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If highly active chemicals belong to the highest activity levels in Table 17-1 and Table 17-2, they must be operated in an independent and fully enclosed space
In recent years, the research and development of cytotoxic anticancer drugs has been very active, and great achievements have been made
If an antibody drug conjugate ADC is measured and assessed their OEL is 50 ug ~ 20 is / m ³ , belongs to class 5 Protection System 3, or 4 in stage 2 protection system
According to the different physical forms of various highly active chemicals, the three-level protection measures are as follows.
1.
It is generally believed that the occupational exposure range for operators in the working environment should be less than 40ng/m 3 of highly active chemicals (such as the chemical medicine part in ADC)
(1) Level I exposure risk: preparation, weighing, dissolution, transfer, and handling of pharmaceutical solid powders greater than 10 mg or ADC freeze-dried powders greater than 100 mg
(2) Level II exposure risk: Dilution, transfer, and processing of ADC sample solutions with a daily processing volume of less than 10 mg or a daily processing volume of less than 100 mg
(3) Level Ⅲ exposure risk: the reception, distribution, storage and transfer of ADC sample powder or solution with good airtight packaging
2.
(1) For the experimental operation of level I exposure risk, the personal protective measures shall not be lower than the following standards:
It is carried out in a relatively negative pressure laboratory (the exhaust air volume is greater than the air supply volume), and the sample processing is performed in a special high-efficiency filter glove box (the air outlet extends out of the room)
(2) For the experimental operation of level II exposure risk, the personal protective measures shall not be lower than the following standards: the sample processing shall be carried out in a special negative pressure fume hood or level II biological safety cabinet (with the air outlet extending out of the room)
Operators wear personal protective equipment such as protective glasses, double-layer activated carbon masks, double-layer nitrile gloves, and laboratory clothes
(3) For the experimental operation of level III exposure risk, the personal protective measures shall not be lower than the following standards: the sample must be kept in a sealed state during transfer and placed in a secondary container with an uncontaminated surface
Operators wear protective glasses, activated carbon masks, nitrile gloves, disposable PE gloves, laboratory clothes and other personal protective equipment, and put disposable PE gloves in nitrile gloves
All kinds of personal protective equipment should be replaced as needed and discarded in the specified barrels
3.
Emergency handling
If leakage or spillage occurs during the handling of highly active chemical samples, the personal protective equipment that may be contaminated should be replaced immediately, and the residual spillage should be absorbed with clean paper towels or cotton cloths, and the contaminated surface should not be enlarged
.
If the operator’s skin comes in contact with a sample of highly active chemicals, first wipe it with a clean paper towel or cotton cloth, and then rinse it with running water for at least 15 minutes, and seek medical attention immediately if necessary
.
4.
Waste treatment
The wastes and utensils that contain highly active chemicals should be quenched with 1.
0% to 2.
0% NaClO (or H 2 O 2 and other suitable oxidants)
.
Potentially contaminated waste generated during the processing of highly active chemical animal test samples must be placed in special yellow garbage bags, and incineration by qualified units in accordance with the HW02 category specified in the "National Hazardous Waste List"
.
The wastes that have not been tested on animals can be put in barrels of ordinary chemical waste and be incinerated by qualified units
.