Introduction

Cleanroom validation is the process of verifying and thoroughly evaluating these environments. This process, which usually involves establishing and evaluating the design, construction, performance, and compliance with standard requirements, is carried out to ensure the optimal and safe operation of these rooms. During this process, various equipment and systems are rigorously tested and evaluated to ensure that all environmental parameters, including temperature, humidity, pressure, and particulate matter, are fully controlled. This validation, which is carried out under various national and international regulations, ensures that the cleanroom environment is capable of providing the necessary conditions for the production of high-quality products and compliance with legal requirements.

Therefore, cleanroom validation is not only essential for maintaining quality standards, but is also recognized as a vital factor in preventing health hazards and increasing productivity. In the following, we will examine the various criteria that must be considered for cleanroom validation and explain how this process is carried out in detail.

Definition of a clean room and its importance in various industries

A clean room, simply put, refers to an environment in which the amount of pollutants, dust, microbes, and other airborne particles is reduced to the minimum possible amount. These environments are controlled through advanced ventilation systems and special filters to provide the conditions required for sensitive processes. Depending on the specific application, clean rooms can have different characteristics, but in all of them the most important factor is the precise control of air pollution.

Clean rooms are used in various industries and play a fundamental role in ensuring the quality and safety of products. One of the most important industries that uses these rooms is the pharmaceutical industry. In this industry, the production process of drugs and vaccines is carried out under controlled conditions that require clean rooms with very strict standards. For example, in the production of biological drugs, even the smallest contamination can cause changes in the composition of the drug and, as a result, harm to the patient. For this reason, clean rooms in pharmaceuticals must be able to remove 99.97% of suspended particles as small as 0.3 microns. Ario Pharmed Pishro, as one of the leading companies active in the field of clean room design and implementation, is ready to cooperate with pharmaceutical companies and…

The necessity of clean room validation

Clean room validation is a process used to ensure proper operation and compliance with standard requirements. This process not only helps maintain the quality and efficiency of the clean room, but is also of great importance from a legal perspective. In many countries, especially in the pharmaceutical, medical device, and semiconductor industries, clean room validation is directly supervised by health and safety authorities and must be carried out in accordance with legal requirements and international standards.

In fact, validation standards are specifically designed to ensure that a cleanroom is capable of creating the right conditions for producing high-quality products that meet global standards. For example, according to ISO 14644, cleanrooms must be able to reduce contaminants to a specified level and control airborne particulate matter. This standard addresses not only the quality of the environment, but also the safety of processes and products.

However, assessing environmental conditions alone is not enough to validate a cleanroom. This process should also include a thorough assessment of equipment, ventilation systems, filters, and temperature and humidity controls. For example, in the pharmaceutical industry, any defects in ventilation systems or filters can directly affect the quality of drugs and vaccines, leading to the production of unacceptable products. Therefore, cleanroom validation plays a crucial role in these industries as an essential and vital process to ensure product quality and safety.

Cleanroom Validation Steps

Cleanroom validation is a rigorous and technical process that involves evaluating and verifying four key steps. These steps include reviewing the design, construction, performance, and compliance with actual production conditions. In this section, we will discuss each of these steps in detail.

Design Qualification (DQ)

Design Qualification is the first step in cleanroom validation, where the cleanroom design is reviewed from a technical and operational perspective. The goal of this step is to ensure that the cleanroom design is capable of providing the appropriate controlled conditions for the specific processes. In this step, the design of ventilation systems, filters, temperature, humidity, pressure, and other equipment are reviewed to ensure that all of these systems are properly incorporated into the design and meet the requirements of the standards.

In cleanroom design, special attention should be paid to the various spaces and equipment layouts. For example, in pharmaceutical cleanrooms, proper spacing between ventilation systems and production lines must be considered to prevent the transfer of contamination. In addition, it must be ensured that the filtration and ventilation systems are capable of reducing the amount of airborne particles to the level of the ISO 14644 standard.

Construction Qualification (CQ)

In this stage, the establishment and installation of equipment and systems are checked. This stage includes close monitoring of the cleanroom implementation process, installation of ventilation systems, filters, and other equipment. All installation steps must be carefully established and documented according to the design to ensure the correct operation of the systems. Ventilation systems must be installed in such a way that the air inside the cleanroom flows in the desired direction and removes contaminants. Also, HEPA or ULPA filters must be properly positioned to prevent particulate contamination.

Operational Qualification (OQ)

In this phase, cleanroom systems and equipment are tested to evaluate their performance under real-world conditions. In this phase, the establishment of temperature, humidity, pressure, and ventilation control systems is examined. For example, devices may be used to measure air pressure, filter airflow rate, and particulate matter. This phase is performed to assess the correctness of the systems’ performance and ensure that real-world conditions meet standards.

Performance Qualification (PQ)

In the final phase of validation, the performance of systems and equipment is evaluated under real-world operating and production conditions. In this phase, it is necessary to establish conditions similar to the real-world production process and test the cleanroom’s performance under these conditions. Tests such as checking the amount of particles during production and measuring the performance of filters under operational load are performed. The goal of this phase is to verify that the cleanroom is capable of maintaining quality and controlling contamination under real-world conditions.

Equipment and Tools Required for Validation

To perform cleanroom validation, specific equipment and tools are needed to accurately assess the condition of the cleanroom. This equipment is usually used at each stage of the validation process.

Particle counters are one of the most important tools used in the validation process. These devices are able to accurately measure the number and size of airborne particles. To assess the air quality of the cleanroom, these devices must be able to measure particles of various sizes, including particles smaller than 0.5 microns, which are very important for many sensitive industries such as pharmaceuticals.

Thermometers and Hygrometers

Temperature and humidity are among the parameters that must be accurately controlled in the cleanroom. Thermometers and hygrometers must be able to accurately measure these two parameters in short time intervals to ensure that environmental conditions remain constant. These devices are usually connected to automatic air control systems to automatically make adjustments when the temperature or humidity changes.

Common Challenges and Problems in Cleanroom Validation

Cleanroom validation is a complex and time-consuming process in which various challenges and problems may arise. These challenges can range from technical problems with the equipment to issues related to compliance with national and international standards. In this section, some of the common challenges and problems in the cleanroom validation process will be examined and solutions will be presented.

Technical and Equipment Problems

One of the most common challenges in the cleanroom validation process is problems with measurement equipment and ventilation systems. Here, especially in the early stages of installation, ventilation systems may not be installed correctly or filters may not function properly. In some cases, accurate particle measurements can be subject to error, especially if the measuring devices are not calibrated or require maintenance. To combat this problem, standard, high-precision equipment should be used and this equipment should be accurately calibrated after each step.

The need for continuous monitoring to maintain quality

After validation is complete, continuous monitoring of ventilation systems, filters, temperature, humidity, and other environmental factors should be carried out regularly. These monitoring is to ensure that environmental conditions remain within the standard range and that there are no deviations from the specified values. If major changes are observed in any of the parameters, immediate measures should be taken to correct and restore the conditions to the standard.

Preventive maintenance

Preventive maintenance is essential to prevent system and equipment failure. For example, air filters should be replaced periodically, and ventilation systems should be inspected and tested to ensure they are operating optimally. Failure to perform periodic maintenance can lead to a decrease in environmental quality and an increase in the possibility of contamination. Especially in sensitive industries such as pharmaceuticals, even the smallest changes in cleanroom conditions can have a negative impact on production and product quality.

Continuously monitor regulatory requirements

With the constant changes in laws and regulations, it is also essential to continuously monitor regulatory requirements. Cleanrooms must continuously comply with new laws and standards. For this reason, specialized teams must constantly monitor new laws and take the necessary measures to comply with them. This monitoring and compliance is especially important in industries with strict regulations such as pharmaceuticals.

Conclusion

Cleanrooms are a vital part of many sensitive industries that require controlled environmental conditions to produce quality and safe products. Cleanroom validation is a complex and necessary process that involves a thorough assessment of design, construction, performance, and compliance with operating conditions. This process, which is governed by national and international standards, is carried out in order to ensure the quality and safety of products and processes.

Validation steps, including Design Quality (DQ), Construction Quality (CQ), Performance Quality (OQ), and Operational Quality (PQ), must be followed carefully to ensure that the cleanroom is functioning properly. Also, special equipment is used to measure various parameters, including particulate matter, temperature, and humidity, in the validation process.

Finally, there are various challenges that must be addressed during the validation process. These include technical issues with the equipment, difficulties in performance evaluation, and the need for detailed documentation. Also, after validation is complete, continuous monitoring and periodic maintenance are essential to maintain controlled conditions.

By performing thorough validation and continuous follow-up, it is possible to ensure that cleanrooms are operating optimally and produce high-quality products. This process is not only essential for maintaining quality standards, but is also recognized as a critical factor in preventing health hazards and increasing productivity.

Ario Pharmed Pishro, as one of the leading companies active in the field of clean room design and implementation, is ready to provide the most reliable clean room equipment to pharmaceutical companies and…