The products in the pharmaceutical industry are gradually developing towards high toxicity and high activity, and the limit of drug exposure is also decreasing. Due to the fact that drugs can be damaged by the skin

Special attention should be paid to any potential skin contact risks associated with mucosal absorption.ICH Q7 states that the production of API highly active drugs should be carried out as much as possible

Adopt enclosed or sealed equipment to prevent contamination and cross contamination during the drug production processAPI drugs are exposed and stored during the production process

In order to ensure the safety of operators in occupational hazards and drug contamination risks, we need to consider the toxicity and activity of the produced drugs

Confirm their occupational exposure limitsOEL(occupational exposure limits)。 The calculation method of OEL varies domestically and internationally,Domestic reference

《GBZ2.1-2019 Occupational Exposure Limits for Hazardous Factors in the Workplace Part 1, calculated by using the weight reduction method to determine the amount of dust adsorbed by the film

calculateOEL value. According to the Guidance on setting In-house Occupational Exposure Limit forairborne

The OEL calculation formula provided by Therapeutics (1995) requires consideration of introducing a safety factor. In addition, it can be directly queried

websitelimitvalue.ifa.dguv.deAccording toObtain the OEL value directly from the CAS number of API drugsAccording to the United StatesNIOSH proposes occupational exposure

limit The corresponding table for the exposure hazard level (OEB occupational exposure classification) of drugs with OEL, with a production OEL limit of 1-10ug/m3 and less than

API drugs with a density of 1ug/m need to consider using OEB4 or Grade 5 isolators. Esco produces a containment isolator device that meets API high activity drug requirements

The key points are as follows:

1.Sealed isolatorOEB4Level and above protection performance, leakage rate<0.25%；

2.Multi stage chamber pressure gradient design, any form of pressure cascade reversal will trigger an alarm;

3.Exhaust adoptsPUSH-PUSH safely replaces the dual stage filter compartment to achieve full turbulent air discharge;

4.Provide negative air pressure protection for critical work areas exposed to the product;

5.Under the linkage between the leakage protection isolator control and the room pressure difference, the emergency mode of the isolator is automatically activated;

6.Glove online replacement design, designed to protect against leakage, with a cross-sectional wind speed at the glove opening>0.7m/s；

7.equipA-B valve or bag in bag out to achieve fully enclosed production transfer of materials;

8. Multi parameter monitoring system for cabin temperature, relative humidity, pressure, etc., integrated cleanable weighing device, drainagecomprehensiveIntegrated water and gas dual-purpose water gun, personalized storage bracket, automatic switching between standby mode, automatic leak detection mode, working mode, destruction mode, emergency mode, and maintenance mode;