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Testing Methods for Blister Package

Testing Methods for Blister Package
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Testing Methods for Blister Package Abstract: Blister Packaging is the main stream of solid drug packaging. This article analyzes the testing requirements for blister packages, and introduces the corresponding testing methods for specific indexes based on specific pharmaceutical package testing standards. Key Words: blister, PTP, oxygen transmission rate, heat seal strength, impact resistance strength Pharmaceutical blister packaging, also called PTP (press through packaging), is one of the main forms of pharmaceutical packaging. It’s suitable for the mechanized packaging for solid medicine with remarkable advantages. The main advantages of blister packaging are as follows: the medicine can be kept in stable and reliable condition; minor amount and serial packaging can be realized easily; the package is safe, hygienic, portable and convenient; it’s with great adaptability and long storage period. Meanwhile, blister packaging possesses many functions, including identification and counter forgery, etc. Now, blister packaging takes up about 30% of the global pharmaceutical packaging market with a trend of stable increase, and will be the main stream for the packaging of Western Medicine and its capsules and tablets, as well as for the packaging of Traditional Chinese Medicine, such as pills, powder and granule, etc. 1. Testing Requirements for Blister Packaging The main packaging subject for blister package is the solid drug. The package should separate the pharmaceuticals from the outside, and avoid the evaporation, release or leakage of the active ingredients inside them. The volatile pharmaceutical ingredients can dissolve inside the packaging material, and diffuse to the outside under the function of pressure differences. For example, the fragrant or volatile ingredients of the solid drug would evaporate and transmit through the materials. On the other hand, the package should guard against the air, moisture, foreign matter and microorganism from direct contact with pharmaceuticals inside. Oxygen, moisture, large amount of microorganism and foreign matters can be found in the air. When such ingredients enter into the packages, they would lead to oxidation, hydrolysis, degradation, pollution and fermentation of the pharmaceuticals. Since the PTP aluminum foil, PVC sheets and the PVC/PVDC laminated sheets applied for the blister packages would contact the pharmaceuticals directly, the material testing should be especially noticed. The testing items include appearance, barrier property, tensile strength, impact resistance strength, thermal tensile ratio and other mechanical properties as well as hygiene indexes, etc., all of which have their respective testing methods and standards (or manufacturer’s standards). Hereinafter, the important testing items for blister packages will be introduced. 2. Barrier Property Testing Barrier property testing is the key testing item for blister packages. Blister barrier property testing includes oxygen transmission rate testing and water vapor transmission rate testing. The testing of oxygen transmission rate for aluminum foil is not mentioned in the standards. However, owing to the fact that this index is in close relationship with the number of the pinholes, if this number can satisfy the requirements in the standards, the oxygen transmission rate can meet the requirement for usage. In actual application, both aluminum and PVC material have high barrier properties. Thus, instruments with high precision should be chosen when purchasing. The testing technologies for oxygen transmission rate and water vapor transmission rate have been popularized. The testing www.labthinkinternational.com.cn

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technology for the barrier property of whole blisters will be emphasized hereinafter. The testing technology for whole package barrier property has become mature. Yet, owing to its small sizes, the whole blister package cannot be tested by the existing whole package testing fixtures. Meanwhile, the strength of aluminum foil is weaker than that of plastics; and thus, whole package barrier property testing technology has not been put to use in blister packages. In fact, owing to the evenness of the adhesives, thermal tensile ratios of the materials as well as the force of aluminum foil, the...

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heat seal strength. 4. Thermal Tensile Ratio Testing Thermal tensile ratio is the important testing item for PVC sheet or PVC/PVDC laminated sheet; it’s defined as the size changes after enduring a certain temperature within a certain period of time, and is the ratio of the spot distance variation and the initial spot distance in percentage. The test should be carried out according to YBB00292004, Test Method for Thermal Tensile Ratio. Cut two square pieces, with each side of 120mm± 1mm, from the sheet. Cut through the central position; and carve two vertical lines, namely AB (lengthwise)...

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