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Blister Package testing

Product catalog summary

Introduction
This document discusses the testing methods for blister packaging, a prevalent form of pharmaceutical packaging known for its stability, safety, and convenience. Blister packaging is widely used for both Western and Traditional Chinese Medicine.

1. Testing Requirements for Blister Packaging
The primary function of blister packaging is to protect solid drugs from external factors such as air, moisture, and microorganisms, which can lead to degradation. Testing focuses on materials like PTP aluminum foil and PVC sheets, assessing their appearance, barrier properties, tensile strength, and hygiene.

2. Barrier Property Testing
Barrier property testing is crucial, focusing on oxygen and water vapor transmission rates. Although whole package testing is challenging due to the small size and weaker strength of aluminum foil, specialized fixtures and methods are used to assess the barrier properties effectively.

3. Heat Seal Strength Testing
Heat seal strength is vital for ensuring the sealing performance of blister packages. The testing involves sealing PVC sheets with aluminum foil and measuring the force required to peel them apart.

4. Thermal Tensile Ratio Testing
This test measures the size change of PVC sheets after exposure to heat, ensuring they remain within a ±6% variation as per standards.

5. Impact Resistance Strength Testing
Impact resistance is tested using a falling ball impact tester to ensure the material can withstand the manufacturing process without damage.

6. Conclusions
While blister packaging standards are developing, they lag behind those of developed countries. Improving and updating these standards is essential for advancing testing technology and packaging quality.

Catalog excerpts

LabthinkInstruments Co.,L TD 144 Wuyingshan Road, Jinan, China Tel: +86-531-85811021 85864214 Fax: +86-531-85812140 E-mail: [email protected] 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’ suitable for the mechanized packaging for solid medicine with remarkable s 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’ with great adaptability and long storage period. Meanwhile, blister packaging s 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’ standards). Hereinafter, the important testing items for blister packages will be s 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 technology for the barrier property of whole blisters will be emphasized hereinafter.

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LabthinkInstruments Co.,L TD 144 Wuyingshan Road, Jinan, China Tel: +86-531-85811021 85864214 Fax: +86-531-85812140 E-mail: [email protected] 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...

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LabthinkInstruments Co.,L TD 144 Wuyingshan Road, Jinan, China Tel: +86-531-85811021 85864214 Fax: +86-531-85812140 E-mail: [email protected] 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’ defined as s 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,...

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