DiSINFECTANT

CHAPTER II
TOPICS

DEFINITION (REVIEW)

STANDARD OF CONCENTRATION

DISINFECTION TECHNIQUE

EXISTING DISINFECTANT AT
VAKSINDO
 Back to Basics - Disinfection

• The process of removing or destroying micro-organisms

and reducing them to an acceptable level.
• Efficacy is dependant on several factors:
• Concentration
• Temperature
• Time
• Soiling
• Mode of application
• Type of organism
The Ideal Disinfectant
• Kills all micro-organisms
• Non-corrosive
• Safe to use
• Leaves no residues
• Sterile (for Grade A and B areas)
• Fast acting
• Compatible with other agents
• Compatible with cleanroom surfaces
• Cost effective (price, time to prepare/use, PPE, wastage)
 STANDARD
Golongan Desinfektan Dosis Daya Aksi Mikroba Target

Aldehid Formalin 0,1 ppm Rentang jam Virus

0,5 ppm Mikroorganisme
Glutaraldehid
15.000 ppm Jamur dan Ragi
Oksidator KMnO4 0,02 % 0,5 - 2 jam Mikroorganisme & Virus
Natrium 0,1 - 5,0 % 10 - 30 menit Bakteri vegetatif & lipovirus
Perkarbonat
Fenol Kreosol 0,1 - 5,0 % 10 - 30 menit Virus & spora
Halogen Povidone Iodine 1,0 - 5,0 % 10 - 30 menit Virus

Garam (A.K) Benzalkonium 0,1 – 5,0 % 10 – 30 menit Bakteri vegetatif dan lipovirus
Chloride
Alkohol Etanol 70 - 90 % 30 menit Mikroorganisme

[KKP] Kementerian Kelautan dan Perikanan. 2011. Pedoman Teknis Tindakan Karantina Ikan Secara Terintegrasi
Berbasis In Line Inspection. Jakarta (ID)
DISINFECTION TECHNIQUE
EU GMP Annex 1: Manufacture of Sterile Medicinal Products

EU GMP Chapter 3: Premises and Equipment

 Small Surfaces
Typically treated by spraying and/or wiping

Significant variation in technique:

• Spray onto the wipe vs. spray directly on to the

surface
• Dry wipes vs. pre-impregnated wipes
• Spraying without wiping
• Wiping (with pre-impregnated wipes) without
spraying
• Spraying and wiping with impregnated wipes
 Spraying & Wiping
BEST PRACTICE: Spray and wipe to ensure maximum
bioburden reduction and particulate removal

• Microbes are killed by

exposure to the disinfectant
• Microbes not killed are
physically removed from the
surface due to the mechanical
action of wiping
• Particulates are removed from
the surface due to mechanical
action
 Spraying & Wiping
Effect of spraying and/or wiping with 70% IMS on
reducing surface bioburden (% reduction)*
Organism Spray Wipe Spray then Wipe then
Wipe Spray
S. aureus 99.8 99.6 100 Not tested

C. albicans 96.4 Not tested 99.3 100

A. brasiliensis 84.2 Not tested 98.5 98.6

B. subtilis 27.6 80.6 93.9 96.7

(spores)

Industrial Methylated Spirit

NOTE: study wipes pre-impregnated with IPA, not dry wipes *Beaney et al 2001
Wiping vs. Spraying

• Use of a pre-impregnated wipe in conjunction

with spraying will result in the maximum
bioburden reduction
• Spray directly onto the surface where possible
to ensure maximum biocidal contact
*wipe should appear wet, folded wipes should be sprayed on either side
Wiping technique
• Wipe in unidirectional over-lapping strokes
• Use slow, deliberate movements so as not to generate
particulates and minimise disruption to airflows
• A careful technique is required to maximise mechanical
action and ensure good contact of the surface with the
biocide
• Wipe should be folded to allow maximum surface usage
• Ideally a fresh surface of the wipe should be used for
each stroke
• Order of wiping just as important as it is with mopping
(back > front, top > bottom, cleanest > dirtiest)
 Folding Wipes
Points to consider
• Wipe should be folded to roughly hand size
• How often the wipe must be re-folded to expose
a “clean” side will depend on how dirty the
surface is and the criticality of the surface.
• There is a potential for contamination from the
used surface of the wipe to be transferred to the
gloved hand!
• Prefer to use a small wipe and not fold it all for
use in for Grade A areas for this reason.
 Folding Techniques

Side 1 Side 1A Side 2 Side 2A

Side 1B Side 2B

“Front” of Wipe “Back” of Wipe

Wiping Technique – maximum surface area

Surface area to be covered by 1 stroke will

depend on the criticality of the surface. For
example:
• Grade A LAF - one side of the cabinet may be wiped
using only one side of the wipe
• Grade A/B Filling line - one stroke may cover only a
short distance (~50 cm)
• Grade C/D room - one stroke may cover a larger
distance (~1 m)
 Wipe Quality
• There is no such thing as a “particulate/lint free
wipe”
• Some grades of wipe will shed more
particulates that others - dependant on material
of construction and method of manufacture
• Ensure that the wipe selected is compatible
with the disinfectant/alcohol in use.
• Wipes manufactured using chemical binders
may not be compatible
• Wipes should be single use, re-used wipes will
degrade and shed more particulates each time
they are re-processed
 Typically treated by mopping
Large Surfaces

• Single bucket systems

• Double bucket systems
• Triple bucket systems

16
Mop & Bucket Systems - Single

 Disinfectant/cleaning solution
quickly becomes contaminated
due to soiling reducing the
efficacy of the solution
 Not suitable for use in a GMP
environment
Mop & Bucket Systems - Double
 Slight improvement on  Declining use of this
single bucket system due to system in pharmaceutical
addition of waste bucket. industry
 Mop head is rinsed in
“clean” solution

Waste Clean
Mop & Bucket Systems - Triple
 Most efficient system due to
addition of waste and rinse bucket
 Reduces potential for contamination
of rinse solution and application
solution
 Offers a compromise
between risk & practicality
 Offers significant
advantages even in C/D
areas

Waste Rinse Clean

Mop & Bucket Systems - Triple

Mop dipped into “clean” Mop, rinsed in middle

solution, wrung out and bucket and wrung out
applied to the surfaces into the waste

Waste Rinse Clean

 Bucket Systems – rinse agent

 Use of disinfectant as a rinse agent is best practice

Avoids the potential for the solution in the front
bucket to become diluted
 Water may be used as a rinse agent to control cost
 Note that some disinfectants are more sensitive to
dilution than others, resulting is significant reduction
in efficacy (e.g. phenol-based disinfectants)
 “Pull and Lift” Technique
• Unidirectional mopping technique with over-lapping
strokes
• Ensures the whole surface is evenly covered and avoids
spreading contamination around the surface
• Surface contamination is actively removed with the “lift”

PULL
LIFT

Tim Sandle , CDC Handbook, 2012

 Alcohol
❑ Broad spectrum of activity ❑ Not sporicidal
❑ Low toxicity ❑ Flammable
❑ Rapid action ❑ Unsuitable for use on large surfaces – potential
❑ Non-corrosive to exceed exposure limits
❑ Evaporate quickly leaving low residues
 Isopropyl
Ethanol
alcohol
 FORMALINE/FORMALDEHYDE (ch2o)

Structure of
Formaldehdye Formaline

Formaldehyde/methanal) is
a naturally
37% occurring organic
compound with
the formula CH2O (H−CHO).
Concentration in a It is the simplest of
the aldehydes (R−CHO).
liquid phase
Globally Harmonized System of Classification
and Labelling of Chemicals (GHS) of Formaline

GHS08: Health hazard GHS05: Corrosive GHS02: Flammable GHS06: Toxic

 GLUTARALDEHYDE

Glutaraldehyde, sold under the

brandname Cidex and Glutaral among
others, is a disinfectant, medication,
preservative, and fixative.

50%
Globally Harmonized System of Classification and
Labelling of Chemicals (GHS) of glutaraldehyde

GHS08: Health hazard GHS07: Harmful

Na2CO3·1.5H2O2 (Sodium Percarbonate)

Sodium percarbonate uses active oxygen

to penetrate carbon or protein soils and
has a high kill rate on wide range of
microorganisms making it an effective
sanitizer as well as cleaner.
Globally Harmonized System of Classification and
Labelling of Chemicals (GHS) of glutaraldehyde

GHS05: Corrosive GHS03: Oxidizing GHS07: Harmful

 KMnO4 (Potassium Permanganate)

Potassium It can be used for

Permanganate is a disinfection, removing
very versatile hardness, removing
chemical. iron and manganese.

This chemical is a very powerful oxidizer and it should not

be stored anywhere near acids or fuel sources or it could
result in fires, explosions and/or toxic gases being formed.
 CRESOL

Crude cresol (commercial

cresol) is a mixture of aromatic
compounds containing about
20% of o-cresol, 40% of m-
cresol, and 30% of p-cresol
with small amount of phenol
and xylenols.
Cresol is used as disinfectant, in
production of phenolic resins,
tricresyl phosphate, ore
flotation, textile scouring
agent, organic intermediate,
and manufacture of
salicylaldehyde, coumarin, and
herbicides, surfactant.
 BENZALKONIUM CHLORIDE
 BZK, BKC, BAC, Alkyldimethylbenzylammonium chloride and ADBAC, is a type of cationic
surfactant.
 It is an organic salt classified as a quaternary ammonium compound.
 It has three main categories of use:
 as a biocide,
 a cationic surfactant, and
 as a phase transfer agent.
 In which the alkyl group has various even-numbered alkyl chain lengths.
 Povidone iodine

 Povidone-iodine (PVP-I), also known as iodopovidone, is

an antiseptic used for skin disinfection before and
after surgery. It may be used both to disinfect the skin of
the patient and the hands of the healthcare providers. It
may also be used for minor wounds. It may be applied to
the skin as a liquid or a powder.
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