Life Science

Getting Started: Best Practices #1 and #2 for a Pharmaceutical Manufacturing Upgrade Project

Written by Guest Blogger, Richard Parapar

It’s hard to address flaws in an existing system if you don’t know what they are. And the more information that a facility has about existing weaknesses in a system, the better able they will be to target the most important areas for updating. Conducting a comprehensive risk assessment that identifies possible “failure modes”— that is, how a piece of a system could fail to perform its duty— can provide exactly that kind of targeting.

Pharmaceutical Manufacturing Upgrade Project Schneider Electric

As a best practice, risk assessments have proven value. When they’re detailed and comprehensive, they shed light on what the most pressing system issues are, and make it easier for facility managers to establish priorities for their upgrades— to direct their retrofit efforts to address the most important concerns, and prioritize other areas for subsequent improvement.

Genentech conducted a major risk assessment in late 2007, after becoming clear that at least some of their manufacturing systems would require upgrades to sustain continued plant operations. Their risk assessment showed that critical components of their manufacturing systems were either already obsolete, or getting very close. The impact of the failure of those parts of the system had the potential to be disastrous for the facility, and the company’s overall manufacturing supply chain. The risk assessment results clearly highlighted those software applications and system hardware components that were the most important and necessary priorities for the retrofit.

#2: Review vendor offerings for compatibility with your legacy systems, databases, and software applications.

Many companies using “legacy” equipment— that is, equipment that’s either already out of date or well on its way— will find that their vendors are now providing updated, upgraded versions of the same.  As a best practice, it is recommended that companies carefully review these potential upgrade candidates, to determine if those new offerings have maintained compatibility with the facility’s legacy systems, to reduce the need to re-train plant personnel and hopefully cut down on the impact and scope of the retrofit effort..

Finding compatible systems can have big benefits for pharmaceutical manufacturers. By adopting an upgrade path supplied by an existing vendor, companies can make the retrofit process faster, more affordable, and can often minimize production downtime while the new systems and components are implemented.

Vendors often also still have resources and employees dedicated to maintaining or upgrading legacy systems. Planning a retrofit is always easier when the vendor is already familiar with the legacy systems and how best they can be replaced by, or integrated with new ones. Finally, because vendor product roadmaps often anticipate customer upgrades, suppliers may already have transition strategies and resources in place for performing system upgrades and replacements.

Genentech, during their upgrade, moved to new application software from the same vendor— WonderWare, a branch of Schneider Electric. The replacement software was developed in a newer technology, but had been derived from the original design, so the old and new systems maintained a high degree of compatibility, allowing the transfer process between versions to be expedited and made significantly easier.

If you haven’t already done so, be sure to familiarize yourself with the first two blogs in this series.

 

Download our white paper to read more about all eight best practices and Genentech’s use of them!

What possible “failure modes” are you worried about in your facility? Are you looking at a retrofit? Tell us in the comments below.

Richard Parapar has over 30 years experience delivering advanced automation solutions for the life sciences, petrochemical refining, high purity gas production, and consumer food processing industries. Richard recently retired after over 21 years at Genentech/Roche as a Senior Principal Engineer and Technical Lead for Automation Engineering, where he was responsible for delivery of major strategic automation projects and shaping the longterm direction of manufacturing execution and process automation systems for Genentech.

Leave a Reply

  • (will not be published)

Time limit is exhausted. Please reload CAPTCHA.