1. Antimicrobials in a Germy World
Thomas E. Hopkins, PHD
Chief Scientific Officer

2. Perspective Acknowledgements
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

3. Outline What are Germs? What is an Antimicrobial?
Antimicrobial Materials and Products
So, Why Should I Care?
Problems are Really Opportunities in Disguise.

4. Disclosure and Promises
Everyone here knows more about air filtration than I ever will.
I will, in many cases, be presenting my interpretation of information made available to me. I could be wrong!
I will not try to baffle you with Bovine stuff.

5. 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.

6. What Are Germs? Germs consist of the following: Viruses Bacteria Fungi
Protozoa
Also known as microbes.

7. 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

8. Extremophile - Hot

9. Extremophile - Cold

10. Extremophile - Pressure

11. Captain Smith’s Bathroom

12. Germs / Microbes can and do live anywhere and everywhere.
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?

13. 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.

14. 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

15. 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

16. 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!

17. What are Antimicrobials?
An antimicrobial pesticide is any substance of natural, semi-synthetic, 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)

19. 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.

20. Antimicrobial Compounds
The current EPA list of antimicrobial compounds consists of:
808 total compounds of which –
483 (59.8%) are no longer active (325 active)
78 are under re-registration (24% pre 1984)
240 are under registration review (15 year cycle)
1 registered
6 pending registration
There are > 5,000 registered antimicrobial products indicating a single antimicrobial compound is being used for multiple registered products.

21. Classes of Antimicrobial Compounds
There are several classes of antimicrobial compounds:
Sodium Hypochlorite (bleach)
Phenols
Quaternary Ammonium Compounds (QAC)
Accelerated Hydrogen Peroxide
Botanicals
Metals
Nouvex like polymers
Miscellaneous others

22. The “Claim”
The process of registration of an antimicrobial active ingredient or product is dependent on what a manufacturer wishes to claim.

23. Antimicrobial Uses
According to the USEPA there are two major uses of antimicrobial pesticides:
Protect inanimate objects
Disinfect, sanitize, reduce, mitigate a microbial infestation

24. Categories of Antimicrobials
There are two major EPA based categories of antimicrobials:
Non-Public Health Products
Public Health Products
Sanitizers
Disinfectants
Sterilizers

25. 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

26. 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:

27. 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.

28. 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

29. Sanitizers
non-food contact products - Non-food contact surface sanitizers include:
carpet sanitizers
air sanitizers
laundry additives
in-tank toilet bowl sanitizers.

30. Disinfectants
Used on hard inanimate surfaces and objects to destroy or irreversibly inactivate infectious fungi and bacteria but not necessarily their spores.

31. 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.

32. 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.

33. 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).

34. Data may or may not be required depending on the claim.
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.

35. 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

36. 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)

37. 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

38. 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!

39. 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

40. 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

41. 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.

42. 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.

43. 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.

44. 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….

45. 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.

46. 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)

47. 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.

48. For your time and attention.
Thank You!
For your time and attention.
Questions / Comments