Testing requirements for blister packaging

Testing requirements for blister packaging

The main packaging object of blister packaging is solid drugs. The packaging should isolate the drug preparations contained in the packaging from the outside world, so as to prevent the volatile, escape and leakage of the active ingredients of the drug on the one hand. Volatile pharmaceutical ingredients can be dissolved in the inner side of the packaging material and spread to the other side under the action of osmotic pressure, such as solid pharmaceutical preparations containing aromatic ingredients and endogenous volatile active ingredients, whose active ingredients are volatile and penetrate some materials. On the other hand, it can prevent the outside air, moisture, foreign matter and microorganisms from entering and contacting with the drug. The air contains oxygen, water, a large number of microorganisms and foreign matter particles, these components into the packaging will lead to oxidation, hydrolysis, degradation, contamination and fermentation of the drug.

PTP aluminum foil and PVC rigid sheet or PVC/PVDC composite rigid sheet used for blister packaging will come into direct contact with drugs. Therefore, special attention should be paid to the detection of materials, including appearance, barrier properties, tensile strength, impact strength, thermal shrinkage and other mechanical properties, as well as health indicators, etc. There are corresponding detection methods and standards (or enterprise standards).