From core to shell: How modular planning brings flexibility to pharmaceutical production

(Re-Print)

The principle of modular pharmaceutical production facilities requires a process-oriented, far-sighted approach right from the early planning phase. The experts from Glatt’s Process & Plant Engineering division know why this is essential for flexible pharmaceutical solids production.
(Re-Print, translated with DeepL.com)

authors: Anke Mothes, Head of Department Pharmaceutical Projects, Design & Project Management and Aileen Rominger, former Sales Engineer Process & Plant Engineering at Glatt Ingenieurtechnik GmbH, Weimar.
originally published in German language in the magazine ‘PharmaTEC’, issue 03/2018, Vogel Communications Group
Vom Kern zur Hülle: Wie modulare Planung Flexibilität in die Pharmaproduktion bringt (vogel.de)

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The constant search for new, improved, increasingly specialized or patient-specific drugs, often with highly potent active ingredients, requires high expenditure in research and development. Once an active ingredient candidate has overcome the approval hurdles, a quick start to production and a short time-to-market are the top priorities: by building a new plant, expanding an existing factory or converting existing facilities and premises. However, high-performance production no longer means “more of the same” as it used to, but more variety at ever shorter intervals, more effort, fluctuating throughput – in short, more flexibility. As a result, the principle of modular plant engineering is on everyone’s lips. But what does modularity mean here?

Advantage through simplification

While in the chemical industry and biotechnology the term modularity refers to modular process plants, prefabricated skids and container designs, the focus in the pharmaceutical solids industry is different. Here, modular plants for many process steps have not been available until now. At Glatt Process & Plant Engineering, modularity is a fundamental mindset that determines the holistic planning approach of the internationally sought-after engineering experts. The company has been using modular planning for many years in the areas of process and technology planning, layout development, media planning as well as building and site master planning. Holistic modular planning is considered with a dual focus: in relation to the technology/process and in relation to the building/building technology. What is important here is a concerted interplay between the specialist trades of both focal points and a systematic approach.

Glatt relies on the use of ideal modules that follow the principle of simplification and standardization. If different room modules are combined with each other, we speak of train concepts. Material and personnel flows are clearly separated from each other; the product flow is horizontal. Train concepts are suitable for mono-production in campaigns as well as for the parallel production of several products. Their advantage is their high level of flexibility: they can be equipped with additional process steps and can be flexibly expanded during operation. The efficiency and flexibility in day-to-day production results from the grouping of the products to be manufactured, allowing an optimum number of production lines to be designed. Planning is always carried out from the inside out – starting with the manufacturing processes, continuous or batch production, manufacturer-independent technology through to media systems and building constellations planned with foresight.

Modular planning hierarchy

Regulatory expansion

The import restrictions on pharmaceuticals to Russia that have been in place since the end of 2015 forced pharmaceutical manufacturers to either look for local partners or produce in Russia themselves. The pharmaceutical company Astra Zeneca brought the planners from Glatt Ingenieurtechnik into an ongoing greenfield project at the Kaluga site in order to benefit from their expertise in pharmaceutical technology, clean room design, media supply and decades of experience in implementing projects in Russia. The process transfer of products from various locations worldwide to the new site in Russia represented a major challenge. Optimization potential was also to be identified and included in the transfer of processes. In addition, the new production facility, with a production capacity of around one billion tablets per year, was to be as compact as possible and flexibly expandable. First, the planners carried out risk assessments and categorized the products, taking into account the production technology. Based on the specific customer requirements (URS) and intensive collaboration with the customer, a solution with two production lines or trains was developed for the new production site. One train is designed for the production of pharmaceuticals using highly potent active ingredients with an OEL < 1 µg/m³ in a high containment design. A second train is used for the manufacture of non-toxic products.

Modular trains for generics production

The advantages of modular train concepts are reflected above all in the efficiency of production, as the example of a large generics manufacturer in Asia shows. The pharmaceutical company asked the process experts from Glatt India Pharma Engineering for a second opinion on an ongoing project. Its plans for a new production facility with a production capacity of 14 billion tablets had originally been awarded to a competitor. Glatt’s planning team impressed with the development of a train concept for the specific requirements, which comprehensively took into account the large capacities, product changes to be planned, the best possible utilization of the systems and the optimization of throughput times. A particular challenge in this project was the required speed of implementation. Planning took place during construction. The concept resulted in an order for the general planning with possible capacities of

< 100 kg batches for mono or campaign production and multipurpose production

< 300 kg batches for mono or campaign production and multipurpose production.

Several Wurster systems were required for special products, for which a separate train was also developed.

Production layout of an OSD production factory. Modular planning hierarchy with train concepts by Glatt Pharmace

The illustration shows different train concepts, which can be combined as required and – depending on the customer’s production program and capacity – can be implemented in an efficient and future-oriented production facility. These concepts can only be developed in close partnership with the customer.

Train 1: Dedicated train for mono or campaign production
Train 2: Hybrid train for multi-purpose production
Train 3: Customized product-specific design in the train concept, the focus is on a special process step in the train

Production layout of an OSD production factory

Expansion concept for multiflexible production

Glatt’s holistic planning approach is of course also suitable for the construction of new factories in Western Europe and solves tasks that engineering experts are encountering more and more frequently and for which the URS provides essential framework conditions but allows planning freedom. A globally active pharmaceutical company commissioned the conceptual layout development for a new flexible solids production facility with a connection to the existing infrastructure in the industrial park. The planned production facility should be able to manufacture established products as well as transfer processes from development to production. A total production capacity was not specified, but a classification of the products to be manufactured according to active ingredient classification, production in accordance with GMP and FDA requirements and a desired consideration of technologies available on the market for batch and continuous production. In addition, all trades from the process technologies to the media supply had to be planned on a modular basis.

Conclusion

Holistic planning incorporates the possibilities and limits of modularity from the individual process step through to the building and infrastructure. This approach is indispensable for multiflexible production as a basis for the requirements of the present and the future.

You want to know more about this topic? Simply contact the Glatt experts!

Further information on this topic and related topics can also be found in the following publications:

Glatt article on ''The design and modularisation of API synthesis plants'', originally published in the magazine ‘Manufacturing CHEMIST’, issue 12/2023, HPCi Media Limited

Published article: ‘The design and modularisation of API synthesis plants’ PDF, English

Glatt article on ''Cleanroon Design (Part I) – It's all in the Details. Planning cleanrooms, but doing it right", originally published at process-worldwide.com, Vogel Communications Group, February 2022

Published article: ‘Planning is everything. Avoiding mistakes in cleanroom construction’ PDF, Englisch

Glatt article on ''XXL EFFECTIVENESS IN A SLIM-FIT SUIT – Containment solutions only cost-effective when adapted". English Re-Print of the german article, originally published in the magazine ‘Pharma+Food’, issue 03/2016, Hüthig GmbH

Published article: ‘Containment solutions only cost-effective when adapted’ PDF, English

Glatt_FA_060_The modularisation of chemical API synthesis_en_ManufacturingChemist_2018-12

Published article: ‘The modularisation of chemical API synthesis. Improve overall plant efficiency. Reduce planning time.’, PDF, English

Glatt article on 'High Containment Processes in the Solid Drugs Production', originally published at process-worldwide.com, Vogel Communications Group, May 2013

Published article: ‘High Containment Processes in the Solid Drugs Production’ PDF, Englisch

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From core to shell: How modular planning brings flexibility to pharmaceutical production

Advantage through simplification

Regulatory expansion

Modular trains for generics production

Expansion concept for multiflexible production

Conclusion

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