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Bondtech Autoclave Validation Test Results


Bondtech Autoclave Validation Test KA 622-98-01
Mr. Angel Aguiar
Vice President
Bondtech Corporation
2400 North Highway 27
Somerset, Ky 43503

Subject: Medical Waste Sterilization Efficacy Testing of Two Bondtech Autoclave Systems

Dear Mr. Aguiar:

In accordance with your request, I have summarized the results of the medical waste sterilization efficacy tests conducted by Koogler & Associates Environmental Services on two Bondtech high vacuum/high pressure medical waste autoclave systems on January 26, 1994. The results of the testing were originally published in our report prepared and certified by me as a registered Professional Engineer on February 15, 1994. The results summarized in the following abridged report accurately summarize the results reported in our original report. Our abridged report has been re-certified by me on this date.

The efficacy testing was conducted to demonstrate compliance with permitting requirements established by the Florida Department of Environmental Protection. The standards promulgated by FDEP exceed the guidelines established by the U.S. Environmental Protection Agency.

The results of the medical wate sterilization testing demonstrated that both Bondtech autoclave systems achieved 100 percent sterilization effectiveness using Bacillus stearothermophilus as the biological indicator. This kill rate is in excess of log6 (in excess of 99.9999%) and meets or exceeds all regulations and standards extablished by the U.S. Environmental Protection Agency and U.S. state environmental agencies.

If there are any questions regarding the results of these tests, please do not hesitate to contact me at 352-377-5822.


Very truly yours,
koogler




1.0 INTRODUCTION

On January 26, 1994, Koogler & Associates Environmental Services of Gainesville, Florida, performed biological sterilization efficacy testing on two Bondtech high-vacuum/high-pressure medical waste autoclave systems. The efficacy test program was required by the Florida Department of Environmental Protection prior to the Company receiving an environmental operation permit for the two Bondtech autoclave systems.

The purpose of the testing was to demonstrate the medical waste treatment efficacy of both the Bondtech autoclave systems whose construction was permitted by the Florida Department of Environmental Protection. The Florida Department of Environmental Protection has promulgated medical waste regulations that exceed the guidelines established by the United States Environmental Protection Agency.

The permitted medical waste treatment facility consisted of two Bondtech high-vacuum/high-pressure autoclave systems each capable of processing over 1,500 pounds of waste per hour. The process cycles for this Bondtech installation are controlled by programmable controllers that continously monitor and record the temperature and pressure within each sterilizer while controlling the complete sterilization cycle.

2.0 PROCESS CYCLE

Prevacuum. The sterilization cycle in initiated by reducing the pressure to 0.06-0.16 bars (a vacuum of 25-28 inches of mercury). The prevacuum removes residual air from the autoclave vessel and ensures thorough permeation of steam throughout the entire medical waste load.

Pressurization. After completing prevacum, the Bondtech autoclave is pressurized with saturated steam to 4.34 bars (50 pounds per square inch gauge). At this pressure, the minimum operation temperature is 148°C (298°F).

Blowdown. Following the pressurization, the steam in the Bondtech autoclave is vented through a steam condenser and the condensate safely drained to the sewer. The generation of odors is effectively controlled by the Bondtech steam condenser along with the post-vacuum process.

Post-Vacuum. A post-vacuum is applied to the vessel prior to the end of the cycle. The post-vacuum ensures that no steam remains in the autoclave vessel and therefore minimizes the occupational exposure of operating personell. Removing the steam during the post-vacuum (drying) process also prevents the waste from being wetted by condensed residual steam thus eliminating the additional weight of moisture to the waste.

The total cycle time during the efficacy test program averaged 30.6 minutes. The total load-to-load process cycle time averaged about 40 minutes. The waste loads to each Bondtech autoclave ranged in weight from 379-665 kilograms per cycle (835-1465 pounds per cycle). The average hourly waste processing rate of each Bondtech autoclave was about 820 kilograms per hour (1800 pounds per hour).

The test program was designed to provide a comprehensive challenge to validate the sterilization efficacy of the Bondtech high-vacuum/high-pressure autoclave system. The validation efficacy test program is described in the following section.

3.0 STERILIZATION TEST

Biological Test Indicator. The biological indicator chosen for the validation testing was Bacillus stearothermophilus spores. The spore vials used each had a mean population of 1.6 million colony forming units (cfu). This organism is commonly used by health industry professionals due to a resistance to heat that is considerably greater than pathogenic organisms. A log 6 kill of Bacillus stearothermophilus(99.9999% kill) is referred to as the "sterility assurance level or sterilization level." This is the standard used by the medical device industry for the sterilization of large quantities of medical devices in steam autoclaves.

Most state environmental agencies require a log 4 kill of Bacillus stearothermophilus (99.99% kill). A log 6 kill represents a kill rate 100 times higher than the log 4 kill. Medical waste treatment to a log 6 kill meets or exceeds all regulations and standards established by the United States Environmental Protection Agency and state environmental agencies.

Validation Efficacy Test Program.

Feedstock Test 1: Bags. Two Bacillus stearothermophilus test vials were placed in a rigid plastic shaprs container that was lined with absorbent underpads. The rigid sparps container was then sealed and placed in a red bag and sealed. Two test bags were placed in each waste load; one in the geometric center of the front Bondtech autoclave waste bin and the other in the geometric center of the back waste bin. Two waste bins are introduced to a Bondtech autoclave during each sterilization cycle.

Feedstock Test 2: Boxes. Two Bacillus stearothermophilus test vials were placed in a rigid plastic sharps container that was lined with absorbent underpads. The rigid sharps container was then sealed and placed in a red bag and sealed. The sealed test bag was placed inside an approved medical waste cardboard box. Two cardboard boxes were placed in each waste load as described above.

4.0 TEST RESULTS

Sterilized tests were conducted by placing three waste loads of boxed medical waste and three waste loads of bagged medical waste in each one of the two Bondtech autoclaves. The results of the 12 tests demonstrated that both Bondtech autoclaves were 100 percent effective for sterilizing the bagged and boxed waste loads based on a 100 percent kill rate of the biological indicator. The results of the testing are summarized in the following table.

5.0 CONCLUSION

The results of the medical waste sterilization efficacy testing conducted on two Bondtech high-temperature/high-vacuum autoclave systems on January 26, 1994, demonstrated both autoclave systems achieved 100 percent sterilization effectiveness using Bacillus stearothermophilus as the biological indicator. This is a biological indicator kill rate in excess of log 6 (in excess of 99.9999%); the standard commonly used by health care industry professions for the sterilization of medical instruments.

A log 6 kill of Bacillus stearothermophilus (99.9999% kill) is referred to as the "sterility assurance level or sterilization level." Both Bondtech autoclaves achieved this sterilization treatment level which meets or exceeds all medical waste treatment standards established by the United States Environmental Protection Agency and all U.S. State Environmental Agencies. The tests were conducted on both bagged and boxed medical wastes at sterilization rates in excess of 820 kilograms per hour (1800 pounds per hour) for each of the two Bondtech autoclaves.

6.0 CERTIFICATION OF RESULTS

To the best of my knowledge, all applicable field and analytical procedures comply with the Florida Department of Environmental Protection requirements and all test data and plant operating data are true and correct.

certificate

STERILIZATION CYCLE TIME, WASTE LOAD WEIGHTS

AND STERILIZATION TEST RESULTS

 

BONDTECH

STEAM AUTOCLAVES

 

JANUARY 26, 1994

 

Bondtech

Autoclave

Waste

Packaging(1)

Test

Load

No.

Load

Weight

(kg) (lb)

Cycle

Time

(min)

Test

Results (2)(3)

1

 

Bag

1

613

1352

30.25

+ / +

1

2

560

1235

30.25

+ / +

1

3

500

1103

29.75

+ / +

1

 

Box

1

450

991

29.75

+ / +

1

2

484

1068

29.25

+ / +

1

3

537

1183

28.80

+ / +

2

 

Bag

1

622

1371

32.27

+ / +

2

2

665

1465

32.30

+ / +

2

3

654

1442

32.85

+ / +

2

 

Box

1

558

1231

30.80

+ / +

2

2

379

835

29.75

+ / +

2

3

494

1089

30.70

+ / +

Average Bag Weight

602

1328

|

|

Average Box Weight

484

1066

|

|

Average Cycle Time (min)

|

|

30.56

|


(1) Bag-bagged waste Box-boxed waste

(2) Biological indicators were incubated at 55° C for 60 hours. A 100% kill of Bacillus stearothermophilus is

an indication of a successful test. Test marked (+) were successful (100% kill).

Tests marked (-) were not successful (<100% kill).

(3) + / + - Biological test indicator results for front and back waste bin of each test load.

 


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