1. The purpose
Establish HEPA air filter replacement procedures to clarify the technical requirements, purchase and acceptance, installation and leak detection, and cleanliness testing of clean air for clean air in the production environment, and finally ensure that the air cleanliness meets the specified requirements.
2. Scope
1. This standard is applicable to the replacement of high-efficiency air filters in air filtration systems that provide clean air for production environments in the pharmaceutical production process of the pharmaceutical factory. It includes the following parts:
1.1 HVAC system (also known as air purification system);
1.2 Medical spray drying tower inlet air filtration system;
1.3 Medical airflow smashing air filtration system.
Responsibilities
1. Extraction workshop maintenance personnel: In accordance with the requirements of this standard, it is responsible for the acceptance, storage, and sanitary cleaning and replacement of high-efficiency air filters, and cooperates with the inspection personnel to test leaks.
2. Clean area operators: in accordance with the requirements of this standard, responsible for the maintenance personnel to clean the clean area and efficient air filter replacement work.
3. Installation of the high efficiency air filter according to the requirements of this standard.
4. QC personnel: responsible for the installed high-efficiency filter leak detection, air volume test, cleanliness test, and issued test records.
5. The length of the medical workers, the extraction workshop director: in accordance with the requirements of this standard, responsible for the high-efficiency air filter purchase plan declaration, and organize acceptance, storage, installation, leak detection, cleanliness test work.
6. Equipment Division: Responsible for the high-efficiency air filter plan review, and report to the company’s equipment department for approval, record collection and archive management.
7. Quality Division: Responsible for the supervision and management of the HEPA air filter in accordance with the requirements of this standard.
Reference documents
1. National standard for high efficiency air filter GB13554-92.
2. Design specifications for clean workshops GB50073-2001.
3. Clean room construction and acceptance specifications JGJ71 90.
5. Definition
1. High Efficiency Air Filter (HEPA): consists of a filter element, frame and gasket. Under the rated air volume, the air collection filter has a collection efficiency of 99.9% or more and a gas flow resistance of 250 Pa or less.
2. There is a partition plate filter: the filter element is formed by folding the filter material back and forth according to the required depth, and is supported by the corrugated partition plate between the folded filter materials to form a filter for the air passage.
3. No partition plate filter: The filter element is made by folding the filter material back and forth according to the required depth, but a paper tape (or wire, linear adhesive or other support) is used between the folded filter materials. A filter that supports the formation of an air passage.
4. Leak test: Check the airtightness test of the air filter and its connection to the mounting frame.
5. Cleanliness test: It is to determine whether the number of suspended particles in the clean room (area) meets the clean room cleanliness level by measuring the number of suspended particles containing more than or equal to a certain particle size per unit volume of air in a clean environment.
6. Filtration efficiency: Under the rated air volume, the difference between the air dust concentration N1 and N2 before and after the filter and the dust concentration of the air before the filter is called the filtration efficiency.
7. Rated air volume: Under the specified filter outer dimensions, multiply the effective filter area by a certain filter speed, and the obtained air volume after the integer is obtained, the unit is m3/h.
8. Filtration speed: The speed at which air flows through the filter in meters per second (m/s).
9. Initial resistance: The resistance when the new filter is used is called the initial resistance.
10. Static: The facility has been completed, the production equipment has been installed, and it is operated without production personnel.
6. Procedures
1. Overview of high efficiency air filter:
1.1***The HEPA filter of the HVAC system, spray-drying air filtration system and airflow pulverizing air inlet filter system of the pharmaceutical factory is installed at the end of the air supply, and the particle size of 0.1um is equal to or larger than 0.1um, ensuring the fine baking package. The clean area, spray-dried air, and air-jet blast air quality meet the 300,000-class cleanliness requirements.
1.2 HVAC system HEPA air filter, installed vertically on the top of the clean room (area) ceiling. The HEPA filter of the spray-dried air inlet filter system is installed at the front end of the heat exchanger, and the HEPA filter of the airflow pulverizing air inlet filter system is installed at the front end of the jet to ensure that the filtered clean air is in direct contact with the medicine.
1.3 Due to the high temperature moisture generated in some rooms of the clean baking zone, the spray drying and airflow pulverizing air volume is large. For the HEPA air filter, it is necessary to select filter materials that are not easily damaged and resistant to temperature and humidity, so as to prevent mold and mildew. Blowing.
1.4 Fine-baked HVAC system, airflow pulverizing air inlet filter adopts HEPA filter with partition plate, and the air inlet of spray drying tower adopts HEPA filter without partition plate. The treated air volume of each filter should be less than or equal to the rated air volume.
1.5 Each system’s HEPA filter should ensure that its resistance and efficiency are consistent. The difference in resistance will affect the air volume balance and airflow uniformity. The difference in efficiency will affect the air cleanliness and ensure simultaneous replacement.
1.6 The installation quality of the HEPA filter directly affects the air cleanliness level. After the HEPA filter is replaced, a leak test must be performed to evaluate the tightness of the installation site.
1.7 After the HEPA filter leak test is passed, the air volume test and dust particle test shall be carried out to prove that the air quality meets the specified cleanliness requirements.
2. HEPA air filter quality standards
2.1 HEPA air filter quality is directly related to ensuring air cleanliness. When replacing, it is necessary to use a quality filter that meets the specified quality standards. The quality requirements are shown in Table 1 “*** Quality Standards for HEPA Air Filters in Pharmaceutical Factory”.
2.2 The quality requirements of HEPA air filters involve four categories: basic requirements, material requirements, structural requirements, and performance requirements. This quality standard refers to the “High Efficiency Air Filter National Standard GB13554-92″ document.
3. HEPA air filter replacement frequency
3.1 With the accumulation of operating time of the air purification system, the dust holding capacity of the HEPA filter is increasing, the air volume is reduced, the resistance is increased, and replacement is necessary. The HEPA air filter should be replaced in any of the following cases.
3.1.1 Airflow speed is reduced to a minimum. Even after replacing the primary and secondary air filters, the airflow speed cannot be increased.
3.1.2 The resistance of the HEPA air filter reaches 1.5 to 2 times the initial resistance.
3.1.3 The HEPA air filter has an unrepairable leak.
4. Purchase and acceptance requirements
4.1 HEPA filters When planning to purchase, the installation location and quality requirements shall be specified in detail and must be reviewed by the branch quality department to ensure that it is suitable for the intended use.
4.2 Suppliers must provide production, factory inspection, product marking, packaging, transportation and storage in accordance with the “High Efficiency Filter Quality Standard GB13554-92″ when providing HEPA filters to ensure that users are provided with qualified HEPA filters.
4.3 For new suppliers, when providing HEPA filters for the first time, all tests must be carried out in accordance with GB13554-92 to confirm the supplier’s quality of supply.
4.4 After the HEPA filter provided by the supplier arrives at the factory, according to the purchase contract and G B13554-92 requirements, the company will organize the acceptance of the goods. Arrival acceptance includes:
4.4.1 transportation mode, packaging, packaging mark, quantity, stacking height;
4.4.2 Specifications, model size, rated air volume, resistance, filtration efficiency and other technical parameters;
4.4.3 Supplier’s factory inspection report, product certificate, and delivery list.
4.5 After the acceptance is correct, send the HEPA filter to the designated area of the fine bake package and store it according to the box mark. Shipping and storage must:
4.5.1 During transportation, it should be handled gently to prevent severe vibration and collision.
4.5.2 The stacking height shall not exceed 2m, and it is forbidden to store in the open place where the rats are bitten, wet, too cold, overheated or where the temperature and humidity change drastically.
5. Clean before installation
5.1 HVAC system, spray drying tower or airflow pulverizing system stops running, remove the high-efficiency filter that needs to be replaced, and clean out the fine-baked package in time to prevent the absorbed dust from spreading.
5.2 Wipe the HVAC system efficient mounting frame and clean the clean room thoroughly. Start the fan and blow it for more than 12 hours.
5.3 After the air blow of the HVAC system is over, the fan stops running. Clean the mounting frame again and install the high-efficiency filter immediately after the clean room is thoroughly cleaned.
5.4 Spray drying tower Inlet air and airflow pulverizing In the high-efficiency filter installation part to the internal air duct at the medium efficiency filter, the installation frame is completely cleaned, and the high-efficiency filter is installed immediately.
6.1.1 Unpacking requirements
Open the outer packaging of the filter from the front, fold the package to the ground, slowly lift the box, expose the filter, and unpack the film.
6.1.2 Check item:
Appearance requirements: Check the surface of the filter frame, filter material, partition plate and sealant, which should meet the requirements;
Dimensions: Check the filter side length, diagonal, thickness dimension, depth, verticality, flatness, and the skewness of the partition plate, which should meet the requirements;
Material requirements: Check the filter material, partition plate, sealant and adhesive, which should meet the requirements;
Structural requirements: Check the filter element, frame and gasket, which should meet the requirements;
Performance requirements: Check the physical quantity of the filter, the resistance, the filtration efficiency, and the design requirements should be consistent;
Marking requirements: Check the filter product mark and airflow direction mark, which should meet the requirements;
Each product should have a product certificate.
6.2 Unqualified filters shall not be installed, packaged in the original packaging, sealed and returned to the manufacturer.
6.3 The installation quality of the high efficiency air filter directly affects the air cleanliness level. When installing, you must ensure that:
6.3.1 Filters with too high or too low resistance should be removed, and filters with similar resistance should be arranged in the same room;
6.3.2 Filters with different resistances in the same room shall be evenly distributed;
6.3.3 The arrow on the outer frame should be consistent with the direction of the airflow. When it is installed vertically, the crease seam of the filter paper should be perpendicular to the ground;
6.3.4 The installation should be flat, firm and in the right direction. There should be no gap between the filter and the frame, frame and retaining structure.
7. Leak test
7.1 After the high-efficiency filter is installed, notify the QC inspectors to check the installed high-efficiency filter. Leak detection operations shall be carried out in strict accordance with the “High Efficiency Air Filter Leak Detection Procedures”.
7.2 In the leak test, the leak detected may be sealed with epoxy rubber and bolted. When the method of plugging or fastening is used, the test is re-scanned and the filter is still not replaced when the seal is still not guaranteed.
8. Cleanliness test
8.1 Before the detection of dust particles, the air inlet volume test of the replacement high-efficiency filter should meet the design requirements.
8.2 After the air volume test is adjusted, the dust particles should be tested under static conditions and should meet the requirements of Class 300,000 clean rooms.
9. Schedule
1. *** pharmaceutical factory fine baking package high efficiency air filter quality standards.
2. High efficiency air filter acceptance, installation record.
Post time: Jul-03-2018