How to check whether the punching process of penicillin bottles meets the standards?
With the standardization of drug clinical trials by the National Drug Administration, the standards and quality of drug clinical trials have been improved. All drugs need to undergo container sealing integrity CCIT testing before they can be put into the market. The airtightness of containers can be tested using physical integrity methods and methodological validation, while most containers use penicillin bottles.
Microporous penicillin bottles also need to be punched and processed according to the standards of the Food and Drug Administration in order to pass the inspection. For example, when punching small holes on penicillin bottles and ampoule bottles, laser punching machines are generally used to complete the process. Laser punching machines can complete micro scale small hole processing, and the punching speed is fast and the quality is good. Traditional drilling machines are unable to drill micro sized holes on this material, and only laser technology can meet the processing requirements for micro hole drilling in ampoules.
So, how do you check if the punching process of penicillin bottles meets the standards?
The advantage of laser drilling technology compared to other processing methods is that the geometric shape and internal gas flow behavior of the leakage hole are close to real defects. The leakage channel generated by laser drilling is an irregular and tortuous channel, which is very close to real defects. Moreover, the area affected by laser drilling heat is very small, and it will not produce thermal effects on the glass, so the effect of laser penicillin glass bottle micro hole processing is very ideal.
National New Technology Metrology Quality Testing:
In addition to self testing with equipment, testing can also be conducted through national quality calibration laboratories and recognized by CNAS. The calibration basis of the National High tech Measurement Station is the calibration method SSF0129-2013, which is tested through a three-dimensional measuring microscope and provides a calibration report.
Laser drilling is suitable for processing a large number of high-density group holes, and can also process small holes on inclined surfaces of difficult to machine materials. Therefore, drilling micro holes on penicillin bottles and ampoule bottles is fast, efficient, and cost-effective, in line with the standards of the Food and Drug Administration.