ABSTRACT

Fogging in a pharmaceutical
facility is a critical process
used for disinfection and
decontamination to maintain
the required cleanliness and
sterility standards. This
process helps in controlling
microbial contamination in
both the air and on surfaces,
ensuring a safe manufacturing
environment for
pharmaceutical products.

FOGGING Here's an overview of the

fogging mechanism in a
pharmaceutical facility

[Author name]
MECHANISM IN Naveen Kumar Rompilli

PHARMACEUTICAL
FACILITY
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Dry fogging and wet fogging are two different methods of applying disinfectants or other
solutions in the form of aerosols, each with distinct characteristics and applications. Here’s a
detailed comparison:

Dry Fogging

Characteristics:

1. Particle Size:
o Produces very fine aerosol particles, typically less than 10 microns in
diameter.
2. Moisture Content:
o Generates a "dry" mist with minimal moisture content, resulting in less
condensation and residue.
3. Suspension Time:
o Fine particles remain airborne for a longer duration, allowing for more
thorough air and surface coverage.
4. Penetration:
o Effective at penetrating small crevices, cracks, and difficult-to-reach areas due
to the small particle size.

Applications:

1. Environments:
o Ideal for sensitive environments such as pharmaceutical cleanrooms, data
centers, and electronic manufacturing areas where moisture can be damaging.
2. Disinfection:
o Used for disinfection of spaces where complete and even distribution of the
disinfectant is critical.
3. Sterilization:
o Often used in environments requiring high-level sterilization, such as hospitals
and laboratories.

Advantages:

1. Minimal Residue:
o Leaves little to no moisture on surfaces, reducing the risk of damage to
sensitive equipment.
2. Comprehensive Coverage:
o Provides uniform distribution, ensuring thorough disinfection of both air and
surfaces.

Disadvantages:

1. Equipment Cost:
o May require specialized equipment that can be more expensive.
2. Airborne Hazards:
o Fine particles can be inhaled more easily, necessitating proper ventilation and
safety measures.
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Wet Fogging

Characteristics:

1. Particle Size:
o Produces larger droplets, typically 20-50 microns or more.
2. Moisture Content:
o Generates a "wet" mist with higher moisture content, resulting in more
noticeable condensation and wetting of surfaces.
3. Suspension Time:
o Larger droplets settle more quickly, providing quicker surface coverage.
4. Penetration:
o Less effective at reaching small crevices compared to dry fogging due to the
larger particle size.

Applications:

1. Environments:
o Suitable for less sensitive environments such as agricultural settings, large
warehouses, and industrial spaces where moisture is less of a concern.
2. Disinfection:
o Used for surface disinfection where direct contact with the disinfectant is
required.
3. Pest Control:
o Commonly used for pest control applications where larger droplets can be
beneficial.

Advantages:

1. Cost-Effective:
o Generally uses simpler and less expensive equipment.
2. Surface Coverage:
o Provides effective direct surface disinfection.

Disadvantages:

1. Residual Moisture:
o Can leave surfaces visibly wet, which may not be suitable for all applications.
2. Limited Airborne Coverage:
o Less effective for air disinfection due to quicker settling of larger droplets.

Fogging chemicals

Minicar fogging is a method used for disinfection and decontamination of small spaces,
including vehicles such as cars, vans, and small rooms. This process utilizes fogging
technology to distribute disinfectant solutions in a fine mist, ensuring thorough coverage of
all surfaces, including hard-to-reach areas.
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Key Features of Minicar Fogging

1. Compact Equipment:
o The fogging devices used for minicar fogging are typically compact and
portable, designed for easy use in confined spaces.
o These devices can generate a fine mist of disinfectant, which can penetrate
upholstery, air ducts, and other intricate parts of the vehicle.
2. Disinfectant Solutions:
o Various disinfectants can be used in minicar fogging, including quaternary
ammonium compounds, hydrogen peroxide, and other EPA-approved
solutions.
o The choice of disinfectant depends on the target pathogens and the level of
disinfection required.
3. Application Process:
o The vehicle or small space is prepared by removing loose items and ensuring
that all surfaces are accessible.
o The fogging device is then activated inside the space, releasing the disinfectant
mist.
o The mist is allowed to settle on all surfaces, ensuring comprehensive
coverage.
4. Effectiveness:
o Minicar fogging is effective against a broad spectrum of microorganisms,
including bacteria, viruses, fungi, and spores.
o The fine mist ensures that the disinfectant reaches all areas, including those
that are difficult to clean manually.
5. Advantages:
o Provides thorough disinfection of all surfaces, including hard-to-reach areas.
o Reduces the risk of cross-contamination and ensures a high level of hygiene.
o Quick and efficient process, minimizing downtime for vehicle use.
6. Disadvantages:
o Requires proper ventilation after fogging to ensure the removal of any residual
disinfectant.
o Some disinfectants may leave a residue or odor that needs to be addressed.

Common Uses

 Vehicle Disinfection: Widely used for disinfecting taxis, buses, ambulances, and
personal vehicles, especially in the context of preventing the spread of infectious
diseases.
 Small Room Disinfection: Applicable to small rooms or confined spaces in
residential or commercial settings where thorough disinfection is needed.

Safety Considerations

 Personal Protective Equipment (PPE): Operators should wear appropriate PPE,

including masks and gloves, to protect against exposure to disinfectants.
 Ventilation: After fogging, the space should be ventilated to disperse any lingering
disinfectant particles and ensure the area is safe for use.
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 Disinfectant Choice: Select disinfectants that are safe for use on various materials
within the vehicle or space to prevent damage or adverse reactions.

Formaldehyde Fogging

Formaldehyde (HCHO) is a potent chemical used for sterilization and decontamination

purposes.

1. Mechanism:
o Formaldehyde works by alkylating the amino and sulfhydryl groups of
proteins and ring nitrogen atoms of purine bases.
o This results in the inactivation of microorganisms, including bacteria, viruses,
fungi, and spores.
2. Process:
o Formaldehyde is vaporized or aerosolized into the environment to be
decontaminated.
o The space is sealed to ensure the formaldehyde gas reaches all surfaces and
crevices.
3. Advantages:
o Highly effective broad-spectrum antimicrobial agent.
o Penetrates well into hard-to-reach areas.
4. Disadvantages:
o Toxic and carcinogenic, requiring strict safety measures during use.
o Requires thorough aeration post-fogging to ensure complete removal of the
gas before the area is reoccupied.
5. Common Uses:
o Sterilizing laboratory spaces, cleanrooms, and medical equipment.
o Decontaminating areas after handling hazardous biological materials.

Potassium Permanganate Fogging

Potassium permanganate (KMnO₄) is used in conjunction with formaldehyde to enhance

the decontamination process.

1. Mechanism:
o Potassium permanganate acts as an oxidizing agent, which helps to release
formaldehyde gas when mixed with formalin (a solution of formaldehyde in
water).
o The reaction between potassium permanganate and formalin generates
formaldehyde gas and heat.
2. Process:
o Potassium permanganate crystals are added to formalin in a controlled
manner.
o The exothermic reaction produces formaldehyde gas, which is then dispersed
into the environment.
o The space must be sealed to allow the gas to penetrate all areas.
3. Advantages:
o Effective method for generating formaldehyde gas for decontamination.
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o Potassium permanganate ensures a controlled and sustained release of

formaldehyde.
4. Disadvantages:
o Handling and mixing require careful control to avoid excessive heat and
potential hazards.
o The process generates a significant amount of heat, which needs to be
managed.
5. Common Uses:
o Often used in conjunction with formaldehyde for decontamination of large
spaces like hospital rooms, cleanrooms, and pharmaceutical manufacturing
areas.
o Effective for sterilizing equipment and surfaces that are difficult to clean
manually.

Key Differences and Considerations

 Formaldehyde alone is often used in vapor or liquid form for fogging, while
potassium permanganate is typically used to facilitate the release of
formaldehyde gas in a controlled manner.
 Safety: Both chemicals are hazardous, and their use requires stringent safety
protocols, including proper personal protective equipment (PPE) and ventilation.
 Effectiveness: Both methods are highly effective for broad-spectrum microbial
decontamination, but the use of potassium permanganate can enhance the efficacy and
control of formaldehyde gas release.
 Post-Treatment: After fogging, extensive aeration and monitoring are necessary to
ensure that formaldehyde levels are reduced to safe levels before reoccupation of the
treated area.

Reasons for the Ban on Potassium Permanganate Fogging

1. Health Hazards:
o Toxicity: Potassium permanganate is toxic and can cause serious health
effects if inhaled, ingested, or if it comes into contact with skin. Exposure can
lead to respiratory issues, skin burns, and eye damage.
o Oxidizing Properties: As a strong oxidizer, it can cause fires or explosions if
it comes into contact with combustible materials.
2. Safety Concerns:
o Handling and Storage: Requires careful handling and storage to prevent
accidents. The risks associated with its use make it unsuitable for
environments where stringent safety protocols cannot be consistently
enforced.
o Reaction with Formaldehyde: Historically, potassium permanganate has
been used in combination with formaldehyde for fogging. The reaction
between these chemicals generates formaldehyde gas, which is a potent
sterilant but also a known carcinogen and irritant. This combination poses
significant health risks to personnel and occupants.
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3. Regulatory Restrictions:
o Many regulatory agencies and health organizations have restricted or banned
the use of potassium permanganate in fogging due to the aforementioned
health and safety risks.
o Alternatives with better safety profiles and similar or superior efficacy are
preferred, reducing the reliance on potassium permanganate.

Alternatives to Potassium Permanganate Fogging

1. Hydrogen Peroxide Fogging:

o Advantages: Effective broad-spectrum disinfectant, decomposes into water
and oxygen, leaving no toxic residues.
o Applications: Widely used in healthcare, pharmaceutical manufacturing, and
cleanroom environments.
2. Peracetic Acid Fogging:
o Advantages: Effective against a wide range of microorganisms, including
bacteria, viruses, and spores. It breaks down into non-toxic byproducts (acetic
acid, oxygen, and water).
o Applications: Suitable for various disinfection applications, including food
processing and healthcare facilities.
3. Chlorine Dioxide Fogging:
o Advantages: Effective disinfectant with a broad spectrum of activity. It leaves
minimal residues and breaks down relatively quickly.
o Applications: Used in water treatment, healthcare, and industrial disinfection.

Implementation and Safety Measures

1. Proper Training:
o Ensure that personnel handling disinfectants and fogging equipment are
properly trained in safety protocols and the correct use of the chemicals.
2. Personal Protective Equipment (PPE):
o Use appropriate PPE, such as gloves, masks, goggles, and protective clothing,
to minimize exposure risks.
3. Ventilation:
o Ensure adequate ventilation during and after fogging to disperse any residual
disinfectant particles or vapors.
4. Regulatory Compliance:
o Follow guidelines and recommendations from regulatory agencies, such as the
WHO, CDC, and local health authorities, regarding the use of disinfectants
and fogging methods.

Key Regulatory Bodies and Guidelines

1. U.S. Food and Drug Administration (FDA)

o Guideline: The FDA provides guidelines for cGMP (current Good
Manufacturing Practice) for pharmaceutical manufacturing, including aspects
related to environmental control and disinfection.
o Key Documents:
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 21 CFR Part 211: Regulations governing the manufacturing,

processing, packing, or holding of drugs; includes requirements for
cleanliness and disinfection in manufacturing environments.
 Guidance for Industry: “Sterile Drug Products Produced by Aseptic
Processing—Current Good Manufacturing Practice” provides specific
recommendations for maintaining sterile environments.
2. European Medicines Agency (EMA)
o Guideline: The EMA sets guidelines for the quality and safety of
pharmaceutical products in Europe.
o Key Documents:
 EU GMP Guidelines: Part of the European Commission's guidelines
for Good Manufacturing Practice, including detailed requirements for
cleanliness and disinfection.
 Annex 1: “Manufacture of Sterile Medicinal Products” provides
comprehensive guidelines on maintaining sterile conditions, including
disinfection practices.
3. World Health Organization (WHO)
o Guideline: WHO offers global guidelines for pharmaceutical manufacturing
and environmental controls.
o Key Documents:
 WHO Good Manufacturing Practices: Provides guidance on GMP
practices including cleaning and disinfection in pharmaceutical
manufacturing.
 WHO Technical Report Series: Includes detailed recommendations
for disinfection and sterilization processes.
4. International Organization for Standardization (ISO)
o Guideline: ISO standards provide international guidelines and best practices
for quality management and environmental control.
o Key Documents:
 ISO 14644: “Cleanrooms and Controlled Environments” – Standards
for cleanliness and contamination control in cleanrooms.
 ISO 17025: “General requirements for the competence of testing and
calibration laboratories” – Relevant for validation of cleaning and
disinfection processes.
5. Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-
operation Scheme (PIC/S)
o Guideline: PIC/S guidelines provide a framework for GMP practices and
inspections worldwide.
o Key Documents:
 PIC/S GMP Guide: Provides detailed requirements for the
manufacture of medicinal products, including cleaning and disinfection
protocols.

Summary:
 Dry Fogging: Produces very fine particles, suitable for sensitive environments where
minimal residue is required, and provides comprehensive coverage of both air and
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surfaces. It is ideal for high-level disinfection and sterilization in areas like

cleanrooms and hospitals.
 Wet Fogging: Produces larger droplets, suitable for environments where some
moisture is acceptable. It is effective for direct surface disinfection and pest control
but may leave surfaces wet and is less effective for thorough air disinfection.
 Minicar fogging is an effective and efficient method for disinfecting small spaces and
vehicles, ensuring thorough coverage and reducing the risk of contamination. By
using portable fogging devices and appropriate disinfectant solutions, it provides a
high level of hygiene with minimal downtime. Proper safety measures and ventilation
are crucial to ensure the process is safe and effective.
 Formaldehyde and potassium permanganate fogging are specific methods used for
chemical decontamination and sterilization in various settings, including laboratories,
pharmaceutical environments, and cleanrooms. Here's a detailed comparison and
explanation of each method:

 Formaldehyde fogging: Utilizes the vaporized form of formaldehyde for

decontamination.
 Potassium permanganate fogging: Uses potassium permanganate to generate
formaldehyde gas through a controlled chemical reaction.
 Potassium permanganate is a strong oxidizing agent that has been used in various
disinfection and sterilization processes, including fogging. However, due to its
potential hazards and safety concerns, the use of potassium permanganate for fogging
has been restricted or banned in many contexts. Here's an overview of why potassium
permanganate fogging is often banned and the implications:
 Potassium permanganate fogging is often banned or restricted due to its health
hazards and safety concerns. Safer and more effective alternatives, such as hydrogen
peroxide, peracetic acid, and chlorine dioxide, are preferred for disinfection and
sterilization in various settings. Proper training, the use of PPE, and adherence to
regulatory guidelines are essential to ensure the safe and effective implementation of
fogging practices.
 Particle size in fogging processes impacts the effectiveness of disinfection, coverage,
and safety. Dry fogging typically produces very fine particles ideal for comprehensive
air and surface coverage, while wet fogging generates larger droplets suited for direct
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surface contact. Ultrasonic and thermal fogging methods offer different particle size
ranges, each with its own applications and advantages. Understanding these
differences helps in selecting the appropriate fogging method for specific
environments and needs.