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In a highly competitive marketplace, one where new drugs are being brought to market quicker than ever before and where a drive towards customisation is clear, pharmaceutical manufacturers need to evolve and adapt their operations to become more flexible and responsive to customer needs, while continuing to drive cost and efficiency gains. The move towards Industry 4.0 is helping businesses improve productivity and enable a flexible approach to manufacturing - exactly the type of flexibility that will ultimately allow for the highly customised production of medicines at mass market cost. This combined with faster market readiness and assured product quality and data integrity poses a bright and competitive future.
Electronic Batch Record
A medication medicine has to go through a highly complex and often very lengthy processes before it can be used to cure. In this process all manufacturing steps have to be recorded precisely. This means massive costs for manual documentation.
Siemens is paving the way to paperless manufacturing – with the integration of SIMATIC IT eBR and SIMATIC PCS 7 in real time. Electronic user guidance for manual process steps: the system generates electronic work instructions to minimise the risk of error. The employee must confirm correct implementation with an electronic signature. This ensures production reliability. The electronic batch record software solution makes documentation and review easier and more efficient – without breaching the strict standards imposed by the regulatory authorities.
Paperless manufacturing on the basis of the electronic batch record allows review by exception. This means that when a batch is released only deviations have to be reviewed assessed instead of the whole batch documentation. This makes release faster and more efficient.
Benefits at a glance:
Thus, SIMATIC IT eBR plays a key role in cost-effective implementation of the smallest batches – a major step towards personalized medicine.
In a challenging industry landscape, pharmaceutical manufacturers must adapt manufacturing processes to meet current demands in order to remain profitable and meet patient needs. Continuous manufacturing is playing a vital role in meeting these objectives, by delivering higher productivity, flexibility and lowering the cost of quality.
As pharmaceutical companies are seeking to optimise manufacturing processes and maintain high product quality, continuous methods are a key enabler to building quality by design (QbD) into the complete product lifecycle, from R&D through to manufacturing, with the ultimate aim of getting safer medicines to market in a more efficient and cost-effective way.
Using in-line quality testing enables right first time production, therefore reducing waste and the time typically afforded to product testing, evaluation and batch review.
Alwyn Jones, Head of Pharmaceutical and Life Sciences – Siemens UK and Craig Johnston, Industry Director at CMAC talk about the opportunities of continuous manufacturing for the pharmaceutical industry.
Examples of successful projects relating to digitalization – take a look at some of our references here.
The Chinese pharmaceutical company Chengdu Rongsheng Pharmaceutical Co., Ltd. modernized its process with a manufacturing execution system.
The blood plasma production plant in Chengdu now relies on highly modern electronic charge documentation.
As a result, it is considerably more stable and efficient.
Next to its main campus in Stevenage, England, GSK
has set the course for the future of pharmaceutical manufacturing:
the IIM Digitisation Lab.
With its personalised vaccine, BioNTech is a pioneer in the battle against cancer.
To enable the active pharmaceutical ingredient (API)
to be produced faster and in large quantities, the company has installed an entirely paperless manufacturing system featuring Simatic IT eBR and Preactor.
News and Events
Find out about Siemens’ latest developments
If you have questions about digitalisation in the pharmaceutical industry, our experts will be happy to help.