Commonly used purification air conditioning system in GMP sterile workshop

Commonly used purification air conditioning system in GMP sterile pharmaceutical cleanroom

This article briefly introduces the air-conditioning systems and their characteristics commonly used in GMP aseptic workshops.

1. Conventional circulating air system

Conventional circulating air system is a common purification air conditioning system.

Its features are:

(1) The fresh air is mixed with the return air and sent to the clean room...

Text label: GMP sterile pharmaceutical cleanroom, purification air conditioning system

Purification air conditioning system commonly used in GMP sterile workshop

This article briefly introduces the air-conditioning systems and their characteristics commonly used in GMP aseptic workshops.

1.

Conventional circulating air system

Conventional circulating air system is a common purification air conditioning system.

Its features are:

(1) The fresh air is mixed with the return air and sent to the clean room

The fresh air used to be filtered by coarse air filter. This practice has now been developed: the fresh air itself is filtered by a fresh air treatment device (or fresh air purification unit) which is a combination of coarse, medium and high efficiency or sub-high efficiency filters. As a result, the blockage of related components in the system, such as heaters, surface coolers, etc., has been greatly reduced, and the blockage phenomenon has caused a sharp drop in indoor fresh air volume and incidents of fainting.

The fresh air volume of the purification air-conditioning system is much larger than that of the general air-conditioning system. More than 90% of the dust particles in the system come from the fresh air, and the dust particles are the carriers of bacteria and are rich in nutrients needed by bacteria, so they will bring pollution to the system. Therefore, fresh air treatment is an important link in the system. It is ideal to use coarse, medium, medium or high-efficiency three-stage filtration for fresh air filtration, which has been clearly stipulated in other national standards.

(2) After the blower and before the air outlet, there is a medium-efficiency filter

That is, the medium-efficiency filter should be placed in the positive pressure section of the fan, and even the muffler in the system should be placed in front of it. This is because this medium-efficiency filter, also known as a pre-filter, is the protector of the high-efficiency filter on the air outlet.

Indoor air return vents must also be equipped with medium-efficiency filters and low-efficiency filters, which are required to prevent two-way contamination of the system and indoors, airflow, backflow, fine-tuning of tuyere resistance and improved visibility.

(3) A sub-high-efficiency or high-efficiency filter is provided on the air outlet

That is to say, the sub-high-efficiency or high-efficiency filter should generally be located at the end, which is the main feature of the purification system different from the general air-conditioning system.

(4) The purification system is generally equipped with a single fan instead of a double fan

Because the double fan is easy to form negative pressure in the room when the resistance of the return air system is small, the system resistance balance is well set or the room height is too high, and the indoor positive pressure must be maintained in most clean rooms. Zhongjing Global Purification can provide consulting, planning, design, construction, installation and transformation of sterile workshops and GMP workshops and other supporting services.

2. Fresh air system

This is an all-outdoor air system designed for odorous production processes, which consumes a lot of energy.

Its features are:

(1) All the air volume comes from the outdoors and is sent indoors after being treated.

(2) The indoor air return port does not suck the air back into the system, but sends it into the exhaust duct, and is discharged to the outside by the exhaust fan or after treatment. Each room can be discharged separately, or several rooms can be combined emission.

(3) When the exhaust air volume is less than the supply air volume, the room maintains a positive pressure, otherwise it is negative.

3. System with continuous local exhaust

This is designed for the continuous generation of local pollution in the workshop (such as process dust in the tablet workshop), and it is designed for local extraction during production.

Its features are:

(1) Concentrate the pollution emitted by the production site through the suction hood and then discharge it to the outside, or send it to the return air system after treatment. The larger the inhalation speed is, the less pollution will be dissipated into the room, but the energy consumption is also large.

(2) How much fresh air should be used to supplement the amount of air discharged.

(3) When the exhaust air volume is greater than the indoor air supply volume, the indoor pressure is negative, otherwise it is positive pressure.

4. Systems with intermittent local exhaust

This is designed for intermittent pollution in the workshop. For example, contamination occurs when a piece of equipment is turned on, and this equipment is used occasionally. Another example is that the workshop has requirements for regular fumigation and disinfection, and exhaust air is required after disinfection. However, it should be emphasized that: for clean rooms and purification air conditioning systems, there is generally no need for fumigation.

Its features are:

(1) Generally, the pollution emitted by the production site is concentrated and discharged to the outside of the macro through the suction device, or discharged to the outdoor after recycling, and is no longer sent to the return air system.

(2) It is difficult to control the room pressure. Generally, the exhaust air can be matched and interlocked with the fresh air (which can also be specially designed); or it can be matched and interlocked with the return air; Air volume control device.

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