Package Compatibility and Packaging Sealability Testing

Different drug dosage forms and different types of packaging materials have different compatibility study methods. CD Formulation designs a reasonable extraction scheme based on the characteristics of the packaging materials, different dosage forms, and the potential risk assessment of extractable extracts to clarify the target leachate, develop leachate testing methods and validate them, and stability sample testing; finally, the data is aggregated for the overall assessment of package material compatibility. Finally, the data is aggregated for overall package compatibility assessment.

The overall sealing performance and internal gas residue of the vacuum packaging of drugs directly affects the quality of drugs, especially for sterile drugs, the leakage of the packaging will directly cause the invasion of microorganisms, and for nitrogen-filled unstable drugs, the invasion of air will directly cause changes in the chemical properties of drugs. Once there are unqualified drugs into the market, it will cause great potential danger to patients' drug safety.

The vacuum decay method in the drug package sealing test is applicable to many dosage forms, fast detection, and accurate test results. The following table shows the test method of package tightness.

Detection method	Application scope	Common packaging types
High pressure discharge method	The product is conductive and the packaging is relatively non-conductive.	Soft bags, BFS, ampoules
Laser headspace analysis method	With certain headspace conditions, such as N₂, CO₂ or vacuum packaging, and the packaging container needs to be transparent.	Controlled syringes, ampoules
Mass extraction method	Suitable for all packaging forms and products of conventional chemical injectables.	Almost all types of packaging such as cillin bottles, ampoules, infusion bags, pre-filled and sealed, BFS, etc.
Vacuum decay method	Suitable for most chemical injection packaging forms and products.	Nearly all rigid containers such as syringine bottles, ampoules, pre-filled and sealed and some PP infusion bottles
Pressure decay method	Only suitable for rigid container solid formulations, not for solution formulations.	Lyophilized/powder injection vials
High pressure discharge method	The product is conductive and the packaging is relatively non-conductive.	Soft bags, BFS, ampoules

Our Services

CD Formulation offers a full range of packaging testing services, including package compatibility and package sealability services, which can cover the mechanical and climatic conditions that products may encounter during transportation and storage. As part of our testing program, we are able to determine the vulnerability of a product and therefore determine the appropriate level of packaging protection. In addition to reducing the risk of product breakage during shipping, we provide advice that can help you keep costs as low as possible by removing excess or unnecessary packaging.

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Why is Packaging Compatibility and Sealability Testing so Important?

Packaging testing ensures that your packaging will protect your products from damage or degradation during shipping and distribution. Packaging testing can also help you reduce costs by discovering the most appropriate level of protection and by reducing the amount of material required for packaging.

If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.

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Please note: Our products and services are not intended to be used directly in diagnostic or therapeutic procedures.