Packaging

在所有药品开发过程中，选择最合适的包装细节的验证是一组重要的考虑因素。产品包装的方式是一个关键的处理步骤，可以影响药物稳定性，安全性和功效。因此，通常有必要直接对包装本身，包装中的产品（作为生产控制方法）或下游包装的内容进行测量，例如在稳定性调查中或作为调查测试。

为了确保最终产品的质量控制，制药公司采用了检查权重的过程，称重物品的能力并提供了最高的权衡准确性和可重复性。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.

Defects of the packaging or abnormalities in the different dosage forms of the pharmaceuticals can also be analysed using FT-IR microscopy. 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 can be used.

X-ray microscopyprovides a fast way to non-destructively inspect drug packaging. XRM is used to inspect the seal integrity of glass vials containing the API. In the same analysis the residual volume in the vial can be quantified. Another application of XRM inspection is QC of drug delivery devices such as syringes and inhalers to ensure proper dosing. Thanks to the non-destructive 3D visualization of the interior, obstruction by deposits or misalignment of internal parts can be detected while maintaining the sterile environment.