CHENGDU OCI MEDICAL DEVICES CO.

, LTD
No.2401, West Port Avenue, Southwest Airport Economic Development Zone,
Shuangliu District, Chengdu, Sichuan Province, China.
Tel.: +86-28-67085899 Fax: +86-28-67085880

Flowchart of Product Manufacturing Process

Injection molded parts

Product Name: Polyethersulfone Hollow Fiber Hemodialyzer

1. The Flow Chart of the Manufacturing Process Rough cleaning

PES/DMAC
Fine cleaning of housing Polyurethane
glue

Preparing of spinning Cleaning Embedding of

Rotating Potting▲
Spinning▲ of fiber
solution and core liquid fiber bundle

Internal Testing of Ultrasonic welding Initial

Drying Reinspecting Cutting
packaging★ pressure of the end cap▲ inspecting
★

External Sterilizing★ Testing Warehousing

packing

NOTE: ▲Stands for “KEY PROCESS”; ★Stands for “SPECIAL PROCESS”.

The processes in the dashed box are conducted in the purifying area of class 100,000.

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CHENGDU OCI MEDICAL DEVICES CO., LTD
No.2401, West Port Avenue, Southwest Airport Economic Development Zone,
Shuangliu District, Chengdu, Sichuan Province, China.
Tel.: +86-28-67085899 Fax: +86-28-67085880

2. General summary of the manufacturing process

No. Process Brief Description

1 PES/DMAC Purchasing raw material PES/DMAC from supplies.

PES is the material of the membrane, DMAC is the solution for PES;
Spinning solution charge mixture:
According to the formula, add solvent DMAC, add water, add additives, and finally add PES;
Open the dosing kettle to heat and dissolve the above solution;
Start the vacuum pump to defoaming the spinning solution;
Preparing of spinning solution
2 The spinning solution is kept at certain temperature and pressure;
and core liquid
Core liquid charge mixture:
Add solvent DMAC and add water according to the formula;
Core liquid circulation to discharge bubble;
Adjust the core liquid concentration to the required value;
The spinning solution and core liquid will be ready.
The spinning solution and core liquid were processed by spinning machine and spinneret. The core liquid and spinning
solution in the agitator are pumped to the head of the spinning machine through the pipe. By controlling the head temperature
3 Spinning the fiber
and pressure, the nozzle of the spinning machine will eject the fiber, which flows into the condensation tank and is
immediately formed into hollow fiber.
Since there is still solvent DMAC on the formed hollow fiber, in order to remove these solvent residues, the hollow fiber will
4 Cleaning of fiber be washed with purified water through several water washing systems. After washing the hollow fiber, moisture will remain.
Therefore, it needs to go through several drying systems to dry the hollow fiber at a certain temperature to remove moisture.
Pull the hollow fiber out of the wave shaping machine and put the hollow fiber into the suction port; Remove static electricity
from hollow fiber; Install the fiber collecting wheel; Set the number of reels on the counter; Winding the hollow fiber onto the
5 Rotating
take-up rack; Stop reeling after receiving the required quantity; Wrap the hollow fiber on the take-up frame with wrapping
film and cut it as required; Then carry out fine cutting on the fine cutting machine.
Injection molded parts and Purchasing raw material Injection molded parts (Housing/End Cap/Pot Cap/Supporting bond/Supporting ring) and
6
Polyurethane glue Polyurethane glue from supplies.
Through the ultrasonic cleaning tank, clean the externally purchased injection molded parts with purified water at the
7 Roughing cleaning
specified temperature and ultrasonic frequency for several minutes; The injection molding parts are cleaned and then

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CHENGDU OCI MEDICAL DEVICES CO., LTD
No.2401, West Port Avenue, Southwest Airport Economic Development Zone,
Shuangliu District, Chengdu, Sichuan Province, China.
Tel.: +86-28-67085899 Fax: +86-28-67085880
transferred to the clean room of class 100,000.
In the clean room area, through the ultrasonic cleaning tank, use the mixed water of purified water and injection water to
8 Fine cleaning clean the finely cleaned injection molded parts for several minutes at the specified temperature and ultrasonic frequency, and
dry them for standby in the clean room of class 100,000.
Install the supporting ring on the cleaned and dried housing, put the finely cutting hollow fiber into the housing, and then pull
9 Embedding of fiber bundle out the wrapping film. Then these products are placed on the aluminum foil sintering machine station stably, and aluminum
foil sheets are sintered on both ends.
Install the mixing pipe on the glue injection valve;
Place the product in the centrifuge, and place 3 products in each centrifuge; Place the product steadily and cover it.
10 Potting Start the equipment and inject glue into the product;
After the centrifuge stops running, take out the product, put it into the turnover box (or other storage equipment) for glue
curing.
After the start-up spot check is completed and it is confirmed that there is no abnormality, place the products to be cut on the
cutting machine, and press the start buttons on both sides at the same time;
11 Cutting
After the products are cut in turn, removed the excessive end of the fiber bundle. the products are removed and placed in the
material cart, and the cut products are transferred to the preliminary inspection process;
Turn on the table lamp and prepare the product and magnifying glass.
Check the product appearance first.
The operator shall observe with the naked eye or through a magnifying glass, and record the number of inaccuracies seen
12 Initial inspecting
through the principle that it can reflect light when blocked by glue.
If nonconforming products are found, put them into the nonconforming product turnover box.
Put the inspected products into the turnover box and fill in the production record on duty.
Start the leak detector equipment, install the flushing sample, and flush the leak detector pipeline for 3 times;
After washing, spot check all stations of the leak detector with qualified samples and unqualified samples;
After the spot check is confirmed, place the product on the qualified station;
Start the button and the product enters the detection state;
13 Reinspecting After the test, the indicator light displays green to indicate qualified, and the indicator light displays red to indicate
unqualified;
Press the green button to remove the product;
The qualified products are transferred to the drying process for drying; If the test is unqualified, put the unqualified products
in the unqualified product turnover box and mark them properly.

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CHENGDU OCI MEDICAL DEVICES CO., LTD
No.2401, West Port Avenue, Southwest Airport Economic Development Zone,
Shuangliu District, Chengdu, Sichuan Province, China.
Tel.: +86-28-67085899 Fax: +86-28-67085880
Spot check the drying process parameters;
After the drying machine passes the spot check, install the product on the station;
Start the switch, and the product enters the drying state;
14 Drying
When the outlet exhaust temperature of each drying station of the dialyzer meets the requirements, the station will
automatically stop running;
After drying, remove the product, put it into the turnover box and flow into the next process.
Turn on the power supply and compressed air, turn on the power switch of the controller, and start the welding procedure;
Key parameter check and process monitoring; Key parameters shall be checked and recorded every four hours, and each
Ultrasonic welding of the end
15 batch shall be checked at least twice;
cap
Put the product into the station for automatic welding;
After welding, check whether there is any defect. If it is qualified, it will flow to the next process.
Start up spot check and confirmation;
Spot check of pressure test equipment: spot check each station of pressure test equipment with spot check samples of
qualified and unqualified products;
16 Testing of pressure Place the products on the position where the pressure test equipment has passed the spot inspection;
Observe the pressure test results. If the pressure test indicator is green, it means that the pressure test is qualified; if the
indicator is red, it means that the pressure test is unqualified;
Qualified products flow into the next process.
Confirmation of label printing content: the first printed label of the shift or the first printed label after changing the batch must
be confirmed by the operator and quality personnel. The production date shall is set as the first packaging time of the batch;
Confirmation of the process parameters of the packaging machine: confirm the packaging temperature according to different
types of primary bags and the corresponding packaging process parameters of the equipment;
After the product label is printed and confirmed to be correct, place the product on the automatic labeling machine for
automatic labeling. After labeling, check again that the label information of the labeled product is correct and the product
17 Internal packaging
appearance is free of defects;
Put the qualified products into bags;
Confirm that the temperature of the sealing machine meets the requirements in the inner package process parameters, and the
plastic sealing speed is specified at certain rate;
After the sealing temperature and plastic sealing speed are confirmed to be correct, the bagged products shall be sealed in the
inner bag and flow into the outsourcing process.
After the outer carton is brought into the external packing room, the sterilization instruction label shall be pasted at the
18 External packaging
designated position;

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CHENGDU OCI MEDICAL DEVICES CO., LTD
No.2401, West Port Avenue, Southwest Airport Economic Development Zone,
Shuangliu District, Chengdu, Sichuan Province, China.
Tel.: +86-28-67085899 Fax: +86-28-67085880
Use cartons of corresponding models and specifications. First put a layer of clapboard at the bottom of the outer box. After
each layer of products, put a layer of clapboard. Each layer has 5/6 pieces, a total of 4 layers, 20/24 products are a box. After
the last layer of products is loaded, put a instruction for use. Put the last layer of clapboard into the back sealing box, weigh
and pack.
Check whether the weight is within the specified range by a electronic scale.
Put the packed products on a pallet and transport the whole vehicle to the outsourced irradiation institution for irradiation
19 Sterilization
gamma sterilization. The Sterilization dose range is between 16.2KGY to 28KGY.
The personnel of the quality department shall take a certain proportion of samples for delivery inspection; The test contents
20 Inspection shall be in accordance with relevant standards and requirements. After passing the inspection, the legal department shall
release the product and enter the warehouse for storage.
Store the products in the warehouse under the specified temperature and conditions according to the requirements: Store in a
21 Warehousing
dry place with ventilated, clean, non-corrosive air within the temperature of 0~40oC.

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