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Current Decontamination & Waste Disposal Methods

TECHNOLOGY OR METHOD APPLICABLE TO NON-DISEASED

CARCASS DISPOSAL

APPLICABLE TO INFECTIOUS DISEASED CARCASS DISPOSAL

APPLICABLE TO TDE (PRION)

DISEASED CARCASS DISPOSAL

RELATIVE OPERATING

COST(1 LOW, 3

HIGH)

RENDERING COOKING Y Y N 1

HIGH SPEED COOKING Y Y N 1

BIO-DIGESTION Y N N 1

INCINERATION (BURNING) Y Y *Y 3

COMPOSTING Y N N 1

LAND-FILLING (LINED) Y N N 1

BURIAL (TRENCH) Y N N 1

CHEMICAL DIGESTION Y Y Y 2

REFRIGERATION N N N 2

FERTILIZATION Y N N 1

* Issues with potential Prion release to atmosphere & surrounding land

Medical, Laboratory and Animal Waste Treatment Update

Conventional autoclaves in the news!

Previously “grandfathered” by regulations. as long as they complied with historic time, temperature, and pressure requirements

•State and Territorial Association on Alternative Treatment Technologies (STAATT III)•Autoclaves are finally starting to receive scrutiny regarding the treatment of dense materials, bulk liquids and whole blood

Placement of the test indicators inside of the load and actual waste temperatures will dictate cycle times

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Q-1. How long do you think it takes to cook this 20 Lb. Thanksgiving turkey at 350 degrees F?

Q-2. How Hot do you think the inside of this turkey is after that cooking time?

A-1: Approx. 18 mins./Lb X 20 Lbs = 360 mins. A bag of medical waste averages 22 lbs.

A-2: 165-177 degrees F. internal temperature!

• Due to difficulty in treating large/heavy waste loads, Regulators are requiring new efficacy testing standards for previously approved autoclaves

• Ensure complete treatment of bulk liquids and dense waste loads such as animal carcasses

• Previous 60 minute cycle times may extend to 4 to 6 hours causing operating costs of autoclaves to sky rocket

This is important point to note if this is current method of decontamination of infectious animal carcasses or dense waste loads.

Alkaline Hydrolysis…..the Green alternative to Incineration or Burial disposal methods

• Optimal process for decontamination and disposal of infectious biological and anatomic waste

• Recommended by the USDA, EU, & CFIA for inactivation & destruction of Prions and their associated TSE diseases (mad cow, chronic wasting disease, scrapie)(mad cow, chronic wasting disease, scrapie)

• Process utilizes time, pressure, temperature, and circulation of a caustic solution to ensure high level of sterility.

• Liquifies fats, water, and proteins leaving only the skeletal remains

• Produces a safe, sterile effluent suitable for safe discharge to drain or used as a sustainable resource (fertilizer, bio-fuel, or bio-gas).

• Does not emit any pollutants into the atmosphere

Alkaline Hydrolysis…..the Green alternative to Incineration or Burial disposal methods

y p p

• Does not re-initiate the contamination cycle

• Reduces overall disposal costs per pound

• Reduces the risk of contamination during transport

• 100% Automated process for full or partial loads.

Reduces mass volume by as much as 95%

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Process invented for decontamination and disposal of infectious radiological waste at Albany Medical Center, NY (lab rats)

Th (3) i ti ti t d t i th ti

Alkaline Hydrolysis Process

Three (3) year investigation to determine the proper time, temperature, pressure, and amount of caustic solution required to inactivate & destroy prions –Somerville Report

• Process gained world-wide notoriety as the only process to destroy & inactivate prions

• Validation of the process led to US & International patents

Tissue Digestion Applications• Anatomic waste: research animals, livestock, wildlife

• Prion-induced Transmissible Spongiform Encephalopathy (TSE) diseases: mad cow, CWD. Scrapie

• Infectious diseases: anthrax, foot & mouth, avian bird flu

• Low-level radioactive biological waste

• Chemotherapeutic Agents: Anti-neoplastic drugs, Cytotoxins

• Aldehyde-containing fixatives & embalming fluids• Aldehyde-containing fixatives & embalming fluids

• Forensic Labs : Evidence / Human cadavers

• Biological Warfare Agents: bacteria, rickettsaie, fungi, viruses, toxins, recombinant organisms, recombinant molecules

• Pathological waste (Healthcare operating suites)

• Egg waste from human or animal vaccine production

• Disposal of OTC & prescription drugs

• Stem cell / DNA / RNA waste disposal

• Aquatic biology

Tissue Digestor Markets

Life Sciences:

Animal Research, Pharmaceutical, Biotech

Biological Containment

Healthcare

Wildlife Management & Animal Control

Livestock Agriculture

Homeland Security / Bio-Defense

Mortuary Science

Rendering / Meat Processing

Forensic

Digestor Target Companies & Institutions

Veterinary Colleges & Universities

Agricultural Colleges & Universities

CDC & NIH Funded entities

Human & Animal Vaccine Manufacturers

Contract Research Organizations & Animal Providers: Harlan, Charles River, Marshall, Covance, Alpha Genesis, Genentech

Medical Science Schools

Bio-containment Facilities: military installations, BSL3 labs

3Ag facilities

State & County Environmental / Animal Testing Labs / Animal Control Agency

Forensic Labs

Labs researching Recombinant DNA Molecules , Proteins, & Organisms

Zoological Societies

Cosmetic Manufacturers

Tissue, Blood, & Organ Banks

Institutions for Regenerative Medicine

Tissue Digestor Models

Lab 55 Kg / 11 Lb CapacityLow Pressure Model120VAC Wall OutletOperates @ 212FInternal Heater20 Hr Cycle Time

Lab 5H5 Kg / 11 Lb CapacityHigh Pressure ModelUses 80-100 psig steamOperates @ 305F7-10 Hr Cycle Time

Tissue Digestor ModelsHigh Pressure Models

Lab 30Lab 45BE 18-20-80BE 30-26-200BE 30-31-280BE 34-38-500BE 48-24-600BE 48-32-750

Model Number Designations

BE – inside diameter– inside depth – Lb Capacity

BE 48-32-750BE 48-52-1500BE 48-68-2000BE 72-52-3000BE 96-34-3500BE 84-52-4000BE 72-96-5500BE 96-68-7000BE 96-100-10000*All Models use 80-100 PSIG Steam supply

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Tissue Digestor Loading

Loading

Post-process

Tissue Digestor Sizing• Assumptions:

• Non-prion related research - 3 to 4 hour exposure times at min 250F, Total cycle time = 6 to 7 hours

• Prion-related work research – 6 hour exposure times at 300F, Total cycle time = 10 to 11 hours

Cycle times are not dependent on load size or the size of the tissue digestortissue digestor

• Digestor Size = Total Weight to process per cycle

- Based on the total amount of waste to process per 5 dayweek and the capability to run one (1) prion cycle or two (2) non-prion cycles per day

- Size of the anatomic waste to process

- Placement into the Digestor: whole or sectioned?

Tissue Digestor Sizing

Example:

Customer wishes to dispose of 7,000 Lb of animal carcassesper week using most economic method for prion-related research. No sectioning allowed.

Digestor Sizing:

( 7,000 Lb / week) x ( 1 week / 5 days) = 1,400 Lb / day

= 1,400 Lb / Cycle

Therefore select a 1,500 Lb capacity digestor

Process Effluent

Neutralization of pH

Liquified Or GaseousCO2

Sewage Treatment

Plant

pH Range7.5 – 8.5

Process Effluent

Biological Oxygen DemandReduction Methods

GrossRefinement

100K mg/L

BOD ReductionSystem

1.Water Dilution

2. Timed Release

90% Water 10% Landfill

Refinement

Polishing Filter

< 10,000 mg/L

2. Timed Release

3. BOD Reduction Systems< 10,000 mg/L< 1,000 mg/L < 1,000 mg/L

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Acid

Extraction Compound

Extraction

Process Effluent

Bio-Fuel Generation

Acid

Transesterfication

Liquid Decanter

Glycerin

Methyl Esters Polishing Bio-Diesel11%-16% recoverybased on weight of digestor contents

**For large-scale operations only

Process Effluent

Fertilizer Generation / Zero Waste

Dehydration

Scrubber

Water

Landfill

Fertilizer

The “Zero Waste” concept

Post-treatment of sterile digestor effluent into a usable product:

• Provides a method of attaining zero waste removal while lowering the cost of operation.

• Fertilizer generated from concentrated effluent sold as “product”*

• Fertilizer for use in Land broadcasting*

* based on studies & current practical applications at Universities of GA and Ky.

Zero WasteDegrees of Recovery

• Sterile Effluent re-claimed for use or sale as fertilizer *

• Rinse water reclaimed for digestor feedwater, di h t d i zero discharge to drain

* based on studies & current practical applications at Universities of GA and Ky.

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Horizontal Designs

•Single Door or Pass-through designBio-containment Seal

•Horizontal Loading & Unloading

Top Loading in Containment

Vertical Design

•Pass-through double door operation

BioSeal w/ floor removedfor clarity

operation

•Bio-containment Seal

•Top Loading from inside containment barrier for large animals

Bone removal port outsideof containment

BSL3 containment barrier

Vertical Designs:Vertical Designs:Vertical Designs:

Vertical Designs – Top Loading

BarrierFloor

Sub-containment barrier

Vertical Designs:Vertical Designs:Vertical Designs:

Vertical Top Loading Design

Containment Area

Bio-Seal

Bone out port

Vertical Top Loading Design

Outside of ContainmentUniversity of Georgia Athens, GA USA

Model 100-72-96 2,500 Kg/cycle

Double door, vertical pass-thru design

BSL-3 containment seal package

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Kansas State University Bio-Security Research Institute- Manhattan, KS USA

Model 100-72-96 2,500 Kg/cycle

Double door, vertical pass-thru design

BSL-3 containment seal package

USDA – APHIS Ames, IA USA

Model 100-96-68 3,250 Kg/cycle

Single Door, vertical design

100 HP boiler system

12,000 L cooling water reclamation tank

Dehydration system.

European Union ApprovedCanadian Food Inspection Agency

Regulatory Recognition

Alkaline Hydrolysis has been recommended by the above agencies as the only “green” process to inactivate and destroy prions

The recommendations are based on BioSAFE’s Alkaline Hydrolysis patent.

Efficacy in Alkaline HydrolysisRequirements based on USDA / EU / CFIA

recommendations & BioSAFE Patents

Hydroxide (caustic) solution calculated on a mass per mass basis

Equal to or > 9% of the weight of the infectious material which corresponds towhich corresponds to

15% Sodium Hydroxide (NaOH)OR

19.3% Potassium Hydroxide (KOH)

Minimum Exposure time of 180 minutes

Somerville Report - determined min amounts of caustic to ensure a high level of efficacy

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Validation & Commissioning Performance Testing:

Use of Bio-indicators

Geobacillus Stearothermophilus

Mycobacteria Terrae

Animal Carcasses inoculated with above

Temperature Distribution Mapping

After processing, place Bio-indicator in a petri dish w/ media

7 Day incubation period of bio-indicator to determine sterility:

Growth in petri dish: indicates lack of sterility

No growth in petri dish: indicates sterility

Microbial Death Rates(spore dependent)

Microbial Death Rates

Thank you for joining us today !Bi SAFE E i i BioSAFE Engineering

485 Southpoint Circle

Brownsburg, IN 46112

317-858-8099 ph

317-858-8202 fax

www. biosafeengineering.com