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In the GMP clean room management of the pharmaceutical industry, air particle monitoring plays a crucial role and is divided into two main categories: clean room classification and daily environmental monitoring. Although both are critical to ensuring the quality of the pharmaceutical manufacturing environment, many practitioners have a vague understanding of their similarities and differences.
For the daily environmental monitoring of GMP clean rooms, the regulations are usually customized by the head of the clean room according to the actual situation. However, the lack of clear guidance often leads to two extremes: first, the monitoring process is too cumbersome, increasing the risk of interference and potential contamination of critical areas; The second is to simply copy the clean room classification standard to develop the monitoring meter, ignoring the risk assessment based on the threat of drug contamination. In fact, daily environmental monitoring should focus on identifying and addressing high-risk areas where drugs may be exposed in the clean room, so the sampling point may be very different from the sampling point at the time of classification.
Next, we explore in depth the similarities and differences between GMP clean room classification and daily environmental monitoring, as well as matters needing attention.
The heart of clean room grading
Clean room classification mainly focuses on the performance evaluation of the clean room itself. This process follows the 1S014644-1:2015 standard and takes full account of clean room air quality without adding additional sampling points. The classification results reflect the performance level of the clean room as a whole, requiring that the concentration of air particles at all sampling points meet the preset level. Staging tests are usually conducted every six months to a year, so their statistical validity is relatively limited. In short, the purpose of clean room classification is to verify that the air quality of clean rooms is better than the grade limits specified by GMP, ensuring the basic quality level of the production environment.
It is important to note that whether it is clean room grading or daily environmental monitoring, the key is to understand and apply the respective core principles and avoid confusing the two. Beijing Zhongbang Xingye Company, as an expert in the field of clean room particle monitoring, can provide professional consulting, test program customization and data analysis services to help pharmaceutical companies accurately grasp the clean room air quality status, optimize the monitoring process, and ensure the safety and compliance of the drug production environment.
In Annex 1 of EU GMP for sterile drugs, FDACGMP and Chinese GMP, it is stipulated that the classification of clean rooms should be carried out in accordance with the method defined in ISO14644-1:2015, but the difference is that EUGMP and Chinese GMP Appendix 1 have their own particle limit requirements. A limit of 5um particles for grading and daily monitoring in Class A zones is included, but in 1S014644-1:2015, the equivalent of Class A zones does not specify any limit for 5um particles.
01 ISO14644-1:2015 Summary of content on clean room classification
Use lookup tables to define the number of sampling points required for cleanroom grading
The sampling points should be evenly distributed in the clean room
The position of the sampling depth needle should be at the same height as the work activity in this area of the clean room
In the case of unidirectional flow, an isodynamic probe should be used and the probe should be oriented towards the airflow source
The minimum amount of samples to be collected at each sampling point is specified
If multiple samples are taken at one sampling point, the results at that sampling point should be averaged
If the concentration of dust particles at all sampling points is below the maximum allowable concentration of air particles required for the cleanroom grade, the cleanroom is considered to have passed the grade.
What is clean room daily environmental monitoring?
Clean room daily environmental monitoring is a regular monitoring activity based on risk assessment to ensure that the pharmaceutical manufacturing environment maintains established standards of cleanliness during ongoing operations. Unlike cleanroom classification, daily environmental monitoring is more flexible and targeted, monitoring different areas at different frequencies depending on the level of pollution risk in the production process.
In daily environmental monitoring, critical areas (such as areas with direct exposure to pharmaceuticals, high-risk operating areas, etc.) may need to be monitored daily to ensure that their air quality always meets GMP requirements. For secondary critical areas, the frequency of monitoring can be appropriately reduced, such as once a week. This high frequency monitoring not only provides a wealth of data support, but also enables companies to trend pollution levels in clean rooms and identify and correct potential problems in a timely manner.
The selection of sampling points is particularly important in daily environmental monitoring. Unlike the minimum number of sampling points specified in the clean room classification, the sampling points for daily environmental monitoring are determined based on the results of the risk assessment of the specific production process. This means that sampling points should be located in locations that may expose the drug to a higher risk of contamination, such as material entrances, personnel passageways, and around equipment. In this way, daily environmental monitoring can more accurately reflect the actual pollution threats faced during drug production and demonstrate the normal operation of these critical areas before and during drug production.
In summary, clean room daily environmental monitoring is a highly customized, risk-oriented monitoring strategy that ensures the cleanliness and safety of the pharmaceutical manufacturing environment in ongoing operations through frequent monitoring of critical areas and sampling site selection based on risk assessment.
02 Locations that may expose drugs to contamination risks include, but are not limited to
There may be operator intervention locations, bacteria manufacturing and filling areas, sterilization equipment packaging, drug dispensing areas, processing equipment.
GMP abstracts on clean room air particle counts
According to the risk assessment and clean room classification, clean rooms and air purification equipment need to be monitored on a daily basis during operation.
The amount of sampling monitored with an automated system is usually a function of the sampling rate of the system used and does not have to be the same as that used for cleanroom grading.
The Level A zone shall be monitored at an appropriate frequency and with an appropriate amount of sampling to detect all human intervention, contingencies and damage to any system when the alarm limit is exceeded.
In Class A and Class B zones, the monitoring of 25.0μm particle concentration counts is of special significance, as it is an important diagnostic tool for timely detection of problems. 5.0u particle counts may be false counts due to electronic noise, stray light, coincidence, etc. However, continuous or regular low-level counts are indicators of possible contamination events and should be investigated.
