In industrial clean room, pharmaceutical factory is often encountered engineering design, according to GMP requirements for clean plant, there are several important parameters should be paid attention to.
How to choose the right parameters in the workshop of process products. According to the different craft products, how to choose the design parameter correctly is the fundamental problem in
the design. The following table shows the air cleanliness levels stipulated by the GMP in 1998 in China. Meanwhile, WHO(World Health Organization) and EU(European Union) have different requirements on the clean levels. The above grades have been specified for the number, size and state of the particles.
It can be seen that the cleanliness with high dust concentration is low, while the cleanliness with low dust concentration is high. Air cleanliness level is the core index to evaluate the clean air environment. If the level of air cleanliness is not determined accurately, there will be the phenomenon of horse-drawn cars, which is neither economical nor energy-saving. For example, the class 300, 000 standard is produced by a new packaging specification of the Pharmaceutical Administration, which is not suitable for the main product process, while the effect is very good for some auxiliary rooms.
Therefore, the choice of what level is directly related to the quality of the product and economic benefits. Impact mainly comes from dust source of the purity of the process the goods producing dust in the process of production, the flow of the operator and an outdoor fresh air with atmospheric dust particles, etc., is the effective means to control the source of dust into the interior in addition to producing dust process equipment adopts closed exhaust dust removal device, the new air conditioning system of return air and personnel traffic blowing shower filter three degrees in coarse, medium and high efficiency.
2. Number of air changes
The ventilation frequency of general air conditioning system is only 8~10 times per hour, while the ventilation frequency of industrial clean room is 12 times at the lowest level and hundreds of times at the highest level. Obviously, the difference of air ventilation frequency makes a huge difference in air volume and energy consumption. In the design, on the basis of accurate positioning of cleanliness, sufficient ventilation times should be ensured, otherwise, a series of problems such as unsatisfactory operation result, poor anti-interference ability of clean room, correspondingly longer self-cleaning ability and so on will be lost.
3. Static pressure difference
Different grades of clean room and non-clean room between no less than 5Pa, clean room and outdoor no less than 10Pa and a number of other requirements. The method of controlling static pressure difference is mainly to supply a certain positive pressure air volume. The positive pressure devices commonly used in the design are residual pressure valve, differential electric air volume regulator and air damping layer installed at the return air outlet. In recent years, the design often adopts the way of making the air supply more than the return air and the exhaust air in the initial debugging without the positive pressure device, and the corresponding automatic control system can achieve the same effect.
4. Air distribution
The air distribution in a clean room is a key factor to ensure the cleanliness level. At present, the air distribution usually adopted in the design is determined according to the cleanliness level. For example, the method of top to top return is often used in class 300,000 clean rooms, while the air flow is usually used in class 100,000 and class 10,000 clean rooms, and the horizontal or vertical one-way flow is usually used in class 100,000 and class 10,000 clean rooms.
5. Temperature and humidity
In addition to the special process, from the perspective of heating, ventilation and air conditioning, the main maintenance of operator comfort, namely the appropriate temperature and humidity. In addition, there are several indicators should cause our attention, such as wind speed of tuyere duct section, noise and tuyere duct section wind speed, noise, illumination and the proportion of new air volume, etc., can not be ignored in the design of these aspects of consideration.
Three, biological clean room design
Biological cleanrooms are divided into two categories. General biological cleanrooms and biological safe cleanrooms. Hvac engineers are usually exposed to the former, which mainly controls the contamination of operators by living particles. In some sense, industrial cleanrooms with increased sterilization processes. For industrial clean room, heating ventilation and air conditioning design, an important means to control the level of cleanliness is through filtering and positive pressure, for biological clean room in addition to mining industry clean room the same way, also need to be from the perspective of biological safety, sometimes need to adopt the means of negative pressure to prevent pollution to the environment.
In recent years, the development of biological products has been rapid, our hospital has gradually involved in the field of biological products in the design of many pharmaceutical factories. Biosafety cleanrooms are mainly used for scientific research and development of biological products. Biological products are one of the major categories of pharmaceuticals. They are active agents made from the toxins and biological tissues of microbial parasites as starting materials, prepared by separation and purification technology or biological technology, and controlled by biological technology and separation technology for the quality of interproducts and finished products.
The operation of high risk pathogenic factors is involved in the production process of the product, and the air purification system and other facilities should meet special requirements. Unlike industrial cleanrooms, biosafety cleanrooms must first ensure that the operating area is maintained in a negative pressure state, although the production level of such cleanrooms is not very high, but there is a high biological risk level. As for biological risk, there are corresponding standards in China's WTO and other countries in the world.
The usual measure is secondary isolation, first by a safety cabinet or isolation box, to isolate the pathogen from the operator once, mainly as a barrier to prevent the overflow of dangerous microorganisms. Secondary isolation is the isolation of the laboratory or work area into a negative pressure area. Corresponding measures should be taken for the air purification system, such as maintaining negative pressure of 30Pa~10Pa indoors and setting negative pressure buffer between it and the adjacent non-clean area.
The quality control of the clean room in the pharmaceutical factory is the guarantee of the production of drugs, and the design, construction and operation of the clean room in the pharmaceutical factory are for the purpose of controlling environmental particles and microorganisms. So in pharmaceutical cleanrooms and related controlled environment should be integrated in the design, operation and management control of all aspects of the factors, select the appropriate could satisfy the requirement of production technology, airflow, air changes, air flow, according to relevant national clean room construction and acceptance standard for clean room into the line of construction, acceptance, validation, training of relevant personnel in and out of the clean room, scientifically and reasonably use the clean room, make pharmaceutical clean room design, testing, operation can fully meet the needs of the pharmaceutical production.