Supervision points of the clean room of the pharmaceutical factory
1, clean room
1.1 Air cleanliness regulations
According to the provisions of the new "Good Manufacturing Practices" on March 1, 2011: Air cleanliness level is divided into 4 levels: A, B, C, D; air cleanliness is guaranteed by air purification facilities. Once the qualified air is sent to the clean room, it can only be protected and maintained by the enclosure of the clean room.
1.2 clean room enclosure structure
(1) The material of the building envelope structure: it must be airtight and its deformation is the smallest when the temperature and humidity change.
(2) Structural decoration panels should be smooth, smooth, dust-free, easy to clean, water-resistant, waterproof, easy to maintain, air flow or friction, no particles are generated or detached, glare is avoided, and the light reflection system should be 0.6-0.8 .
(3) The connection parts of the clean indoor wall and the ceiling, the ground, etc. should be curved, and all the R angles and round corners are made of aluminum alloy profiles and have a reliable seal.
(4) The floor of the clean room should be good in integrity, smooth, wear-resistant, impact-resistant, difficult to accumulate static electricity, easy to dust and clean.
(5) The structure of the door and window of the clean room should be flat and simple, not easy to be dusted, easy to clean and good airtight; the surface should be free of scratches and bumps; the window is generally a fixed double glazing.
(6) All the color plate connection parts in the clean room are sealed with high-quality neutral silicone, which is dense, uniform, continuous and no tumor.
1.3 Supervision points for clean room and enclosure structure
1.3.1 Material inspection
(1) Aluminum honeycomb and rock wool color steel plate: The color difference of the plate should be relatively uniform, the appearance should be flat, the thickness and the bulk density should be up to standard, and the thickness of the substrate should not be less than 0.5mm.
(2) Clean room doors and windows: variety, type specifications, structure and profile thickness, size and air tightness meet the requirements.
(3) Self-flowing material: Whether the brand, manufacturer, factory time, and quality inspection report meet the requirements.
(4) PVC floor: review the quality inspection report of thickness, color difference, water permeability and acid and alkali corrosion resistance.
1.3.2 Quality control checkpoint during construction
(1) The slings of the plates shall be installed separately from the slings such as ducts, pipes, lamps and tuyères, and the corresponding bearing capacity shall be ensured.
(2) Clean indoor compartment line: It is required to use the red radiation radiation locator to release the line. According to the design drawing line, after the inspection line passes, the installation of the upper and lower opening rails and the ground rails will be carried out. Provides continuous electrostatic grounding for the entire clean room partition system.
(3) Respond to the splicing of partition wall and ceiling color board: firstly, the construction unit is required to carry out secondary design and issue a secondary design plan. The figure must indicate: high-efficiency air outlet number and size code in clean area, air outlet number in non-clean area, room name; It is necessary to confirm before entering the construction site, it is forbidden to open a large area, and the gap between the plates is 3-4mm. If there is a soil pillar in the exhaust or return air lane, it needs to be wrapped with color plates.
(4) Self-construction construction: mainly the flatness and thickness of the construction shall be measured, checked according to the drawings, including the slope requirements of the floor drain, and the control construction temperature shall not be lower than 15 °C.
(5) PVC floor: The color of the flower line follows the direction of the flow of people. The glue before bonding should be uniform. There should be no air bubbles after compaction. The welding at the joint should be straight, high and low, and there should be no leakage.
(6) Sealing: After the gap between the wall panels is evenly adjusted, the glue is glued, and the various pipes that enter and exit the clean room are decorated with a decorative cover and rubber seal, especially the switch, the socket, the door and window frame, the return air outlet, and the air outlet diffuser. The color plates in the exhaust or return air must be sealed and sealed, and must be clean and tidy after construction.
2, power distribution system
The power distribution system mainly includes: lighting, power, communication and fire protection. The production area should have moderate lighting. The lighting in the visual operation area should meet the operation requirements; the materials such as lamps, switches and sockets should meet the requirements of clean room use. Guaranteed sealing. In addition to meeting cleanliness, energy conservation should also be considered.
2.1 Supervision points of clean power distribution system
2.1.1 Material inspection
(1) The lighting fixture uses a ceiling-type transparent cover to purify the lamp, the switch uses a clean switch, and the socket uses a clean socket.
(2) The packaging of electrical appliances and electrical materials shall be in good condition, the appearance of the materials shall not be damaged, and the accessories and spare parts shall be complete.
(3) The specifications and models of electrical appliances and electrical materials shall comply with the design requirements and the relevant provisions of the current national electrical product standards.
2.1.2 Inspection during construction
(1) The switchboard (cabinet), control display panel (cabinet) and switch box of the clean room should be embedded, and the gap between the wall and the wall should be airtight.
(2) The maintenance doors of the switchboard (cabinet) and control panel (cabinet) should not be opened in the clean room. If it is necessary to be installed in the clean room, the airtight door should be installed for the plate and cabinet.
(3) The construction of the clean room power distribution system meets the requirements of the current national standard “Building Electrical Engineering Construction Quality Acceptance Specification†GB50303, and the materials and construction used should also meet the requirements of the clean room.
(4) The power line in the clean area and the line in the non-clean area should be laid separately; the main work (production) area and the auxiliary work (production) line should be laid separately.
(5) The metal frame and base steel of the switchboard must be grounded to PE or connected to zero PEN.
(6) The current value of lighting power density should meet the design requirements. The illumination of the main workplace in the purification area should be no less than 300LX, and the auxiliary studio, corridor, personnel clean room and material purification room of the purification area should be 150~200LX. The illumination of the non-purification area office, instrument room and laboratory is not less than 300LX, and the illumination between the distribution rooms is not less than 200LX.
(7) When installing the power socket, the left side of the socket should be connected to the neutral line (N), the right side should be connected to the phase line (L), and the middle upper part should be connected to the protective ground line (PE).
(8) The electrical piping in the clean room should be concealed, and the pipe material is made of non-combustible material.
3, ventilation and air conditioning
The filter device is the main component of the purification means. A clean production environment is the need to produce industrial gas, and it is necessary to ensure the product yield and product quality reliability and long life. With the development of China's national economy, the requirements of the temperature, relative humidity and cleanliness of the production environment are getting higher and higher in all walks of life.
3.1 Air purification treatment
(1) Air filter classification: The first category is coarse, medium-efficiency, sub-efficient, high-efficiency and ultra-efficient, and the filter particle size is ≥5, >1, <1, ≥0.5, ≥0.1μm; The efficiency of filtration is divided into A, B, C, and D, and the efficiency is 99.9, 99.99, 99.999, and 99.999% (particle size 0.1 μm).
(2) Filter setting: The coarse filter is set in the pre-treatment of the new fan; the medium-efficiency filter is used for the pre-filtration before the high efficiency, and the life of the high-efficiency filter is prolonged; the high-efficiency filter is set in the clean, which is the key to ensure the cleanliness. .
(3) The high-efficiency filter is located in the clean room: it means that when no harmful substances are generated during the production process, the return air is used as much as possible for energy saving. The unidirectional flow clean room with high cleanliness level adopts fresh air centralized treatment plus FFU purification air conditioning system. That is, the direct circulation of the clean room return air is composed of a plurality of fan filter unit devices.
(4) Frequency conversion speed control fan: In the air conditioning system, the air volume is affected by the change of the resistance, and the frequency conversion speed regulation is adopted to achieve the constant air volume or the constant pressure control. The variable frequency device is controlled by the differential pressure change of the high efficiency filter. The system has significant energy savings.
3.2 Supervision points for clean air conditioning
3.2.1 Material inspection
(1) Materials for ventilation ducts
a. The material, specifications, performance and thickness of the metal duct comply with the design and current national standards. When there is no design rule, it should be implemented according to the specifications. And there is a corresponding factory inspection certificate.
b. The material type, specification, performance and thickness of non-metallic ducts shall comply with the design requirements and the current national product standards. When there is no design, it should be implemented according to the specifications. And there is a corresponding factory inspection certificate. Non-metallic ducts shall provide proof of fire and sanitation testing.
c. The material of fire damper, frame and fixing material, gasket material must be non-combustible material, and its fire resistance rating should meet the design requirements. Inspection quantity: 10% of the batch number of materials processed, not less than 5 pieces. Inspection method: check the quality certification document, performance test report, observation inspection ignition test.
d. The cladding material of the composite duct must be non-combustible material, and the internal insulating material is also non-combustible or flame-retardant B1 grade, and is harmless to the human body. According to the number of batches of material processing, 10% should be checked, and should not be less than 5 pieces. Inspection method: check the quality certification document, performance test report, observation inspection ignition test.
e. The surface of galvanized steel sheet shall not have cracks, crusting or scratching. It shall have a galvanized layer crystal pattern, and shall not have obvious defects such as oxide layer, pinhole, pitting, peeling and plating peeling off.
f. Galvanized sheet should have good plasticity, electrical conductivity, thermal conductivity and corrosion resistance, and the surface should not be scratched or worn.
(2) Insulation materials for air ducts: Clean air-conditioning ducts use rubber and plastic insulation, and require the purchasing unit to issue inspection reports from manufacturers or inspection departments; whether the thickness and fire rating meet the design requirements.
(3) Matching parts: check the static pressure box material, air tightness and rigidity; the air tightness and sensitivity of various dampers; the technical specifications of various filters, focusing on checking the FFU or laminar flow hood unit Structure, static pressure box, fan and filter element meet the requirements.
(4) Equipment inspection: The main inspection equipment is air conditioner and ozone generator, a. First check whether the appearance is intact; b. Secondly, in addition to meeting the corresponding qualification requirements, the equipment should have packing list, equipment manual and product quality. For random documents such as certificates and product performance test reports, the imported equipment should also have the certificate of conformity of the commodity inspection; c. The inspection of the parts should meet the requirements (such as the air treatment equipment, the table cooler has no barbs; the filter is sealed and easy to maintain) Wait).
3.2.2 Quality control of air duct production and installation process
(1) The materials, specifications and dimensions used for the duct must meet the design requirements.
(2) Ducts of the air duct must be tight, without holes, half-biting and other defects.
(3) Welds are strictly prohibited from defects such as burn through, leakage welding and cracks. Longitudinal welds must be staggered.
(4) All the joints of the clean system duct, fittings and static pressure box must be tight.
(5) The surface of the clean system must be smooth and smooth. It is strictly forbidden to have a horizontal joint joint and a reinforcement frame in the pipe or a rib reinforcement method.
(6) The clean air duct must be kept clean, free from oil and dust, and sealed with a film.
(7) The appearance of the air duct should be flat and straight, the arc should be even, the two ends should be parallel, no angle, the surface roughness should be no more than 5mm, the air duct and the angle steel flange should be firmly connected, the flange should be flat, and it should be close to the flange width. Should be less than 7mm, and cut off the overlap, cracks and holes in the flange should be coated with sealant.
(8) The pitch of the air duct flange should meet the design requirements and construction specifications, the welding is firm, the screw holes are not provided at the weld, and the screw holes are interchangeable. When used for Class 5 and above Class 5 cleanliness, the bolt holes on the angle steel flange and the rivet hole spacing on the pipe fittings shall not exceed 65 mm, and shall not exceed 100 mm when the grade 5 or lower. Bolt holes shall be provided at the four corners of the rectangular flange, and the flange joints shall be avoided from the bolt holes. Bolts, nuts, washers and rivets shall be galvanized.
(9) The duct reinforcement should be firm, reliable, tidy, suitable for spacing and uniform symmetry.
(10) The surface of the galvanized duct should be free of cracks and other defects, and the surface of the duct is not damaged.
(11) The width of the iron insert flange should be the same, and it is firm and reliable after inserting both ends.
(12) The allowable deviation and inspection method for the dimensions of the duct and flange are to be carried out in accordance with relevant regulations.
(13) Special control during the manufacture and installation of the air duct: the rivet is detached; the flange of the air duct is not tightly connected; the four corners of the flange are leaking; the pipe is connected with a hole.
3.2.3 Quality issues that should be paid attention to during installation of ducts
(1) When the air duct passes through a fireproof or explosion-proof wall or floor that needs to be closed, a pre-buried or protective casing shall be provided, and the thickness of the steel plate shall not be less than 1.6 mm. Between the air duct and the protective casing, the flexible material that is incombustible and harmless to the human body should be sealed, and the surface should be decorated at the end.
Inspection method: verify the air duct performance test report provided by the inspection organization; observe or inspect the relevant material test by contrast method; measure the wall thickness of the pre-embedded pipe; the wall thickness of the air duct should be 10 mm from the inner side of the flange edge of the pipe ends 4 points were detected at 20 mm and averaged.
Inspection quantity: 20% by quantity, not less than 1 system.
(2) The duct installation must meet the following requirements:
a. Other pipelines are strictly prohibited in the air duct.
b. The air duct system containing flammable or explosive gas or installed in a flammable and explosive environment should have good grounding, and there should be jumper wires between the flanges. It must be tight through living areas or other production rooms, and no interface is required. The air duct containing the bio-aerosol air that is harmful to the human body shall be transported without openings. The necessary openings or joints shall be located in the negative pressure zone.
c. The fixed cable of the outdoor riser is strictly prohibited from being pulled on the lightning rod or lightning protection net.
d. Inspection quantity: 20% by quantity, not less than 1 system.
3.2.4 Air duct section air leakage test
Each system shall be implemented according to the design requirements. After the assembly of the single-branch system, the light leakage inspection shall be carried out. After the inspection, the air leakage shall be tested. The test method may be in accordance with the “clean room construction and acceptance specification†GB50591-2010 Appendix A ?A.2 The air duct section air leakage detection method is carried out.
3.2.5 Installation of the ventilator shall comply with the following provisions:
(1) The model and specifications shall comply with the design regulations, and the direction of export shall be correct.
(2) The impeller should rotate smoothly, and should not stay in the same position every time after stopping.
(3) The anchor bolts of the fixed ventilator should be tightened and have anti-loose measures.
Number of inspections: full inspection.
Inspection method: check and observe according to the design drawing.
Note: The most effective and rough way to check the quality and balance of the installation of the fan impeller at the engineering site is to rotate the impeller and observe its rotation and whether it will stay in the same position.
3.2.6 Clean room test project
(1) Detection of temperature, humidity and pressure difference;
(2) Air volume detection (number of air changes);
(3) Air filter leak test;
(4) Detection of indoor air cleanliness level;
(5) Detection of indoor planktonic bacteria and settled bacteria;
(6) Detection of indoor air temperature and humidity;
(7) Detection of the average speed of the cross section of the unidirectional flow clean room;
(8) Detection of indoor noise and illuminance;
(9) Detection of self-cleaning time;
(10) Detection of ozone concentration.
The above test items can be referred to the “Clean Room Construction and Acceptance Specifications†GB50591-2010 Appendix E.
4, clean pipeline
A clean pipe is a pipe that transports high-purity liquid and high-purity gas between before and after the process equipment. There are certain special requirements for the material of the pipeline to ensure that the gas liquid is not polluted during the transportation process, and the pipeline is not corroded. The process puts clean requirements on the pipeline, especially the roughness of the inner wall of the pipeline meets the requirements (Ra=0.25um is suitable) ).
4.1 Introduction to clean pipelines
Clean pipelines include: pharmaceutical water systems (purified water pipelines, pure steam pipelines, injection water pipelines), industrial media systems (clean compressed air pipelines, vacuum pipelines, nitrogen, industrial steam pipelines, cold heat medium pipelines, etc.), water supply and drainage pipelines, Alcohol pipelines, etc., mainly introduce pipelines, clean air ducts and vacuum pipelines involved in pharmaceutical water systems.
Purified water pipeline: The material is 316L stainless steel inner electric polishing tube, the pipeline adopts automatic track protection welding, the shielding gas is argon gas with purity of 99.999%, the valve is sanitary high temperature resistant diaphragm valve, welding or clamp connection, rock wool insulation , aluminum skin outsourcing, stainless steel skin outsourcing in clean room.
Pure steam pipe: polished stainless steel pipe with 316L, the pipeline adopts automatic track protection welding, the shielding gas is argon gas with purity of 99.999%; the valve on the pipeline is sanitary diaphragm valve, clamp connection, rock wool shell insulation, The interlayer is covered with aluminum skin and is outsourced in stainless steel with a dust-free interior.
Injection water pipeline: The material is 316L stainless steel inner electric polishing tube, the pipeline adopts automatic track protection welding, the shielding gas is argon gas with purity of 99.999%, the valve adopts sanitary grade high temperature diaphragm valve, welding or clamp connection. Rock wool insulation (δ=50), aluminum skin outsourcing; dust-free indoor insulation thickness 20 mm, stainless steel skin outsourcing.
Clean compressed air pipe and vacuum pipe: The material is SUS304 stainless steel pipe, the pipe is fully automatic track protection welding, and the shielding gas is argon gas with a purity of 99.999%.
Valves, fittings and gauges on the process piping should be compatible with the material of the piping in which they are located.
4.2 Pickling passivation of clean pipes (mainly referred to as pure water pipes, injection pipes and pure steam pipes)
The process: pure water circulation pre-flushing, lye circulating cleaning, pure water washing, pickling, pure water washing, passivation, pure water washing, discharging, disinfection.
4.3 Supervision points for clean pipelines
4.3.1 Material inspection
(1) Outer packaging of clean pipes: check for damage, pollution, water stains, etc.
(2) Whether the external appearance of the pipeline (material label, pipe diameter and wall thickness, cleanliness level, roughness grade, standard number, production plant standard, etc.) meets the design requirements.
(3) Check wall thickness and roughness according to relevant standards and factory material reports.
(4) Random data: certificate of conformity, material report, customs declaration procedures for imported materials, etc. are complete.
4.3.2 Inspection during construction
(1) Pushing and unloading environment of clean pipeline: It should be placed indoors to avoid rain.
(2) Unloading environment of clean pipeline: It should be located in a room that can avoid rain, dust and is closed.
(3) There should be special cutting tools: including pipe cutting machine, nozzle processor, etc., the lower material pipe must be sealed and transported to the welding site.
(4) Before the pipeline is welded, the sample is required to be welded, and the time, place, name and welding parameters are indicated on the sample. The sample is sent to the supervision inspection at regular intervals.
(5) Label the same format as the sample next to each weld on the pipe and number it.
(6) Try to avoid manual welding, flanges and clamps are required to have short tubes.
(7) The weld seam should be radiographically inspected, the manual welding detection rate is 100%, and the automatic welding detection rate is 10%.
(8) According to the design requirements, the pressure test shall be carried out. Before the pressure is pressed, the construction unit shall be required to report the pressure suppression scheme and safety measures.
(9) Cleaning of pipelines: The construction unit is required to do the cleaning plan, and it will be executed after modification and approval.
(10) In addition to meeting the process requirements, the valves and fittings used in the clean room should adopt a convenient structure for disassembly, cleaning and overhaul.
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