The lights were still on in the laboratory at three o'clock in the morning. Xiao Liu from the quality inspection department stared at the microscope and suddenly jumped up: "It's done! The 30th peel test, the sealing strength is completely up to standard!" This joy started half a year ago-at that time, a leading medical device factory in China came to the door and pointed to the packaging machine being debugged in our workshop and said: "Do you dare to take on a hard bone? We have to pass ISO 11607 certification!"
The lesson taught by surgical blades
Medical device sterilization packaging is not an ordinary food bag. The suture strength alone must withstand the dual test of steam sterilization and long-distance transportation. There is a special case in the samples brought by the customer: the packaging bag of a certain brand of surgical blades was cut through the sterile barrier by the blade tip during transportation. We dismantled more than 300 failed samples and found that the problem lies in the pressure fluctuation of the heat sealing head of the traditional packaging machine.
"We have to make every action of the packaging machine medical device sterilization as smooth as an electrocardiogram!" Technical Director Lao Chen led the team to redesign the pressure compensation module. Now when the machine is heat-sealed, even if the assembly line speed is switched from 20 bags per minute to 50 bags per minute, the pressure fluctuation is controlled within ±5% of the industry standard. Last month, when the customer video acceptance was conducted, a 0.1 mm thick Teflon film was used for testing. The peel strength at the seal was 30% higher than that of conventional materials.
Equip the packaging bag with an "anti-theft lock"
What are medical devices most afraid of? It's not sterilization failure, but secondary contamination after sterilization! We added a "double insurance" to this packaging machine medical device sterilization system:
1. The online visual inspection instrument scans each packaging bag like a security inspection machine, and directly kicks it out if it finds a pinhole defect
2. The laser microcode is printed on the seal, which is equivalent to equipping each sterile barrier system with an ID card
The last time I went to the customer factory for training, I happened to encounter their flight inspection. The auditor randomly selected ten packaging bags to scan the code, and all the codes from the sterilization date to the operator number matched. He gave a thumbs up on the spot: "This traceability system is hardcore enough!"
Golden parameters were found in three months
The most fatal thing about medical device sterilization is parameter stability. If the temperature deviation of ethylene oxide sterilization exceeds 2°C, the entire batch of products will be scrapped. Our factory's debugging team spent three full months in the customer's workshop and recorded three full notebooks of data:
· Developed a temperature and humidity curve library suitable for different packaging materials
· Developed a sealing algorithm that automatically compensates for changes in ambient air pressure
· Created a unique "secondary buffer edge sealing" technology for sharp products
Now their production line is amazing. In the morning, they are still vacuum packaging orthopedic drills, and in the afternoon, they switch to large-volume surgical instrument packages. The sterilization process parameters are automatically matched, and the switching time is compressed from two hours to twenty minutes. The workshop director, Lao Li, joked: "Your machine is smarter than our dishwasher!"
The real test shows the truth
The most exciting moment was the joint verification last month:
1.Accelerated aging test: After simulating a three-year storage environment, the tearing force of the packaging bag still exceeds the industry standard by 20%
2.Transportation simulation test: After 72 hours of high-frequency vibration, the sterile barrier system is 100% intact
3.Clinical scenario test: Medical staff can easily tear open the package even with seven layers of gloves
The customer slapped his thigh with the report: "If we had known that your packaging machine medical device sterilization is so reliable, we could have saved seven figures in the loss of the return batch last year!"
"Unexpected harvest" at four o'clock in the morning
There was an episode during the verification period - one day the night shift worker mistakenly raised the sealing temperature by 10℃, but the system immediately alarmed and locked the equipment. This incident made the customer's quality director discover a treasure: "Your fool-proof design is more useful than the ERP system we bought at a high price!" Now all ten of their OEM factories have installed the same early warning module.
Standing in the customer's workshop and looking at the glittering packaging machine, I suddenly remembered the days when I followed my master to repair the first domestic sterilizer 20 years ago. Who could have thought at that time that our Chinese-made packaging equipment can now withstand the test of top international certification? At the next industry forum, I must let those colleagues who always talk about "imported equipment" take a good look at what the hard power of Chinese smart manufacturing is!
(Note: To protect customer privacy, the company information in the article has been blurred)
