[Key Points] Huiju | Zhang HuiYi: key points of high activity pharmaceutical preparation workshop design
On April 2, the Fourth Lecture of "know the time online" of TianJuShi Group was held successfully. At the meeting, Zhang HuiYi, a pharmaceutical and chemical process expert and deputy chief engineer of engineering design company of TianJuShi Group, was invited to discuss the classification and OEB level of high activity drugs, and how to choose different measures according to OEB level, with the theme of "key points of high activity drug preparation workshop design", aiming at the key problems in the design process of high activity drugs such as anti-tumor drugs and hormone drugs Some problems are discussed.
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Point 1 how to grade high activity drugs OEB (occupational exposure range)?
The purpose of OEB classification is to select appropriate production facilities and operating procedures for each product production and establish a classification standard.
This parameter is very important for the design and facility selection of pharmaceutical plants.
According to MSDs (chemical safety data sheet), OEB level can be calculated.
OEB was divided into five levels, and the activity increased from low to high from category 1 to category 5.
Point 2 how to protect highly active drugs?
First barrier: sealing of equipment and material transmission system
Second barrier: Design of indoor HVAC system
Third barrier: personal protection of operators
Point 3 what are the key points of designing high activity pharmaceutical preparation workshop?
Clear understanding of drug OEL and OEB;
According to the level of OEL and OEB of the drug, select reasonable sealing measures, such as α β valve, etc;
Weighing, granulating, total mixing, tablet pressing and coating, capsule filling, solution preparation and filling are high risk areas. Protective measures consistent with OEB level shall be selected to avoid leakage of high active drugs;
Each unit operation in the clean area is provided with flow of people, logistics and cleaning room, which limits high-risk operation in the unit area;
It is better to separate the personnel in and out of the dressing room, and take measures of air shower or fog shower when leaving the clean area;
OEL and OEB are respectively provided with independent air conditioning zones;
Air conditioning exhaust and process equipment exhaust (granulation drying, coating, etc.) need to be treated for exhaust air (high-efficiency filtration or spray washing), and high-efficiency filter adopts bag in bag out type to protect operators;
The room in OEL area is negative pressure relative to the outdoor area to avoid leakage of highly active drugs;
The waste water in the high activity production area is collected in a centralized way, and then goes to the waste water treatment after being inactivated according to the characteristics of API;
Laundry in OEL area and non OEL area should be washed separately.