What are the environmental control factors and techniques for clean room testing in bioburden testing?

With the continuous advancement of science and technology, the production environment of the clean room, including indoor and outdoor environments, is particularly important. The following editor will explain the specific content of bioburden testing clean room testing.

Indoor environment refers to a clean indoor environment. The indoor environment may affect product quality, and the outdoor environment may affect the quality of the indoor environment.

Control Requirements for Bioburden Test Cleanroom Test Environment

1. Provide the air cleanliness level required for workshop process production, and clean the dust particles and microorganisms in the workshop air.

2. The temperature, relative humidity, pressure difference and airflow of the clean workshop are compatible with its production and process requirements. Control requirements of clean room environment

3. The setting of changing rooms, bathrooms and toilets must not have adverse effects on the clean room.

4. An effective dust collector should be installed in the room where dust is generated to prevent cross-contamination of dust.

5. The biological clean room should be disinfected regularly, and the disinfectant used must not contaminate equipment, materials and finished products. The types of disinfectants should be replaced regularly to prevent the emergence of drug-resistant strains.

Importance of particle (dust) control for bioburden testing:

1. Biological clean room or clean area refers to the area where environmental control of dust particles and microbial contamination is required. Its building structure, equipment and use have the function of reducing the intervention, generation and retention of pollution in the area.

2. In terms of controlling particles in the environment, biological clean rooms are equally important. Particles, especially dust particles, directly affect the quality of medicines and endanger people's lives. A large number of clinical data show that drugs contaminated by 7-2m dust particles, especially intravenous drugs, can lead to pyrogen reaction, lung inflammation, microthrombus or foreign body sarcoma, etc. It can be fatal in severe cases. The harm of particulate matter entering the vascular system to the human body is related to the number, diameter and physical and chemical properties of the particulate matter.

3. However, the control of environmental cleanliness in biological clean rooms is not limited to particles.

A clean room for bioburden testing is a room in which the concentration of suspended particles in the air is controlled. Its construction and use should reduce indoor induced, generated and retained particulate matter. Other indoor parameters such as temperature, humidity and pressure should be controlled. A clean zone is a confined space where the concentration of particulates in the air is controlled. Its construction and use should reduce the introduction, production and retention of particles in the space. Other relevant parameters in the space should be controlled such as temperature, humidity and pressure.

Cleaning areas can be open or enclosed. Air cleanliness refers to the number of dust particles in the air in a clean environment. If the dust concentration is high, the cleanliness is low and the dust concentration is low. The specific level of air cleanliness is distinguished by the level of air cleanliness. The level of air cleanliness is expressed by the dust concentration counted in the air during the running time, that is, from a low dust concentration to no more than another high dust concentration The range of dust concentration is a certain level of air cleanliness. Suspended particles refer to solid and liquid particles in the air that are used for air cleanliness classification with a particle size range of 0.15m.