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René Nanninga

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René Nanninga
MSc Director Engineering & Technical Support

René Nanninga has a master degree in chemical engineering. He has over 20 years of professional experience in manufacturing, engineering and business management. The last 10 years he has been responsible for engineering and consultancy in the (bio) pharmaceutical and healthcare field.

As Director Engineering and Technical Support René is heading a team of professionals realizing projects in facility engineering and (bio)process engineering. In conjunction with professionals from other Xendo departments projects were realized ranging from the establishment of new manufacturing and lab facilities to cost saving projects.

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Our engineering and technical services team supports the full life cycle of your (bio) pharmaceutical and medical device facilities. From project inception right through to the design, construction and qualification phases, our engineers work together with our experienced users – who include pharmaceutical scientists and operational experts – to offer you a pragmatic approach to the delivery of GMP-compliant facilities. With our Metrology team, we demonstrate compliance during the initial qualification phase as well as during revalidation. Our Maintenance Support and Asset Management services help you keep your facilities fit-for-purpose in a cost-effective way. Depending on your project needs, our multidisciplinary teams can work from our Leiden office or can provide you with professional support on location.

(Bio) Process Engineering

Xendo delivers a broad range of expertise in upstream and downstream bioprocessing, process development, upscaling and process improvement, single-use /disposable technologies and continuous manufacturing. Our team of experts in (Bio)processing, Compliance, Engineering and Regulatory Affairs guarantees a multi-disciplinary approach to a wide range of issues during the development and production of biopharmaceuticals, including GMP compliance and regulatory strategy.

Process Architecture and Facility Design

The design and engineering of facilities for pharmaceutical and medical device industries, hospitals and blood banks is our specialist area and is based on the in-depth knowledge we acquire of your manufacturing processes. Xendo’s team of engineers can meet all your needs, regardless of whether you require new facilities or modifications to existing systems. Our approach is built on pragmatism, a detailed knowledge of pharmaceutical technology and GxP compliance.

Process Automation and Data Integrity

The computerised systems used in the pharmaceutical industry, in medical devices and in healthcare institutions such as hospital pharmacies must all comply with the GxP regulations. The focus of the inspectors of the various authorities is increasingly on data integrity and the validation of computerised systems. Our dedicated team of specialists with backgrounds in IT and Life Science possesses extensive experience in the field of Computerised Systems Validation. We base our approach on the globally accepted GAMP 5 guide, which takes the entire life cycle of an automated system into account. This includes the design, procurement, installation, configuration and validation phases up to and including operational maintenance and decommissioning. If your organisation does not have the expertise or the capacity to deal with these issues, we can assist you directly or provide you with consultancy services.

Procurement and Construction Supervision

Amongst other things, we can help you with the procurement of cleanrooms, equipment and installation work, including the technical and commercial analysis of bids, vendor auditing and selection.

We can supervise the construction of new or revamped facilities to ensure the projected quality, timing and safety during the construction process. We proactively monitor progress and the budget in order to ensure that we meet our clients’ expectations using our own APEX project management tool.

Commissioning, Qualification & Validation

We have the in-house expertise and capacity to assist you during all the V-Model phases. By carefully examining and specifying the operational requirements, we make sure that all the systems or components in your facility are designed, installed, tested and operated according to your wishes.

We regard Qualification and Validation as regulatory requirements as well as good business practices. This integrated approach ensures that you can comply with the required qualification and validation status of your facilities, utilities, equipment, processes, analytical methods and products and thus improve the efficiency of your business.

V-Model

Calibration and Re-Qualification

Calibration and re-qualification should be synchronised to ensure optimal operational efficiency and efficacy. For example, we deliver a wide-ranging portfolio of hands-on calibration services for critical utilities, equipment and instruments.

This dedicated team is trained continuously and our equipment is calibrated to national and international standards. Our main focus is on:

  • EMS / BMS sensors (temperature, humidity & pressure)
  • Storage units, refrigerators and freezers
  • Autoclaves
  • Storage & production vessels
  • Clean steam

Maintenance management consultancy

The primary responsibilities of a maintenance manager include reducing costs and improving the performance and quality of manufacturing equipment and systems. Due to the increasing pressure on maintenance costs and the focus on GMP compliance, it is often challenging to find the right balance between higher priority tasks and maintenance issues.

We develop risk-based and science-based maintenance strategies to optimise the balance between maintenance costs and your performance and / or compliance targets. We can help you draw up maintenance plans that reflect your strategies and enable you to excel in maintenance. We do this by sharing our best practices for setting up or improving your maintenance SOPs and work instructions for the full life cycle of your assets.

Periodic Systems Review

Keeping the quality of your equipment and utilities under control and maintaining them in a validated state is a compliance demand that could be compromised by urgent or high priority operational issues. By conducting Periodic Reviews, we can identify potential out-of-compliance issues and opportunities for improvement in good time. In this way, we help you prevent breakdowns, reduce the cost of quality-related activities and improve overall compliance.