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Most recently developed inspection units, such as the Bosch KKX 3900, are able to simultaneously check all quality features like weight, foreign particles, deformation of capsule top and bottom, as well as length in real-time and at high throughput rates. The exact process control adopts several functions of visual systems for error identification and provides packaging errors.”
Pharmaceutical Regulator Guidelines – What they Mean
Strict pharmaceutical quality and safety standards such as the American Food and Drug Administration’s (FDA) Process Analytical Technology (PAT) guidance, as well as Good Manufacturing Practice (GMP) set the framework for pharmaceutical manufacturing processes. They aim at reducing the risk of product recalls and, most importantly, are designed to safeguard consumers’ welfare. In order to comply with these regulations, the industry requires reliable and high-end inspection technology equipment to be integrated in their production lines. Seconding the same, Harbauer elucidates, “Since 100 per cent control has become obligatory, manufacturers are continuously challenged to increase output and improve efficiency, as well as inspection accuracy.
Therefore, the main focus is on fully automated solutions with high throughput rates. Manual and semi-automated devices remain in use for research purposes, customized smaller batch applications and the reinspection of rejects from fully automated machines. Physical inspection via spectroscopic methods, pressure decay or high-voltage can be used to detect leakages and fissures of containers.”
Localised Regulations for a Globalised World
Regulation of FDA is different in various countries. According to Director - R&D, Ansapack Group, Dr Erwin Pasbrig, The SFDA (China) has special tests and procedures in place to secure that the pharmaceutical packaging supplier supplies high grade quality products.
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