Clean pharmaceutical cleanroom pharmaceutical cleanroom self-cleaning, illumination and uniformity test

The purpose of the clean room self-cleaning test is to determine the time it takes for a non-unidirectional flow clean room or clean area and its system to return to a stable cleanliness level after a brief particle emission in the clean space; The HVAC system of the clean room is in...
Text label: Self-cleaning test in clean workshop, illuminance and uniformity test in clean workshop

Clean pharmaceutical cleanroom workshop self-cleaning, illumination and uniformity test


The purpose of the clean room self-cleaning test is to determine the time it takes for a non-unidirectional flow clean room or clean area and its system to return to a stable cleanliness level after a brief particle emission in the clean space; The HVAC system of the clean room is in operation; set the counter or photometer according to the instructions; the sampling probe should not be placed directly under the high-efficiency filter or room air supply, identify the poor airflow area, turbulent area, etc. in the test area, and sample The probe should be slightly higher than the working surface height or the height where the product may be exposed; particle dust is generated in the clean workshop or clean area when the air handling system is working, and the initial particle concentration is raised to 1000-10000 times the target cleanliness level; use a The remote instrument can measure 4 sampling points, and the sampling tube as long as 8m can extend out of the clean area to the counter and photometer. Start time, and start measuring the aerosol concentration, record the aerosol concentration value every minute with a sampling period of 6-12S, until the particle count falls back to 10 times the target cleanliness level, record and give the particle concentration of each sampling point and Corresponding graph of time; self-cleaning time is expressed in minutes, the time it takes for the particle concentration to decrease by 2 orders of magnitude, that is, the time for each location to go from 1000 times the target concentration to 10 times the target concentration.


The purpose of illuminance and uniformity testing is to verify that the illuminance and uniformity of the installed luminaires meet the specified requirements; although the test procedures to be followed vary depending on the actual luminaire arrangement, some common items are applicable to all Tests, such as luminaire conditions, measurement conditions, instruments and equipment, draw a representative grid for the test location. Instruments and equipment required: ceiling plan or floor plan, such as a floor plan that may include furniture or equipment; tape measure; bright colored dots or other means of marking the location of the test grid; up to the height of the working surface, generally 750mm high The portable test stand, instruments and photosensors can be placed horizontally on the stand. For high-intensity or fluorescent lighting systems in relatively new lamps, the lighting time should be at least 100 hours before measurement; for ordinary-sized incandescent lamps, the lighting time should be at least 20 hours; high-intensity lamps or fluorescent lighting systems must be illuminated for at least 2 hours before measurement , to ensure normal operating output and normal operating temperature. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean workshops and purification plants.














Light measurement should be carried out under actual working conditions, all lighting in the area, including general lighting, special lighting and supplementary lighting, should be in normal use; the height of the working surface should be measured, and at the specified working point This point has both natural light and electric lighting; verify that the thermal condition of the space is stable; pay attention to and consider the influence of natural light sources. During the test, determine the position of the measurement grid, which should include a representative area of u200bu200bthe working plane, obstacles above the working plane, avoid pillars, tall equipment, filing cabinets, etc., should be marked; In this method, the average illuminance can be kept within 10% of the value obtained by the grid method. The grid method is to divide the area into 0.6m squares, take readings in each square and calculate the average; get the readings , the photosensitive element is in a horizontal position and 750mm from the ground.
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Five reasons and solutions for insufficient hardness of the tablet press. During the operation of the tablet press, it is inevitable that the tablet is not hard enough, which is a very distressing thing. Today we will analyze the reasons and solutions for the insufficient pressure of the tablet press. Reason: The amount of binder or lubricant is small or improper, so that the particle distribution is uneven, and the coarse and fine particles are stratified, even if the tablet press increases the pressure, it cannot be overcome.

ISO Class 7 cleanrooms are regulated environments that are designed to meet specific cleanliness standards for various industries, including pharmaceutical, medical device, and electronic manufacturing. These guidelines help to ensure that products manufactured in these environments are of high quality and safe for use by consumers. In this article, we will take a closer look at the guidelines for ISO Class 7 cleanrooms and why they are important for ensuring product quality and safety.

The Importance of ISO Class 7 Cleanrooms

ISO Class 7 cleanrooms play a critical role in ensuring the quality and safety of products manufactured within them. These cleanrooms are designed to limit the concentration of airborne particles in the environment, ensuring that the products being manufactured are not contaminated during the production process. This is particularly important in industries such as pharmaceutical and electronic manufacturing, where even small particles can have a significant impact on the quality and performance of the final product.

In pharmaceutical manufacturing, for example, ISO Class 7 cleanrooms are essential for ensuring that medications and vaccines are free from contamination. Any particles present in the environment could potentially contaminate the products being manufactured, leading to potential health risks for consumers. Similarly, in electronic manufacturing, the presence of particles in the environment can impact the performance and reliability of electronic components, making ISO Class 7 cleanrooms crucial for ensuring product quality.

Guidelines for ISO Class 7 Cleanrooms

The guidelines for ISO Class 7 cleanrooms are outlined by the International Organization for Standardization (ISO) in the ISO 14644-1 standard. This standard specifies the maximum allowable concentration of airborne particles in the cleanroom environment, along with other requirements for design, monitoring, and maintenance. In order to meet the requirements for ISO Class 7 certification, cleanroom operators must adhere to these guidelines to ensure that the environment meets the necessary cleanliness standards.

One of the key requirements for ISO Class 7 cleanrooms is the maximum allowable concentration of airborne particles in the environment. According to the ISO 14644-1 standard, an ISO Class 7 cleanroom must maintain a particle count of no more than 352,000 particles per cubic meter of air, sized 0.5 micrometers and larger. This strict limit on particle concentration is crucial for ensuring that the environment remains free from contamination during the manufacturing process.

In addition to particle concentration, the ISO 14644-1 standard also outlines requirements for cleanroom design and operation. This includes specifications for air filtration, temperature and humidity control, and airflow patterns within the cleanroom. These design requirements are intended to create an environment that minimizes the introduction and accumulation of particles, ensuring that the products being manufactured are not contaminated during the production process.

Monitoring and Maintenance of ISO Class 7 Cleanrooms

In order to maintain ISO Class 7 certification, cleanroom operators must regularly monitor the environment to ensure that it continues to meet the necessary cleanliness standards. This involves the use of particle counters and other monitoring pharma machinery to measure the concentration of airborne particles in the environment. By regularly monitoring the cleanroom environment, operators can identify any potential issues and take corrective action to ensure that the environment remains within the allowable limits for ISO Class 7 certification.

In addition to monitoring, regular maintenance of the cleanroom environment is also crucial for ensuring that it continues to meet the necessary cleanliness standards. This includes activities such as filter replacement, cleaning of surfaces and equipment, and calibration of monitoring pharma machinery. By maintaining the pharma clean room environment according to the manufacturer's recommendations, operators can ensure that the environment remains free from contamination and continues to meet the requirements for ISO Class 7 certification.

Benefits of ISO Class 7 Cleanrooms

The use of ISO Class 7 cleanrooms offers several benefits for industries that require high levels of cleanliness in their manufacturing processes. By meeting the guidelines for ISO Class 7 certification, cleanroom operators can ensure that the products being manufactured are of high quality and safe for use by consumers. This can help to enhance the reputation of the company and build trust with customers, ultimately leading to increased sales and revenue.

In addition to ensuring product quality, ISO Class 7 cleanrooms also offer benefits for worker safety and productivity. By creating an environment that is free from contamination, cleanroom operators can minimize the risk of exposure to harmful particles for workers, protecting their health and safety. This can help to reduce absenteeism and turnover, ultimately leading to a more productive and efficient workforce.

Summary

In conclusion, ISO Class 7 cleanrooms play a critical role in ensuring the quality and safety of products manufactured in regulated environments. By meeting the guidelines for ISO Class 7 certification, cleanroom operators can create an environment that is free from contamination, ensuring that the products being manufactured are of high quality and safe for use by consumers. By adhering to the requirements outlined in the ISO 14644-1 standard, cleanroom operators can maintain ISO Class 7 certification and reap the benefits of product quality, worker safety, and increased revenue.

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