Fast and accurate in-package analysis of filling products

Modern drug development and manufacturing monitoring requires the creation of efficient processes, fine-tuned evaluation of efficacy and establishment of safety and manufacturing controls in order to provide high quality, safe, active pharmaceutical ingredients (APIs) and finished dosage forms. Pharmaceutical manufacturing requires continual monitoring and development of all aspects of the process including, production, final product Quality Control, filling and packaging, and storage following FDA approval.

Packaging is an important component in the development of various drug formulations in the pharmaceutical industry. Packaging of pharmaceutical dosage forms has a close relationship between a pharmaceutical preparation and its package which is a major concern to the drug stability and safety.

In order to ensure quality control of final product, pharmaceutical companies employ the process of checkweighing, the ability to weighs items and provide highest weighing accuracy and repeatability. Contactless check weighing (CCW) is a non-destructive process already in use at Roche, using an established procedure for at-line process control for different vials and syringes using CCW to measure the filling weight of parenteral drug product solutions in vials and syringes. The pharmaceutical product is filled into syringes, vials or ampoules to a certain mass or volume, a quantity which has to be carefully controlled. The common method is weighing via a balance, which, for obvious reasons, is a two-step process. This in-package analysis is critical for pharma quality assurance purposes, pushing manufacturing efficiencies and delivering real-time data on process, product completeness and full compliance with cGMPs and regulations worldwide. This in-package analysis of products, without damage to the contents, enables the pharma company to avoid product wastage.

Rapid non-destructive analytical techniques such as X-ray fluorescence spectrometry (XRF) also have a wide range of (bio-)pharmaceutical applications in final product quality control. The main advantage this technique provides is a reduction in analysis time providing higher throughput which can lower costs and shorten the time to market. A measurement using this process and a modern handheld XRF gun for in-package analysis can be made in a matter of seconds.

Defects of the packaging or abnormalities in the different dosage forms of the pharmaceuticals can also be analysed using FT-IR microscopy (LUMOS II). Coatings on various surfaces of diagnostics can be analysed by IR and/or Raman microscopes, with deposits on stoppers, syringes, hollow needles or packaging material are typical samples for this technique. To measure deposits on the inner surface of glass vials or even to perform a depth profiling of multilayer materials, compact Raman microscopes (SENTERRA II) can be used.