Page 5 - Automated 14 - Maintenance matters

merica’s pharmaceutical R&D
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treatment and an increased survival rate. This progress has included the development of medication like Gleevac, which now cures most chronic myeloid leukaemia (CML) cases. After being approved for use in the US it was soon added to the World Health Organisation’s list of essential medications.
Without government backing and significant investments in R&D, medication for cancer treatment may never have advanced to the standard we know today. However, even with federal investment, budgets are not infinite and pharmaceutical organisations must justify every cent spent on R&D. To invest heavily in R&D, organisations are under increasing pressure to cut costs from other areas, including the manufacture of pharmaceuticals.
Pharmaceutical manufacturing
Most new manufacturing equipment and software are being designed to work with legacy systems to save manufacturers money. However, this is only effective if manufacturers can keep legacy systems operational, even if obsolete components break.
Consider this as an example. A programmable logic controller (PLC) has broken down in a pharmaceutical manufacturing plant. The failure — like 80 per cent of all PLC break downs — is because of an Input/Output (I/O) module failure. The I/O module needs replacing, but this requires an exact replacement. For a legacy system like this one, it may prove difficult to find an identical copy.
This is where obsolescence management comes in. Developing an effective obsolescence management plan may seem counter intuitive in an industry focused on innovation and investment in R&S, but it’s an easy way to help save money, reduce downtime and accommodate change.
That said, replacing a broken-down component is not always as simple as introducing a brand-new piece of equipment. A major concern for pharmaceutical manufacturers is regulatory compliance. In the pharmaceutical industry, when a machine breaks down, introducing a new part from a different manufacturer can lead to a traceability and validation nightmare.
Take CFR21/11 as an example. It is the most recent version of the 21 CFR part 11 Code of Federal Regulations from the US Food and Drug Administration (FDA). The regulation concerns electronic record keeping, such as maintaining electronic signatures, validation and time stamps. Put simply, the regulation’s aim is to maintain an audit trail of production.
“Replacing a broken-down component is not always as simple as introducing a brand-new piece of equipment”
At EU Automation, one of our key offerings to the pharmaceutical sector is our ability to deliver nearly any component, irrespective of how rare the piece of equipment is — avoiding the validation nightmare of an entirely new component.
The American Civil War was instrumental in the birth of the modern pharmaceutical landscape, but the era’s medicines and treatments are now obsolete. So, get a copy of EU Automation’s Book of Obsolescence Management (BoOM) to find out how managing the obsolete can help find funds for R&D.
MAINTENANCE MATTERS
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