Chemdye® Helix-PCD devices have been designed to evaluate the penetration capability of the sterilizing agent (Steam, Ethylene Oxide, Formaldehyde and Hydrogen Peroxide). For a successful sterilization, the sterilizing agent must contact all external and internal surfaces of the item to be sterilized.

To achieve this, air and other non-condensable gases (NCG) must be evacuated from the sterilizer chamber prior to the sterilant injection. Chemdye® Helix-PCD devices simulate hollow instruments of different levels of complexity allowing testing of the penetration capability of the sterilizing agent.

Handling information

1- Choose an appropriate chemical indicator for the sterilization cycle to evaluate.

2- Fold the indicator strip in the middle through the punched line, the reactive ink must be facing the inside. Avoid folding the printed zone.

3- Place the chemical in the screw cap pin (metal capsule) or in the screw cap cavity (plastic capsule). Put the folded end first. IMPORTANT: Avoid contact between chemical indicator and capsule inner surface, since the results can be altered.

4- Put the capsule cap by applying moderate pressure.

5- Place the system inside the fabric bag and then onto a stainless steel tray. Put the tray in the sterilization chamber near its door. IMPORTANT: Do not use the fabric bag for Hydrogen Peroxide, Formaldehyde and Ethylene Oxide processes.

6- Run the desired sterilization cycle. For Ethylene Oxide processes, cycles shorter than 90 min or with less than 300 mg/l should not be evaluated with these devices.

7- Once the sterilization process is finished, remove the Chemdye® Helix-PCD from the sterilization chamber.

CAUTION: For Steam processes, gloves should be worn. Also, allow 15 min for the load to cool down in order to avoid burns. For EO, Formaldehyde or Hydrogen Peroxide processes, gloves, glasses and mask should be worn to avoid contact with the agent remains. For EO, a 24-hour ventilation period or a time period suggested by the manufacturer, should be taken into consideration.

8- Remove the indicator and evaluate the result.

9- Record results by adhering the self-adhesive strip on your register book.

Chemical Indicator

Choose the appropriate chemical indicator according to the sterilization process to be evaluated.

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Chemical Strips (Type 2 Chemical Indicator according to ISO 11140-1:2014) for use with Helix-PCD in the monitoring of Formaldehyde Sterilization Processes.

Instructions for use

1. Insert the chemical indicator according to the selected process conditions within the pin (metal capsule) or slot (plastic capsule) of the screw cap; settle the reactive indicating ink towards the capsule lumen, and avoid folding zones printed with reactive indicating ink.

IMPORTANT: Avoid contact between chemical indicator and capsule interior surface, because result can be altered.

2. Put the capsule cap with a moderate pressure. CAUTION! Do not put the system into the fabric bag, it could interfere in the process.

3. For LTSF processes, start the selected program and test the process.

Initial color: bordeaux

Final color: green

4. After the period of ventilation, remove the indicator and evaluate the result. If the 4 bars reach the final color, the result can be considered successful, the sterilizer is working correctly. If one bar doesn't reach the final color, it means that residual air is present in the sterilizer, therefore a malfunction of the equipment.

We suggest running the test once again, before sending the equipment to technical service.

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Chemical Strips (Type 2 Chemical Indicator according to ISO 11140-1) for

use in Helix-PCD for Hydrogen Peroxide.

Instructions for use

1-A. Remove the threaded cap from the metal or plastic capsule. Only for metal capsule Helix devices, remove the bolt attached to the cap (the bolt should NOT be used in Hydrogen Peroxide processes).

1-B. Place de chemical indicator in the capsule. Settle the reactive ink toward the capsule lumen, avoiding folds into the chemical ink.

IMPORTANT: Avoid the contact between the chemical indicator and the capsule internal surface, since the result can be altered.

2. Place the lid of the capsule with moderate pressure. ATTENTION! Do not place the system inside the cloth bag, since it can interfere with the process. The cloth bag must be used in steam processes.

NOTE: Terragene® suggests using the system Chemdye® Helix-PCD designed for small sterilizers (CDPCD2X025).

3.Start the selected program and test the process.

Initial color: purple

Final color: green

4. After the period of ventilation, remove the indicator and evaluate the result. If the 4 bars changed to the final color, the result is successful, the sterilizer is working correctly. If one bar is different to the final color, it shows the presence of residual air in the sterilizer, therefore an equipment malfunction.

We suggest retrying the test once again, before sending the equipment to technical service.

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Bowie-Dick test simulation for use with Helix-PCD system to control steam sterilization processes (Type 2 Chemical Indicator according to ISO 11140-1:2014). Indicators 100% free of toxic heavy metals.

Instructions for use

1. Insert PCD-A-3.5BD chemical indicator, according to the selected process conditions, within the pin (metal capsule) or slot (plastic capsule) of the screw cap; settle the reactive indicating ink towards the capsule lumen, avoiding folding those areas printed with the reactive indicating ink. IMPORTANT: avoid contact between PCD-A-3.5BD chemical indicator and capsule interior surface, because it can alter the result.

2. Put the capsule cap with moderate pressure.

3. Settle the system into the fabric bag.

4. The entire system should be sterilized in a vacuum chamber under conditions that depend on the chemical indicator to be used:

PCD-A-3.5BD Bowie-Dick cycle 3.5 min. 134 ºC

5. Remove the indicator and evaluate the result. If the 4 bars change from blue to dark grey/black, the result can be considered successful, which means the sterilizer is working correctly. If one bar doesn€™t reach the final color, it means that residual air is present in the sterilizer, therefore a malfunction of the equipment.

The reasons for the failure can be insufficient air removal, leakages and noncondensable gases in steam. We suggest to perform the test once again, before sending the equipment to technical service.

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