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GMP Standard Cleanroom System Workshop Cleanliness LevelⅠ

GMP Standard Cleanroom System Workshop Cleanliness LevelⅠ

2024-05-30



According to the Good Manufacturing Practice for Drugs (GMP), the production environment parameters such as temperature, relative humidity, and pressure difference in clean factories for drug production are determined by the production process. Generally, the temperature is between 18 ℃ and 24 ℃, and the relative humidity is between 45% and 65%. The implementation guidelines for GMP are relatively specific. The temperature and relative humidity in a clean pharmaceutical production plant are based on the principle that operators wearing clean work clothes do not feel uncomfortable or uncomfortable.

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Grade A: High-risk operation areas, such as filling areas, areas where rubber stoppers are placed and open packaging containers that come into direct contact with sterile preparations, and areas where sterile assembly or connection operations are carried out, should be maintained in a one-way flow operating platform (cover) to maintain the environmental state of the area. The unidirectional flow system must provide a uniform air supply in its working area, with a wind speed of 0.36-0.54m/s (guide value). There should be data to prove the state of one-way flow and verified.

In a closed isolation operator or glove box, lower wind speeds can be used.

Grade B: Refers to the background area where A-level clean areas are located for high-risk operations such as sterile preparation and filling.

Grade C and Grade D: refer to clean areas in the production process of sterile drugs where the importance of operational steps is relatively low.

The standard regulations for air-suspended particles of the above grades are shown in the table below:

Grade of cleanroom

Maximum allowable number of suspended particles/m³

Static

Dynamic

≥0.5μm

≥5.0μm

≥0.5μm

≥5.0μm

Grade A

3520

20

3520

20

Grade B

3520

29

352000

2900

Grade C

352000

2900

3520000

29000

Grade D

3520000

29000

No stipulation

No stipulation


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Dynamic monitoring of suspended particles in clean areas should be carried out according to the following requirements

1. Based on the results of cleanliness level and air purification system confirmation and risk assessment, determine the location of sampling points and conduct daily dynamic monitoring.

2. Throughout the entire critical operation process, including equipment assembly, suspended particle monitoring should be carried out in the A-level clean area. When pollution during the production process (such as live organisms and radiation hazards) may damage the dust particle counter, testing should be conducted during equipment debugging and simulation operations. The frequency and sampling volume of A-level clean area monitoring should be able to detect all human interventions, occasional events, and any system damage promptly. When filling or dividing, due to the particles or droplets generated by the product itself, it is allowed to have a filling point ≥ 5.0 μ The suspended particles of m do not meet the standards.

3. A monitoring system similar to that of an A-level clean area can be used in B-level clean areas. The sampling frequency and amount can be adjusted based on the degree of impact of B-level clean areas on adjacent A-level clean areas.

4. The monitoring system for suspended particles should consider the influence of the length of the sampling tube and the radius of the bend on the test results.

5. The sampling amount for daily monitoring can be different from the air sampling amount for cleanliness level and air purification system confirmation.

6. When a small amount of suspended particles ≥ 5.0 µ m appear continuously or regularly in Grade A and Grade B clean areas, an investigation should be conducted.

7. After all production operations have been completed, the operators have withdrawn from the production site and self-cleaned for 15-20 minutes (guidance value), the suspended particles in the class 100 clean area should meet the "static" standard in the table.

8. Dynamic monitoring of C-level clean areas and D-level clean rooms (if necessary) should be carried out by the principles of quality risk management. The monitoring requirements, warning limits, and correction limits can be determined based on the nature of the operation, but the self-purification time should meet the specified requirements.

9. Temperature, relative humidity, and other parameters should be formulated based on the nature of the product and operation, and these parameters should not hurt the specified cleanliness.

To be continued...



Suzhou Pharma Machinery Co.,Ltd.

2024/05/30

Tia




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