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Very poor Quality Audit score in case of cleaning & sanitizing
Throughout all Emami units.
Major gaps observed -
There is no prerequisite program for
master cleaning & sanitization
Objective:
The methods of cleaning and sanitizing,
the types of chemicals used,
the frequency of cleaning activities,
and
the control of microbes must all be
done expertly
to protect our finished products from
contamination issue.
Why special focus on
cleaning & sanitizing !!!
3S is the part of
5S
(technique applied for
Good House Keeping)
3S
The First “S"
1S Activities
Indicators of
success
Seiri (sorting/
segregation)
- Sort though
- Identify what is needed and
discard the unnecessary
items.
- Productive area saving
The Second “S"
2S Activities
Indicators of
success
Seiton
(arrangement)
- Set item in order by creating
place for everything and put
everything in its place
- Keep accessibility
- Labeling
- Time saved in searching
and returning
The Third “S"
3S Activities Indicators of success
Seiso (shine/
cleanliness)
- Eliminate dirt and
foreign matter
- Reduction in m/c downtime
- Increased life of m/c parts
- Reduction of no. of accidents
- Reduction of rejection/rework
- Higher productivity
- Healthy environment
Deep cleaning
 Removing physical contaminants such as soil, unwanted
materials, dirt particles & waste materials from surface by rinsing
and washing through the use of physical and chemical action.
 Cleaning removes 90-99% of the bacteria, but thousands of
bacteria may still be present.
Cleaning
Types of cleaners
Alkaline: CAUSTIC SODA
Anionic / Nonionic : TEEPOL
Standard
Solution in
master
plan
Standard
Quantity
in master
plan
Frequency Used in
present
time
Area Quantity
use
Colin Daily Max Glass
Teepol Not
mentioned
Daily Teepol 1Cap /1
ltr.
Lyzol 1 capful/4
ltr. water
Daily Lyzol Admin &
Quality
Phenyl 2 capful/5
Ltr.water
Daily Max Total area
Area Process
Admin Firsty cleaninig with the washing powder (like
(active wheel ),then sanitizing with Lyzol.
Quality Firsty cleaninig with the like (active wheel ,then
sanitizing with Lyzol.
Mfg Firsty cleaninig with the Teepol & ditergent
powder like (active wheel ).
Pkg Firsty cleaninig with the ditergent powder (active
wheel),then sanitizing with phenyl.
How cleaning agent work?
Cleaning agent having surfactant reduce the surface tension of water
The surfactant's water-hating end is attracted to the oil in the soil. At
the same time, the water-loving end is attracted to the water
molecules.
The droplets of oil, surrounded by the detergent molecules form an
emulsion in the water and are able to be washed away.
Caustic Soda
Conditions to apply ?
• 1% solution
• Temp 50-60oC
• Contact time: 20 minutes
How it works?
It can dissolve grease, oils , fats and protein based deposits.
Suitable use for?
SS equipments cleaning,
Plastic drum & crate,
Drain cleaning,
Teepol
 Active ingredients:
Sod. Benzene Sulphonate,
Alcohol ether sulphate
 Concentration: 1%
 Used for: Equipment, floor, glassware cleaning
Sanitizing - “Treating a cleaned surface to destroy and
reduce the microorganism to a safe level”
Types of sanitizers:
 Heat
 Chlorine
 VU
 IPA
 Lysol
 Phenyl
For any chemical disinfection:
(1) Must first satisfy the disinfectant
demand
(2) Must then establish a disinfectant
residual
(3) Must maintain the concentration &
contact time effectively
Heat
Dry heat kills the organisms by destructive oxidation of essential cell
constituents.
Conditions: temp 160 °C for 60 mins.
Dry heat is employed for glassware, metal instruments which are not
spoiled by high temperatures.
Moist heat kills the organisms by coagulating and denaturing their
enzymes and structural protein.
Conditions: temp 121 °C for 15 mins.
Moist heat is used for the sterilization of culture media where steam can
penetrate.
Moist heat is more effective than dry heat
Chlorine
 Chlorine is available in several forms
 calcium hypochlorite (solid)
 sodium hypochlorite (solution)
◦ In water, chlorine forms hypochlorous acid
(HOCl) and hypochlorite anion (OCl-)
◦ HOCl is 80 to 100 times more potent germicide
than the hypochlorite ion (OCl-)
Best practice for water disinfection:
6-8 mg/L Free Chlorine Residual for 2 Hours Min contact time.
UV Treatment
UV range = ~100 to 400 nm
Germicidal
Wavelengths
UV dose of 30,000 microwatt-
seconds/cm2 at the end of 8,000
hours of use
Efficiency highly
dependent on
water quality (
must be free of
suspended
solids to form
scale on UV
tube)
UV Treatment mechanism
Primary mechanism is
absorption of UV by the DNA,
and disruption of the
chemical bases.
Renders the cell unable to
reproduce their DNA, and,
therefore, cannot grow.
At least a three-log (99.9%) reduction in
bacteria, yeast and viruses
70% IPA- Disinfectant
 Isopropyl alcohol ( Isopropanol ) can be considered as a
disinfectant as well as an antiseptic, antimicrobial agents that
destroy microorganisms on living tissue. IPA affects the outer
cell membrane of bacteria by making the lipids in the
membrane soluble to water. This solubility causes the cell
membrane to lose its structure, allowing alcohol into the cell
where it denatures proteins. The denatured proteins become
coagulated.
 Disinfectant: Destroy pathogenic microorganism (E.Coli-
diaria, Salmonellae-typhoid).
70% IPA- Disinfectant
 Why 70% IPA better than 100%?
 100% IPA causes protein to coagulate instantly. The
coagulated proteins create a hardened protein wall around
the cell, protecting the interior. With the inside of the cell
protected, the organism is not killed but remains
dormant.
 70% IPA is combined with 30% water. This dilution allows
protein coagulation to occur gradually as the organism
absorbs the alcohol at a slower rate. The microorganism
is slowly overcome and dies.
Lysol - Disinfectant
 The active ingredient in of the Lysol is
Benzalkonium Chloride ( cationic surface acting agent )
 Suitable for floor cleaning and disinfecting ( 7% in water )
Phenyl - Disinfectant
It is a mixture of phenols and cresols, used as a disinfectant.
Spectrum of action – gram positive, gram-negative bacteria. No
activity against viruses, fungi and spores.
Mode of Action
It acts by rupture of cell membranes and denaturation of
cellular constituents.
Indications
· Disinfectant for floors, washbasins, drain etc.
· Waste disinfection – infective wastes such as urine.
Fumigation
Formaldehyde is active against bacteria, fungi and many viruses
and spores. It acts by protein denaturation and reacting with the
amine group in the cells, thus acting as a cytotoxic agent.
Formaline is a commercially available as a 40% solution of
formaldehyde vapour in water. When it is heated, formaldehyde
vapour is generated. Fumigation is most effective above a
temperature of 20 C and relative humidity of 65%.
Mixing formaline and water with potassium permanganate crystals is
not recommended (This can result in a violent reaction if the correct
relative concentrations of the two components are not used )
Use 100 ml formaline plus 900 ml water per 1000 ft3 of space.
The door should be locked for 12hrs.
Fumigation is a hazardous operation, and it should be performed with extra care
Air filters fundamentals
Air filters (Mechanical) are used to remove air born contaminations
Pre-filters
Efficiency: 99 % down to 5 microns
( 5 to 7 Layers of high density poly ethylene mesh)
Fine filters
Efficiency: 99 % down to 3 microns
(Non woven synthetic media sandwiched between 2 layers of HDPE Mesh)
High – Efficiency Particulate Air filter ( HEPA )
The filter has a minimum efficiency of 99.97 % when tested with an
aerosol of essentially mono dispersed 0.3 µm challenge aerosol.
 Dettol antiseptic are insoluble in water, it produces a white -
coloured milky emulsion of oil droplets when diluted ( 2% ) with
water during use in cuts, wounds.
 The active ingredient in Dettol is chloroxylenol (C8H9ClO)
Dettol - Antiseptic
The main differences between antiseptics and disinfectants are that
disinfectants are used primarily to sanitize objects, and antiseptics
are used on human skin.
They both act as antimicrobials that kills the microbes that cause
infection
Personal Hygiene
Sanitization of equipments & vessels of NRO ( R&D ref )
Manufacturing section-
Splash hot LLP (80 C) through the walls and drain
through the filter after two circulation.
Transfer 1 ltr. IPA into the mixer and actives
blender and closed for 1hrs.
Drain out IPA, allow the odor to get off, by keeping
the vessels open for some time.
Sanitization of equipments & vessels of ZB and MPB ( R&D ref )
Manufacturing section-
Clean the batch mixing using a steam inject for
melting and removing The product.
Heat about 30kg LLP in the melting kettle to about 75
to 80 C and circulate it in all other vessel by transfer
line.
Splash 3 ltr IPA into the mixer and actives blender
and closed for 1hrs.
Drain out IPA, allow the odor to get off, by keeping the
vessels open for some time.
Sanitization of equipments & vessels of BPAC ( R&D ref )
 Clean the batch mixer using a steam injects for
melting and removing the product adhered to the walls
and blades of the mixer.
 Fill the melting kettle with DM water and heat to 75 to
80 C circulate it in all other vessel by transfer line and
drain. Repeat the process using fresh hot DM water.
 Then using 3ltr IPA and Close the lid for 1 hr then
drain out, allow the odor to get off, by keeping the
vessels open for some time.
Manufacturing section-
CIP
Clean in Place means cleaning and sanitizing the
manufacturing system without dismantling the connected
pipelines, vessels, valves, filters etc.
Sequence of CIP operation:
1. Heat caustic solution ( 1% in water) upto 80C in steam
jacketed vessel.
2. Circulate the hot caustic solution min 30mins then drain.
3. Rinse by water.
4. Circulate citric acid solution ( 1% in water) for 30mins
then drain.
5. Check pH ( std 7 ).
Frequency: once per 6 months
Pest control
Target Pest Recommended
chemicals
Service frequency
Crawling insects Deltamethrin,
Allethrin,
Kerosene,
Imidacloprid,
Polybutene glue,
Bromadiolone
Monthly
Weekly
Lizard
Weekly
Cockroach
Weekly
Rat
* No Pest control activity is allowed inside process area
To prevent flies, air curtains and insect light traps to be installed suitably
Key Learning
SOP of cleaning and sanitization should be justified by basic
chemistry and applied uniformly as a benchmark.
Effectiveness of cleaning & sanitization depends on
a) maturity level, b) eye level and c) interest level
of HK zone owner.
GHK evaluation to be done based on
1. Sub-zones and overall Plant
2. Snap shot
3. Chemical compliance as specified
4. Frequency compliance as specified
5. Micro testing result monitoring
6. Score as per 1s/ 2s/ 3s/ 4s/ 5s std
Cleaning & sanitization

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Cleaning & sanitization

  • 1.
  • 2. Very poor Quality Audit score in case of cleaning & sanitizing Throughout all Emami units. Major gaps observed - There is no prerequisite program for master cleaning & sanitization Objective: The methods of cleaning and sanitizing, the types of chemicals used, the frequency of cleaning activities, and the control of microbes must all be done expertly to protect our finished products from contamination issue. Why special focus on cleaning & sanitizing !!!
  • 3. 3S is the part of 5S (technique applied for Good House Keeping) 3S
  • 4. The First “S" 1S Activities Indicators of success Seiri (sorting/ segregation) - Sort though - Identify what is needed and discard the unnecessary items. - Productive area saving
  • 5. The Second “S" 2S Activities Indicators of success Seiton (arrangement) - Set item in order by creating place for everything and put everything in its place - Keep accessibility - Labeling - Time saved in searching and returning
  • 6. The Third “S" 3S Activities Indicators of success Seiso (shine/ cleanliness) - Eliminate dirt and foreign matter - Reduction in m/c downtime - Increased life of m/c parts - Reduction of no. of accidents - Reduction of rejection/rework - Higher productivity - Healthy environment Deep cleaning
  • 7.  Removing physical contaminants such as soil, unwanted materials, dirt particles & waste materials from surface by rinsing and washing through the use of physical and chemical action.  Cleaning removes 90-99% of the bacteria, but thousands of bacteria may still be present. Cleaning
  • 8. Types of cleaners Alkaline: CAUSTIC SODA Anionic / Nonionic : TEEPOL
  • 9. Standard Solution in master plan Standard Quantity in master plan Frequency Used in present time Area Quantity use Colin Daily Max Glass Teepol Not mentioned Daily Teepol 1Cap /1 ltr. Lyzol 1 capful/4 ltr. water Daily Lyzol Admin & Quality Phenyl 2 capful/5 Ltr.water Daily Max Total area
  • 10. Area Process Admin Firsty cleaninig with the washing powder (like (active wheel ),then sanitizing with Lyzol. Quality Firsty cleaninig with the like (active wheel ,then sanitizing with Lyzol. Mfg Firsty cleaninig with the Teepol & ditergent powder like (active wheel ). Pkg Firsty cleaninig with the ditergent powder (active wheel),then sanitizing with phenyl.
  • 11. How cleaning agent work? Cleaning agent having surfactant reduce the surface tension of water The surfactant's water-hating end is attracted to the oil in the soil. At the same time, the water-loving end is attracted to the water molecules. The droplets of oil, surrounded by the detergent molecules form an emulsion in the water and are able to be washed away.
  • 12. Caustic Soda Conditions to apply ? • 1% solution • Temp 50-60oC • Contact time: 20 minutes How it works? It can dissolve grease, oils , fats and protein based deposits. Suitable use for? SS equipments cleaning, Plastic drum & crate, Drain cleaning,
  • 13. Teepol  Active ingredients: Sod. Benzene Sulphonate, Alcohol ether sulphate  Concentration: 1%  Used for: Equipment, floor, glassware cleaning
  • 14. Sanitizing - “Treating a cleaned surface to destroy and reduce the microorganism to a safe level” Types of sanitizers:  Heat  Chlorine  VU  IPA  Lysol  Phenyl For any chemical disinfection: (1) Must first satisfy the disinfectant demand (2) Must then establish a disinfectant residual (3) Must maintain the concentration & contact time effectively
  • 15. Heat Dry heat kills the organisms by destructive oxidation of essential cell constituents. Conditions: temp 160 °C for 60 mins. Dry heat is employed for glassware, metal instruments which are not spoiled by high temperatures. Moist heat kills the organisms by coagulating and denaturing their enzymes and structural protein. Conditions: temp 121 °C for 15 mins. Moist heat is used for the sterilization of culture media where steam can penetrate. Moist heat is more effective than dry heat
  • 16. Chlorine  Chlorine is available in several forms  calcium hypochlorite (solid)  sodium hypochlorite (solution) ◦ In water, chlorine forms hypochlorous acid (HOCl) and hypochlorite anion (OCl-) ◦ HOCl is 80 to 100 times more potent germicide than the hypochlorite ion (OCl-) Best practice for water disinfection: 6-8 mg/L Free Chlorine Residual for 2 Hours Min contact time.
  • 17. UV Treatment UV range = ~100 to 400 nm Germicidal Wavelengths UV dose of 30,000 microwatt- seconds/cm2 at the end of 8,000 hours of use Efficiency highly dependent on water quality ( must be free of suspended solids to form scale on UV tube)
  • 18. UV Treatment mechanism Primary mechanism is absorption of UV by the DNA, and disruption of the chemical bases. Renders the cell unable to reproduce their DNA, and, therefore, cannot grow. At least a three-log (99.9%) reduction in bacteria, yeast and viruses
  • 19. 70% IPA- Disinfectant  Isopropyl alcohol ( Isopropanol ) can be considered as a disinfectant as well as an antiseptic, antimicrobial agents that destroy microorganisms on living tissue. IPA affects the outer cell membrane of bacteria by making the lipids in the membrane soluble to water. This solubility causes the cell membrane to lose its structure, allowing alcohol into the cell where it denatures proteins. The denatured proteins become coagulated.  Disinfectant: Destroy pathogenic microorganism (E.Coli- diaria, Salmonellae-typhoid).
  • 20. 70% IPA- Disinfectant  Why 70% IPA better than 100%?  100% IPA causes protein to coagulate instantly. The coagulated proteins create a hardened protein wall around the cell, protecting the interior. With the inside of the cell protected, the organism is not killed but remains dormant.  70% IPA is combined with 30% water. This dilution allows protein coagulation to occur gradually as the organism absorbs the alcohol at a slower rate. The microorganism is slowly overcome and dies.
  • 21. Lysol - Disinfectant  The active ingredient in of the Lysol is Benzalkonium Chloride ( cationic surface acting agent )  Suitable for floor cleaning and disinfecting ( 7% in water )
  • 22. Phenyl - Disinfectant It is a mixture of phenols and cresols, used as a disinfectant. Spectrum of action – gram positive, gram-negative bacteria. No activity against viruses, fungi and spores. Mode of Action It acts by rupture of cell membranes and denaturation of cellular constituents. Indications · Disinfectant for floors, washbasins, drain etc. · Waste disinfection – infective wastes such as urine.
  • 23. Fumigation Formaldehyde is active against bacteria, fungi and many viruses and spores. It acts by protein denaturation and reacting with the amine group in the cells, thus acting as a cytotoxic agent. Formaline is a commercially available as a 40% solution of formaldehyde vapour in water. When it is heated, formaldehyde vapour is generated. Fumigation is most effective above a temperature of 20 C and relative humidity of 65%. Mixing formaline and water with potassium permanganate crystals is not recommended (This can result in a violent reaction if the correct relative concentrations of the two components are not used ) Use 100 ml formaline plus 900 ml water per 1000 ft3 of space. The door should be locked for 12hrs. Fumigation is a hazardous operation, and it should be performed with extra care
  • 24. Air filters fundamentals Air filters (Mechanical) are used to remove air born contaminations Pre-filters Efficiency: 99 % down to 5 microns ( 5 to 7 Layers of high density poly ethylene mesh) Fine filters Efficiency: 99 % down to 3 microns (Non woven synthetic media sandwiched between 2 layers of HDPE Mesh) High – Efficiency Particulate Air filter ( HEPA ) The filter has a minimum efficiency of 99.97 % when tested with an aerosol of essentially mono dispersed 0.3 µm challenge aerosol.
  • 25.  Dettol antiseptic are insoluble in water, it produces a white - coloured milky emulsion of oil droplets when diluted ( 2% ) with water during use in cuts, wounds.  The active ingredient in Dettol is chloroxylenol (C8H9ClO) Dettol - Antiseptic The main differences between antiseptics and disinfectants are that disinfectants are used primarily to sanitize objects, and antiseptics are used on human skin. They both act as antimicrobials that kills the microbes that cause infection
  • 27. Sanitization of equipments & vessels of NRO ( R&D ref ) Manufacturing section- Splash hot LLP (80 C) through the walls and drain through the filter after two circulation. Transfer 1 ltr. IPA into the mixer and actives blender and closed for 1hrs. Drain out IPA, allow the odor to get off, by keeping the vessels open for some time.
  • 28. Sanitization of equipments & vessels of ZB and MPB ( R&D ref ) Manufacturing section- Clean the batch mixing using a steam inject for melting and removing The product. Heat about 30kg LLP in the melting kettle to about 75 to 80 C and circulate it in all other vessel by transfer line. Splash 3 ltr IPA into the mixer and actives blender and closed for 1hrs. Drain out IPA, allow the odor to get off, by keeping the vessels open for some time.
  • 29. Sanitization of equipments & vessels of BPAC ( R&D ref )  Clean the batch mixer using a steam injects for melting and removing the product adhered to the walls and blades of the mixer.  Fill the melting kettle with DM water and heat to 75 to 80 C circulate it in all other vessel by transfer line and drain. Repeat the process using fresh hot DM water.  Then using 3ltr IPA and Close the lid for 1 hr then drain out, allow the odor to get off, by keeping the vessels open for some time. Manufacturing section-
  • 30. CIP Clean in Place means cleaning and sanitizing the manufacturing system without dismantling the connected pipelines, vessels, valves, filters etc. Sequence of CIP operation: 1. Heat caustic solution ( 1% in water) upto 80C in steam jacketed vessel. 2. Circulate the hot caustic solution min 30mins then drain. 3. Rinse by water. 4. Circulate citric acid solution ( 1% in water) for 30mins then drain. 5. Check pH ( std 7 ). Frequency: once per 6 months
  • 31. Pest control Target Pest Recommended chemicals Service frequency Crawling insects Deltamethrin, Allethrin, Kerosene, Imidacloprid, Polybutene glue, Bromadiolone Monthly Weekly Lizard Weekly Cockroach Weekly Rat * No Pest control activity is allowed inside process area To prevent flies, air curtains and insect light traps to be installed suitably
  • 32. Key Learning SOP of cleaning and sanitization should be justified by basic chemistry and applied uniformly as a benchmark. Effectiveness of cleaning & sanitization depends on a) maturity level, b) eye level and c) interest level of HK zone owner. GHK evaluation to be done based on 1. Sub-zones and overall Plant 2. Snap shot 3. Chemical compliance as specified 4. Frequency compliance as specified 5. Micro testing result monitoring 6. Score as per 1s/ 2s/ 3s/ 4s/ 5s std