cGMP stands for Current Good Manufacturing Practice. They are the standards set by the US Food and Drug Administration (FDA) to regulate the development, manufacturing, testing, and sale of food, pharmaceuticals, and medical devices in the United States.
These regulations also apply to cleanrooms, the controlled environments where many of these products are manufactured. Maintaining a cleanroom in the manufacturing facility is crucial for ensuring the products’ quality and safety.
With the growing awareness of the benefits of having a cleanroom, the demand for cleanrooms in manufacturing facilities is increasing. Grand View Research said that in 2020, the cleanroom technology market was worth US $4.0 billion. It is projected to increase at a CAGR of 5.4% from 2021 to 2028. It indicates a steady increase in the use of cleanroom technology worldwide.
However, cleanrooms must meet some specific standards to comply with cGMP guidelines. This article highlights the six key cGMP compliance guidelines for having a cleanroom in manufacturing facilities.
By understanding and implementing these guidelines, manufacturers can ensure their cleanroom is cGMP compliant and effective in producing high-quality products.
1. Active Usage of Continuous Particle Counting Systems
It is important to ensure cGMP compliance in cleanrooms of a manufacturing facility. These systems monitor the air quality in real time, detecting and counting particles in the air. It allows for quick identification and correction of any issues that may arise, ensuring that the cleanroom remains within the established particle count limits.
Furthermore, continuous monitoring provides a historical record of the cleanroom’s particle count, which one can use for trending analysis and validation purposes. Regular calibration and maintenance of the particle counting systems are essential to ensure accurate results.
2. Installation of Digital Temperature Alarms
According to GM Insights, the market for temperature sensors has grown significantly, surpassing USD 8 Billion in 2022. This trend is expected to continue, with projections of a 4% CAGR from 2023 to 2032.
This growth can be attributed to the increasing adoption of wearable medical devices and portable healthcare technology, which drive the demand for temperature-sensing technology in the industry. Temperature control is critical for maintaining the integrity of products and equipment and preventing the growth of microorganisms in a cleanroom.
Digital temperature alarms allow for the constant monitoring of the temperature in the cleanroom and will immediately alert staff if the temperature deviates from the set limits. These alarms should be placed in strategic locations throughout the cleanroom, such as near equipment and storage areas, to ensure that any temperature changes are promptly identified and addressed.
Additionally, it is important to keep accurate records of temperature variations to validate the environmental conditions.
3. Cleanrooms Must Have Digital Room Pressure Alarms
Room pressure is an indicator of the airflow within the cleanroom, and maintaining the correct pressure differential is a must to prevent contaminants’ entry.
Digital room pressure alarms monitor the pressure in the cleanroom in real time and immediately alert staff if the pressure deviates from the set limits. These alarms should be placed in strategic locations throughout the cleanroom, such as near doors and air handling units, to ensure that any pressure changes are promptly identified and addressed.
Additionally, it is important to keep accurate records of pressure variations to validate the environmental conditions.
4. Hands-Free Bootie Systems in Cleanrooms
These systems are designed to minimize the risk of contamination by preventing personnel from tracking in dirt and other particles from the outside environment.
Hands-free bootie systems typically consist of a mat placed at the cleanroom entrance, which personnel step before putting on disposable shoe covers. The mat is designed to remove dirt and debris from the soles of shoes, and the disposable shoe covers are worn inside the cleanroom to prevent further contamination.
Hands-free bootie systems should be cleaned and maintained regularly to ensure that they remain effective in preventing contamination.
5. Regular Monitoring and Testing
It includes regularly testing the air quality, temperature, humidity, and pressure within the cleanroom to ensure they are within the established limits. It also includes monitoring and testing surfaces, equipment, and personnel for contamination.
These tests should be conducted at regular intervals, with the results recorded to ensure that the cleanroom complies with cGMP guidelines. Additionally, regular testing allows for identifying trends and patterns that one can use to improve the overall performance of the cleanroom and ensure that the products being produced are of the highest quality.
6. Timely Cleaning and Sanitizing of Cleanrooms
It includes regular cleaning of surfaces, equipment, and air handling systems to remove dust, debris, and other contaminants. Sanitizing surfaces is also necessary to eliminate microorganisms that may be present in the cleanroom.
Cleaning and sanitizing protocols should be established and followed, and a regular cleaning and sanitizing schedule should be established and adhered to.
Cleanrooms should use proper cleaning and sanitizing methods to comply with cGMP guidelines. In addition, you must keep accurate records of cleaning and sanitizing activities to validate the cleanliness of the environment.
Till now, the World Health Organization’s (WHO) Good Manufacturing Practice (GMP) provisions have been adopted by over 100 countries as part of their national medicines laws. Additionally, numerous other countries have taken inspiration from these provisions and used them as a basis for their national GMP requirements.
Maintaining a cleanroom in the manufacturing facility is crucial for ensuring the products’ quality and safety. Compliance with cGMP guidelines is essential to meet these standards. The six key cGMP compliance guidelines for having a cleanroom in a manufacturing facility are mentioned above.
By understanding and implementing these guidelines, manufacturers can ensure their cleanroom is cGMP compliant and effective in producing high-quality products. You must keep accurate records of all activities in the cleanroom to validate the environmental conditions.