Device FAT Specifications

General rules for FAT acceptance of Incheon clean equipment

1. Principles of machine acceptance:

1. Check carefully one by one against the company's general acceptance criteria for equipment.

2. Check carefully one by one against the factory standard and configuration list provided by the manufacturer.

3. Check carefully one by one against the specific equipment acceptance criteria drawn up in advance.

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

5. Check that the mechanical and electrical production and installation comply with EU CE requirements and Chinese national standard requirements.

2. Requirements for technical data:

1. Information before reaching the contract intention with the equipment manufacturer:

online collection

Equipment manufacturers voluntarily provide.

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

Product Catalog and Atlas

Equipment Instruction Manual

Equipment standard configuration list

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

Equipment structure diagram, mechanical schematic diagram

Electrical schematic diagram, wiring diagram

4. The manufacturer should provide the following information before the completion of the equipment production and acceptance:

Equipment instruction manual (in 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 piping diagram, mechanical lubrication diagram, etc.

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

List of equipment configuration, mechanical accessories, electrical components, bearings, connectors, fasteners, pipes, wearing parts, consumables, molds, tools, etc. name and specification list

Operation manuals, certificates of conformity, etc. of purchased products such as mechanical and electrical accessories, accessories, materials, etc.

Measurement verification report and measurement certificate of equipment testing instruments and meters

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

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

Internal inspection, testing and processing records during equipment production, installation and commissioning

Equipment acceptance report and commissioning data.

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

Electronic files of 2-4 items (provide as much as possible), software backup of touch screen, PLC, etc.

5. Information when the equipment is packed and accepted:

Verify whether all the above official documents have been obtained, if not, the acceptance must be complete.

Product certificate, packing list.

3. Equipment configuration check:

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

2. Check whether the accessories, accessories, molds, etc. of the equipment are complete, and whether they are consistent with the order and list.

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

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

4. Appearance, structure and material inspection:

1. The signs and logos on the machine are complete, the touch screen interface should also be prepared according to the contract requirements, and the control panel should be in Chinese and English or the language specified in the contract.

2. All parts of the whole machine must be installed completely and completely. The inner and outer surfaces are uniformly polished, flat and smooth, easy to clean, not falling off particles, not hiding pollutants, not polluting medicines, no burrs, rust, scratches, bumps, and smooth welds Smooth, no solder joints, black scars, complete, uniform and bright painted surface, no color spots, dripping, falling off, the installation door is neat and beautiful, no deformation, flexible switch, including adding silicone pads around the control box door, inside the box No solder joints, no burrs around, the whole machine is clean and bright.

3. All operation buttons, switches, indicator lights and other components should be clearly marked. All rotating components such as motors, handwheels, turntables, and adjustment knobs should be marked with directions. All external media such as power supplies, control line plugs, inlet and outlet pipes, compressed air, vacuum Other interfaces should be marked and specified with specifications, such as voltage, compressed air pressure, vacuum degree and dosage, etc. There are eye-catching electrical signs and other operating warnings on the machine, such as beware of scalding, careful rolling, etc.

4. The operation and transmission parts of the machine must be lubricated according to the regulations before commissioning, and the lubricating parts of the machine must be marked with lubrication points. The non-stainless steel parts on the surface of the machine should be treated with anti-rust treatment, and the positioning of all transmission parts and fasteners should be accurate and firm without loosening.

5. The material of each part of the equipment must meet the requirements. The parts that are in direct contact with the drug should be made of 316L stainless steel (or the material specified in the contract), and argon arc welding is used. After welding, it needs to be polished. The surface reaches 0.3, the outer surface is 0.8, and materials such as silica gel, Teflon, and cloth bags should meet the requirements of GMP standards (check material certification documents, etc.).

6. The electrical circuit and process pipeline of the whole machine should be arranged reasonably and installed in an orderly manner. Each wire hole should have a rubber sheath, the wire should be threaded, the joint should meet the electrical requirements, the circuit should have a label, and each electrical part should be labeled.

7. Various specifications of accessories, spare parts and molds must be specified, and the materials must meet their respective quality requirements. Before packing, they should be cleaned and oiled after inspection and acceptance. After packaging, there will be a list of names, specifications and quantities.

5. Operation check:

1. No-load operation, all switches, buttons and indication signals work normally, each layer of keys is controlled accurately, and the data is displayed correctly. The text of the touch screen interface must be consistent with the contract (especially note that the alarm prompt must use the language specified in the contract), the home page of the touch screen must be the screen specified in the contract, and any trademarks and words of the manufacturer must not appear on the touch screen screen.

2. When no-load, all machine parts start and run normally. Adjust from low-speed operation to high-speed operation. It should be sensitive and reliable. The machine should run smoothly without abnormal noise. Misalignment or abnormal action. The running time shall not be less than 2 hours. (Note: the parts that cannot be run without load shall not be run without load)

3. No-load adjustment to limit high-speed operation without abnormality. (The specifics should be determined according to the characteristics of the machine)

4. The adjustment parts should be easy, effective and accurate to adjust, and the replacement parts should be simple, fast, accurate in positioning, and easy to disassemble.

4. When feeding with load, it should be adjusted to the upper limit speed (the speed that the machine should reach or the speed specified in the contract) and run for not less than 30 minutes. The machine should run smoothly without abnormal noise, and the working noise should not be higher than the noise specified by the machine. The movements of all moving parts and mechanisms are coordinated, flexible and reliable, and the materials should be unimpeded during transportation. The machine should meet the specified technical requirements: such as speed, output, loading, pass rate, breakage rate, and the products produced meet the quality standards stipulated in the contract Require.

5. Various fault factors are set artificially, and the test protection, operation interlock, online quality inspection, and rejection of unqualified products should be normal and reliable.

6. When the load is adjusted to the extreme high-speed operation, the equipment itself shall not have abnormal phenomena, and the product qualification rate shall not be lower than 90%. (depending on the performance of the machine)

7. During the operation of the equipment, the temperature rise of the mechanical part, electrical part and motor should be checked. The noise of the machine should not exceed the specified limit. The running parts, lubrication system, cooling system and air control system should not cause pollution to medicines and packaging. Water system, compressed air, vacuum, cooling, filtration, sealing system must not have leakage.

8. During the operation of the equipment, check that the liquid, powder and other drugs shall not leak, and there shall be no accumulation of liquid, powder or dust on the work surface.

9. During the operation of the equipment, observe whether the setting of the control system is correct, whether the program is reasonable, whether the coordination of various components is accurate and smooth, whether the detection system is perfect, and whether the machine needs to be improved.

10. If it is necessary to adjust equipment parts and replace different molds when changing production varieties and specifications, it is necessary to exchange all specifications and all molds according to the above requirements and conduct all operation tests, which must not be omitted.

Six, packaging inspection:

1. After the machine is installed and debugged, the interior and exterior should be clean, and if necessary, it should be refinished, rust-removed, polished, repainted, added with various lubricating greases, and subsidized with various operation signs.

2. After the machine has passed the inspection, the metal surface should be cleaned and oiled, wrapped with foam paper, and then vacuum-packed, tightly packed in a neutral blank wooden box that meets the export European commodity inspection, and the wooden box must be non-coniferous wood or five plywood, Seven plywood packaging, the base is placed on a pallet or bracket, which is suitable for handling by forklifts at the dock. The inside and outside and the bottom should be scraped off to avoid residual bark, tree knots and tree holes.

3. A layer of 3-4mm calcium-plastic board, plastic board, linoleum or a layer of plastic film should be laid on the bottom, surrounding and cover of the wooden box. Before sealing the box, put a plastic cover on the machine, and then seal the box. .

4. The details of receipt and delivery should be sprayed on the middle of the corresponding wooden box with the inkjet printer, or printed on A3/A4 paper and pasted in the middle of the corresponding wooden box, sealed and protected with transparent tape or film, and the marks and internal packaging of each wooden box Things should be in one-to-one correspondence.

7. Supplementary instructions:

1. In addition to the detailed list provided by the manufacturer during the inspection, it is necessary to collect as much as possible the names, specifications, origins, Manufacturer's information and make records.

2. The acceptance inspection needs to have records, and the records need to be filled in in detail. If there are unqualified items, you need to fill in the acceptance and rectification notice, and submit them to the company and the equipment manufacturer respectively, and urge them to make serious improvements. A complete machine acceptance report is required.

3. Debugging and operation acceptance Record the operation steps as much as possible, learn to install, debug, and operate the machine correctly, and learn to deal with general failures.

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

5. In addition to the detailed acceptance of different machines according to the above rules, different acceptance rules should be formulated according to the characteristics of different machines, which should be used at the same time as these regulations.