Track 11: Pharmaceutical Engineering
What is Pharmaceutical engineering
Pharmaceutical engineering is concerned with planning, constructing, and enhancing pharmaceutical manufacturing facilities. NNE's engineers are solely focused on providing solutions for the best manufacturing processes within pharmaceutical production facilities, despite the fact that some pharma engineers also work with developing and formulating medications.
The pharmaceutical industry's stringent criteria for good manufacturing practise are one of the most significant differences between pharmaceutical engineering and other areas of engineering (GMP). In order to ensure that the medication produced is safe for patients, you must be able to manage the GMP requirements, which are becoming more and more complex. From early conceptual design to the implementation and execution of a pharmaceutical quality system, GMP considerations are essential in all design phases.
Pharmaceutical industry, which collectively includes pharmaceutical engineering practises:
- API and Biotech
- Solid oral dosage
- Finish the filling
- Put together and pack
Read on to learn more about the market and explore each of the four Pharma engineering competence areas:
API and Biotech (active pharmaceutical ingredient)
The active pharmaceutical ingredient (API) and the excipient, such as lactose or sesame oil, are the two basic components of a medicine. The API in medicines might be biotechnological, synthetic, or a combination of the two.
By 2020, the pharmaceutical medication business will be dominated by biotech, notably the field of biopharmaceuticals, which is expanding quickly. There are many distinct types of biopharmaceuticals, each needing a different production technology. Mammalian or microbial expression systems are used in the majority of industrial processes, although other systems are used for specific goods like vaccines. The advent of novel and increasingly complicated pharmaceuticals, such as antibody drug conjugates, has also presented new hurdles for the industry (ADC). These necessitate the use of facilities that can simultaneously handle both biologics and potentially hazardous small compounds.
Therefore, in order to accommodate a variety of manufacturing methods as well as volume needs, facilities of the future must be developed in a flexible manner. These needs range from very small quantities needed for individualised therapy, a few hundred kilogrammes for orphan drugs, and thousands of supplies for widespread illnesses including diabetes, rheumatoid arthritis, and some forms of cancer.
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OSD (oral solid dosage)
The most popular delivery method for active medicinal ingredients in use today is a tablet, orally solid dose (OSD).
Pharmaceutical manufacturing facilities are still most frequently used to produce OSD products. However, the majority of the once-popular OSD products are currently without a patent. Higher potency new OSD products are often sold in lower quantities and demand for a highly flexible manufacturing setup.
Manufacturers of OSDs are under constant pressure to increase production's efficiency. Every year, fresh high-potency medications are introduced to the market with the introduction of cutting-edge delivery systems like sustained release, sprays, and chewing gum. Generic drug producers are simultaneously expanding their capacity while there is a broad shift to produce in emerging markets. Regulatory requirements as well as environmental, health, and safety norms also keep expanding.
In addition to flexibility and affordability, OSD manufacturers place a high premium on making ensuring that the facilities comply with current regulatory requirements. Due to the high potency of many new products, there are strict regulations as well as OHS (occupational health and safety) and EHS (environmental, health and safety) criteria.
Finish the filling
Sterility and proper dose are key factors in pharmaceutical manufacture. As a result, one of the most crucial steps in the production process is actually loading the pharmaceutical product into vials, syringes, or blister packaging.
Fill finish has traditionally been a field where "established solutions" have been prioritised over innovation. However, this is altering as a result of changes in the pharmaceutical sector.
Manufacturers are being pushed to boost aseptic production's level of flexibility by a growing trend toward small batch sizes. Multiple items that are very valuable, delicate, potent, and manufactured in tiny batches must be accommodated by processes. As a result, facilities that can offer greater flexibility, lower investment costs, and boost productivity for smaller batch sizes are required (format change, cleaning, sterilization, maintenance, qualification etc.).
Assembly and pack
Optimized assembly and packing methods can significantly impact costs, although not being as important as product filling. Pharma producers also need to take into account new specifications for tracking medicinal products globally.
The world of pharmaceutical packaging in the modern era presents difficulties that have a substantial impact on production costs. Things are getting more complicated due to the demand for compliance, quality, and product tracking in the future. Additionally, the trends toward serialization, late-stage customization, and patient-centricity point to a rise in stock keeping units, which will have an impact on efficiency once more.
As a result, organizations, processes, assembly, and packaging disciplines must change in order to remain competitive with unit cost. In the end, having the ability to scale and create these operations provides you a competitive advantage in the pharmaceutical sector.
Pharmaceutical engineering and manufacturing are evolving.
There are several developments happening in the pharmaceutical sector. Most notably, future-proof engineering now heavily weighs sustainability and data-driven, digital facilities.
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