Introduction

Clean rooms, as controlled environments, play a key role in sensitive and advanced industries. These rooms are used especially in the pharmaceutical, medical device, biotechnology and electronics industries to prevent microbial contamination and fine particles. In such environments, microbial control is of particular importance to maintain the quality, effectiveness and safety of products. Clean room microbial monitoring, as the process of monitoring the amount of microorganisms present in these spaces, is one of the basic principles in pollution control. Considering that even a small particle of microbial contamination can change the quality of the final product or create health and safety risks, continuous and accurate microbial monitoring is an undeniable necessity, especially in the production process of drugs, vaccines and medical devices. Therefore, to ensure high standards of health, safety and quality, it is necessary to use advanced tools and methods for microbial monitoring.

The Importance of Microbial Monitoring in Cleanrooms

Microbial contamination in cleanrooms can have serious consequences for sensitive industries. In the pharmaceutical industry, for example, bacterial or fungal contamination can lead to changes in the structure of drugs, reduce the effectiveness of drugs, or even cause dangerous side effects for patients. Similarly, in the medical industry, the presence of microbial contamination in medical equipment may lead to hospital infections and disease transmission. According to reports, a study on drugs manufactured in cleanrooms showed that 90 percent of contaminated drugs were due to microbial contamination during the production process in cleanrooms. This indicates the high importance of microbial monitoring to reduce risks and ensure product safety. In this regard, continuous monitoring using advanced devices can help reduce the possibility of contamination and maintain product quality. Another advantage of microbial monitoring is that it can lead to reduced costs and waste caused by contamination. By identifying and controlling contamination in a timely manner, financial losses and reduced performance can be prevented and the production process can be optimized.

Standards and regulations related to microbial monitoring

Microbial monitoring in clean rooms must be carried out in accordance with international standards to maintain product safety and quality. Standards such as ISO 14698 and ISO 14644 have been developed to control contamination in these spaces. ISO 14644 focuses specifically on the control of particles in the air and on surfaces and sets more precise requirements for the performance of clean rooms. The ISO 14698 standard on microbial monitoring of clean rooms emphasizes the need for continuous and continuous monitoring of microbial contamination. In this standard, measurements of microorganisms in the air and on surfaces should be carried out periodically and the results should be recorded regularly so that any possible contamination can be identified quickly. This standard also places particular emphasis on the impact of culture media and laboratory equipment. In addition, Good Manufacturing Practice (GMP) regulations also emphasize the need for strict control of production conditions and microbial monitoring in sensitive spaces such as clean rooms. According to these regulations, companies are required to not only calibrate their equipment regularly, but also monitor all production activities and ensure that production processes comply with standards.

Cleanroom Microbial Monitoring Methods

Microbial monitoring in clean rooms is carried out through various methods, each of which can be used depending on the type of contamination, clean room conditions and type of production processes. The most important methods are discussed below.

Air Microbial Monitoring

Air microbial monitoring is one of the most important methods for controlling contamination in clean rooms. Airborne contamination is of particular importance, especially in clean rooms with higher classes (A and B) that have higher sensitivity. This method uses air samplers that collect air from the environment to identify microorganisms in the air. According to ISO 14644-1 standards, airborne contamination levels must be measured regularly and at specified intervals. These measurements usually involve counting colonies from settler plates or active sampling of room air.

Surface monitoring

Surface monitoring is another common method in microbial monitoring. In this method, microorganisms are sampled from various surfaces in the cleanroom. Contact plates and swabs are used to collect microorganisms from surfaces. Swabs are particularly useful for sampling uneven and inaccessible surfaces. Also, the use of contact plates is very popular as an accurate and rapid method for examining surface contamination.

Personnel Monitoring

Microbial monitoring of personnel is one of the essential elements in microbial monitoring of clean rooms. Personnel are often the main source of contamination in clean rooms. According to various reports, more than 70% of microbial contamination in clean rooms occurs due to personnel contact with various surfaces and environments. For this reason, continuous monitoring of personnel clothing and gloves is essential to prevent the transmission of contamination. This monitoring can include the use of wet swabs to collect microbial samples from gloves, clothing or other personnel equipment.

Equipment required for microbial monitoring

Microbial monitoring in clean rooms requires advanced and accurate equipment. Some of the most important equipment required are:

Air sampling devices: To sample the air and identify microbial contamination in the clean room.
Culture plates: for culturing and growing microorganisms.
Swabs: for collecting microbial samples from different surfaces.
Incubators: to provide suitable conditions for the growth of microorganisms.

All of these equipment must be regularly calibrated and maintained in ideal conditions to ensure the accuracy of monitoring results.

Conclusion

Cleanroom microbial monitoring is essential not only to maintain product quality and safety but also to comply with global standards and regulations. The use of advanced and accurate methods for microbial monitoring is of great importance, especially in sensitive industries. Continuous and planned monitoring of microbial contamination can help prevent serious problems, reduce risks, and optimize the performance of production processes.