle pressure. Do not store in cars exposed to summer heat.
- Light: Protect from direct sunlight and store in the original container to prevent degradation of excipients.
- Position: Keep bottles upright with caps securely tightened. Wall-mounted dispensers should be designed for alcohol-based products and regularly inspected for leaks.
- Ignition sources: Do not store near open flames, hot surfaces, electrical equipment, smoking areas, or oxidising agents.
- Ventilation: Store in a well-ventilated area. In large healthcare facilities, bulk storage must comply with local fire regulations governing flammable liquids.
- Out of reach of children: Keep all Sterillium bottles secured out of reach and sight of children, in a locked cupboard where appropriate.
Shelf Life and In-Use Stability
Sterillium generally has a shelf life of 36–60 months from the date of manufacture when stored unopened under the recommended conditions. The exact shelf life is printed on the bottle label and outer carton. The expiry date refers to the last day of the month indicated. Once opened, the product remains stable up to the printed expiry date, provided the cap is always replaced after use and the bottle is not contaminated with water or other liquids.
Unlike some aqueous antiseptics, Sterillium does not require preservatives against bacterial growth; its high alcohol content prevents microbial contamination of the product itself. However, wall dispensers and pump bottles should be cleaned periodically, and empty bottles should not be refilled from bulk containers outside a controlled pharmacy environment, since this practice increases the risk of contamination and dilution.
Disposal
Empty and partly used containers should be disposed of in accordance with local regulations for flammable packaging waste. Do not incinerate unopened pressurised containers. Do not pour large volumes into drains or natural water bodies. In healthcare settings, follow your institution's pharmaceutical and hazardous waste policies. Small household quantities may generally be returned to a pharmacy or municipal hazardous waste collection point.
What Does Sterillium Contain?
Sterillium Classic contains three active ingredients: propan-2-ol (isopropyl alcohol) 45 g per 100 g, propan-1-ol (n-propanol) 30 g per 100 g, and mecetronium etilsulfate 0.2 g per 100 g. Excipients include glycerol (for skin conditioning), tetradecan-1-ol, fragrance, patent blue V (E131) and purified water.
Sterillium is manufactured as a ready-to-use, clear blue-tinted liquid with a characteristic fresh scent. The formulation is the result of decades of optimisation to combine high antimicrobial efficacy with excellent skin tolerance. The table below summarises the composition of Sterillium Classic, the most widely used variant. Related variants such as Sterillium Classic Pure (fragrance- and dye-free) and Sterillium Med (dermatologically tested) use the same active ingredients with adjusted excipients.
Active Ingredients
| Ingredient | Content | Function |
|---|---|---|
| Propan-2-ol (isopropyl alcohol) | 45 g / 100 g | Rapid broad-spectrum antimicrobial action through protein denaturation and membrane disruption |
| Propan-1-ol (n-propanol) | 30 g / 100 g | Complementary alcohol broadening the antimicrobial spectrum and enhancing virucidal activity |
| Mecetronium etilsulfate | 0.2 g / 100 g | Quaternary ammonium compound providing residual (long-acting) antimicrobial effect on the skin |
Excipients
The non-active ingredients in Sterillium Classic support skin tolerance, product identification, and user acceptance:
- Glycerol (glycerin) 85%: Humectant and skin-conditioning agent that reduces dryness during frequent use
- Tetradecan-1-ol (myristyl alcohol): Fatty alcohol used as a skin-feel modifier
- Fragrance compound: Gives the product its characteristic scent; replaced with unscented excipients in Sterillium Classic Pure
- Patent blue V (E131): Colouring agent that distinguishes Sterillium from water-clear products at a glance
- Purified water: Necessary for the denaturing antimicrobial action of the alcohols and for product stability
Physical Properties
- Appearance: Clear, blue-tinted, mobile liquid
- Odour: Characteristic fresh scent (unscented in Sterillium Classic Pure)
- Density: Approximately 0.86 g/ml
- pH: Approximately 6–7
- Flashpoint: Approximately 23°C (classified as a flammable liquid)
- Total alcohol content: Approximately 75% (w/w)
Available Package Sizes
| Package Format | Size | Primary Use Case |
|---|---|---|
| Pocket bottle | 50 ml – 100 ml | Individual carry-along for mobile healthcare workers, dentists, community staff |
| Pump bottle | 500 ml – 1,000 ml | Bedside or desk use in clinical rooms, practices and laboratories |
| Dispenser bottle | 500 ml – 1,000 ml | Wall-mounted dispensers at hospital bed entrances, ward entrances, clinic doors |
| Refill canister | 5 L | Central refilling of approved pump bottles within pharmacy or facility services |
Not all package sizes are marketed in all countries, and the availability of specific variants (Sterillium Classic, Sterillium Classic Pure, Sterillium Med, Sterillium Gel, Sterillium Virugard) depends on local regulatory registration and market. Users should check with their local supplier or pharmacy for currently available presentations.
Manufacturer and Marketing Authorisation
Sterillium is manufactured by BODE Chemie GmbH, Melanchthonstraße 27, 22525 Hamburg, Germany. BODE Chemie is a subsidiary of the HARTMANN Group (PAUL HARTMANN AG), a German medical products company founded in 1818. Sterillium was first launched by BODE in 1965 as the first commercial alcohol-based hand rub for healthcare use, and it has since been distributed in more than 80 countries. All manufacturing facilities operate under Good Manufacturing Practice (GMP) standards and are regularly inspected by relevant regulatory authorities.
Information for Healthcare Professionals
Sterillium meets the requirements of European Norms EN 1500 (hygienic hand rub) and EN 12791 (surgical hand disinfection) when used with the validated volumes and contact times. In surgical use, the product must be kept continuously wet on the hands and forearms for 1.5 minutes. Skin-care strategies and dispenser placement are integral to effective hand-hygiene programmes.
The following information is directed to physicians, nurses, infection prevention and control (IPC) specialists, pharmacists, occupational health teams, and facility managers responsible for selecting and implementing hand hygiene products.
Compliance with European Norms
- EN 1500 (Chemical disinfectants and antiseptics. Hygienic hand rub): Sterillium achieves the required log reduction of test microorganisms within the specified contact time of 30 seconds using a volume of 3 ml.
- EN 12791 (Surgical hand disinfection): Sterillium demonstrates the required reduction of resident skin flora with application for 1.5 minutes and is validated for continuous use throughout surgical procedures.
- EN 14476 (Virucidal activity): Activity has been demonstrated against enveloped and certain non-enveloped viruses relevant to healthcare-associated infections.
- EN 13624 and EN 13727: Basic bactericidal and yeasticidal activity.
Surgical Hand Disinfection Protocol
- Before the first procedure of the day, clean under the fingernails and wash hands and forearms with a neutral soap and water. Dry completely with a clean, single-use paper or cloth towel.
- Dispense sufficient Sterillium into the cupped hand and apply it first to the skin of one arm, working from the fingertips up to just above the elbow, and then repeat on the other arm.
- Re-apply further portions (3–5 ml each) to maintain continuous wetness of the hands, wrists, and forearms throughout the required contact time (1.5 minutes).
- Concentrate the last phase of application on the hands and fingertips, using the WHO six-step technique for hands.
- Keep elbows below hand level, and do not rinse or towel-dry; allow complete evaporation before donning sterile gown and gloves.
Integration into Hand-Hygiene Programmes
To translate product efficacy into reductions of healthcare-associated infections, Sterillium should be deployed within a structured, multimodal hand-hygiene programme. Key elements include:
- Point-of-care availability: Wall-mounted dispensers or bedside pump bottles at every patient bed, clinical zone, and clinical work surface
- Training: Regular training on WHO "Five Moments of Hand Hygiene" and correct technique, including simulation with fluorescence markers
- Observation and feedback: Direct observation audits with personalised feedback to clinical teams
- Reminders in the workplace: Posters, screen savers, and verbal prompts
- Institutional safety climate: Clear visible leadership commitment and inclusion of hand-hygiene performance in quality indicators
Alcohol-based hand rub does not replace the required moments of hand hygiene before and after glove use. Apply Sterillium before donning gloves (ensuring the hands are fully dry) and again after glove removal. Gloves do not replace hand hygiene and can themselves transmit pathogens if reused inappropriately.
Frequently Asked Questions
Medical References & Sources
All medical information is based on peer-reviewed sources, international standards, and regulatory guidelines.
- World Health Organization (WHO). WHO Guidelines on Hand Hygiene in Health Care. WHO, Geneva, 2009 (and subsequent updates).
- World Health Organization. My Five Moments for Hand Hygiene. WHO Patient Safety Programme.
- European Committee for Standardization (CEN). EN 1500: Chemical disinfectants and antiseptics – Hygienic hand rub – Test method and requirements (Phase 2 / Step 2).
- European Committee for Standardization (CEN). EN 12791: Chemical disinfectants and antiseptics – Surgical hand disinfection – Test method and requirement (Phase 2, Step 2).
- European Committee for Standardization (CEN). EN 14476: Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of virucidal activity in the medical area.
- Centers for Disease Control and Prevention (CDC). Guideline for Hand Hygiene in Health-Care Settings. Boyce JM, Pittet D. MMWR Recommendations and Reports. 2002;51(RR-16):1-45.
- Kampf G, Kramer A. Epidemiologic background of hand hygiene and evaluation of the most important agents for scrubs and rubs. Clinical Microbiology Reviews. 2004;17(4):863-893. doi:10.1128/CMR.17.4.863-893.2004
- Kampf G. Antiseptic Stewardship: Biocide Resistance and Clinical Implications. Springer International Publishing, 2018.
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