19th International exhibition of equipment, raw materials and technologies for pharmaceutical production 21 – 24 November 2017 Crocus Expo IEC, pavilion 2, Moscow, Russia

Operator’s Safety is Top Priority!

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Microbiological safety cabinets are designed for protection of an operator and environment from toxic and hypertoxic agents during manipulations with microorganisms and pathogens. LAMSYSTEMS designed the biosafety cabinet class II CYTOS specifically for work with such agents – anticancer (cytostatic and cytotoxic) drugs. The main difference of the cabinet that distinguishes it from its fellows is prefilters installed under the tabletop.
Operator’s Safety is Top Priority!

Apart from the filters, the safety of an operator working with toxic agents is also ensured by the air curtain in the work opening created by laminar air downflow and inflow. There are a lot of techniques for testing the protection efficiency of the air curtain. One of the most precise and reliable techniques is a KI Discus Test used by our specialists for testing the class II biosafety cabinets. The testing procedure is recommended by DIN EN 12469:2000.

During the test, a spinning disk sprays the finest droplets of potassium iodide imitating a dangerous aerosol in the work chamber. Simultaneously, outside of the work chamber alongside the work opening through which an operator works in the cabinet, centripetal samplers are installed. The particles of potassium iodide that escape from the work chamber through the air curtain are caught by the filters of the centripetal samplers. Upon finishing the spraying, the filter membranes are put into the palladium chloride solution which indicates the particles of potassium iodide as gray-brown dots. The number of particles that escaped the air curtain helps to determine the protection factor of the cabinet. Moreover, the results are available within few minutes upon the completion of the test.

Usually, the cabinets are tested at operating mode with specified airflow velocities (as per DIN EN 12469:2000). This test was passed successfully: out of 62 particles allowed by the standard, only 42 particles escaped the air curtain.

However, in accordance with the new edition of the German standard DIN 12980:2017-05 Laboratory Installations -Safety Cabinets and Glove Boxes for Cytotoxic Substances and Other CMR Drugs, the cabinets shall pass the aperture protection factor test at so-called challenge points (CP):

- CP1 – air inflow and downflow velocities are decreased to their threshold values (-20%, not less than 0.05 m/s);
- CP2 – air inflow velocity is decreased to its threshold (-20%, not less than 0.05 m/s) while the downflow velocity is increased to its threshold (+20%, not less than 0.05 m/s).

In light of the new requirements, the specialists of LAMSYSTEMS decided to conduct additional tests for challenge airflow velocities at alarm thresholds. Therein, the cabinet also presented itself well: after three additional tests, the maximum number of particles escaped was 56 comparing to the same 62 particles allowed by the standard.

The test results were presented in the protocol affirming that the cabinet for work with cytotoxics passed the aperture protection factor test and ensured the required level of safety for an operator and environment.

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