admin@hepacleanroomfilter.com
The Good Manufacturing Practice for Pharmaceuticals is the basic principle for pharmaceutical production and quality management, and the application of dust removal technology in GMP transformation projects is an important part of technical transformation.
When embarking on GMP transformation, dust removal factors must be fully considered. When building and renovating the plant in accordance with GMP requirements, dust removal technology should be applied in dust-producing rooms and areas to control dust within a reasonable range, regardless of whether it is a general production plant or a clean production plant. The following should be done:
1. Control indoor pressure, and keep relative negative pressure in dust-producing rooms and areas;
2. Reasonable airflow organization; local exhaust should be implemented in dust-producing areas when necessary;
3. Dust removal equipment should be installed at dust-producing points and areas. First, remove dust on the spot near the dust source;
4. Design a reasonable capture device.
In the production process of solid preparations of traditional Chinese medicine, dust collectors are mainly used to separate dust from airflow in the process of generating dust. Using bag dust collectors as dust removal devices for the production of solid preparations of traditional Chinese medicine is a good choice. Bag dust collectors (or filter barrel dust collectors) are devices that allow dust-containing gas to pass through filter materials and separate and capture dust. With reasonable design parameters, appropriate capture devices, and appropriate filter materials, the dust removal efficiency of bag dust collectors can be as high as 99.9% or more. In the past, only bag dust collectors imported from abroad could achieve this dust removal efficiency. In the past two years, domestically produced bag dust collectors or filter barrel dust collectors have been greatly improved. Due to the configuration of appropriate filter materials, their dust removal effect can also reach 99.9%. Therefore, domestic dust collectors can completely replace imported dust collectors of the same type.
The application of dust removal technology in GMP production plants requires solving a series of technical problems:
1. In terms of airflow organization, the clean air conditioning airflow and the dust removal airflow must be matched with each other (the discharged air should be treated before being discharged, and the recycled air should be treated before being recycled);
2. The dust removal airflow organization is subject to the clean air conditioning airflow organization of the clean plant, the air volume is balanced, and the pressure difference meets the requirements;
3. Select and configure a suitable dust collector, etc.
The above problems can all achieve ideal results through modern air conditioning clean technology and dust removal technology.
When designing and laying out the plant, on the one hand, it is necessary to make full use of the room partition to separate the personnel operation room from the machine room to avoid the operator being directly in a noisy and dusty working environment; at the same time, when selecting the crushing equipment, the dust collector should be matched according to the airflow and dust-generating points of the equipment operation.
The key to the ideal dust removal effect depends on the capture device at the end of the pipeline. The function of the capture device is to form an effective airflow to collect the dust raised by the dust-generating points during production, but not to absorb the powder in the production materials. In the traditional Chinese medicine pretreatment process and solid preparation clean workshop of our company, different forms of dust collection device pipeline terminal devices are designed and adopted in combination with the different characteristics of equipment, process, and site:
1. The dry granulator is equipped with a negative pressure exhaust pipe in the discharge frame of the machine, so that the discharge chamber of the machine forms a negative pressure area, effectively controlling the dust source from flying out of the machine chamber, thereby achieving dust-free pollution in the dry granulation room.
2. In the sugar crushing room, the crushing equipment is equipped with a dust removal system and a fully enclosed structure. The crushed sugar powder is discharged after separation by the separator. During the discharge, there is still a lot of sugar powder flying in the discharge chamber, polluting the site environment. Therefore, at the sugar powder outlet of the separator, a capture device is designed and installed to effectively control the flying of sugar powder during discharge.
3. Similar devices are also used in the mixing process of sugar particles to solve the problem of dust overflow and flying during the preparation of soft materials for particle production. The dust removal effect is very ideal through the dust removal system of the dust collector and the capture device.
4. In the production of sugar-free granules, when spray drying is completed, the bucket truck carrying the dried sugar-free granules is moved out of the spray dryer and loaded with stainless steel barrels, a large amount of dust is generated. In view of this situation, a circular inverted cone laminar dust collection device can be used to effectively absorb the dust generated during the operation, etc. The use of these measures and technologies has better achieved effective control of dust sources, ensured the required cleanliness of the clean area, and overcome the difficulties of using dust removal technology in a closed plant. It provides technical guarantee for GMP transformation.
