瓶裝生物指示劑Bacillus atrophaeus 10⁶

專供E.O.滅菌週期使用。  

試驗(Test): 有顏色改變(由橘紅色變黃色)或顏色有點變黃則指示出一個失敗的滅菌週期。 試劑瓶保持原來的橘紅色沒有混濁物或顏色改變的話，則指示出完成了適當的滅菌週期。

BA/6 瓶裝生物指示劑

BIOLOGICAL INDICATOR     S

         Self-Contained

CERTIFICATE OF ANALYSIS      

Reorder No. BA/6  
Bacillus atrophaeus (Bacillus subtilis var. niger)              ATCC 9372

For:         Ethylene Oxide Sterilization.

Culture:   EZTest Media, 35-39°C. The supplied bacteriological medium will meet requirements for growth promoting ability.

Storage:  Controlled room temperature. Store away from sterilants. Do not desiccate.

Disposal: Incinerate or autoclave at 121°C for not less than 30 minutes.

Purity:     No evidence of contaminants using standard plate count techniques.

Lot No.:   G-112P

Manufacture Date: 2002 JUNE 13

Expiration: 24 months from Manufacture Date.

Heat Shocked Population:    2.3 x 10⁶     Spores/Unit

Assayed Resistance:

Ethylene Oxide (600 ± 30 mg/l, 60% ± 10% RH, 54 ± 1°C)

D-value⁽¹⁾            Survival⁽²⁾                 Kill⁽²⁾

   3.7                   16.1                         38.4     minutes

D-value reproducible only when exposed in an AAMI BIER vessel and cultured under the exact conditions used to obtain results reported here. MPN method used.

Units are manufactured in compliance with SGM Biotech's quality standards, USP, EN 866 and ISO 11138 guidelines and all appropriate subsections.

111 D-value calculated using the Spearman-Karber method.

"'Survival/Kill values are calculated according to USP and ISO 11138.

Monitoring Frequency:

For optimum control of hospital sterilized goods, we recommend that an EZTest biological indicator be used to monitor every load of ethylene oxide sterilized supplies.

Instructions For Use:

A. Exposure:

1. Remove an appropriate number of EZTest units from the box and identify the indicators by labeling with pertinent process information.

2. Place an EZTest indicator in a suitable test pack which is representative of the load.

3. Place this test pack in the most challenging area of the sterilizer, generally on the bottom shelf near the door. NOTE: If a test pack is not being used, the EZTest unit should be EZTest unit should be oriented in a horizontal position during load processing.

4. Process the load as usual.

5. After sterilization, do either a or b:
   a. Open the sterilizer door according to the manufacturer's instructions, transfer the   load to the aerator and remove the test pack. Remove the biological indicators from the test pack. Return the remainder of the test pack to the load for aeration according to the health care facility's policy.
   b. If the sterilizer/aerator combination does not allow the test pack to be removed, then at the end of the aeration cycle, remove the biological and chemical indicators from the test pack. Dispose of the remaining test pack as soon as the aeration is complete.

6. The chemical indicator on the label changes from yellow to blue when exposed to ethylene oxide. This distinguishes exposed from unexposed units. NOTE: A blue color does not indicate acceptable sterilization.

B. Incubation:

Any microbiological incubator that is adjusted for 35 to 39°C will satisfy the Incubation conditions for the EZTest. To activate the media, place the Indicator In an upright position In a plastic crusher. Gently squeeze the crusher to break the glass ampoule. Place the activated Indicator in the Incubator rack, and incubate Immediately.

C. Interpretation

1. Examine the indicator at regular Intervals for any color change (i.e. 18 hours, 24 hours, 48 hours). The appearance of a yellow color Indicates bacterial growth. No color change indicates adequate sterilization.

2. Act on a positive test (a color change of yellow) as soon as the color change Is noted. Notify appropriate hospital personnel (i.e. Infection Control).  Always retest the sterilizer with several EZTest indicators throughout the test load. EZTest indicators can be subcultured if EZTest indicators throughout the test load. EZTest indicators can be subcultured if identification of positive growth Is desired.   Recommended subculturing procedure techniques are available upon request from SGM Biotech. SGM Biotech.

3. The recommended incubation time Is 48 hours.

4. Record the results.

5. Dispose of all used EZTest Indicators in accordance with your institution's policy. Incinerate or autoclave any positive cultures at 250°F (121 °C) for not less than 30 minutes.

Use of Controls:

1. As a positive growth control, place an activated, non-sterillized EZTest indicator in each incubator on a daily basis. It is best to do this on a Monday.  

2. Examine the positive Indicator at regular intervals such as 18 and 24 hours. The yellow color is evidence of bacterial growth. Record the results. Remove all positive indicators as the yellow color Is noticed, and dispose of as mentioned above.

3. If the positive control does not grow, do not use the units from this box. Contact SGM Biotech.

4. Reversion may occur from a yellow positive with extended incubation time or on an underexposed unit. The color will be a fuchsia red color and turbid. Reversion will only occur if living spores are present on the spore strip.

Storage:

1. Store EZTest Indicators at controlled room temperature conditions (15°C to 30°C) and 40 to 70 percent relative humidity.

2. Do not store these Indicators near sterilants or other chemicals.

3. EZTest Indicators have a 24 month shelf life which is clearly designated on each box. Rotate your stock accordingly.  
   NOTE： Do not use after expiration date printed on package. Dispose of expired indicators by autoclaving at 121 °C for not less than 30 minutes.