Indicator “PHARMA-TEST” 121/15 steam universal chemical disposable, class 4 (multi-variable) GOST ISO 11140-1-2011, on a paper-film base with two marks: indicator and reference mark of the color, which should acquire at observance of sterilization parameters. It is intended for operative visual control of compliance with critical parameters of only one sterilization mode indicated on the indicator - sterilization temperature, sterilization holding time and the presence of saturated water vapor inside the products and packages at 121°C/15min. It is used in steam sterilizers with forevacuum or multistage vacuum method of air removal from the sterilization chamber.

It is highly recommended to use the universal indicator “PHARMA-TEST” 121°C /15min. in one cycle, both outside the sterilized items and inside the sterilized items and packages, in order to simultaneously monitor the parameters inside the package with instruments and the performance of the sterilizer.

Indicators are supplied in A4 sheets and are separated from each other along the perforation line. Indicators are packed in individual packaging with a label (marking) corresponding to the name and type, complete with this instruction and logbook of sterilization parameters F.257/U.

The sticky layer ensures that the indicator is securely fixed at the control point.

- sterilization departments of medical facilities
- sanitary and epidemiological facilities
- disinfection stations.

Universal indicator “PHARMA-TEST” 121°С/15min is designed for professional users-personnel of hospitals, disinfection and sanitary-epidemiological services, as well as other organizations and institutions that have the right to carry out sterilization and disinfection activities in the operational visual control of the parameters of regimes and conditions in each cycle of steam sterilization of medical devices, inside and outside of stacks, packages, sterilization boxes in steam sterilizers with forced method of sterilization of medical devices.

Indicators allow to detect deviations from the regulatory parameters of modes and conditions of steam sterilization caused by:

• the presence of air inside the sterilization chamber;
• presence of air inside sterilizable packages, stacks in sterilization boxes;
• insufficient duration of the air removal phase, lack of tightness (air leakage) of the sterilizer lid connections during the air removal phase (“purging”);
• inhomogeneity of supplied steam parameters or its non-compliance (fluid, dry, superheated) with the set parameters;
• improper sterilizer configuration or loading volume; sterilization mode parameter setting error or failure.

To place and fix the indicator “PHARMA-TEST” 121°C/15min inside and outside of each sterilization package, stack on the back side of the left part of the indicator, freely from the thermo-indicator mark, separate a part of the protective paper covering, covering the sticky layer, and fix the indicator inside the sterilized package, stack with an adhesive layer.

Indicators are recommended to be used in each sterilization cycle.

The number of indicators used for control depends on the volume of the sterilization chamber, the number of sterilization boxes, packages, stacks with sterilized articles.

Control of compliance with the regime parameters inside the package: it is recommended to place sterilization control indicators inside each sterilization box, package, stack.

Control of compliance with the parameters of the regime in the sterilization chamber: Indicators, designed to control the parameters of regimes in the sterilization chamber, are numbered in accordance with the numbering of control points of the sterilizer and placed in each control point of the sterilizer, fixing them outside on sealed packages, stacks or on the tags of sterilization boxes. The number and location of control points is regulated by the “Methodological guidelines for disinfection, pre-sterilization cleaning and sterilization of medical devices”