Primary packaging qualification and ancillary tests

Full client support for the in-process materials qualification and ancillary tests according to the last regulatory guidelines. An unique team of project managers is able to define the validation studies, issue the validation documentation and support clients until regulatory submission and audit. An expert team of laboratory technicians perform tests in GMP-oriented regime.

Main regulatory and technical references: Annex 1, USP <87>, USP <88>, USP <381>, USP <661.2>, USP <1660>, USP <1663>, USP <1664>

Tests that we are able to perform on process and test filters are:

 

Adsorption test: to demonstrate that the final container al does not bind drug components affecting product specifications, e.g. API title decrease. The evaluation in performed by comparison of the product composition pre and post accelerated storage study.

Extractables test: to demonstrate that the final container does not alter, under worst-case storage conditions, the quality of the drug product. Specific analytical techniques (GC/MS, Q-TOF and ICP/MS) are performed to evaluate the presence of extractables compounds potentially toxic for patients. Semi-quantitative analysis are applied to detect and quantify a wide range of extractables compounds. Following extractables results, specific toxicological assessment can be issued.

Leachables test: to demonstrate that the final container does not alter, under routine storage conditions, the quality of the drug product. Specific analytical techniques are validated to monitor the presence of potential leachables compounds at different time points during the overall storage time. Leachables studies are designed following extractables studies. Following leachables results, specific toxicological assessment can be issued.

Glass inner surface durability test: to demonstrate the suitability of the glass packaging components through pH, conductivity and glass particles measurements; individual extracted elements (ICP/MS) and glass surface evaluation (SEM-EDS).

Container closure integrity test: to demonstrate the integrity of the container closure simulating the stresses during storage, distribution and use. Relevant types of stress include temperature, pressure and relative humidity extremes, shock and vibrational stress and exposure to microorganisms

Biological tests: to evaluate the biological reactivity of plastics and elastomers on cell culture and animals and classify plastics accordingly.

Physic chemical and functionality tests: to perform specific tests that allow a well-characterization of the materials for pharmaceutical use, e.g. appearance of solution, acidity or alkalinity, absorbance, penetrability, fragmentation, self-sealing capacity, etc.

For more information, please contact:

Manfredi