Hand and surface sanitizers - A Practical Compounding Guide www.fagron.com
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Hand and surface sanitizers A Practical Compounding Guide version 2.0 www.fagron.com
Definition of terms according to
WHO Guidelines on hand hygiene in health care
A. Practices
Antiseptic handwashing
Washing hands with soap and water, or other detergents containing an antiseptic agent.
Antiseptic handrubbing (or handrubbing)
Applying an antiseptic handrub to reduce or inhibit the growth of microorganisms without the need
for an exogenous source of water and requiring no rinsing or drying with towels or other devices.
B. Products
Alcohol-based (hand) rub
An alcohol-containing preparation (liquid, gel or foam) designed for application to the hands to inactivate
microorganisms and/or temporarily suppress their growth. Such preparations may contain one or more types
of alcohol, other active ingredients with excipients, and humectants.
Antiseptic agent
An antimicrobial substance that inactivates microorganisms or inhibits their growth on living tissues.
Examples include alcohols, chlorhexidine gluconate (CHG), chlorine derivatives, iodine, chloroxylenol (PCMX),
quaternary ammonium compounds, and triclosan.
Waterless antiseptic agent
An antiseptic agent (liquid, gel or foam) that does not require the use of exogenous water.
After application, the individual rubs the hands together until the skin feels dry.
* This guide was produced based on WHO Guidelines
on Hand Hygiene in Health Care (ISBN 978 92 4 159790 6)A brief comparison of the main antiseptics
used for hand hygiene
Gram- Gram-
Viruses Viruses Myco-
Antiseptics positive negative Fungi Spores
enveloped non-enveloped bacteria
bacteria bacteria
Alcohols +++ +++ +++ ++ +++ +++ -
Chloroxylenol +++ + + ± + + -
Chlorhexidine +++ ++ ++ + + + -
Hexachlorophenea +++ + ? ? + + -
Iodophors +++ +++ ++ ++ ++ ++ ±b
Triclosand +++ ++ ? ? ± ±e -
Quaternary
ammonium ++ + + ? ± ± -
compoundsc
Antiseptics Typical cone. In % Speed of action Residual activity Use
Alcohols 60 - 70% Fast No HR
Chloroxylenol 0.5 - 4% Slow Contradictory HW
Chlorhexidine 0.5 - 4% Intermediate Yes HR, HW
Hexachlorophenea 3% Slow Yes HW, but not recommended
Iodophors 0.5 - 10% Intermediate Contradictory HW
Triclosand 0.1 - 2% Intermediate Yes HW; seldom
Quaternary HR,HW;
ammonium Slow No Seldom;
compoundsc +alcohols
+++ Good HR Handrubbing
++ Moderate HW Handwashing
+ Poor * Activity varies with concentration.
± Variable a
Bacteriostatic.
- None b
In concentrations used in antiseptics, iodophors are not sporicidal
c
Bacteriostatic, fungistatic, microbicidal at high concentrations.
d
Mostly bacteriostatic.
e
Activity against Candida spp., but little activity against filementous fungi.
Source: adapted with permission from Pittet, Allegranzi & Sax, 2007.479
4Alcohol as the focus
The antimicrobial activity of alcohols results from their ability to denature proteins.
Alcohol solutions containing 60 - 80% alcohol are most effective, with higher concentrations being less potent.
This paradox results from the fact that proteins are not denatured easily in the absence of water.
The alcohol content of solutions may be expressed as a percentage by weight (m/m), which is not affected by
temperature or other variables, or as a percentage by volume (v/v), which may be affected by temperature, specific
gravity and reaction concentration. For example, 70% alcohol by weight is equivalent to 76.8% by volume if prepared
at 15 ºC, or 80.5% if prepared at 25 ºC. Alcohol concentrations in antiseptic handrubs are often expressed as
a percentage by volume.
Most alcohol-based hand antiseptics contain either ethanol, isopropanol or n-propanol, or a combination of two
of these products. Concentrations are given as either percentage of volume (= ml/100 ml, abbreviated % v/v),
percentage of weight (= g/100 g, abbreviated % m/m), or percentage of weight/volume
(= g/100 ml, abbreviated % m/v).
Important points
• Alcohols are rapidly germicidal when applied to the skin, but
have no appreciable persistent (residual) activity – that is the
reason why viscous formulations are recommended.
• Alcohols are not good cleansing agents and their use is not
recommended when hands are dirty or visibly contaminated
with proteinaceous materials.
• Because alcohols are volatile, containers should be designed
so that evaporation is minimized and initial concentration is
preserved.
Formulation tip!
Frequent use of alcohol-based formulations for hand antisepsis
tends to cause drying of the skin unless humectants or other
skin conditioning agents are added to the formulations.
For example, the drying effect of alcohol can be reduced or
eliminated by adding 1 - 3% glycerin or other skin conditioning
agents.
Moreover, in prospective trials, alcohol-based solutions or gels
containing humectants caused significantly less skin irritation
and dryness than the soaps or antimicrobial detergents tested.
5Who-Recommended Handrub
Formulations
7I. Formulation I (glycerinated ethanol 80%, v/v)
DOSAGE FORM:
solution
FORMULA:
To produce final concentrations of ethanol80% v/v,
glycerol 1.45% v/v, hydrogen peroxide (H2O2) 0.125% v/v.
Ingredients Quantity
Ethanol 96% v/v 833.3 mL
H2O2 3% 41.7 mL
Glycerol 98% 14.5 mL
Distilled water, qs 1000 mL
Only pharmacopoeial quality reagents should be used
(e.g. The International Pharmacopoeia) and not technical grade products
USE/TYPE:
Human use. Non-Sterile
Preparation: solution.
A. METHOD OF PREPARATION C. PRESERVATION, PACKAGING AND STORAGE
1. The alcohol is poured into the large bottle or tank • In a suitable container, made of amber glass or
up to the graduated mark. high-density opaque plastic, perfectly closed and
2. H2O2 is added using the measuring cylinder. protected from light, at room temperature.
3. Glycerol is added using a measuring cylinder. As the
glycerol is very viscous and sticks to the walls of the
measuring cylinder, it can be rinsed with some sterile D. STABILITY
distilled or cold boiled water to be added and then
emptied into the bottle/ tank. • A beyond-use date of 180 days can be used for this
4. The bottle/tank is then topped up to the corresponding preparation when stored in room temperature
mark of the volume (10-litre or 50-litre) to be prepared (USP ).
with the remainder of the distilled or cold, boiled water.
5. The lid or the screw cap is placed on the bottle/tank
immediately after mixing to prevent evaporation. E. STANDARD OPERATING PROCEDURE
6. The solution is mixed by gently shaking the recipient FOR QUALITY CONTROL
where appropriate (small quantities), or by using • Quality-control assessment can include alcohol
a wooden, plastic or metallic paddle. Electric mixers concentration (alcoholmeter), H2O2 concentration
should not be used. (titrimetry: oxydo-reduction reaction by iodine in acidic
7. After mixing, the solution is immediately divided into conditions), density, viscosity, and physical appearance
smaller containers (e.g. 1000, 500 or 100 mL plastic (color, uniformity). Moreover, the absence of microbial
bottles). The bottles should be kept in quarantine for contamination (including spores) can be checked by
72 hours. This allows time for any spores present in the filtration, according to the European Pharmacopeia
alcohol or the bottles to be eliminated by H2O2. specifications.
B. LABELING
The bottles should be labelled in accordance with
national guidelines. Labels should include the following:
• Name of institution
• Date of production and batch number
• Composition: ethanol or isopropanol, glycerol and
hydrogen peroxide (% v/v can also be indicated) and the
following statements:
• WHO-recommended handrub formulation
• For external use only
• Avoid contact with eyes
• Keep out of reach of children
• Use: apply a palmful of alcohol-based handrub and cover all
surfaces of the hands. Rub hands until dry. Flammable: keep
away from flame and heat.
8II. Formulation II (glycerinated isopropyl alcohol 75%, v/v)
DOSAGE FORM:
solution
FORMULA:
To produce final concentrations of isopropyl alcohol 75%
v/v, glycerol 1.45% v/v, hydrogen peroxide 0.125% v/v
Ingredients Quantity
Isopropyl alcohol (with a purity of 99.8%) 751.5 mL
H2O2 3% 41.7 mL
Glycerol 98% 14.5 mL
Distilled water, qs 1000 mL
Only pharmacopoeial quality reagents should be used
(e.g. The International Pharmacopoeia) and not technical grade products.
USE/TYPE:
Human use. Non-Sterile
Preparation: solution.
A. METHOD OF PREPARATION C. PRESERVATION, PACKAGING AND STORAGE
1. The alcohol is poured into the large bottle or tank • In a suitable container, made of amber glass or
up to the graduated mark. high-density opaque plastic, perfectly closed and
2. H2O2 is added using the measuring cylinder. protected from light, at room temperature.
3. Glycerol is added using a measuring cylinder. As the
glycerol is very viscous and sticks to the walls of the
measuring cylinder, it can be rinsed with some sterile D. STABILITY
distilled or cold boiled water to be added and then
emptied into the bottle/ tank. • A beyond-use date of 180 days can be used for this
4. The bottle/tank is then topped up to the corresponding preparation when stored in room temperature
mark of the volume (10-litre or 50-litre) to be prepared (USP ).
with the remainder of the distilled or cold, boiled water.
5. The lid or the screw cap is placed on the bottle/tank
immediately after mixing to prevent evaporation. E. STANDARD OPERATING PROCEDURE
6. The solution is mixed by gently shaking the recipient FOR QUALITY CONTROL
where appropriate (small quantities), or by using a • Quality-control assessment can include alcohol titre,
wooden, plastic or metallic paddle. Electric mixers density, viscosity, and physical appearance
should not be used. (color, uniformity).
7. After mixing, the solution is immediately divided into
smaller containers (e.g. 1000, 500 or 100 mL plastic • Quality-control assessment can include alcohol
bottles). The bottles should be kept in quarantine for concentration (alcoholmeter), H2O2 concentration
72 hours. This allows time for any spores present in the (titrimetry: oxydo-reduction reaction by iodine in acidic
alcohol or the bottles to be eliminated by H2O2. conditions), density, viscosity, and physical appearance
(color, uniformity). Moreover, the absence of microbial
contamination (including spores) can be checked by
filtration, according to the European Pharmacopeia
B. LABELING
specifications.
The bottles should be labelled in accordance with
national guidelines. Labels should include the following:
• Name of institution
• Date of production and batch number
• Composition: ethanol or isopropanol, glycerol and
hydrogen peroxide (% v/v can also be indicated)
and the following statements:
• WHO-recommended handrub formulation
• For external use only
• Avoid contact with eyes
• Keep out of reach of children
• Use: apply a palmful of alcohol-based handrub and cover
all surfaces of the hands. Rub hands until dry. Flammable:
keep away from flame and heat.
9Other Hand Sanitizers
FormulationsI. Ethanol 70% (m/m)
DOSAGE FORM:
solution
FORMULA:
Ingredients Quantity
Ethanol 96% v/v 72.91 mL
Distilled water, q.s. 100.0 mL
USE/TYPE:
Human use. Non-Sterile
Preparation: solution.
A. METHOD OF PREPARATION D. STABILITY
1. In a suitable container, mix ethyl alcohol and water. Shake. • A beyond-use date of 180 days can be used for this
2. Leave to stand until the bubbles are completely eliminated preparation when stored in room temperature
and check the ethanolic titre of the solution (USP ).
B. LABELING E. STANDARD OPERATING PROCEDURE
FOR QUALITY CONTROL
• Keep away from heat sources.
• Keep out of the reach of children. • Quality-control assessment can include alcohol titre,
• External use. density, and physical appearance (color, uniformity).
• As an antiseptic, apply to the skin. As a disinfectant, Moreover, the absence of microbial contamination
apply to surfaces or objects to be disinfected. (including spores) can be checked by filtration,
according to the European Pharmacopeia specifications.
C. PRESERVATION, PACKAGING AND STORAGE
• In a suitable container, made of amber glass or
high-density opaque plastic, perfectly closed and
protected from light, at room temperature.
12II. Hand sanitizer (alcohol gel) with Carbopol
DOSAGE FORM:
gel
FORMULA:
Ingredients Quantity
Ethanol 96% v/v 72.91 mL
Carbopol 980 0.5 g
Triethanolamine (sol. 50%) qs
Glycerin 1.0 – 3.0g
Water, q.s. 100.0 mL
USE/TYPE:
Human use.
Non-Sterile Preparation: gel (fluid, transparent).
A. METHOD OF PREPARATION D. STABILITY
1. Mix the ethanol and water. • A beyond-use date of 180 days can be used for this
2. Disperse Carbopol with shaking. preparation when stored in room temperature
3. Add glycerin. (USP ).
4. Bring the volume with water and then adjust
pH to 5.0 - 8.0 with triethanolamine
E. STANDARD OPERATING PROCEDURE
FOR QUALITY CONTROL
B. LABELING • Quality-control assessment can include alcohol titre,
density, viscosity, and physical appearance (color,
• Keep out of the reach of children.
uniformity). Moreover, the absence of microbial
• External use.
contamination (including spores) can be checked
• As an antiseptic, apply to the skin. As a disinfectant,
by filtration, according to the European Pharmacopeia
apply to surfaces or objects to be disinfected.
specifications.
C. PRESERVATION, PACKAGING AND STORAGE
• In a suitable plastic container, well closed, protected
from light and temperature below 25 ºC.
13III. Hand sanitizer (alcohol gel) with hydroxyethylcellulose
DOSAGE FORM:
gel
FORMULA:
Ingredients Quantity
Ethanol 96% v/v 72.91 mL
Hydroxyethylcellulose* 2.5 - 4.0 g
Glycerin 3.0 g
Distilled water, q.s. 100.0 mL
*Natrosol™ 250 HHR
USE/TYPE:
Human use.
Non-Sterile Preparation: gel (fluid, transparent to yellowish).
A. METHOD OF PREPARATION D. STABILITY
1. Dissolve hydroxyethylcellulose in water. • A beyond-use date of 180 days can be used for this
Shake until no lumps are visible. preparation when stored in room temperature
2. Add ethanol and glycerin. (USP ).
3. Bring the volume with water.
E. STANDARD OPERATING PROCEDURE
B. LABELING FOR QUALITY CONTROL
• Keep out of the reach of children. • Quality-control assessment can include alcohol titre,
• External use. density, viscosity, and physical appearance (color,
• As an antiseptic, apply to the skin. As a disinfectant, uniformity). Moreover, the absence of microbial
apply to surfaces or objects to be disinfected. contamination (including spores) can be checked
by filtration, according to the European Pharmacopeia
specifications.
C. PRESERVATION, PACKAGING AND STORAGE
• In a suitable plastic container, well closed, protected
from light and temperature below 25 ºC.
14IV. Hand sanitizer (alcohol gel) with hydroxypropylcellulose
DOSAGE FORM:
gel
FORMULA:
Ingredients Quantity
Ethanol 96% v/v 72.91 mL
Hydroxypropylcellulose 1.0 g
Glycerin 3.0 g
Water, q.s. 100.0 mL
USE/TYPE:
Human use.
Non-Sterile Preparation: gel (fluid, transparent).
A. METHOD OF PREPARATION D. STABILITY
1. Mix the ethanol and the water, and then dissolve glycerin. • A beyond-use date of 180 days can be used for this
2. Add hydroxypropylmethylcellulose in small portions, preparation when stored in room temperature
with intensive agitation to prevent the formation of lumps. (USP ).
3. Let it to stand for 24h.
4. Agitate once again in high speed for a few minutes.
E. STANDARD OPERATING PROCEDURE
FOR QUALITY CONTROL
B. LABELING
• Quality-control assessment can include alcohol titre,
• Keep out of the reach of children. density, viscosity, and physical appearance (color,
• External use. uniformity). Moreover, the absence of microbial
• As an antiseptic, apply to the skin. As a disinfectant, contamination (including spores) can be checked
apply to surfaces or objects to be disinfected. by filtration, according to the European Pharmacopeia
specifications.
C. PRESERVATION, PACKAGING AND STORAGE
• In a suitable plastic container, well closed, protected
from light and temperature below 25 ºC.
15V. Hand sanitizer (alcohol gel) with hydroxypropylmethylcellulose
DOSAGE FORM:
gel
FORMULA:
Ingredients Quantity
Ethanol 96% v/v 72.91 mL
Hydroxypropylmethylcellulose
2.0 - 4.0 g
(minimum 1500 cps)
Glycerin 1.0 - 3.0 g
Water, q.s. 100.0 mL
USE/TYPE:
Human use.
Non-Sterile Preparation: gel (fluid, transparent).
A. METHOD OF PREPARATION D. STABILITY
1. Dissolve hydroxypropylmethylcellulose in water with • A beyond-use date of 180 days can be used for this
intensive agitation to prevent the formation of lumps. preparation when stored in room temperature
2. Add ethanol and glycerin. (USP ).
3. Bring the volume with water.
B. LABELING E. STANDARD OPERATING PROCEDURE
FOR QUALITY CONTROL
• Keep out of the reach of children.
• External use. • Quality-control assessment can include alcohol titre,
• As an antiseptic, apply to the skin. As a disinfectant, density, viscosity, and physical appearance (color,
apply to surfaces or objects to be disinfected. uniformity). Moreover, the absence of microbial
contamination (including spores) can be checked
by filtration, according to the European Pharmacopeia
specifications.
C. PRESERVATION, PACKAGING AND STORAGE
• In a suitable plastic container, well closed, protected
from light and temperature below 25 ºC.
16VI. Hand sanitizer (alcohol gel)
with Ammonium Acryloyl dimethyltaurate/VP Copolymer
DOSAGE FORM:
gel
FORMULA:
Ingredients Quantity
Ethanol 96% v/v 72.91 mL
Ammonium Acryloyl
0.7 - 3.0 g
dimethyltaurate/VP Copolymer*
Propylene glycol 2.0 g
Glycerin 2.0 g
Water, q.s. 100.0 mL
*Aristoflex® AVC
USE/TYPE:
Human use.
Non-Sterile Preparation: gel (viscous, transparent).
A. METHOD OF PREPARATION D. STABILITY
1. Mix Aristoflex® AVC in water and isopropyl alcohol until • A beyond-use date of 180 days can be used for this
complete dispersion. If necessary, allow to stand for 24h. preparation when stored in room temperature
2. Add propylene glycol and glycerin to the previous step. (USP ).
3. Bring the volume with water.
B. LABELING E. STANDARD OPERATING PROCEDURE
FOR QUALITY CONTROL
• Keep out of the reach of children.
• External use. • Quality-control assessment can include alcohol titre,
• As an antiseptic, apply to the skin. As a disinfectant, density, viscosity, and physical appearance (color,
apply to surfaces or objects to be disinfected. uniformity). Moreover, the absence of microbial
contamination (including spores) can be checked
by filtration, according to the European Pharmacopeia
specifications.
C. PRESERVATION, PACKAGING AND STORAGE
• In a suitable plastic container, well closed, protected
from light and temperature below 25 ºC.
17VII. Hand sanitizer (alcohol gel)
with Acrylates / C10-30 Alkyl Acrylate Crosspolymer
DOSAGE FORM:
gel
FORMULA:
Ingredients Quantity
Ethanol 96% v/v 72.91 mL
Acrylates / C10-30 Alkyl Acrylate
0.3 - 1.0 g
Crosspolymer*
Glycerin 3.0 g
Neutralizing agent q.s. pH 7.0
Water, q.s. 100.0 mL
*PemulenTM TR1
USE/TYPE:
Human use. Non-Sterile Preparation: gel (fluid, transparent).
A. METHOD OF PREPARATION D. STABILITY
1. Dissolve Acrylates / C10-30 Alkyl Acrylate Crosspolymer • A beyond-use date of 180 days can be used for this
in water with intensive agitation (~4,000 rpm), with for preparation when stored in room temperature
20 minutes to prevent the formation of lumps. (USP ).
2. Blend ethanol, isopropyl alcohol and glycerin, and then
add the mixture to the previous step.
3. Bring the volume with water.
E. STANDARD OPERATING PROCEDURE
4. Neutralize the system to obtain gel consistency.
FOR QUALITY CONTROL
• Quality-control assessment can include alcohol titre,
density, viscosity, and physical appearance (color,
B. LABELING
uniformity). Moreover, the absence of microbial
• Keep out of the reach of children. contamination (including spores) can be checked
• External use. by filtration, according to the European Pharmacopeia
• As an antiseptic, apply to the skin. As a disinfectant, specifications.
apply to surfaces or objects to be disinfected.
C. PRESERVATION, PACKAGING AND STORAGE
• In a suitable plastic container, well closed, protected
from light and temperature below 25 ºC.
18VIII. Hand sanitizer (alcohol gel) with Polyacrylamide
(and) C13-14 Isoparaffin (and) Laureth-7
DOSAGE FORM:
gel
FORMULA:
Ingredients Quantity
Ethanol 96% v/v 72.91 mL
Polyacrylamide (and) C13-14
1.5 - 3.0 g
Isoparaffin (and) Laureth-7*
Water, q.s. 100.0 mL
*SepigelTM 305.
USE/TYPE:
Human use.
Non-Sterile Preparation: gel (fluid (1.5%) to viscous (2.5%), transparent).
A. METHOD OF PREPARATION D. STABILITY
1. Dissolve Polyacrylamide (and) C13-14 Isoparaffin (and) • A beyond-use date of 180 days can be used for this
Laureth-7 in water with with regular agitation until preparation when stored in room temperature
no lump is visible. (USP ).
2. Add ethanol and mix gently.
E. STANDARD OPERATING PROCEDURE
B. LABELING FOR QUALITY CONTROL
• Keep out of the reach of children. • Quality-control assessment can include alcohol titre,
• External use. density, viscosity, and physical appearance (color,
• As an antiseptic, apply to the skin. As a disinfectant, uniformity). Moreover, the absence of microbial
apply to surfaces or objects to be disinfected. contamination (including spores) can be checked
by filtration, according to the European Pharmacopeia
specifications.
C. PRESERVATION, PACKAGING AND STORAGE
• In a suitable plastic container, well closed, protected
from light and temperature below 25 ºC.
19Surface Sanitizers
Persistence of SARS-CoV-2 in surfaces
There is no official data concerning the persistence 21 to 23°C and 40% relative humidity over 7 days. On
of SARS-CoV-2 in dry surfaces. In fact, its stability in plastic and stainless steel, viable SARS-CoV-2 was
the environment depends on several factors includ- detected up to 72 hours after application to these
ing relative temperature, humidity, and surface type. surfaces; on copper, no viable SARS-CoV-2 was mea-
Although the viability of the virus can be affected by sured after 4 hours; on cardboard, no viable SARS-
such factors, an estimate or average time in which CoV-2 was measured after 24 hours.
the SARS-CoV-2 can remain in surfaces can help to They also evaluated the SARS-CoV-2 in aerosols for 3
create strategies to decrease its population in differ- hours, and the virus remained viable throughout the
ent materials. duration of the experiment. Thus, aerosol and fomite
A recent study conducted by van Doremalen et al. transmission of SARS-CoV-2 is plausible, since the
(2020) evaluated viruses applied to copper, card- virus can remain viable and infectious in aerosols for
board, stainless steel, and plastic – all maintained at hours and on surfaces up to days.
Source: van Doremalen et al. (2020)
Considering the box above, we can see that the SARS-CoV-2 can remain viable in surfaces for hours to days, thus mak-
ing sanitization of such surfaces an important key point to reduce the propagation of the virus throughout the world.
In addition to that, the World Health Organization (WHO) provided a list additional care that should be taken – especially
if you are providing home care for patients with suspected COVID-19 who present with mild symptoms*. The recom-
mendations include disinfection of surface and materials.
* patients with mild symptoms and without underlying chronic conditions − such as lung or heart disease,
renal failure, or immunocompromising conditions that place the patient at increased risk
of developing complications − may be cared for at home.
Some of the WHO recommendations described in the “Home care for patients with COVID-19
presenting with mild symptoms and management of their contacts” are:
• Perform hand hygiene after any type of contact with • Daily clean and disinfect surfaces that are frequently
patients or their immediate environment. Hand hygiene touched in the room where the patient is being cared
should also be performed before and after preparing for, such as bedside tables, bedframes, and other bed-
food, before eating, after using the toilet, and whenever room furniture. Regular household soap or detergent
hands look dirty. If hands are not visibly dirty, an alco- should be used first for cleaning, and then, after rinsing,
hol-based hand rub can be used. For visibly dirty hands, regular household disinfectant containing 0.1% sodi-
use soap and water. um hypochlorite (i.e. equivalent to 1000 ppm) should
be applied.
• When washing hands with soap and water, it is prefera-
ble to use disposable paper towels to dry hands. If these • Clean and disinfect bathroom and toilet surfaces at
are not available, use clean cloth towels and replace least once daily. Regular household soap or detergent
them frequently. should be used first for cleaning, and then, after rins-
ing, regular household disinfectant containing 0.1%
sodium hypochlorite should be applied.
21• Clean the patient’s clothes, bed linen, and bath and the context, either utility or single-use gloves can be
hand towels using regular laundry soap and water or used. After use, utility gloves should be cleaned with
machine wash at 60 - 90 °C (140 - 194 °F) with com- soap and water and decontaminated with 0.1% sodium
mon household detergent, and dry thoroughly. Place hypochlorite solution. Single-use gloves (e.g. nitrile or
contaminated linen into a laundry bag. Do not shake latex) should be discarded after each use. Perform hand
soiled laundry and avoid contaminated Clean the pa- hygiene before putting on and after removing gloves.
tient’s clothes, bed linen, and bath and hand towels us-
• Any surfaces that become soiled with respiratory secre-
ing regular laundry soap and water or machine wash at
tions or other body fluids during transport of patients
60 - 90 °C (140 - 194 °F) with common household deter-
(hospital-house or house-hospital) should be cleaned
gent, and dry thoroughly. Place contaminated linen into
with soap or detergent and then disinfected with a
a laundry bag. Do not shake soiled laundry and avoid
regular household product containing a 0.5% diluted
contaminated.
bleach solution (equivalent 5000 ppm).
• Gloves and protective clothing (e.g. plastic aprons)
should be used when cleaning surfaces or handling
clothing or linen soiled with body fluids. Depending on
Additionally, WHO also stated in its ”Water, sanitation, hygiene,
and waste management for the COVID-19 virus” Interim Report the following:
• 70% ethyl alcohol to disinfect small areas between uses,
such as reusable dedicated equipment (for example, thermometers);
• sodium hypochlorite at 0.5% (equivalent to 5000 ppm) for disinfecting surfaces.
This same publication cites the use of chlorinated water (0.05%)
in the following situations:
• If an alcohol-based hand rub and soap are not available, • Linens can be soaked in hot water and soap in a large
then using chlorinated water (0.05%) for handwashing drum using a stick to stir and being careful to avoid
is an option, but it is not ideal because frequent use splashing. The drum should then be emptied, and the
may lead to dermatitis, which could increase the risk of linens soaked in 0.05% chlorine for approximately 30
infection and asthma and because prepared dilutions minutes. Finally, the laundry should be rinsed with clean
might be inaccurate. However, if other options are not water and the linens allowed to dry fully in sunlight.
available or feasible, using chlorinated water for hand-
washing is an option.
22Cleaning options for different settings
Frequently touched surfaces should be cleaned as often as possible (at least daily and, if possible, more frequently).
Examples of these surfaces are doorknobs and door bars, chairs and armrests, tabletops, light switches, handrails,
water taps, elevator buttons, etc.
[S]: Suggested | [O]: Optional
Healthcare setting Non-healthcare setting General settings
• Neutral detergent AND • Neutral detergent AND • Neutral detergent
• Virucidal disinfectant OR • Virucidal disinfectant OR
• 0.05% sodium hypochlorite OR • 0.05% sodium hypochlorite OR
Surfaces
• 70% ethanol • 70% ethanol
[S] [S] [S]
• Virucidal disinfectant OR
• Virucidal disinfectant OR • Virucidal disinfectant OR
• 0.1% Sodium hypochlo-
• 0.1% sodium hypochlorite • 0.1% sodium hypochlorite
Toilets rite
[S] [S]
[O]
• Hot-water cycle (90°C) AND • Hot-water cycle (90°C) AND
• regular laundry detergent • regular laundry detergent
• alternative: lower temperature • alternative: lower temperature
Textiles cycle + bleach or other laundry cycle + bleach or other laundry N/A
products products
[S] [S]
• Single-use disposable OR • Single-use disposable OR • Single-use disposable OR
• Non-disposable disinfected with: • Non-disposable disinfected with: • Non-disposable cleaned
Cleaning • Virucidal disinfectant OR • Virucidal disinfectant OR at the end of cleaning
equipment • 0.1% sodium hypochlorite • 0.1% sodium hypochlorite session
[S] [O] [S]
• Surgical mask • Surgical mask • Uniform
• Disposable long-sleeved • Uniform and plastic apron • Gloves
water- resistant gown • Gloves
PPE for • Gloves
cleaning staff • FFP2 or 3 when cleaning facilities
where AGP have been performed
[S] [S] [S]
• Infectious clinical waste • In a separate bag in the • Unsorted garbage
Waste category B (UN3291) unsorted garbage
management
[S] [S] [S]
Source: ECDC TECHNICAL REPORT. Disinfection of environments in healthcare
and nonhealthcare settings potentially contaminated with SARS-CoV-2.
23Surface Sanitizers
FormulationsI. Sodium Hypochlorite 0.1% Solution
FORMULA:
Ingredients Quantity
Sodium Hypochlorite 5% Solution 20 mL
Hydrochloric Acid 1N/Water to adjust pH
Water, q.s. 1000.0 mL
USE/TYPE:
Not for human use.
This preparation is to be used to aid in the cleaning and disinfecting of surface components.
A. METHOD OF PREPARATION C. PRESERVATION, PACKAGING AND STORAGE
1. Add Sodium Hypochlorite 5% Solution to a graduated • In a suitable plastic container, well closed, protected
cylinder or volumetric flask. from light and temperature below 25 ºC.
2. Add water to Step 1 and mix well. Use an amount of water
that is approximately 90% of the final volume.
For example, if the final volume is 1000 mL, use 900 mL
D. STABILITY
of water.
3. Adjust the pH of Step 2 to 5.5 - 6.0 using Hydrochloric Acid • A beyond-use date of 30 days can be used for this
1N/Water by adding dropwise. Check pH with a pH Meter preparation when stored in room temperature.
after each addition. Preferably, use solutions freshly prepared daily.
4. Bring to the final volume with water and mix thoroughly.
E. STANDARD OPERATING PROCEDURE
B. LABELING FOR QUALITY CONTROL
• Nor for human use. • Quality-control assessment can include physical
• Keep out of the reach of children. appearance (color, uniformity) and pH (5.5 - 6.0).
• A minimum contact time of 5 minutes is recommended
for maximum disinfection efficacy.
• Care should be used where surfaces (such as stainless steel)
are sensitive to Chlorine. If used on these surfaces, after
allowing disinfectant to sit for a minimum contact time
of 5 minutes, wash with water to remove residual Chlorine.
26II. Sodium Hypochlorite 0.5% Solution
FORMULA:
Ingredients Quantity
Sodium Hypochlorite 5% Solution 100 mL
Hydrochloric Acid 1N/Water to adjust pH
Water, q.s. 1000.0 mL
USE/TYPE:
Not for human use.
This preparation is to be used to aid in the cleaning and disinfecting of surface components.
A. METHOD OF PREPARATION C. PRESERVATION, PACKAGING AND STORAGE
1. Add Sodium Hypochlorite 5% Solution to a graduated • In a suitable plastic container, well closed, protected
cylinder or volumetric flask. from light and temperature below 25 ºC.
2. Add water to Step 1 and mix well. Use an amount of water
that is approximately 90% of the final volume.
For example, if the final volume is 1000 mL, use 900 mL
D. STABILITY
of water.
3. Adjust the pH of Step 2 to 5.5 - 6.0 using Hydrochloric Acid • A beyond-use date of 30 days can be used for this
1N/Water by adding dropwise. Check pH with a pH Meter preparation when stored in room temperature.
after each addition. Preferably, use solutions freshly prepared daily.
4. Bring to the final volume with water and mix thoroughly.
E. STANDARD OPERATING PROCEDURE
B. LABELING FOR QUALITY CONTROL
• Nor for human use. • Quality-control assessment can include physical
• Keep out of the reach of children. appearance (color, uniformity) and pH (5.5 - 6.0).
• A minimum contact time of 5 minutes is recommended
for maximum disinfection efficacy.
• Care should be used where surfaces (such as stainless steel)
are sensitive to Chlorine. If used on these surfaces, after
allowing disinfectant to sit for a minimum contact time
of 5 minutes, wash with water to remove residual Chlorine.
27III. Sodium Hypochlorite 0.05% Solution (chlorinated water)
FORMULA:
Ingredients Quantity
Sodium Hypochlorite 5% Solution 10 mL
Water, q.s. 1000.0 mL
USE/TYPE:
Not for human use.
This preparation is to be used to aid in the cleaning and disinfecting of surface components.
A. METHOD OF PREPARATION D. STABILITY
1. Add Sodium Hypochlorite 5% Solution to a graduated • A beyond-use date of 30 days can be used for this
cylinder or volumetric flask. preparation when stored in room temperature.
2. Add water to Step 1 and mix thoroughly. Preferably, use solutions freshly prepared daily.
B. LABELING
E. STANDARD OPERATING PROCEDURE
• Nor for human use. FOR QUALITY CONTROL
• Keep out of the reach of children.
• Can be used for handwashing if other options are not • Quality-control assessment can include physical
available or feasible. appearance (color, uniformity).
C. PRESERVATION, PACKAGING AND STORAGE
• In a suitable plastic container, well closed, protected
from light and temperature below 25 ºC.
28How to calculate
the active chlorine content in a sanitizer
Active chlorine is a unit of comparison between the oxidizing power of various chlorinated compounds.
It can be calculated by converting the percentage by mass of sodium hypochlorite to its equivalent in active chlorine.
The sodium hypochlorite content is multiplied by the relationship between their respective molecular masses:
Cl2 71
= = 0.953
NaClO 74.5
% Sodium Hypochlorite x 0.953 = Active Chlorine
• Grams per Liter of Sodium Hypochlorite
It is the weight, in grams, of sodium hypochlorite in one liter of solution.
• Grams per Liter of Active Chlorine
The sodium hypochlorite content is multiplied by the ratio between
their respective molecular masses.
g/L of Sodium Hypochlorite x 0.953 = g/L Active Chlorine
• For example, 100mL of a solution with 5% sodium hypochlorite would have
approximately 4.765g of active chlorine (free chlorine) (5 x 0.953 = 4.765).
29References
Ayliffe GAJ, Babb JR, Quoraishi AH. A test for “hygienic” hand dis- Newman JL, Seitz JC. Intermittent use of an antimicrobial hand
infection. Journal of Clinical Pathology, 1978, 31:923–928. gel for reducing soap-induced irritation of health care per-
Boyce JM, Kelliher S, Vallande N. Skin irritation and dryness as- sonnel. American Journal of Infection Control, 1990, 18:194–
sociated with two hand–hygiene regimens: soap-and-water 200.
hand washing versus hand antisepsis with an alcoholic hand
Ojajarvi J, Makela P, Rantasalo I. Failure of hand disinfection with
gel. Infection Control and Hospital Epidemiology, 2000,
21:442–448. frequent hand washing: a need for prolonged field studies.
Journal of Hygiene (London), 1977, 79:107–119.
Boyce, J., Chartier, Y., Chraiti, M., Cookson, B., Damani, N., & Dha-
ran, S. (2009). WHO guidelines on hand hygiene in health Price PB. Ethyl alcohol as a germicide. Archives of Surgery, 1939,
care. Geneva: World Health Organization. 38:528–542.
Dineen P, Hildick-Smith G. Antiseptic care of the hands. In: Mai- Price PB. New studies in surgical bacteriology and surgical tech-
bach HI, Hildick-Smith G, eds. Skin bacteria and their role in nique. JAMA, 1938, 111:1993–1996.
infection. New York, NY, McGraw-Hill, 1965:291–309.
Rotter ML, Koller W, Neumann R. The influence of cosmetic ad-
ECDC TECHNICAL REPORT. Disinfection of environments in
healthcare and nonhealthcare settings potentially contami- ditives on the acceptability of alcohol-based hand disinfec-
nated with SARS-CoV-2. March 2020. tants. Journal of Hospital Infection, 1991, 18(Suppl. B):57–63.
Ferreira AO, Brandão MAF, Polonini HC. Guia prático da farmácia United States Food and Drug Administration. Tentative final
magistral, 2018. monograph for healthcare antiseptic drug products; pro-
posed rule. Federal Register, 1994:31441–31452.
Formulário Nacional. Brazilian Pharmacopeia, 2nd ed.
Gravens DL et al. Septisol antiseptic foam for hands of operating van Doremalen, N., Bushmaker, T., Morris, D. H., Holbrook, M. G.,
room personnel: an effective antibacterial agent. Surgery, Gamble, A., Williamson, B. N., ... & Lloyd-Smith, J. O. (2020).
1973, 73:360–367. Aerosol and surface stability of SARS-CoV-2 as compared
with SARS-CoV-1. New England Journal of Medicine.
Harrington C, Walker H. The germicidal action of alcohol. Boston
Medical and Surgical Journal, 1903, 148:548–552. Walter CW. Disinfection of hands. American Journal of Surgery,
Larson EL et al. Assessment of two hand hygiene regimens for 1965, 109:691–693.
intensive care unit personnel. Critical Care Medicine, 2001,
WHO – World Health Organization. Guidelines on Hand Hygiene
29:944–951.
in Health Care (ISBN 978 92 4 159790 6 )
Larson EL et al. Comparison of different regimens for surgical
hand preparation. Association of Operating Room Nurses WHO – World Health Organization. Home care for patients with
Journal, 2001, 73:412–418. COVID-19 presenting with mild symptoms and management
of their contacts. Interim Report. 17th March 2020.
Larson EL, Eke PI, Laughon BE. Efficacy of alcohol-based hand
rinses under frequent-use conditions. Antimicrobial Agents WHO – World Health Organization. Water, sanitation, hygiene,
and Chemotherapy, 1986, 30:542–544. and waste management for the COVID-19 virus. Interim Re-
Larson EL, Morton HE. Alcohols. In: Block SS, ed. Disinfection, port. 19th March 2020.
sterilization and preservation, 4th ed. Philadelphia, PA, Lea
Winnefeld M et al. Skin tolerance and effectiveness of two hand
& Febiger, 1991:191–203.
decontamination procedures in everyday hospital use. Brit-
Lowbury EJL, Lilly HA, Ayliffe GAJ. Preoperative disinfection of ish Journal of Dermatology, 2000, 143:546–550.
surgeon’s hands: use of alcoholic solutions and effects of
gloves on skin flora. BMJ, 1974, 4:369–372.
31Together we create the future of personalized medicine. Fagron BV Lichtenauerlaan 182 T +31 88 33 11 288 3062 ME Rotterdam F +31 88 33 11 210 The Netherlands www.fagron.com
You can also read
