The program for the pharmaceutical industry GMP renovation purification project bid construction organization design.
1, construction plan
The program for the pharmaceutical industry GMP renovation purification project bid construction organization design. After the successful bidder for the construction of key processes and the company's mature experience will be further detailed and full implementation of the concrete construction to go. Some of the new technologies, new methods, new techniques and partial adjustments proposed in the present case are envisaged to be implemented in the construction after the contract between Party A and Party B is signed.
1.1 The construction sequence of the development
This chart by Huatai Science and Technology replay this fuzzy picture.
According to the characteristics of the pharmaceutical industry purification project formulated the principle of the construction process is "eight", "six at the same time." First of all, after the upper part of the hoisting installation; the first cut off after the ceiling; the first big equipment into the room after the partition closed; first purified installation installation process; Inside and outside; clean room decoration after the completion of ground handling; first adjusted after testing. "Six simultaneous" are: equipment organization and engineering at the same time; auxiliary parts production and material organization at the same time; air conditioning pipe installation and process piping installation at the same time; purification system engineering and delivery of air conditioning equipment at the same time; Professional test run at the same time, while adjusting the test; civil works to close the project and purify the installation at the same time. In the concrete construction, the finished products and semi-finished products on the working procedure must be ensured without damage, and the cross-over construction work between different disciplines must be carried out in good faith and unified with high command.
1.2 Construction Organization Process
Annex I: Construction Organization Process
1.3 equipment, accessories manufacturing
First of all familiar with the project design, summary of equipment specifications, quantity, performance, manufacturers and accessories types, specifications, models, quantity; followed by the construction side to negotiate the need to specify which major equipment to buy and manufacturers to determine which can organize and production ; Third and Design Institute, Party A to confirm the performance requirements of all equipment, accessories, quality standards, sign a technical agreement, and finally combined with the short duration of purification projects, complete engineering expertise, a wide range of projects to develop a detailed step by step Inspection time and methods.
1.4 Purification air conditioning installation project
Purification of air conditioning installation quality is a key part of successful projects in purification projects, we will fully implement GB50243 --- 2002 "ventilation and air conditioning construction acceptance norms" and JGJ71 --- 90 "clean room construction and acceptance of norms." Fully understand the design intent, humbly accept the quality and technical requirements proposed by Party A, rigorously organize construction, focus on the construction, strengthen the technical and quality meanings.
1.4.1 Purification of air-conditioning system duct and components require corrosion-resistant surface, no rust, no dust, no dust, the choice of high-quality galvanized sheet to meet this requirement. Galvanized sheet surface may not have obvious oxide and pinholes, pitting, peeling, foaming, coating shedding phenomenon.
1.4.2 Purified air duct seams easy to air leakage, dust, nor easy to clean. Processing to reduce the patchwork as much as possible, do not allow horizontal splice seam. Duct reinforcement frame can only be high in the duct outside, must not be high in the interior.
1.4.3 Purification air-conditioning system high pressure, requiring good sealing, air leakage less. You can choose double clenching way or commonly used single bite mouth, bite bite mouth, corner bite mouth, joint bite mouth, duct bite interface should be coated with sealant or adhesive sealing tape.
In addition, the flange of the flange of the most prone to cracking, holes, but also coated sealant to prevent air leakage. Generally overlooked flange rivets are also easy to air leakage, but also apply sealant, and can only use galvanized rivets or non-ferrous metal rivets, hollow rivets can not be used.
1.4.4 duct in the installation and installation of zinc coating damage occurred at the mouth and broken mouth, the heart must be strong adhesion to the galvanized steel primer, yellow coating high-quality coating acid and acid paint, and paint Remove dust and oil before. Installed in the air-conditioning equipment and pipelines, flexible pipe between the duct and efficient delivery is to facilitate vibration isolation and installation, all use of non-dust, no dust, airtight and fire-retardant neoprene fiberglass cloth production.
1.4.5 purifying duct sealing requirements, the flange screw holes and rivet hole spacing should be controlled within 100 mm, and four corners to be set screws. Flange production requires right-angle splicing, not allowed to use 45-degree angle connection. Welds to be firm and straight, flat, the choice of angle must be equal angle steel, easy drilling. Air duct cleaning holes and air volume, air pressure measurement holes and filters before and after the dust, pressure hole number and location in strict accordance with the specifications and testing requirements layout.
1.4.6 Purification duct production site to be clean, not open-air operations. Have made a good duct, plenum boxes and accessories, after cleaning and drying in time to the two ends sealed with plastic film to prevent dust pollution, and stored in clean rooms, neatly stacked. Accessories for cleaning before the quality of the re-examination, test the national standard "ventilation and air conditioning engineering quality assessment form" for and record.
1.4.7 Air duct installation Use a 5 mm thick closed-cell rubber flange mats, can not use any adhesive, seal interface form can only be used in several ways to mouth, before installation to check the flange is flat, otherwise it will leak . Installation process, due to dust and more operating environment, the original good film can only be removed while connected to the other end of the connection to be installed until the next section can be removed, in order to avoid dust falling on the cleaned wind Tube inside. Wipe the duct sanitary appliances can only use mercerized towels, nylon cloth, etc., can not use the easy to lose hair and fiber fabrics, cleaning the duct and accessories shall not use acid, alkaline detergent, only use trichlorethylene cleaning agent or Neutral industrial Haoran detergent.
Air duct cleaning and sealing of the two major construction projects focus. The quality of the cleaning quality directly affects the cleaning effect, affecting the life of high efficiency filter. The object to be cleaned is dust and grease on the surface of the galvanized steel sheet, and the cleaning steps are as follows: removing the dust on the surface of the steel plate before the mouth-opening; cutting the mouth with a trichlorethylene cleaning agent or a neutral industrial detergent for degreasing; Clean white silk with water to check the transparent plastic film sealing process.
1.4.8 Purification Duct insulation to be carried out in the air duct leak test after the error. Insulation materials using polyethylene plate. Insulation layer connection using Tongkou, shall not be drilled in the duct. Hanger cross-arm pad to be greater than or equal to the insulation thickness of insulation wood pad, and good preservation. After the insulation shall not affect the control valve, the damper handle the use of regulatory and efficient delivery outlet. After the duct installation is completed, one by one, check whether there is any damage to the coating, repair the tossed taphole on the damaged area and clean it.
1.4.9 Clean indoor installation of high efficiency filter is the most critical process. To be clean room floor, ceiling, partition, doors and windows decoration is completed, clean air-conditioning systems and water, electricity, gas and other pipeline installation is completed, indoor clean-up after a comprehensive clean-up can be carried out. Pre-installation, ceiling, partition, windows and doors, lamps, surface-mounted surface and the ground are not to be cleaned, wiped, wipe with a clean white silk cloth without pollution; air-conditioned room facilities and room wipe clean; take the pipeline ceiling To remove debris and dust; Purification of air-conditioning system ducts, valves, tuyere and air conditioner wipe with a white silk cloth to check for pollution-free; technical mezzanine on the ceiling to be fully clean. Health clearance work is an important means of ensuring acceptance. We will use two health measures to ensure the new plant is clean and free of pollution.
1.4.10 High-efficiency filter transport, storage also has a direct impact on its quality, it must be kept in the direction of its arrow pointing up, and only in a clean and well-ventilated clean plant before the filter can be opened , Check again and do a good job in the installation of sanitary parts, cleaning seals, fasteners and other components and then open the package to start the installation. The clothing must be inspected for filters to ensure compliance with current national standards.
1.4.11 purification air conditioning unit installation must pay attention to the following:
(1) The cleanliness, appearance and brand inspection of the components of the combined air conditioner unit must meet the requirements and make a record;
(2) Leveling the basic platform, pad to rubber plate vibration reduction, the function section connected to the box should be tight;
(3) pay attention to positive pressure section set inside the door, negative pressure section set outside the door, check the door to be sealed;
1.4.12 Purification of air-conditioning system diffusion orifice to be cleaned after each high-efficiency filter leak detection before installation, do not do not see the company's installation practices.
1.4.13 All pipes passing through the clean room should be casing, and filled with non-flammable non-dust sealed sealing material to ensure the cleanliness of the clean room. Should pay attention to a clean area can not be used to produce dust insulation materials, two can not use hollow rivets fixed insulation house.
1.5 clean room partition ceiling decoration works
Purification engineering partition ceiling structure are used double color composite steel, according to different requirements of the building, respectively, using rock wool color steel, polystyrene steel, polyurethane color steel, ceiling panels can also be used keel aluminum-plastic panels and keel Lvkou Ban, etc., according to the requirements of construction units were selected.
1.5.1 color steel paste the surface of the protective film until the end of the installation can be pulled off.
1.5.2 In the hanger layout and ceiling ceiling design load is greater than 80Kg / ㎡, therefore, the long-span suspended ceiling structure with steel girders to ensure that the technical interlayer does not set the horse road, maintenance personnel straight to the roof without causing deformation. Long-span clean room must be based on experience set a certain degree of camber, and set a certain amount of pressure under the top boom.
1.5.3 Purification of the pharmaceutical industry requires that all male and female angle fillet transition, to prevent bacterial parasites. Arc transition aluminum profiles see the technical drawings. When installed, the color steel composite board and the ground, the wall interval to be sealed, all arc line head must be machined arc plug seal.
1.5.4 clean area of the doors and windows process design layout, the use of special aluminum or stainless steel profiles, no threshold under the door to facilitate and produce materials out of the transport.
1.5.5 clean room adjustment. Into the system adjustment phase, through the "wind speed determination method", "basic comparison method", do a good balance of air volume. Maintain the indoor sanitation, air blowing in a dry environment self-cleaning, so that more dust away.
1.5.6 clean room branch of the appearance of the project should meet the following requirements: All kinds of pipes, clean air-conditioning equipment installation should be correct, strong, tight, the deviation should be consistent with the provisions of the filter can be sealed * All kinds of valves Installation of tight, flexible regulation, easy to operate; indoor facilities clean and no dust; return tuyere, lighting, all kinds of pipeline through the maintenance of the structure of the sealing and liquidity of the indoor installation of pipeline protection measures and a variety of brush oil insulation project, both Should meet the regulatory requirements.
1.5.7 Single trial run, with cold (heat) source system normal joint operation of not less than 8 hours. All kinds of equipment in the system must operate in coordination, with correct actions, no abnormalities and clear detection of the status. Detectors must wear clean overalls, as little as possible to walk around the room, according to the completion of the clean-room acceptance test items one by one to detect and record the Hollywood operation.
1.5.8 Stand-alone test run, the system joint commissioning, dynamic or static conditions, clean room performance testing and adjustment, and the relevant construction inspection records after passing the examination, should promptly organize the design, construction and construction units to jointly organize the acceptance.
1.6 Power and lighting engineering
In addition to electrical lighting installation according to "Electrical Installation and Construction Acceptance Code", GB50245-96 to GB50259-96 implementation, but also the implementation of JGJ71-90 "Clean Room Construction Acceptance Code."
1.6.1 First, organize engineering and technical personnel familiar with the drawings, understand the design intent, make technical explanations, to have a planned implementation of the program, and civil works in close cooperation to do a good job. Wire unloading with a toothless saw to overcome the nozzle burr. Electrical wiring according to GBJ232-82 Chapter XIII implementation. Laying the wire should be easy to check, replace. In threading the tube should be blessed water debris removed, except with the device connection, the tube does not leave the connector. Pipeline through the envelope structure installation See details, specific steps, see the company installation manual.
1.6.2 Wires, bobbins and cables laid out according to the rigorous organization of the design, with reference to JSJT-121 atlas construction. Cable laying must be verified before design, with a 500V shake table insulation resistance measurement, before passing off the line, and one by one to write a written cable number, size, type of signs.
1.6.3 clean indoor distribution boards require dust-proof, cabinet to do before the installation of health, but also to do after the installation of health, and to close the door tightly. Install the outlet, outlet box and the box must be clean, close to the wall, the installation is correct. Ceiling lamps should be close to the ceiling, wipe clean, all access to clean room pipe head must not take sealing measures.
1.6.4 Some explosion-proof electrical construction, must be strictly in accordance with the current fire code construction.
1.7 Submission of documents
Accumulation of construction documents, technical information is an indispensable part of project management. When the clean room is completed and accepted, the construction unit shall submit the completion report to the owner, including the following documents:
(1) design documents or change of supporting documents and related agreements.
(2) start the report.
(3) the main materials, equipment and instruments of the factory certificate or inspection documents and inspection orders.
(4) Concealed project closed records.
(5) Self-assessment of unit project, branch project and sub-project quality. Including out of the box records, duct leakage check records, the middle acceptance list, a single degree of operation, the system joint commissioning record, the system adjustment test records and other data.
(6) the completion of acceptance.
2, the main management measures
2.1 technical quality assurance measures
Your company GMP reconstruction project will be listed as my company for the current year's key projects, the establishment of specialized engineering headquarters, direct leadership of the professional coordination. We will be the quality of the project objectives identified as: high-quality projects - GMP will reach the standard works.
2.1.1 Strict implementation of the national spirit of project quality management documents to ensure construction quality. First of all, from the organizational system to ensure the successful completion of the project. The organizational system, see Schedule - List of construction workers, labor pool table.
2.1.2 The establishment of quality assurance system, the implementation of total quality management, the full exercise of the rights of various functional departments, and actively play the role of supervision of the quality department. According to the objectives of quality management, sub-divisions implemented, layers of constraints, the implementation of quality assurance projects all the staff of the risk of mortgaging, arousing great initiative.
2.1.3 Give full play to the company's professional expertise and excellence, GMP compliance of successful experience, according to the characteristics of this project, based on the national standard to develop a higher level of quality inspection standards and strict implementation. Preemptive construction quality management responsibility system, and strictly implement the technical examination, technical review, self-test, mutual inspection, special inspection