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Production Instruction of Disposable Surgical Pack

Sep. 05, 2022

1. Objective: To standardize the production of disposable surgical packs and ensure the production quality of the products.

2. Scope of application: The production of disposable surgical pack.

3. The content:

3.1 Process: Execute the Process of Disposable Sterile surgical pack

3.2 Process Instruction

3.2.1 Raw materials: According to the production plan sheet, the production manager will fill in the material claim sheet, and the raw materials delivery personnel will take the sheet to the warehouse to get the raw materials. When receiving raw materials, check whether the outer packing box of raw materials is complete, whether the box identification and quantity are consistent with the material claim list, and send the raw materials to the buffer room for use after confirmation by the special delivery personnel. In the buffer room, carefully remove the outer packaging of raw materials, carefully check whether the inner packaging is damaged, and check whether the quantity, color and specification of raw materials meet the standard. If qualified, release, and if unqualified, return to the warehouse. The qualified raw and auxiliary materials are loaded into the transfer window, and the window is closed for ultraviolet disinfection. The disinfection time is 20 minutes. After disinfection, the personnel in the clean workshop will take them out. After the production personnel take out the raw materials from the transfer window, carefully check the inner packaging

Complete, specification, size, quantity is consistent, raw materials are smooth and clean.

3.2.2 Compound cutting: The production personnel of the clean workshop shall re-check the specification, size and quantity of the raw materials. After qualified, the raw and auxiliary materials shall be placed on the roller in the workshop according to the requirements of the relevant product technical specifications. The operator is responsible for the counting and cutting of the machine, and the other staff is responsible for the spreading, adjusting and aligning of the cloth. When the desired product is reached

In case of quantity, the operator of the cloth breaking machine shall clean up the remaining raw and auxiliary materials of the equipment, instruments and packages. In the case of profiled cutting, the operator of the cloth cutter is responsible for drawing lines on the flat cloth surface first, operating the cloth cutter, and performing profiled cutting according to the line according to the product specifications.

3.2.3 Pasting: The production personnel in the clean room shall paste the raw and auxiliary materials according to the requirements after confirming that all the cutting materials meet the requirements of the product technical specifications.

3.2.4 Folding: After all raw and auxiliary materials are made, according to the requirements of the product technical specifications, the folded products should be folded according to the direction, order and size, and ensure that all products reach the compliance. The folded finished products should be placed on the finished products shelf for use.

3.2.5 Assembly: Place the self-produced products and purchased products in order, direction and position according to the assembly requirements of product technical specifications, and proceed to the next process after checking.

3.2.6 Wrapping: Wrap the folded raw and auxiliary materials according to the product technical specifications. Ensure the consistency of all products.

3.2.7 Small packaging: The packaging personnel will take the numbered packaging bags and pack the products. In the process of packing, attention should be paid to the orientation of the package. Put into the bag to avoid non-woven cloth stick to the bag and affect the quality of the product. Pack the parcel inside as far as possible in order to seal it.

3.2.8 Small package sealing: Plug in the power supply and turn on the power switch to start the sealing machine at a medium speed. Seal the sealing machine when the temperature reaches 170C-180 "C. When sealing, it is strictly forbidden to enter the sealing machine with your hand. After sealing, it will be put into the finished product export, and outer packaging will be carried out in the packaging workshop.

3.2.9 Packing boxes: The products are packed in the packing shop. After packing, label the product on the mouth of the box and put it into the packing box. After packing, seal the packing case and attach the product label. Turn on the strapping machine. Adjust the length of the feed belt and preheat the temperature. Bundle the product after preheating. After the bundle is finished, put the finished product into export, fill in the warehouse entry Form and submit it to the warehouse for management.

3. 2. 10 Outsourcing sterilization: The warehouse manager shall send the products to be sterilized to the third party for outsourcing sterilization.

3. 2.11 Inspection of finished products: After the completion of sterilization, the quality inspection department shall conduct sampling inspection and issue the Product Delivery Inspection Report. The qualified products shall be put into storage, and the unqualified products shall be executed according to the Nonconforming Product Control Procedure.


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