[Key Points] Huiju | Qiu ZiFu: Discussion on the design of car-t cell treatment and purification system

[Abstract]:

On April 9, the fifth online seminar of "know the time online" of TIANS Group was successfully held. Qiu JiFu, a medical and chemical design expert and chief engineer of Shanghai Design and Research Institute of TIANS Group, was invited to discuss the design of car-t cell treatment and purification system, aiming at the hot issues such as the layout design of car-t cell operation area, how to reduce or avoid the impact of the start and stop of biosafety cabinet on the room pressure difference, and how to effectively reduce the energy consumption of air conditioning system in car-t cell operation area Explore.

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Point 1: what are the characteristics of the process layout design of car-t cell operation area?

The flow of people and logistics is one-way flow with clear flow direction.

It is beneficial to control cross contamination.

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Point 2 what are the strategies and advantages and disadvantages of the system division of car-t cell therapy production?

Each car-t operation room is equipped with an independent purification air conditioning system, which is conducive to the control of cross pollution, but the initial investment is large.

Multiple car-t operating rooms share a set of purification air conditioning system, with less initial investment, but increased operating energy consumption.

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Point 3: what energy saving measures can be taken for car-t cell treatment production purification system?

An intermediate heat medium type heat recovery system is set between the new air and exhaust air to recover the cooling capacity in summer and heat in winter.

A heat pipe is arranged at the front and back of the surface cooling coil tube to reduce the cooling capacity and reheat in summer.

Duty mode can be used to reduce the energy consumption during discontinuous use.

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[Abstract]:

On April 2, the Fourth Lecture of "know the time online" of TIANS Group was held successfully. At the meeting, Zhang HuiYi, a pharmaceutical and chemical process expert and deputy chief engineer of engineering design company of TIANS 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.

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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

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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.

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[Abstract]:

    On March 27, China Association for Engineering Construction standardization organized a network review meeting on the standards of design standards for clean workshop of veterinary medicine industry. Ding ZhiJie, vice president and chief designer of TIANS Group, was invited to serve as the vice chairman of the review group to participate in the review of the standards. Ding ZhiJie, with her rich experience in biosafety, environmental purification, process layout and process pipeline, put forward valuable opinions and suggestions on the wording, expression, coverage and specific terms of the standard, which won high praise from the participating units.

    This standard, edited by China Academy of Building Sciences Co., Ltd., is a technical supporting document for the coming new version of GMP regulations on veterinary drugs. It will provide standardized constraints and technical guidance for the design, construction, inspection, acceptance, operation and maintenance of clean workshops in veterinary medicine industry, improve the basic conditions for the construction of clean workshops in veterinary medicine industry in China, and improve the domestic and foreign specialized large-scale industrialization The lack of building technical standards for veterinary high-level biosafety vaccine production workshop, the preliminary establishment of the veterinary vaccine industry biosafety building standard system, to promote the high-level, efficient, scientific and reasonable construction and development of veterinary medicine industry clean workshops in China.

    As a leading technology group in the field of general contract of pharmaceutical engineering, TIANS Group, with its professional engineering execution ability, proficient process understanding, rich project and engineering experience, provides China's pharmaceutical enterprises with a full range of general contract services. In the future, TIANS Group will promote China's veterinary medicine industry and even the entire pharmaceutical industry with a global vision and full range of customer needs Industry development.