Incheon cleaning equipment FAT acceptance general rules

First, machine acceptance principle:

1, check the company's general acceptance standards for equipment carefully.

2, check the factory standards and configuration list provided by the manufacturer carefully.

3, carefully check the specific equipment acceptance standards drawn up in advance.

4, check the equipment contract, drawings, order configuration list item by item.

5, check the mechanical, electrical production and installation in line with the EU CE requirements and Chinese national standard requirements.

Second, technical data requirements:

1. Before reaching the contract intention with the equipment manufacturer:

Online collection

Voluntarily provided by the equipment manufacturer.

2, before signing a formal contract, the equipment manufacturer should provide the following information:

Product catalog and atlas

Equipment instruction manual

Standard equipment configuration list

3. After signing a formal contract, the equipment manufacturer should provide the following information:

Equipment structure diagram, mechanical schematic diagram

Electrical schematic diagram, wiring diagram

4. Before the equipment is completed, the manufacturer should provide the following information:

Equipment instruction manual (Chinese, English or the language specified in the contract)

Equipment mechanical schematic diagram, mechanical structure diagram, transmission system diagram, pneumatic system diagram, installation plan, process pipeline diagram, mechanical lubrication diagram, etc

Electrical schematic diagram, electrical circuit diagram, external wiring diagram, etc

Equipment configuration list, mechanical accessories, electrical components, bearings, connectors, fasteners, pipes, wearing parts, consumables, molds, tools and other names, specifications list

Instructions and certificates for mechanical and electrical accessories, accessories, materials and other purchased products

Equipment testing instrument, meter measurement verification report, measurement certificate

Legal product quality certification documents for pressure vessels and special equipment accessories

Material certification documents for parts in direct contact with the material (304 stainless steel, 316L stainless steel, silicone tube, Teflon, rubber, cloth bag, etc.)

Records of internal inspection, testing and processing in the process of equipment manufacture, installation and commissioning

Equipment acceptance report and debugging data.

GMP certification documents: IQ, OQ, PQ, DQ, FAT, SOP and other documents (Chinese and English)

Software backup of 2-4 items of electronic files (try to provide), touch screen, PLC, etc

5, equipment packing acceptance data:

Verify that all of the above formal information has been obtained, if not, acceptance needs to be complete.

Product certificate, packing list.

Third, equipment configuration check:

1. Check whether all the configuration components of the equipment are consistent with the order, should be able to meet the configuration of the machine performance requirements, and whether it meets the requirements of the configuration list.

2, check the equipment accessories, accessories, molds, etc., is complete, is consistent with the order and list.

3. Measure whether the dimensions and internal structure of the machine are consistent with the contract order. (Especially the size required to be controlled by the customer)

4. Check whether all the information meets the above requirements.

Fourth, appearance, structure and material inspection:

1, the machine on the label and logo is complete, the touch screen interface should also be prepared in accordance with the contract requirements, the control panel should be for Chinese and English or the contract specified language.

2, all parts of the machine need to be installed completely, the internal and external surface polishing is the same, smooth, easy to clean, do not fall off particles, do not hide pollutants, do not pollute drugs, no burrs, rust, scratches, bumps, smooth welds, no solder joints, black scars, painted surface complete, uniform, bright, no stains, dripping, falling off phenomenon, installation door neat and beautiful, no deformation, The switch is flexible, including the silicone mat around the control box door, no solder joints in the box, no burrs around the machine clean and bright.

3, all operation buttons, switches, indicators and other components need to be clearly marked, all rotating parts such as motor, hand wheel, turntable, adjustment knob need to be marked direction, all external media such as power supply, control line plug, water inlet and outlet, compressed air, vacuum and other interfaces need to be marked and indicated specifications, such as voltage, compressed air pressure, vacuum degree and dosage. The machine has a prominent electrical label and other operating warnings, such as beware of burns, careful running of hands, and so on.

4. The operation and transmission parts of the machine need to be lubricated according to regulations before commissioning, and the lubrication parts of the machine need to be marked with lubrication points. The non-stainless steel part of the machine surface needs to be treated with rust prevention, and the transmission parts and fasteners need to be positioned accurately, firmly, and without loosening.

5. The material of each part of the equipment shall meet the requirements. The parts in direct contact with the drug shall be made of 316L stainless steel (or the material specified in the contract), and shall be polished after welding by argon arc welding. The containers and equipment containing the materials shall be polished with the inner surface of 0.3 and the outer surface of 0.8. Silicone, Teflon, cloth bags and other materials should meet the requirements of GMP standards (check the material certification documents, etc.).

6. The electrical circuit and process pipeline of the whole machine shall be rationally arranged and orderly installed, each line hole shall have rubber sheathing, the wire shall be threaded through the pipe, the connector shall meet the electrical requirements, the line shall have a label, and each electrical part shall be labeled.

7, all kinds of specifications of accessories, spare parts, molds need to indicate the specifications, and the material must meet the respective quality requirements, before the packing inspection and acceptance of clean oil, after the packaging name, specification, quantity list.

5. Operation inspection:

1, no-load operation, the switches, buttons, indicating signals work normally, each layer of key control is accurate, the data display is correct. The text of the touch screen interface should be consistent with the contract (pay special attention to the alarm prompt to use the language specified in the contract), the screen screen should be the screen specified in the contract, and no trademark and text of the manufacturer should appear in the screen of the touch screen.

2, no load when the machine parts start and operate normally, from low speed operation to high speed operation, should be sensitive and reliable, the machine should be stable in operation, no abnormal noise, the moving parts, the mechanism coordination, flexible and reliable, no block, dislocation or abnormal action. The running time shall not be less than 2 hours. (Note: parts that cannot be run without load shall not be run without load)

3, no load adjustment to the limit of high-speed operation, no abnormal. (The specific should be determined according to the characteristics of the machine)

4 The adjustment parts should be convenient, effective and accurate to adjust, change the specification parts should be simple, fast, accurate positioning, easy disassembly.

4, feeding with load work, should be adjusted to the maximum speed (the machine should reach the speed or the speed stipulated in the contract) running not less than 30 minutes, the machine should run smoothly, no abnormal noise, the working noise should not be higher than the noise stipulated by the machine, the moving parts, the mechanism coordination, flexible and reliable, the material should be unimpeded in transport. The machine shall meet the specified technical requirements: such as speed, output, load, pass rate, breakage rate, and the products produced shall meet the quality standards specified in the contract.

5, artificial setting of various failure factors, test protection, operation interlock, quality online detection, unqualified products removal action should be normal and reliable.

6, with load adjustment to the limit of high-speed operation, the equipment itself shall not appear abnormal phenomenon, product pass rate shall not be less than 90%. (Depending on the performance of the machine)

7, the equipment should be checked during the operation of the mechanical part, electrical part, motor temperature rise, machine noise shall not exceed the prescribed limits, moving parts, lubrication system, cooling system, air control system shall not cause pollution to drugs and packaging, air control system, water system, compressed air, vacuum, cooling, filtration, sealing system shall not have leakage.

8, During the operation of the equipment, check the liquid, powder and other drugs shall not leak, and there is no accumulation of liquid, powder and dust on the workbench.

9, During the operation of the equipment, observe whether the control system is set correctly, whether the program is reasonable, whether the various components cooperate accurately and smoothly, whether the detection system is perfect, and whether the machine needs to be improved.

10, such as the change of production varieties, specifications need to adjust equipment parts, replace different molds, need to replace all specifications and all molds in accordance with the above requirements for all operational testing, shall not be omitted.

Six, packaging inspection:

1, after the installation and commissioning of the machine, the interior and appearance should be clean, if necessary, then re-trim, rust removal, polishing, paint, add a variety of lubricating oils, subsidies for various operating signs.

2. After the acceptance of the machine, the metal surface shall be cleaned and oiled, wrapped in foam paper, vacuum-packed, and securely placed in neutral blank wooden cases conforming to the export European commodity inspection. The wooden cases shall be packed with non-conifed wood or five or seven splints, and the base shall be made of pallets or brackets suitable for forklift handling at the dock.

3. A layer of 3-4mm calcium-plastic board, plastic board, linoleum or a layer of plastic film should be laid on the bottom, around and cover of the wooden box. A plastic cover should be set on the machine before sealing the box, and then the box should be sealed.

4. The receiving and shipping details should be sprayed in the middle of the corresponding wooden box by the inkjet printer, or printed on A3/A4 paper and pasted in the corresponding middle, and sealed with transparent tape or film for protection. The marks and internal packaging of each wooden box should correspond one by one.

Vii. Supplementary Explanation:

1, in addition to the detailed list provided by the manufacturer, the inspection should collect all mechanical accessories, electrical components, bearings, connectors, fasteners, pipes, wearing parts, consumables, molds, tools and other names, specifications, origin, manufacturer information and make records.

2. Acceptance inspection shall be recorded, and the records shall be filled in in detail. If there are unqualified items need to fill in the acceptance and rectification notice, respectively submitted to the company and equipment manufacturers, urge them to seriously improve. A complete machine acceptance report is required.

3, debugging operation acceptance record the operation steps as far as possible, learn to correctly install, debug, operate the machine, and learn to deal with general faults.

4. Collect all the information according to the regulations, and bring it back to the company for archiving after acceptance.

5, different machines in addition to the detailed acceptance according to the above rules, but also need to develop different acceptance rules according to the characteristics of different machines, and this provision is used at the same time.