Packaging system integrity solution

Methods of integrity control, detection and verification of film packaging Overview: the integrity of aseptic packaging system is the key control point to ensure the quality of drugs in the process of transportation, storage and transportation Therefore, the index must be controllable, testable and verifiable, and only in this way can the product quality be effectively controlled, and the integrity control strategy needs to be determined in the product development stage and in the control strategy Only through good implementation can safe and effective drugs be applied to patients Packaging integrity detectability: usp1207 chapter describes and specifies this in detail, and divides the detection methods into two categories, including: traditional methods, including: microbial challenge method and color water method, both of which are destructive methods, so they are only suitable for sampling inspection, not for full inspection, so they are probabilistic methods The second method is called new method, which can test the product 100% and can be used in the process of central control to ensure the product quality, including: Vacuum attenuation method (applicable to soft packaging), high-voltage discharge method (applicable to container insulation, filler conductivity, and bottle medicine) and laser method Pharmaceutical enterprises can select appropriate methods according to product characteristics and quality system requirements Packaging integrity verifiability: the verification of the packaging system can be done separately for the packaging system, or combined with the 3Q verification of the equipment, but it should be documented and can prove the integrity effect of the packaging system Iso11607-2 specifies the development and validation of the packaging process of the final sterilized medical devices, including the molding, sealing and assembly of the preformed sterile barrier system and the packaging system Although the standard is aimed at the field of medical devices, it also has reference value in the pharmaceutical industry Controllability of packaging integrity: in order to achieve controllability of packaging system integrity, our way is to use equipment with stable performance, and try to avoid the method controlled by manual experience, because the latter has relatively low reproducibility and great difference between personnel operation Next, we take the heat sealing process of film packaging materials as an example to explain the controllability of the integrity of the packaging system in detail: our equipment is the sealing machine, while the sealing machines in the market are mixed What is the difference between them? To solve this problem, we must start with the principle of sealing machine: The sealing machine can be divided into two types in terms of heating mode, one is continuous heating sealing machine, the other is pulse heating sealing machine The continuous sealing machine is that the temperature of heating wire starts to rise after the power supply is connected, and the temperature will rise with the extension of time Therefore, the typical feature of this kind of sealing machine is that it needs preheating before normal use Pulse type sealing machine is a sealing machine with intermittent heating This kind of sealing machine will not heat immediately after the power supply is connected, but will heat only after the heating switch is turned on When the heating switch is turned off, the heating will stop immediately There is no direct relationship between the temperature of the heating rod and the time when the power supply is connected Therefore, the typical feature of this kind of sealing machine is that it does not need preheating and can achieve pre heating instantaneously Set the temperature Then some friends may ask: is the sealing machine based on pulse principle able to meet the requirements of controllable sealing quality? The answer is clearly no Because the pulse sealer is divided into verifiable and non verifiable, the verifiable sealer can effectively control and verify the three key quality parameters required by the heat sealing process: temperature, time and pressure, while the non verifiable sealer can only control the three key quality parameters formally The specific meanings of the three key quality parameters are as follows: temperature control: it means that after the heating rod reaches the preset temperature, it will not continue to rise with the extension of time, and it can be stabilized at the preset temperature, and the key is to ensure that the heat distribution of each point of the heating rod is uniform; time: it refers to the real heat closing time up to the set temperature, rather than the total time of the heating process; Pressure: refers to the bite force of the packaging material heated and formed after the heating rod is closed This value cannot be too large or too small, and the size of this value needs to be determined according to the nature of the material to be heated, and it needs to be calibrated and adjustable regularly Speed of production and convenience of operation: many influencing factors need to be considered in the production process, because once the operation efficiency and comfort of the staff are affected, the staff may not complete the operation according to the established operation procedures Therefore, the establishment of sealing machine supporting facilities is also very important to ensure the quality of products.