Packaging Pharma

Batch testing ensures compliance with standards and regulations, ensuring consumer safety.

LabAnalysis Life Science can perform quality control analyzes in accordance with the provisions of the main Pharmacopoeias (EP, USP, JP).

The new version of Annex 1 of the EU GMP specifically dedicated to the production of sterile medicinal products has recently come into force.

Major regulatory authorities, including the EMA and FDA, are placing increasing emphasis on the proper design and conduct of closure integrity testing to ensure the safety of pharmaceutical products.

The correct implementation of such practices will not only help preserve the integrity of the container, but also ensure the sterility of the drugs throughout their life cycle.

Container closure integrity testing (CCIT) is essential to maintain the sterility and quality of parenteral products throughout their shelf-life and use1. There are several methods for CCI testing, including dye ingress (Dye Ingress) and microbial ingress (Microbial Ingress) tests. 

Seam integrity and Dye Ingress tests have long been performed in accordance with USP <1207> and according to accredited test procedures such as ASTM F1886/F1886M-16, ASTM F1929-15.

The Dye Ingress test is a very effective test that, if performed well, can give a guarantee on the tightness of closures. 

LabAnalysis Life Science is able to perform Microbial Ingress with various microorganisms including Brevundimonas Diminuta, which due to its small size is the Worst Case of Microbia Ingress.

During the production phase of a drug or during the storage phase, numerous contaminants can be released from the materials, through direct or indirect contact, between the packaging material and the active ingredient or the formulated product.

These molecules are defined as Extractables or Leachables and their determination is one of the regulatory requirements for patient safety. Extractables are all compounds that can be extracted from materials if placed in contact with solvents/simulants under controlled time and temperature conditions, which are worse conditions than those of normal use.

Extractables can potentially migrate into the drug.

Leachables are all compounds that migrate into the pharmaceutical product from any material following contact, direct or indirect, between the material and the product itself during the production phase or during storage of the pharmaceutical product.

LabAnalysis Life Science, making use of consolidated experience deriving from the execution of hundreds of Extractables and Leachables studies, is able to carry out L&E studies on a vast range of materials (primary and secondary packaging, dispensing and dosing systems, industrial components , filtering systems) and pharmaceutical products (active pharmaceutical ingredients and formulated products).

LabAnalysis Life Science also has the latest generation chromatographic and structural characterization technologies:

• HPLC-MS-MS positive and negative for non-volatile compounds
• GC-MS for semi-volatile compounds
• ICP-MS for elemental impurities (metals)
• GC-MS or HPLC-MS for nitrosamines
• HS-GC / MS to highlight volatile compounds (test performed directly on the packaging)
• IC to highlight ionic compounds

LabAnalysis Life Science guarantees the sharing of the technical approach of the Extractables and Leachables studies with the client by drawing up a Study Protocol containing information regarding the purpose of the activity, the analytical methods, the extraction and treatment conditions of the samples, the processing and presentation of results, regulatory references. At the end of the experimental activity, LabAnalysis Life Science guarantees the drafting of the relevant Study Report containing all the experimental information, the numerical data obtained, the structural characterizations, the chromatographic traces and the discussions of the results.