I. Principles for Machine Acceptance:

　　1. Carefully review each item against the company’s general equipment acceptance standards.

　　2. Carefully check each item against the manufacturer’s factory standards and configuration list.

　　3. Carefully review each item against the pre-determined acceptance criteria for the specific equipment.

　　4. Check each item against the equipment contract, drawings, and purchase order configuration list.

　　5. Verify that the mechanical and electrical fabrication and installation comply with EU CE requirements and Chinese national standards.

　　II. Technical Documentation Requirements:

　　1. Documents prior to reaching an agreement in principle with the equipment manufacturer:

　　Online collection

　　Provided voluntarily by the equipment manufacturer.

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

　　Product Catalog and Brochure

　　Equipment User Manual

　　Equipment Standard Configuration List

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

　　Equipment structural diagram, mechanical principle diagram

　　Electrical schematic diagram, wiring diagram

　　4. Before the equipment is completed and accepted, the manufacturer shall provide the following documents:

　　Equipment Instruction Manual (in Chinese, English, or the language specified in the contract)

　　Mechanical principle diagrams, mechanical structure diagrams, transmission system diagrams, pneumatic system diagrams, installation layout drawings, process piping diagrams, mechanical lubrication diagrams, and more.

　　Electrical schematic diagrams, electrical wiring diagrams, external connection diagrams, etc.

　　List of equipment configuration items, mechanical accessories, electrical components, bearings, fasteners, connectors, pipelines, wear parts, consumables, molds, tools, and their specifications.

　　Instruction manuals, certificates of conformity, and other documentation for purchased mechanical and electrical components, accessories, materials, and similar products.

　　Metrological verification reports and metrological certificates for equipment, instruments, and meters.

　　Legal product quality certificates for pressure vessels and accessories for special equipment

　　Material certification documents for parts that come into direct contact with the materials (including 304 stainless steel, 316L stainless steel, silicone tubing, Teflon, rubber, fabric bags, etc.)

　　Internal inspection, testing, and handling records during the equipment manufacturing, installation, and commissioning processes.

　　Equipment acceptance report and commissioning data.

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

　　Electronic files of documents 2-4 (if possible), software backups for touch screens, PLCs, and other similar devices.

　　5. Documentation for equipment packing and acceptance:

　　Verify that all the above-mentioned official documents have been obtained. If not, the final acceptance must include all of them.

　　Product Certificate of Conformity, Packing List.

　　III. Equipment Configuration Check:

　　1. Verify that all configuration components of the equipment match the order and meet the machine’s performance requirements, as well as comply with the requirements specified in the configuration list.

　　2. Check whether the equipment’s accessories, attachments, molds, and other components are complete and consistent with the order and the inventory list.

　　3. Verify that the machine’s external dimensions and internal structure conform to the specifications outlined in the contract. (Pay special attention to dimensions that the customer has explicitly requested be strictly controlled.)

　　4. Verify that all materials meet the requirements mentioned above.

　　IV. Inspection of Appearance, Structure, and Materials:

　　1. The machine must be equipped with all required labels and markings, and the touchscreen interface must be configured according to the contract requirements. The control panel must display information in both Chinese and English or in the language specified in the contract.

　　2. All components of the entire machine must be fully and completely installed. The inner and outer surfaces must be uniformly polished, smooth and flat, easy to clean, free from loose particles, hidden contaminants, and drug contamination. There should be no burrs, rust, scratches, or unevenness; weld seams must be smooth and even, with no visible weld spots or dark scars. The painted surfaces must be intact, uniform, and glossy, free from discoloration, dripping, or flaking. The installed doors must be neat and aesthetically pleasing, without any deformation, and operate smoothly and flexibly. This includes adding silicone gaskets around the control box doors. Inside the box, there should be no weld points, and the surrounding areas must be free of burrs. The entire machine must be clean and brightly polished.

　　3. All operating buttons, switches, indicator lights, and other components must be clearly labeled. All rotating parts—such as motors, handwheels, turntables, and adjustment knobs—must be marked with directional indicators. All external media connections—including power supplies, control cable plugs, inlet and outlet water pipes, compressed air lines, vacuum lines, and others—must be clearly labeled and accompanied by specifications, such as voltage, compressed air pressure, vacuum level, and flow rates. The machine must also feature prominent electrical grounding markings and other operational safety warnings, such as “Beware of Burns” and “Caution: Risk of Hand Entrapment.”

　　4. Before commissioning any rotating or transmission parts of the machine, they must be lubricated according to regulations. All lubrication points on the machine must be clearly marked. Non-stainless steel surfaces of the machine must be treated with rust-proof coatings. All transmission components and fasteners must be accurately positioned and securely tightened, with no looseness whatsoever.

　　5. The materials used for all components of the equipment must meet the specified requirements. Parts that come into direct contact with pharmaceutical products shall be made of 316L stainless steel (or the materials specified in the contract). Argon arc welding must be employed, and after welding, all surfaces must undergo polishing treatment. Containers and equipment that hold materials must be polished to achieve a surface roughness of 0.3 on the inner surface and 0.8 on the outer surface. Materials such as silicone, Teflon, and filter bags must comply with GMP standards (check the material certification documents, etc.).

　　6. The electrical wiring and process pipelines of the entire machine must be laid out reasonably and installed in an orderly manner. Each wire hole must be equipped with a rubber sleeve, wires must be routed through conduit, connections must meet electrical requirements, wiring must be clearly labeled, and all electrical components must be marked with identification labels.

　　7. All accessories, spare parts, and molds of various specifications must clearly indicate their specifications, and their materials must meet the respective quality requirements. Before packing, they must be inspected and accepted, cleaned, and lubricated. After packaging, a detailed list specifying the name, specifications, and quantity of each item must be included.

　　V. Operational Inspection:

　　1. During no-load operation, all switches, buttons, and indicator signals function properly; the keypads on each floor respond accurately, and the data displayed is correct. The text on the touchscreen interface must match the contract (pay special attention to ensure that alarm prompts are in the language specified in the contract). The home screen of the touchscreen must display the screen specified in the contract, and no trademarks or text belonging to the manufacturer may appear on the touchscreen interface.

　　2. When running at no load, all machine components should start and operate normally. The transition from low-speed to high-speed operation should be smooth and reliable. During operation, the machine should run smoothly without any abnormal noises. All moving parts and mechanisms should function in a coordinated, flexible, and reliable manner, with no jamming, misalignment, or unusual movements. The running time must be no less than 2 hours. (Note: Components that cannot be operated at no load must not be run at no load.)

　　3. Adjust the no-load condition to run at the maximum speed, and no abnormalities should occur. (The specific adjustment should be determined based on the machine’s characteristics.)

　　4. Each adjustment component should be easy, effective, and accurate to adjust; when changing parts of different specifications, the process should be simple, quick, accurately positioned, and easy to disassemble and assemble.

　　4. When operating with material feeding and under load, the machine should run at its upper limit speed (the speed the machine is designed to reach or the maximum speed specified in the contract) for no less than 30 minutes. During operation, the machine must run smoothly without any abnormal noises; the operational noise level must not exceed the noise level specified by the machine’s manufacturer. All moving parts and mechanisms should operate in a coordinated, flexible, and reliable manner, and the material flow during transportation should be unobstructed. The machine must meet the specified technical requirements, including speed, output, filling volume, pass rate, and breakage rate. The products produced must conform to the quality standards stipulated in the contract.

　　5. Manually introduce various fault factors and ensure that safety protection, operational interlocks, online quality inspection, and rejection of nonconforming products all function normally and reliably.

　　6. While running at the maximum speed under load, the equipment itself must not exhibit any abnormal phenomena, and the product pass rate must be no lower than 90%. (To be determined based on the machine’s performance.)

　　7. During equipment operation, the mechanical parts, electrical components, and motor temperature rise should be inspected. Machine noise must not exceed the specified limits. Rotating parts, lubrication systems, cooling systems, and pneumatic control systems must not contaminate pharmaceuticals or packaging materials. Furthermore, the pneumatic control system, water system, compressed air supply, vacuum system, cooling system, filtration system, and sealing system must all be free of leaks.

　　8. During equipment operation, ensure that there is no leakage of liquids, powders, or other pharmaceutical substances, and that the work surface remains free of accumulated liquids, powders, and dust.

　　9. During equipment operation, observe whether the control system settings are correct, whether the program is reasonable, whether the various components work together accurately and smoothly, whether the detection system is fully functional, and whether there are any areas of the machine that need improvement.

　　10. If the product variety or specifications are changed, requiring adjustments to equipment components or replacement of different molds, all specifications and all molds must be replaced and subjected to comprehensive operational testing in accordance with the above requirements—no omissions are permitted.

　　6. Packaging Inspection:

　　1. After the machine has been installed and debugged, both its interior and exterior must be thoroughly cleaned. If necessary, reconditioning, rust removal, polishing, and touch-up painting should be carried out. Additionally, various lubricants and greases should be added, and all operational signage should be properly affixed.

　　2. After the machinery has passed acceptance inspection, clean and oil the metal surfaces, wrap them with foam paper, and then vacuum-pack them. Securely place them in neutral, blank wooden crates that meet European export inspection standards. The wooden crates must be made of non-coniferous wood or plywood (either five-ply or seven-ply). The base should be fitted with pallets or racks suitable for handling by port forklifts. Both the interior, exterior, and bottom surfaces must be thoroughly cleaned to ensure no bark, knots, or tree cavities remain.

　　3. The bottom, sides, and lid of the wooden crate should all be covered with a layer of calcium-plastic board, plastic sheeting, roofing felt, or a layer of plastic film, 3–4 mm thick. Before sealing the crate, place a plastic cover over the machine, then seal the crate.

　　4. For shipping and receiving details, use a coding machine to print the information in the center of the corresponding wooden crate, or print it on A3/A4 paper and affix it to the center of the crate. Seal and protect it with transparent tape or plastic film. Each wooden crate’s marking should correspond one-to-one with its internal packaging items.

　　VII. Additional Notes:

　　1. During inspection, in addition to the detailed list provided by the manufacturer, you should collect as much information as possible on all mechanical accessories, electrical components, bearings, fasteners, connecting parts, pipelines, wear parts, consumables, molds, tools, and other items—including their names, specifications, places of origin, and manufacturer details—and keep thorough records and documentation.

　　2. Acceptance inspections must be documented, and the records must be filled out in detail. If any items fail to meet the standards, an acceptance and rectification notice must be completed and submitted separately to the company and the equipment manufacturer, urging them to make thorough improvements. Finally, a complete machine acceptance report must be prepared.

　　3. During commissioning, operation, and acceptance testing, record the operational steps as much as possible. Learn how to properly install, debug, and operate the machine, and also learn how to handle common faults.

　　4. Collect all materials as required and bring them back to the company for filing after acceptance is complete.

　　5. In addition to the detailed acceptance criteria outlined above, different machines shall also have specific acceptance criteria tailored to their respective characteristics; these criteria shall be used concurrently with these regulations.