Antimicrobials in a Germy World
Thomas E. Hopkins, PHD
Chief Scientific Officer
Perspective
PhD in Organic Chemistry
Morton Thiokol – Agricultural and Pharmaceutical Intermediates
Eli Lilly and Company – Antibiotic Process Development
CreoSalus – Amino Acids, Resins, Peptides, Veterinary Pharmaceuticals
Poly Group LLC – Nouvex Antimicrobial Technology
Pragmatist
Acknowledgements
Poly Group LLC
Filtration Technology Systems / S and J Precision, Inc.
National Air Filtration Association
Outline
What are Germs?
What is an Antimicrobial?
Antimicrobial Materials and Products
So, Why Should I Care?
Problems are Really Opportunities in Disguise.
Disclosure and Promises
1)
Everyone here knows more about air filtration than I
ever will.
2)
I will, in many cases, be presenting my interpretation of
information made available to me. I could be wrong!
3)
I will not try to baffle you with Bovine stuff.
What Are Germs?
Germs live everywhere.
Most Germs will not hurt you.
You need some germs to live a healthy life.
BUT
Some Germs are formidable adversaries.
What Are Germs?
Germs consist of the following:
Viruses
Bacteria
Fungi
Protozoa
Also known as microbes.
Microbial Trivia
Microbes live everywhere:
rock
air
ice / Permafrost
hot water
bottom of the ocean
tops of mountains
They’ve been around longer than any other living thing on Earth
Extremophile - Hot
Extremophile - Cold
Extremophile - Pressure
Captain Smith’s Bathroom
Some Conclusions
Germs / Microbes can and do live anywhere
and everywhere.
Germs / Microbes eat everything and
anything.
OK….How many of these critters are
around?
Microbial Trivia
There are 10X more bacterial cells in the average human
digestive tract than in their entire body.
There are millions of microbes on one person’s hand.
4,700 different species, ~150 per hand (so far)
80 – 90% variability (mine not the same as yours)
A Handful of soil contains:
1,000,000,000 bacteria
120,000 fungi
25,000 algae
An ounce of sea water can contain up to 30,000,000
microbes.
Additional Trivia
All forms of life have evolved mechanisms to protect
themselves from competing forms of life.
A famous example is the discovery of penicillin.
The mold Penicillium notatum was found to release a
compound, penicillin, that inhibited the growth of
staphylococcus. When the nature of the inhibition was
understood the production of other antibiotics was inspired.
Staphyloccocus has evolved / acquired a method to protect
itself from penicillin and thus became “resistant”. e.g.
MRSA
Even More Trivia
Mammals, including humans, have evolved a complex
immune system that protects themselves from the millions
of microbes they are exposed to on a regular basis.
Our immune systems work well the vast majority of the
time.
Some microbes, however, have developed / acquired
methods to avoid elimination. e.g. HIV, Ebola
Conclusions Continued
Germs / Microbes can and do live anywhere and
everywhere.
Germs / Microbes eat anything and everything.
Most Germs / Microbes are harmless
Many Germs / Microbes are good for us.
A few Germs / Microbes are bad actors
Resistance is futile…..inevitable!
What are Antimicrobials?
An antimicrobial pesticide is any substance of natural, semisynthetic, or synthetic origin that inactivates, kills, or inhibits
the growth of microorganisms but causes little or no
damage to the host.
An antimicrobial pesticide may also be a device
(e.g. UVC Light)
Regulatory Responsibility
Antimicrobials are regulated at both the national as well as
state level.
The U.S. Environmental Protection Agency (EPA) is the
agency responsible for oversight for the majority of
antimicrobial uses.
The Food and Drug Agency (FDA) is responsible to
antimicrobials used in situations where there is significant
human contact under certain condition.
Antimicrobial Compounds
The current EPA list of antimicrobial compounds consists of:
808
483
78
240
1
6
total compounds of which –
(59.8%) are no longer active (325 active)
are under re-registration (24% pre 1984)
are under registration review (15 year cycle)
registered
pending registration
There are > 5,000 registered antimicrobial products indicating a
single antimicrobial compound is being used for multiple
registered products.
Classes of Antimicrobial Compounds
There are several classes of antimicrobial compounds:
1)
2)
3)
4)
5)
6)
7)
8)
Sodium Hypochlorite (bleach)
Phenols
Quaternary Ammonium Compounds (QAC)
Accelerated Hydrogen Peroxide
Botanicals
Metals
Nouvex like polymers
Miscellaneous others
The “Claim”
The process of registration of an
antimicrobial active ingredient or product is
dependent on what a manufacturer wishes
to claim.
Antimicrobial Uses
According to the USEPA there are two major uses of
antimicrobial pesticides:
1)
Protect inanimate objects
2)
Disinfect, sanitize, reduce, mitigate a microbial
infestation
Categories of Antimicrobials
There are two major EPA based categories of
antimicrobials:
Non-Public Health Products
Public Health Products
Sanitizers
Disinfectants
Sterilizers
Non-Public Health Products
are used to control growth of:
•
•
•
algae,
odor-causing microbes,
microbes which cause spoilage, deterioration or fouling
of materials and microorganisms infectious only to
animals.
This general category includes products used in:
• cooling towers
• jet fuel
• paints
• treatments for textile and paper products.
• air filtration equipment
Public Health Products
- are intended to control microorganisms infectious to
humans in any inanimate environment. The more
commonly used public health antimicrobial products claim
the following:
Sanitizers
Used to reduce, but not necessarily eliminate,
microorganisms from the inanimate environment to levels
considered safe as determined by public health codes or
regulations.
Sanitizers
Sanitizers include:
food contact products - These products are important
because they are used on sites where consumable food
products are placed and stored. Sanitizing rinses for
surfaces such as:
dishes and cooking utensils
equipment and utensils found in:
dairies
food-processing plants
eating and drinking establishments
Sanitizers
non-food contact products - Non-food contact surface
sanitizers include:
• carpet sanitizers
• air sanitizers
• laundry additives
• in-tank toilet bowl sanitizers.
Disinfectants
Used on hard inanimate surfaces and objects to destroy or
irreversibly inactivate infectious fungi and bacteria but not
necessarily their spores.
Disinfectants
Disinfectant products are divided into two major types:
hospital type disinfectants are the most critical to infection
control and are used on:
• medical and dental instruments
• floors, walls
• bed linens
• toilet seats, and other surfaces
general use disinfectants are the major source of products
used in:
•
households
• swimming pools
• water purifiers.
Sterilizers
Used to destroy or eliminate all forms of microbial life including:
• fungi
• viruses
• all forms of bacteria and their spores.
Sterilization is critical to infection control and is widely used in
hospitals on medical and surgical, instruments and equipment.
Sterilizers
Types of sterilizers include:
• steam under pressure (autoclaving)
• dry heat ovens (used primarily for sterilization of medical
instruments)
• low temperature gas (ethylene oxide) (used primarily for
sterilization of medical instruments)
• liquid chemical sterilants (used primarily for delicate
instruments which cannot withstand high temperature
and gases).
The Claim is Key
If a product is going to have an antimicrobial
added, it is important to make the correct
claim.
Data may or may not be required depending
on the claim.
Antimicrobials – Who Cares?
Antimicrobial compounds have been around forever. The
top six classes presented are all well established in their
use. So, why should I listen to the guy drone on about this
stuff?
There are a few reasons –
Some are emotional
Some are practical
Both represent opportunities
An Emotional Reason
There is a general consumer based desire for antimicrobial
products.
High profile events such as –
Zaire Ebolavirus (EBOV)
Anthrax attack
Measles outbreak
Also, the general concern over the germy-ness of the local
environment.
Products must have antimicrobials integrated into their
materials of construction as a means of competing in the
market even if the true benefit in some cases is
questionable. (Non-Public Health Claim)
Practical Reason #1
Microbial based degradation of some materials renders
them less desirable in terms of appearance, texture, and/or
smell.
Some materials do not last as long without some form of
protection.
Uses include:
Cooling Towers (MIC)
Jet Fuel
Paints
Textile and Paper Products
and many more
Practical Reason #2
A change in the reimbursement structure for infections
acquired as a result of a stay in a healthcare facility (HAI).
Insurance (public as well as private) no longer pays for
treatment of infections that were acquired while under their
care.
In addition to the loss of revenue through lower
reimbursements, facilities can also be fined for low
performance. YIKES!
Some Healthcare Statistics
According to the CDC:
100,000 deaths per year can be attributed to HAIs
(8th)
1,700,000 incidents reported per year
$12,000 - $15,000 increase in cost per stay
>11 day increase in ICU stay
$40,000 cost per bloodstream infection
The total impact: >$17,000,000,000
Problems Equal Opportunities
While antimicrobials may be old hat, the market is changing.
EPA is increasing the data required for approval of new entities.
Old antimicrobials are going through a reregistration process
that may require additional data to retain registration status.
Claims of antimicrobial products are being scrutinized.
Healthcare is in need of proven solutions to HAIs
Treatment of Solid Surfaces,
Textiles, etc.
There are large number of options for the reduction of
microbes on solid surfaces.
There are a variety of clearly defined testing procedures to
prove the efficacy of products under defined conditions.
Textiles have similar options and procedures.
But what about air filtration?
Depends on the claim.
Treatment of Air Filters
It is not necessary to prove efficacy with respect to the
protection of a filter element from degradation by microbes
under the Treated Article Exemption (TAE).
The EPA defines a treated article as follows:
An article or a substance treated with or containing a
pesticide to protect the article or substance itself, if the
pesticide is registered for such use.
Treatment of Air
To claim the removal of viable microbes from air requires registration
of the device (filter element). Registration will require the submission
of data that proves efficacy as well as safety.
The EPA states:
Articles or products that claim to be effective in controlling
microorganisms such as E.coli, S.aureus, Salmonella sp. or
Streptococcus sp. must be registered as a pesticide. These articles or
products make a public health claim that goes beyond the
preservation of the treated article itself. EPA requires the submission
of chemical data in support of the public health labeling claims and
patterns of use of the product.
Bottom Line w.r.t. Air Treatment
If a product claims to remove pathogenic microbes from the
air it will need to prove that fact with scientifically sound test
results.
This is going to be difficult.
There are currently few labs capable of this type of testing.
I know of only one lab moving in this direction.
But….
Brass Ring
Given the current struggles of healthcare facility managers
with the new reimbursement regimen, the first company that
can demonstrate a significant reduction in pathogenic
microbes in room air using a relatively simple EPA
registered air filtration methodology will likely generate a lot
of attention.
I think this is doable although it will require a focused and
funded effort.
In Summary
Viruses, Bacteria, Fungi, Protozoans, etc. are ubiquitous in
nature.
For the most part they are harmless and sometimes
beneficial.
Judicious use of the proper antimicrobial can help protect
infrastructure from harm. (Treated Article)
Even More Summary
Pathogenic microbes need to be controlled especially within
the healthcare environment.
There may be a significant gap in cost effective airborne
pathogen control.
The use of antimicrobials materials and methods in the
public health arena is more challenging but also potentially
far more lucrative.
Thank You!
For your time and attention.
Questions / Comments