新自动化的实施和经验

摘要

在成本、及时性和质量驱动业务的环境中，寻找能够应对这些挑战的技术是至关重要的。在诺华制药质量保证部门，自动化和机器人技术已经成为应对这些挑战的工具。虽然自动化在我们部门是一个相对较新的概念，但我们在短短几年内就完全接受了它。由于我们公司进行了合并，通过自愿和非自愿离职，质量保证部门的员工数量有了显著的减少。然而，工作量保持不变，在某些情况下实际上增加了。因此，即使减少了实验室人员，我们仍然面临来自巴塞尔总部和内部的挑战，要求我们在提高生产率的同时保持质量测试的完整性。基准研究表明，在其他工厂中，哈森工厂是首选的生产基地。这是由于suffn工厂员工承诺减少周期时间，提高效率，并保持高水平的法规遵从性。其中一个更重要的因素是实验室的自动化技术，这种技术将继续帮助站点在未来的状态。自动化组最初成立于大约2年前，以满足高质量保证测试吞吐量的需求，并使我们的测试组达到行业标准。 Automation began with only two people in the group and now we have three people who are the next generation automation scientists. Even with such a small staff,we have made great strides in laboratory automation as we have worked extensively with each piece of equipment brought in. The implementation process of each project was often difficult because the second generation automation group came from the laboratory and without much automation experience. However, with the involvement from the users at ‘get-go’, we were able to successfully bring in many automation technologies. Our first experience with automation was SFA/SDAS, and then Zymark TPWII followed by Zymark Multi-dose. The future of product testing lies in automation, and we shall continue to explore the possibilities of improving the testing methodologies so that the chemists will be less burdened with repetitive and mundane daily tasks and be more focused on bringing quality into our products.

化学分析方法杂志

摘要

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