ARTICLES BY TOBIAS KUNERS OF KOENDERS

  • Bio/Pharma Maintenance 4.0: How To Get Started
    Bio/Pharma Maintenance 4.0: How To Get Started

    Part 1 of this two-part series looked at the core aspects of Maintenance 4.0 and outlined a comprehensive maintenance process flow. In this second part, we will discuss how to get started with Maintenance 4.0, along with how to develop benchmark metrics that allow assessment of the gap between the current and desired states.

  • Maintenance 4.0 – The Next Revolution In Bio/Pharma Manufacturing
    Maintenance 4.0 – The Next Revolution In Bio/Pharma Manufacturing

    The next stage in maintenance management, Maintenance 4.0, is to go beyond predictive to the initial stage of an asset — commissioning the assets and deploying the same tools and techniques to set the measures within the design specification from the beginning onward, and using indicative measures to keep the asset in its original design specification.

  • An Introduction To Centerlining For Biopharmaceutical Manufacturing
    An Introduction To Centerlining For Biopharmaceutical Manufacturing

    Many pharma companies struggle to strike the right balance between enough preventative maintenance and not too much corrective maintenance for manufacturing equipment, and to achieve that balance at a reasonable cost. One method known to drive the preventative/corrective ratio in favor of preventative maintenance is centerlining.

Tobias Kuners of Koenders

Tobias Kuners of Koenders

Tobias Kuners of Koenders is managing consultant at Tob Management, a Netherlands-based consulting firm providing business and technical expertise to the pharmaceutical, biotech, medical device, and FSMP (food for special medical purpose) industries. He has worked at Biogen, Ipsen, Patheon, and Danone, among other companies, gaining hands-on experience in engineering services, equipment qualification, maintenance, supply chain, warehousing, and distribution. He has led design, engineering, and construction of multiple facilities to meet cGMP requirements. He performs audits, identifies gaps, and develops remediation plans, working within organizations to assist with deviation investigations and CAPA implementation and to develop scientific, risk-based solutions. You can contact him at connect2tobias@outlook.com.