MONITORING
BOWIE & DICK
The Bowie & Dick MATACHANA Chemical Indicator test pack is a device that evaluates the presence of non-condensable gases in the chamber and the correct extraction of air that hinder the spreading of steam inside the load to be processed. In this way, anomalies in the air extraction due to an abnormal vacuum or possible leaks are detected and the quality of the steam can be distinguished.
The Bowie & Dick test is crucial to identify whether steam penetration is rapid and uniform, as required by ISO 17665-1. It is recommended that the Bowie & Dick test should be incorporated into standard operating procedures wherever saturated steam sterilizers are used.
The Bowie & Dick MATACHANA test pack for Industry applications conforms to ISO 11140-1 and its Chemical Indicator to ISO 11140-3. In addition, it is certified by an external ISO 17025 accredited laboratory, which ensures that the product complies with the specific standard.
The Bowie & Dick MATACHANA test pack is manufactured and developed in compliance with:
- ISO 11140-1,4 and its Chemical Indicator with ISO 11140-3, Class 2 indicator systems for use in the Bowie & Dick steam penetration test.
- EC Regulation 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
PCD-HELIX + CHEMICAL INDICATOR
The Challenge Device (PCD) for saturated steam sterilization processes is a device according to EN 867-5, complementary test to the Bowie & Dick test. The PCD-Helix device is in accordance with the requirements for the testing of material with hollow loads or internal volumes described in EN 285 and ISO 17665-1.
The penetrability test for sterilizers consists of an Helix-type Challenge Device (PCD) and chemical strips (Type 6 Emulating Chemical Indicators). The combination of both components allows a penetrability test to be carried out, where the correct extraction of air and the presence of non-condensable gases are evaluated.
This device is included in the family of Chemical Indicators as Type 2. The Chemical Indicators Penetrability Test for steam sterilizers are evaluated by means of a resistometer (BIER/CIER) according to ISO 11140-1.
The strip and the PCD device are certified by an ISO 17025 accredited external laboratory, which ensures that the product complies with this standard. Furthermore, it is manufactured and developed in compliance with:
- EN ISO 11140-1 Standard. Sterilization of healthcare products. Chemical indicators. Part 1: General requirements.
- Regulation EC 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
- In compliance with EN 867-5 Standard. Non-biological systems for use in sterilizers.
BI + INCUBATOR
MATACHANA Self-Contained Biological Indicators for steam are used for routine monitoring of saturated steam sterilization processes. After those processes, the Self Contained Biological Indicators can be activated by the user himself without the intervention of a microbiology laboratory in accordance with ISO 11138-1.
The MATACHANA Self-Contained Biological Steam Indicators consist of a plastic vial containing a filter paper spore disc with 106 spores of Geobacillus stearothermophillus culture ATCC 7953 and a glass ampoule with culture medium for bacterial growth with a pH change indicator.
Manufactured and developed in accordance with ISO 11138-1. Sterilization of medical devices. Biological indicators. Part 1: General requirements, and ISO 11138-3. Sterilization of medical devices. Biological indicators. Part 3: Biological indicators for steam sterilization processes.