maquira 8 Hour Bioindicator Instructions
- June 13, 2024
- maquira
Table of Contents
BIOINDICADOR 8 HORAS
8-HOUR BIOINDICATOR
8 Hour Bioindicator
Symbology
| Manufacturer.
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| Consult instructions for use.
| Batch code.
| Caution
Consult instructions for use for important preventive information.
| Use-by date.
| Temperature limit.
| Keep away from sunlight.
Content:
Box with 10 plastic tubes containing paper disc permeated with spores of Geobacillus stearothermophillus ATCC 7953 and sealed glass ampoule filled with growth medium.
Indication:
Bioindicators of quick colorimetric reading (8 h) indicated for evaluation of steam sterilization processes.
Product Description:
The BIOINDICATOR for quick colorimetric reading (8 h) is intended to monitor the steam sterilization process. The rapid detection of positive biological indicators occurs through the gradual change in color of the growth medium. If the sterilization process is efficient, after activation of the bioindicator and incubation at 60 °C + 2 °C for 8 hours, the growth medium will remain purple, indicating the absence of live spores of Geobacillus stearothermophillus ATCC 7953. If the sterilization process Is not efficient, after activation of the bioindicator and incubation at 60 °C + 2 °C for up to 8 hours, the growth medium will change color from purple to yellow, indicating the presence of live spores of Geobacillus stearothermophillus ATCC 7953.
Composition:
Each tube contains a population of 105 to 106 in Geobacillus stearothermophilus ATCC 7953 inoculated into a paper disc. It also contains a purple color growth medium contained in the glass vial.
Mode of use:
1. Separate 02 bio-indicator vials from the same manufacturing batch. Identify on each label the sterilizer number, the charge number, and the processing date. Pack one of the ampoules next to the material to be sterilized (Test Ampoule) in a suitable package according to practices recommended for steam autoclaving. The other ampoule will not be autoclaved (Positive Control Vial). If more than one autoclave is evaluated simultaneously, a single Control Ampoule can be used as a reference, provided that all ampoules (Tests and Positive Control) are from the same manufacturing batch, and that the activation and incubation of these ampoules occur simultaneously. 2. Insert the sterilization package containing the Test Ampoule into the autoclave in a difficult access location to the sterilizer (steam), such as in the center of the load and near the door. 3. Start the sterilization cycle of the steam autoclave in the usual way according to the manufacturer’s instructions for use. After the sterilization process, remove the envelope containing the Test Ampoule from the autoclave and wait for 10 minutes to cool. 4. Check that after autoclaving the chemical sterilization indicator printed on the Test Ampoule label has changed from pink to brown. The color change confirms that the biological ndicator has been exposed to steam. If the chemical indicator does not change color, it is necessary to review the sterilization process. NOTE: This color change is not evidence that the sterilization process was sufficient to achieve sterility of the materials. 5. Remove the Test Ampoule from the envelope and perform its activation immediately prior to incubation. To do this, break the ampoule with a Ampoule Breaker or by hand, compressing the Bioindicator tube against the wall of the incubator until the internal glass ampoule ruptures and the growth medium is released, soaking the paper disc inoculated with the spores. Take care not to break the plastic tube during breaking the glass ampoule. With the tube vertically, lightly tap the lower part of the tube with your index finger to allow the removal of air bubbles and favor the full contact of the spores with the growth medium. The activation and incubation process of the Test Ampoule should be started within two hours of its sterilization process. 6. Repeat the activation process with the Positive Control Ampoule. The chemical indicator printed on the label of the Positive Control Ampoule should remain pink, as it was not exposed to steam (autoclaved). Positive Control ensures that incubation conditions were appropriate. 7. Carry out the incubation process of the Test Ampoule and the Positive Control Ampoule at 60 °C + 2 °C, for up to 8 hours. If more than one Test Ampoule is processed simultaneously in the same incubator, only one Positive Control Ampoule may be used, from which all ampoules are from the same manufacturing batch and the activation and incubation of these ampoules start together. 8. Record the results of the two ampoules on the control sheet, as shown, and remove the labels (tags). Immediately afterwards, discard the ampoules. Prior to the disposal of positive-responding ampoules (changed color from purple to yellow), process them in steam sterilizer by gravity air movement at 121 °C for 30 min or at 132 °C for 15 min, or in a sterilizer of vacuum steam at 134 °C for 10 min. 9. Do not reuse the autoclave until the result of the biological indicator is negative.
Results Interpretation:
The rapid detection of positive biological indicators occurs through the
gradual color change of the growth medium, as shown below in the Color
Reference Table. This analysis should be performed under white light.
Ampoule Test: A) If the sterilization process was efficient, after
activation of the bioindicator and incubation at 60 °C + 2 °C for 8 hours, the
growth medium will remain purple (negative result), indicating the absence of
live spores of Geobacillus stearothermophillus ATCC 7953, i.e., the tube was
correctly sterilized and complete destruction of the spores occurred during
the sterilization process. B) If the sterilization process was not efficient,
after activating the bioindicator and incubating at 60 °C + 2 °C for up to 8
hours, the growth medium will change color from purple to yellow (positive
result), indicating the presence of live spores of Geobacillus
stearothermophillus ATCC 7953. In this case, repeat the test to check for
improper tube sterilization, incubator malfunction, improper activation of the
glass ampoule and/or improper storage of the product. If the positive result
is confirmed (color change to yellow) after autoclaving, interrupt the use of
this autoclave, analyze its physical parameters, if there is an overload in
the equipment and refer the equipment for technical assistance. C) If the
spore death time is greater than 19 min and the autoclaving cycle is 15 min at
121 °C, it is possible that after the sterilization process, activation of the
bioindicator and incubation at 60 °C + 2 °C for up to 8 hours, the growth
medium changes color from purple to yellow (positive result), indicating the
presence of live spores of Geobacillus stearothermophillus ATCC 7953. In this
case, repeat the test by processing a new Autoclave Test Ampoule for a time
similar to the time of death indicated in the Certificate of Quality.
Positive Control Ampoule: Since this ampoule was not autoclaved, after
activating the bioindicator and incubating at 60 °C + 2 °C for up to 8 hours,
the growth medium will change color from purple to yellow (positive result),
indicating the presence of live spores of Geobacillus stearothermophillus ATCC
7953. Record the result and process the ampoule as recommended for safe
disposal. If after the incubation process of Positive Control Ampoule the
growth medium does not change color – remain purple (negative result), repeat
the test to certify if incubator malfunction, improper activation of the glass
ampoule and/or incorrect storage of the product.
Result: The sterilization test shall be considered APPROVED or VALID only
if the two ampoules (Test and Positive Control) belong to the same
manufacturing batch and after being incubated together, the Test Ampoule
obtains a negative result (remain purple) and the Positive Control Ampoule
obtains a positive result (have changed color from purple to yellow). In case
of result different from that described, the sterilization test should be
considered FAILED. Do not reuse the autoclave until the result of the
biological indicator – Test Ampoule – is negative.
Precautions: Start the process of activating and incubating the ampoule
within two hours after the sterilization process. Test and Positive Control
Ampoules must belong to the same manufacturing batch.
Do not reuse the biological indicators. Do not use the Biological Indicator 8
hin sterilization processes for ethylene oxide, low temperature for vaporized
hydrogen peroxide, dry heat, formaldehyde or other sterilization processes.
Prior to the disposal of positive-responding ampoules (changed color from
purple to yellow), process them in steam sterilizer by gravity air movement at
121 °C for 30 min or at 132 °C for 15 min, or Vacuum steam sterilizer at 134
°C for 10 min.
Storage and Transport Conditions:
Store at temperatures between 15 °C to 30 °C and relative humidity between 35%
and 60%. Do not freeze. Do not store near sterilizing agents or other
chemicals.
Disposal mode: All material used in the microbiological control must be
processed in a steam sterilizer by gravity air movement at 121 °C for 30 min
or at 132 °C for 15 min or vacuum steam sterilizer at 134 °C for 10 min,
followed by disposal in hospital waste.
References: ANSI/AAMI/ISO 11138-1:2006, Sterilization of health care
products Biological Indicators Part 1 General requirements. ISO 11138-3:2004,
Sterilization of health care products Biological Indicators Part 3: Biological
indicators for moist heat sterilization.
MADE IN BRAZIL
Manufacturer:
Maquira Industria de Produtos Odontoldgicos S.A.
CNPJ: 05.823.205/0001-90
Address:
Av. Melvin Jones, 773
Pq. Ind. Bandeirantes
Maringa – PR| 87070-030 | Brasil
Produto isento de registro.
G SAP:
Customer service
0800 726 5848
sap@maquira.com.br
0403088 – rev. 03