Consumables

  • MATACHANA provides its customers with a service to evaluate the microbiological efficacy of sterilization processes and has specialized products (spore solutions, specific inoculation techniques, etc.) to perform a wide range of tests, depending on the nature of the load used by our customers.

    Bowie & Dick

    The Bowie & Dick MATACHANA Test Package Chemical Indicator is a device that evaluates the presence of non-condensable gases in the chamber and the correct extraction of air that impede the propagation 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 the steam penetration is fast and uniform, as established by the EN ISO 17665-1 Standard. It is recommended that the Bowie & Dick Test should be incorporated into standard operating procedures whenever saturated steam sterilizers are used.

    The Bowie & Dick MATACHANA test package for industrial applications conforms to the European Standard EN ISO 11140-1, and its Chemical Indicator to EN ISO 11140-3. In addition, it is certified by an external ISO 17025 accredited laboratory, which ensures that the product complies with the specific regulations:

    The Bowie & Dick MATACHANA test package is manufactured and developed in accordance with:

    • European Standard EN ISO 11140-1,4 and its Chemical Indicator to EN ISO 11140-3, Class 2 indicator systems for use in the Bowie & Dick steam penetration test.
    • EC 1907/2006 regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

    PCD-Helix + Chemical Strip

    The challenge device (PCD) for saturated steam sterilization processes is a device according to EN 867-5 Standard, complementary assay 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 EN ISO 17665-1 Standards.

    The penetrability test for sterilizers consists of an Helix type Challenge (PCD) device and chemical strips (Emulating Chemical Indicators Type 6). The set of both components allows to execute a penetrability test, where the correct extraction of air and the presence of non-condensable gases is evaluated.

    This device is included in the range of Chemical Indicators as Type 2. Chemical Indicators Penetrability Test for steam sterilizers are evaluated by means of a resistometer (BIER/CIER) according to ISO 11140-1 Standard.

    The strip and the PCD device are certified by an external ISO 17025 accredited laboratory, which ensures that the product complies with specific standards. Furthermore, it is manufactured and developed to comply with:

    • EN ISO 11140-1 Standard. Sterilization of health care products. Chemical Indicators. Part 1: general conditions.
    • EC 1907/2006 regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
    • Comply with European Standard EN 867-5. Non-biological systems for application in sterilizers.

    BI + Incubator

    The MATACHANA Self-contained Biological Indicators for steam are used for validation and routine monitoring of sterilisation processes using saturated steam. Following the sterilization processes, the Self-contained Biological Indicators can be inoculated by the user without using a microbiology laboratory according to EN ISO 11138-1 Standard.

    The MATACHANA Self-contained Biological Indicators for steam are composed of a plastic vial, the inside volume of which contains a spore disc of filter paper with 106 spores of Geobacillus stearothermophilus of the ATCC 7953 culture and a glass ampoule with a culture medium for bacterial growth, and a Ph Indicator.

    Manufactured and developed to comply with ISO 11138-1 Standard. Sterilization of medical devices. Biological indicators. Part 1: general conditions, and with ISO 11138-3 Standard. Sterilization of medical devices. Part 3: Biological indicators for moist heat sterilization.

  • All MATACHANA packaging systems are accepted within the requirements of the SBA (Sterile Barrier Association) and ensure the preservation of sterile conditions up to 365 days.

    Mixed reels

    Product manufactured with a face of medical paper of 60 g/m2 and other side of a complex of PET/PP in blue color, with 12/40 µm of thickness.

    It is presented in mixed reels, it complies with the following standards:

    • EN ISO 11607-1: - ISO 11607-1: Packaging for terminally sterilized medical devices. Part 1: Requirements for materials, sterile barrier systems and packaging systems.
    • EN 868-5: Packaging for terminally sterilized medical devices. Part 5: Sealable pouches and reels of porous and plastic film construction. Requirements and test methods.
    • Manufactured under the quality standard ISO 13485: Medical devices. Quality management systems. Requirements for regulatory purposes.

    Wrapping material are accessories to these products and are therefore subject to the legislation (directive and/or regulation) on medical devices which are classified as class I products. For this reason, the product has CE mark on the boxes and reels.

    Our customers can ask for the certificates of analysis for each lot number.

    Tyvek® Reels

    Tyvek® is a packaging material that offers extreme resistance to tearing and bursting during sterilization processes, with exceptional barrier properties. It is suitable for use in ethylene oxide, gamma radiation, Low Temperature Steam with Formaldehyde (LTSF) and Hydrogen Peroxide, both Plasma and Vaporized. Steam sterilization is also possible if the temperature does not exceed 128 ºC.

    MATACHANA brand Tyvek® reels are manufactured from Tyvek® 1073B, which provides the highest level of protection, making it ideal as a choice for packaging medical devices that require high strength and a high level of microbiological barrier.

    Manufactured from clear, 12/50 thick, high-density polyethylene (HDPE), Tyvek® offers exceptional protection against possible deterioration from sharp surfaces or very heavy materials. Its strength makes Tyvek® 1073B protect and maintain the sterility of high-risk products.

    MATACHANA reels are available in 70 meter long rolls of different widths. The inner mandrel (cylinder) on which the reel is wrapped has an internal diameter of 76 mm.

    TYVEK ® is a registered trademark of DuPont de Nemours, Inc.

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