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18.10.2021

SYRINGE TESTING WITH GBA PHARMA LABS

GBA Pharma Labs have expanded their testing portfolio in the field of syringe testing. With the zwickiLine testing machine from ZwickRoell required tests can be performed with standardized test tools and prepared standard test specifications. This significantly reduces the adjustment effort prior to testing. Tests on primary packaging materials and on the combination of drug and primary packaging material (known as a combination product) have gained in importance. Numerous ISO standards such as ISO 11040 for prefilled syringes and various chapters of the US Pharmacopeia (USP) such as USP <382> or USP <1382> require physical and functional testing of combination products.

Glide force testing on pre-filled syringes according to ISO 11040-4 Annex E/G2.

The requirements for a testing system and especially for those in the regulatory environment are very high. As a testing service provider, there is also the need to implement a wide variety of tests according to our customer´s requirements. Therefor GBA Pharma Labs also offer regulatory compliant handling of potent active ingredients as part of the quality control and release processes for pharmaceutical and biotechnology products. First of all, 2 tests are relevant. Due to the large demand for Corona vaccine, penetration tests with hypodermic needles on vials are required. Furthermore, breakaway and glide force tests on pre-filled syringes according to ISO 11040-4 Annex E and G2 as well as USP <1382> should also be performed.

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