1,Biopharmaceuticals-State of the Industry

Biopharmaceuticalsis considered one of the centers of the world's knowledge economy in the 21st century, and has become the new wind vane of the pharmaceutical industry. As a high-demand, high-technology, high-investment, long-cycle, high-risk industry, the cleanliness of the air in the production area is very demanding, and the cleanliness of the air directly affects the quality and quality of the drugs. The cleanliness of the air will directly affect the quality and quality of the medicine.

In order to ensure better production and storage, biopharmaceutical companies are actively seeking new processes and new systems to efficiently meet the production and storage of pharmaceutical products. In order to ensure better production and storage, biopharmaceutical companies are actively seeking new processes and systems to efficiently meet the environmental needs of drug production and storage processes, and according to the different requirements of the process is divided into a number of different air cleanliness requirements of the region, in the most central area is often required to achieve sterile production.

2. lt;/span>Biopharmaceutical -Related Standards

 Pharmaceutical engineering cleanroom (area) to suspended particles and microorganisms as the main control object, but also should control the pharmaceutical cleanroom (area) environment temperature, humidity, differential pressure, illumination, noise and other parameters, to achieve aseptic process cleanroom of strict standards, to achieve GMPThe air cleanliness required by the specification meets the process requirements of all aspects of pharmaceutical production.

GMP It is a basic guideline for drug production and quality management, applicable to the whole process of drug preparation production and the production of APIs affecting the quality of the finished product in the key processes. Vigorously implement the drug GMP, is to maximize the avoidance of pollution and cross-contamination in the drug production process, to reduce the occurrence of various errors, is to improve the quality of drugs is an important measure.

 In the "GMP Good Manufacturing Practice (GMP)", the company has adopted the "GMP"principle. GMP Pharmaceutical Manufacturing Practice (2010 Revision)"the air cleanliness level is divided into four areas:

Class A:High-risk operation areas, such as:filling area, stopper placement area, container open areas and areas for aseptic assembly or joining operations, where laminar flow benches (hoods) are often used to maintain the environmental status of the area;

Level B:referring to the background area in which high-risk operations such as aseptic preparation and fillingLevel A areas are located;

Grades C and D:means a clean operation area of lesser importance in the production of aseptic drugs. (Class A and B zones are the locations for on-line monitoring of particles and bacterioplankton;Class C and D zones can be used with portable particles and bacterioplankton as a routine detection tool)

3. lt;/span>Biopharmaceuticals-Digitalized Cleanroom Total Solution<<>

Sources of microbial contamination in pharmaceutical GMP cleanrooms

In the drug In the production of pharmaceuticals, due to the influence of various elements (air in the pharmaceutical plant environment, pharmaceutical water, operators, materials, equipment, etc.), can lead to microbial contamination of pharmaceuticals, and the enterprise is limited by the detection of the environment in the production area, monitoring time is long, data lag and other pain points, can not detect the problem in a timely manner, which seriously affects the effectiveness of the drug!

In order to ensure that the quality of the environment can be effectively controlled and objectively evaluated in a timely manner, and to ensure that the production environment meets the requirements, EVERGREEN PURIFICATION pushesDigitalized Cleanroom Solutions for Biopharmaceuticals. The solution has and other features that enable"detection-control-monitoring"whole chain of the trinity of optimization management, covering the cleanroom particles, plankton real-time dynamic monitoring system, cleanroom environment testing instruments, air filters, air purification devices and other one-stop products and third-party testing services, to ensure that the production environment We provide one-stop products and third-party testing services to ensure that the production environment meets the requirements of the relevant standards.

This solution is designed for implementing quality risk control in the aseptic pharmaceutical sector and dynamic environmental monitoring of the entire aseptic production process, and can The solution is designed to effectively remove airborne particles and bacteria, and monitor environmental parameters such as dust particles, planktonic bacteria, differential pressure, temperature and humidity, wind speed, etc., to grasp the trend of air cleanliness in real time, and to take measures to remove possible undesirable operations, sources of contamination, and contamination events before they have a negative impact on the process and products, so as to ensure that the cleanliness standards of the cleanroom are guaranteed during the production process, and that the process of pharmaceuticals is escorted.

These are the most important factors in the production process.