Testing service looks to ensure glass packaging adequacy

By Vassia Barba

- Last updated on GMT

(Image: Getty/andrei_r)
(Image: Getty/andrei_r)

Related tags Packaging Glass packaging Testing Partnership

Glass packaging provider joins forces with a vacuum pump manufacturer to design a packaging testing service.

Italy-based Stevanato Group, a producer of glass primary packaging for pharmaceuticals, announced an agreement with Pfeiffer Vacuum Technologies, in order to provide characterization testing services for container-closure systems.

Under the agreement, the partners aim to assist pharmaceutical manufacturers to comply with ‘increasingly strict’ standard requirements, in terms of reliability of container closure integrity (CCI) testing, explained Abizer Harianawala, Stevanato’s site leader.

The executive added that the project is expected to support the quality, integrity and effectiveness of sensitive biotherapeutics, preventing issues such as moisture, oxygen or microbial contamination.

The joint work will take place at Stevanato’s Technology Excellence Center (TEC), due to open in Boston in Q3 2020, and will include analytical and testing services related to container closure systems and drug delivery devices – as well as a set of customized analytics and testing services for drug formulation and manufacturing processes.

Asked to further explain CCI analysis and its importance for manufacturers, Harianawala tols us that this is a ‘key feature’ in preserving the sterility of a drug product throughout its shelf-life.

Specifically, the technology evaluates the adequacy of container closure systems to maintain a sterile barrier against potential contaminants, such as microorganisms, reactive gases, and other substances.

According to the executive, the testing technology takes into consideration both primary and secondary packaging components, meaning glass vials or syringes, as well as aluminum caps and stoppers.

Challenges in device manufacturing

When asked to explain the manufacturing challenges that the testing service aims to address, Harianawala explained that the main challenge derives from the fact that often the drug must be integrated into a medical device.

“In order to speed up the time to market and streamline the development process, the chance that a device is needed in combination with a drug should be raised as soon as possible, selecting the appropriate route of administration from the very beginning,” ​he said.

Ultimately, the joint service is expected to help clients in building their ‘drug-device combination’ development strategy, by testing their primary packaging in contact with the drug, and the compatibility of the final route of administration, which could be a wearable device, a pen injector, or an auto-injector, with the primary packaging.

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