Pharmaceutical packaging

Dear Customer,

Pharmaceutical packaging is obliged to comply with many functions. And it has an influence on the quality, effectiveness and applicability of pharmaceuticals which cannot be underestimated.

Pharmaceutical packaging

Protection, safety, compatibility, and function

This particularly applies for primary packaging, i.e. packaging which comes or can potentially come into direct contact with the dosage form, such as ampoules, ready-to-fill syringes, blister packs, pharmaceutical stoppers or other types of pharmaceutical seals. Therefore, the requirement profile – protection, safety, compatibility and function – needs to be complied with as early as the packaging development phase.

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Comprehensive tests for pharmaceutical stoppers

Furthermore, test certificates in accordance with USP 381 are required for pharmaceutical stoppers (and other pharmaceutical seals) as primary packaging. What is behind all this? As a general rule, the USP 381 regulates the properties of pharmaceutical seals (elastomeric closures for injections). Specifically, the USP 381 includes both the certificate of bio-compatibility and physical-chemical tests and functional tests.

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Sophisticated TPE varieties for pharmaceutical stoppers

PROVAMED® TPE for pharmaceutical stoppers have been compounded in accordance with various material approaches for a variety of raw materials and subjected to extensive testing. In view of the highest demands on low migration, compatibility on contact with the human body and FDA conformity, it has been possible to present formulae whose performance and conformity comply with USP 381.

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Further tests

As a general rule and for reasons relating to accountability, we subject our materials to further tests, including at the request of our customers, e.g. on the topic of oxygen permeability, non-intentionally applied substances (NIAS) or allergens. The TPE offered by ACTEGA DS are also free of PVC, phthalates, latex and ADC and do not require any cross-linkers such as rubber or vulcanized rubber.

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