Process Challenge Device (KPCD110) for Ethylene Oxide sterilization processes FDA cleared.

Usage

For routine release of Ethylene Oxide sterilized loads. For routine sterilizer monitoring. For periodic validation of the sterilizer (after installation, repair, relocation).

Applicable regulation

Designed under ISO 13485:2016/NS-EN ISO 13485:2016 Quality Management System standards.

ISO 11140-1:2014, ISO 11138-1:2017, ISO 11138-2:2017.

Authorization

ANMAT (Argentinean National Administration of Drugs, Food and Medical Devices) PM 1614-4.

Classification

Class 1, according to the risk (ANMAT).

Characteristics The kit consists of:

PCD110: PET process challenge system designed to challenge the path and arrival of the sterilizing agent to the Bacillus atrophaeusspore population of a Bionova’ BT110 Self-Contained Biological Indicator. On its outer side, the Bionova®’ PCD110 process challenge device also contains a Process Indicator that turns orange after exposure.

Process Indicator Initial color: pink Final color: orange

Self-contained Biological Indicator Bionova® BT110 (inside the challenge device): 10⁶ spores of Bacillus atrophaeusATCC 9372 per vial on a paper carrier. Glass ampoule with growth indicator medium. Label with chemical indicator line printed with Ethylene Oxide reactive ink (color change: brown to green).

Final results: fluorescence reading after incubation for 4 hours at 37 °C (sensitivity 97 %). Optionally, visual confirmation of the result (color change of the medium due to pH change) can be performed after 48 hours and seven days of incubation at 37 °C. NOTE: If the sterilization process is unsuccessful, the culture medium will change to yellow during incubation at 37 °C after 48 hours, indicating the presence of live spores. If the sterilization process is successful, the indicator medium will remain blue after incubation.

Environmental conditions during manufacture

T = 15-30 °C, RH = 30-80 %.

Storage conditions

T = 10-30 °C, RH = 30-80 %, keep the product in the original box away from light.

Transport conditions

Storage conditions should be strictly followed. Carry in closed and reinforced boxes in order to avoid damages. The transport of this product does not represent a risk for health.

Shelf life 2 years.

Packing

25 PCD110 + 25 BT110 Biological Indicators per box.

Data on the package:

Product code and description, the process for intended use, presentation, regulation, storage conditions, manufacturer’s data, and information on the package label.

Labeling

On the package:

Product code and batch number, the Self-Contained Biological Indicator batch number, manufacturing and expiration dates, regulations, bar code, and datamatrix code.

On the BT110 Self-Contained Biological Indicator:

Label printed with EO reactive ink (turns to green), product code, batch number, expiration date, process for intended use and name of the organism.

Possible target markets

Healthcare, Food, Pharmaceutical and Medical Industries.

Other important information

Read product’s instructions for use thoroughly before use.

Precautions

Do not store the product near sterilizing agents.

Do not expose this product to Steam, Dry Heat, Radiation or any other sterilization process than EO.

NOTE: if the lecture was done in 7 days it requires a humidified ambient to prevent the crop getting dry.