Last week, Mr. Zhang from a pharmaceutical company in Guangdong called me in a hurry: "The granule production line that just passed the GMP certification actually detected residues of the previous batch of drugs in the container!" This sounds scary, but Lao Li, an old technician who has worked in our factory for fifteen years, is not surprised - the cleaning dead corners of pharmaceutical granule packaging machines have always been a "tough nut to crack" for pharmaceutical factories.
To talk about the door to container cleaning, we have to start from helping a Yunnan customer transform the production line last year. Their pharmaceutical granule packaging machine, which has been used for eight years, has to be dismantled and soaked in alkaline water every time a variety is changed, and then the machine is installed again. This process alone takes two days. Our workshop director, Lao Wang, watched the three-shift work at the site and found that the workers used a toothbrush dipped in alcohol to poke the gap at the bottom of the cup. He was so anxious that he stamped his feet on the spot: "If this encounters a surprise inspection, ten GMP certificates will not be enough to revoke it!"
After returning, he led our R&D team to work hard. First, the container was changed from integral casting to modular splicing. Now it is only six stainless steel components when disassembled, and the blind spot is reduced by 80%. I went back to the pharmaceutical factory for verification. In front of the QA manager, I reduced the disassembly and assembly time from two hours to twenty minutes. The other party stared at the stopwatch and muttered: "This is more efficient than washing our laboratory beakers!"
The detergent formula is even more difficult. After trying more than 70 combinations, we finally decided on a food-grade alkaline cleaning solution with high-temperature pure water. Last month, I did a cleaning verification for a customer in Northeast China. I took a cotton swab to sample the dead corner of the cup wall. The microbial culture results were cleaner than their clean area countertops. Now this set of cleaning procedures can even deal with the sticky residue of Chinese medicine powder. The washed container feels like a newly opened medical device.
The most amazing one is our self-created "three-light detection method". Use a strong flashlight to shine on the cup wall at a 45-degree angle. If there is no reflection, there is no water stain; use ultraviolet light to shine around, and the fluorescence reaction will immediately appear if it exceeds the standard; finally, use an endoscope probe to extend into the guide trough, and the particle residue will be visible under the lens. Liu, the factory director in Hebei, saw this scene with his own eyes, and sent his entire QA class for training: "Your method is more ruthless than our laboratory equipment!"
Pollution prevention must be treated from the root. Now the container of the medical granule packaging machine we ship out of the factory is all replaced with mirror-grade stainless steel, and the roughness is controlled below 0.8μm - let's put it this way, it is at the same level as the polishing level of surgical blades. A processing company has done a comparative test. The same Panax notoginseng powder, the residue is 60% less when packaged with our equipment than that of other companies.
Cleaning validation data is even more serious. Every machine must pass the "abnormal test" before leaving the factory: deliberately apply honey and pearl powder in the container, run the automatic cleaning program, and then take samples for inspection. Last year, a multinational pharmaceutical company came to inspect the factory. Seeing the three words "not detected" on the test report, it forced us to shoot a half-hour video as a chain of evidence.
Recently, I am working on the intelligent cleaning system again. Install a pressure sensor on the container, and you can tell whether it is cleaned by looking at the data fluctuations. After trying this black technology, Mr. Chen, a customer from Zhejiang, was happy to annotate on the acceptance form: "This time, I am finally not afraid that the night shift workers will be lazy and not rinse it clean!"
In the final analysis, the cleaning of the container of the pharmaceutical granule packaging machine is not a simple flushing and drying, but a protracted battle with GMP. The last time the inspection team raided an old customer, they praised him on the spot after checking the cleaning records: "Your SOP is more detailed than our inspection guide!" These words are encouraging to hear, but we know clearly in our hearts - medicine bottles are related to human lives, and a few grains of residue in a container are like the sword of Damocles hanging over our heads.
