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New standards for clean room released Pharmaceutical quality

New standards for clean room released Pharmaceutical quality


[China Pharmaceutical Network Policy and Regulations] In the pharmaceutical production process, the clean room is a must for pharmaceutical companies. The creation of a clean room not only provides a suitable internal environment for drug production and operation personnel, protects employees and the surrounding environment, but also can reduce The danger of drug contamination and cross-contamination, so the clean room plays an important role in the pharmaceutical production process. The author was informed that in recent days, the National Standards Committee has issued GB/T 36066-2018 "Clean rooms and related controlled environments: analysis and application of testing technology", and the newly released standards will be implemented on July 1, 2018.

The standard gives the requirements for the detection (including verification) of the clean room and related controlled environment, the basic instrument configuration and technical requirements, and is applicable to the analysis and application of the detection technology in clean rooms and related controlled environments. The introduction of this standard is of great significance to the improvement of the pharmaceutical clean room environment and the protection of pharmaceutical quality. Taking the calibration of the testing instrument as an example, this standard puts forward new requirements for the calibration of different testing instruments. For example, the particle counter requires the concentration error to be +-20%, the sampling probe piping must not exceed 8 meters, and the calibration period should not exceed 12 months. In the pharmaceutical clean room and related controlled environment, the position of the testing instrument is very important. “The higher the accuracy of the testing equipment, the smaller the error, and the more the pharmaceutical quality is guaranteed.” Some insiders said.

Cleanrooms serve as installation interfaces for clean public works, clean process pipelines, production equipment, clean furniture, fire protection systems, electrical systems, clean floors, and clean elevators. They play a role in the project and strengthen the cleanroom and related controlled environment. The analysis of the detection technology is of great significance.

The author was informed that the standard also gives an analysis of the causes of deviations of different test items. For example, anomalous conditions in which differential pressure gradients cannot be established may be mainly due to the fact that the unbalanced design of the air volume is difficult to detect and the pressure difference is adjusted to “zero differential pressure”; "Differential pressure" is unreasonable in position selection, and the zero temperature cannot be stabilized and fluctuates too much; there is no buffer room between the inlet and outlet of the negative pressure clean room.

The clean room for pharmaceuticals is also called a clean room. It refers to the space where the cleanliness of the air reaches a specified level for human activities. Its function is to control the pollution of living particles and particles. Since the implementation of GMP in the pharmaceutical industry, the design, management, and analysis of clean rooms have become a basic hardware requirement for the pharmaceutical industry. For example, GMP requires that any surface material in the cleanroom must be resistant to microbial growth. The inner surface of the clean area, wall, floor, and ceiling must be smooth, free from cracks, pores, dust, and cleanliness; the lamps are all clean and embedded. Type and achieve the luminous flux and IP55 requirements; flooring should be selected hard material, good integrity, smooth and flat, no cracking, wear resistance, impact resistance, not easy to accumulate static, easy cleaning, disinfection, corrosion resistant materials.

The pharmaceutical industry is related to people's health and concerns about people's livelihood. The human pursuit of health is endless. With the continuous improvement of living standards, people’s health awareness has become stronger and stronger, with the biopharmaceutical industry developing strongly. The rapid rise of the pharmaceutical industry puts a higher demand on the quality of pharmaceuticals. The pharmaceutical clean room is the “umbrella” that guarantees the quality of pharmaceutical production. If the “protective umbrella” does not meet the requirements, or if it is inherently inferior, then How can pharmaceutical quality be guaranteed?

Nowadays, with the continuous improvement of the quality requirements of pharmaceuticals in the country, pharmaceutical clean rooms have strict requirements in terms of design management and detection technology analysis, and are becoming more and more reasonable. If this standard gives the requirements for self-cleaning detection, the number of air changes in the Class B area during the design of the clean area shall be 60 times/h (guidance value). When using a high-efficiency filter for leak detection, the atmospheric dust source must be used to ensure that the desired concentration is achieved. 

If the various standards of the clean room do not meet the requirements or the environment is contaminated, then the quality of the drug can hardly be guaranteed. In this case, the produced drugs pose a serious threat to the health of the patients. Therefore, the clean room needs to be weighed during the design and construction process. All aspects, strict control of every detail, only to achieve everything, medicine quality can be better maintained, so as to better maintain people's health.