Green Manufacturing for Herbal Remedies with Advanced Pharmaceutical Technology

Abstract

Herbal remedies are in most cases still manufactured with traditional equipment installations and processes. Innovative chemical process engineering methods such as modeling and process intensification with green technology could contribute to the economic and ecologic future of those botanicals. The integration of modern unit operations such as water-based pressurized hot water extraction and inline measurement devices for process analytical technology approaches in traditional extraction processes is exemplified. The regulatory concept is based on the quality-by-design demand for autonomous feed-based recipe operation with the aid of digital twins within advanced process control. This may include real-time release testing to the automatic cleaning of validation issues. Digitalization and Industry 4.0 methods, including machine learning and artificial intelligence, are capable of keeping natural product extraction manufacturing and can contribute significantly to the future of human health.

Ghana’s herbal medicine industry: prospects, challenges and ways forward from a developing country perspective

“…The adoption of innovative chemical process engineering methods such as modelling and process intensification with green technology in the manufacturing of herbal medicines could contribute to the economic and ecologic future of the industry ( Tegtmeier et al, 2023 ). It is also important to consider the potential benefits of artificial intelligence (AI) in the herbal medicine industry ( Wu et al, 2022 ).…”

Is Regulatory Approval without Autonomous Operation for Natural Extract Manufacturing under Economic Competitiveness and Climate-Neutrality Demands Still Permissible?

“…This is based on process analytical technologies (PATs), with a conductivity sensor for the measurement of the dry residue (DR) content to control this process parameter and an FTIR detector, as shown in Figure 1. Studies on various component systems [19,20] have been conducted for the determination of marker/lead substances or even reference substances as defined in the drug master file for regulatory approval [21]. In the following section, this concept is explained in detail and is exemplified as well as discussed and evaluated in terms of industrialization.…”

“…This should be particularly reflected in the GWP balance since each discarded batch included not only the GWP of the process with solvent use but also of the entire value chain beforehand. This started with plant breeding or wild collection and also included GWP-intensive drying, which can make up 90% of the GWP of a botanical product [20,51]. Parameter estimation took 5 min on average but could be shortened to 2.5 min.…”