Validation and Monitoring of Non-burn Health Care Risk Waste Treatment Facilities in Gauteng

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Validation and Monitoring of Non-burn Health Care
Risk Waste Treatment Facilities in Gauteng

• Linda Godfrey, Dave Baldwin, Martella du Preez,
  Pauline Coubrough

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Overview

• Introduction
• Sterilization versus Disinfection
• Approaches and Standards
• Case Studies
• Testing Standards and Protocols
• Evaluation of Efficacy Monitoring Requirements
• Conclusions and Recommendations

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Introduction

• South Africa traditionally utilised incineration
• Minimum Requirements (DWAF, 1998), infectious
  waste must be incinerated or otherwise sterilised
  prior to disposal
• Ash disposed of to an HH or Hh landfill
• Presents the approach adopted by GDACEL for
  validation and monitoring

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Sterilization versus Disinfection

• Introduction of new non-burn treatment
  technologies
• Heat treatment - microwaving, electro-thermal
  de-activation (ETD), autoclaving
• Chemical Treatment chlorine, ozone
• Non-burn treatment facilities are not typically
  required to disinfect health care risk waste
• Distinguish between sterilization and disinfection

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Sterilization versus Disinfection

• Sterilisation reduction in microorganisms by one
  million (106 or more than 99.9999 are killed)
• Low Level Disinfection - most bacteria, some
  viruses and some fungi are killed, complete
  absence of resistant microorganisms e.g. tubercle
  bacilli or bacterial spores cannot be relied on.
• Intermediate Level Disinfection - Myocardium
  tuberculosis, most viruses and fungi are killed,
  but not necessarily bacterial spores.
• High-level Disinfection - all microorganisms,
  with the exception of small numbers of bacterial
  spores are killed.

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BACTERIAL SPORES (e.g. Bacillus Subtilis,
Clostridium sporogenes) ? MYCOBACTERIA (e.g.
Mycobacterium tuberculosis var.
bovis) ? NON-LIPID OR SMALL VIRUSES (e.g.
Poliovirus, Coxsackie virus, Rhinovirus) ? FUNGI
(e.g. Trichophyton spp, Crytococcus spp, Candida
spp) ? VEGETATIVE BACTERIA (e.g. Pseudomonas
Aeruginosa, Staphylococcus Aureus, Salmonella
spp) ? LIPID OR MEDIUM SIZED VIRUSES (e.g.
Herpes Simplex Virus, Cytomegalovirus,
Respiratory syncytical virus, Hepatitis B Virus,
Human Immunodeficiency Virus)
Increasing resistance to treatment
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Approaches and Standards

• State and Territorial Association on Alternative
  Treatment Technologies (STAATT, 1994)
• STAATT 1 recommended Level III microbial
  inactivation
• inactivation of vegetative bacteria, fungi,
  lipophilic/hydrophilic viruses, parasites and
  mycobacteria at 6 Log10 reduction and
• inactivation of B. stearothermophilus or B.
  subtilis spores at 4 Log10 reduction.

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Vegetative Bacteria Staphylococcus aureus (ATCC
6538) Pseudomonas aeruginosa (ATCC
15442) Fungi Candida albicans (ATCC
18804) Penicillum chrysogenum (ATCC
24791) Aspergillus niger Viruses MS-2
Bacteriophage (ATCC 15597 B1) Parasites Cryptos
poridium spp. oocysts Giardia spp.
cysts Mycobacteria Mycobacterium
terrae Mycobacterium phlei Mycobacterium bovis
(BCG) (ATCC 35743) Spores Bacillus
stearothermophilus (ATCC 7953) Bacillus subtilis
(ATCC 19659)
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Approaches and Standards

• STAATT2 (1998) - the use of additional
  biological indicators to demonstrate the
  efficiency of treatment systems provides no
  additional safeguards to public health and
  safety.
• The list of test organisms was reduced to
  Mycobacteria and Bacillus spores only,
• inactivation of mycobacteria at 6 Log10
  reduction, and
• inactivation of B. stearothermophilus or B.
  subtilis spores at 4 Log10 reduction

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International Standards

• Efficacy and monitoring in US States varies
• STAATT1
• Relaxed STAATT1 (exclusion of parasites)
• STAATT2
• Relaxed STAATT2 (exclusion of mycobacteria)
• Emphasis on parametric monitoring
• Varying monitoring frequency and intervals

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South African Standards

• South Africa currently only has draft guidelines
  for the validation and efficacy testing of
  non-burn treatment facilities
• Limited guidance to establishment of non-burn
  treatment facilities
• Reliance on international standards and
  approaches for efficacy testing and monitoring

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Case Study 1

• Evertrade Medical Waste, Johannesburg
• First non-burn treatment facility in SA, 2002
• No SA guidelines for efficacy testing and
  monitoring
• Gauteng DACEL adopted the conservative STAATT
  requirements, i.e. STAATT1
• CSIR and National Health Laboratories

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Case Study 1

• Minimum, Level III microbial inactivation
• One or more biological indicator from each
  microbial group

Fungi Vegetative Bacteria Candida albicans
Staphylococcus aureus Viruses Mycobacteria
MS-2 Bacteriophage Mycobacterium
phlei Parasites Cryptosporidium Spores
Bacillus subtilis
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Problems Experienced

• Availability of organisms in SA
• Availability of correct ATCC cultures
• closest ATCC culture
• B. subtilis indicator vials
• importation of viable Cryptosporidium oocysts
• Method of introduction of samples into treatment
  process
• Medium for sample introduction
• Concentrations required for samples

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Problems Experienced

• Lack of animal testing facilities for
  Cryptosporidium animal infectivity tests
• Percentage viability instead of log reduction
• Laboratory techniques
• Streak Plate Method vs Membrane Filtration Method
  for Candida albicans
• Transport methods B. subtilis
• Time frame for validation testing

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Results

• All test organisms showed the Stericycle ETDTM
  treatment process employed by EMW Operations to
  meet the Level III requirements set by GDACEL of
  
• a 6 Log10 inactivation for vegetative bacteria,
  fungi, lipophilic/hydrophilic viruses, parasites
  and mycobacteria, and
• a 4 Log10 reduction for spores.

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Case Study 2

• Evertrade Medical Waste, Cape Town
• Relaxed standards by Western Cape Department of
  Environmental and Cultural Affairs and Sport,
  i.e. relaxed STAATT 2
• AllkilTM Bacillus subtilis indicators
• Reduced testing requirements resulted in
• cost savings for the company and
• reduced the time required for testing by weeks
• without compromising the validity of results

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Results

• Testing programme showed 100 inactivation of
  Bacillus subtilis spores, i.e. Level III
  inactivation required Western Cape
• a 4 Log10 reduction for spores.
• Calibrated parametric monitoring, e.g.
  temperature, pressure, throughput, residence
  time, etc to support monitoring.

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Testing Standards and Protocols

• Problems and challenges encountered
• Development of Guidelines for Testing Standards
  and Protocols for Non-burn Health Care Risk Waste
  Treatment Technologies
• Identifies 4 testing phases
• Performance Testing
• Regular Testing Programme
• Reduced/Routine Testing Programme
• Investigative Testing

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Testing Standards and Protocols

• Level III inactivation, as a minimum, for all
  non-burn technologies, all sizes
• inactivation of vegetative bacteria, fungi,
  lipophilic/hydrophilic viruses, parasites and
  mycobacteria at 6 Log10 reduction and
• inactivation of B. stearothermophilus or B.
  subtilis spores at 4 Log10 reduction.
• Performance testing programme weekly for a one
  month period, i.e. at least 4 times, on normal
  infectious waste.
• The plant must also demonstrate that it can meet
  the programme on a challenge load.

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Testing Standards and Protocols

• Evaluation of Gauteng draft validation
  guidelines
• Proposed monitoring programme general
  assessment
• Performance testing
• Regular testing
• Analytical procedures for efficacy testing
• Availability of analytical facilities in South
  Africa
• Availability of microbiological organisms in
  South Africa

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Testing Standards and Protocols

• Cost of implementation
• Testing costs for Large Commercial Facilities
• Testing costs for Small on-site Facilities
• Alternative validation programmes
• Proposed requirements
• Estimated costs
• Comparative costs of various validation
  programmes

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Testing Programme Cost R Cost R
Testing Programme Commercial Facilities Small on-site Facilities
STAATT1 Performance Testing (1) R260 800 R125 800
STAATT1 Performance Testing (2) R190 800 R77 800
STAATT2 Performance Testing R37 750 R15 100
Daily Monitoring (a) R400 /m R400 /m
Daily Monitoring (b) R3 200 /m R7 200 /m
Monthly Monitoring R17 000 R7 000
Performance testing scenarios (1) Complete STAATT 1 testing (2) Reduced STAATT 1, excluding parasites Daily monitoring scenarios (a) Suggested Guidelines, i.e. once per day. (b) Draft Gauteng Guidelines, i.e. every 2 hours of operation.

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Challenges

• The limited availability of required ATCC
  organisms in South Africa
• The requirements for the importation of viable
  Cryptosporidium oocysts for every validation test
• The limited availability of accredited
  laboratories in South Africa
• The limited availability of qualified individuals
  to supervise validation programmes

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Challenges

• Interpretation of requirements from authorities
• Interpretation of results by laboratories, the
  proponent and authorities
• Lack of consistency between Provincial
  Authorities in their approach to the validation
  of non-burn treatment technologies
• Lack of national guidelines for validation and
  monitoring

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Conclusions

• Need for capacity to implement and assess testing
  programmes
• Library of required organisms established at an
  accredited laboratory(s)
• Relaxation of STAATT 1
• As a minimum the exclusion of parasites
• Reduction in frequency of regular testing to once
  per day
• Role of parametric monitoring

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The development, implementation and enforcement
of guidelines to support validation and
monitoring of non-burn health care risk waste
treatment facilities, will ensure that these
treatment facilities do not give rise to
environmental and human health risks now or in
the future.