Achema trend scout
Innovations and what’s new in pharmaceuticals technology

Pharmacists are well-known for approaching new processes and technologies with a degree of caution. At the same time, “true” inno-vations tend to be a rare find any-way. It was much the same at Achema, the biggest show in the process industry’s calendar. Nevertheless, our “trend scout”, Günter Körblein, managed to root out some new and interesting ideas. Dominant topics: PAT and the trend for highly active substances.

The problem is not a new one: in comparison to the food industry or even the chip industry, the pharmaceuticals industry is particularly conservative and cautious towards innovations. The reasons are also the same old ones, despite PAT and FDA initiatives:
-regulatory restrictions in the context of registration, for example;
-the time-to-market factor;
-still the lack of pressure to reduce cost.

Technological innovation can only thrive in close collaboration between pharmaceutical companies and machine manufacturers/facility engineers. However, this is often not accepted by pharmaceutical groups. Reason: the focus is not on the development of production technologies. The production of standard dosage forms, such as tablets, capsules, ampoules, tubes etc. is no longer regarded as one of the core competences of the major pharmaceutical companies. If the manufacturing costs of products exceed a certain proportion of sales, greater consideration is given to outsourcing to contract manufacturers than to optimizing in-house production.
True innovations were correspondingly rare at Achema. Any signs of innovation were limited to the manufacturing of solid forms. The central theme running through almost all stands at the show was now the issue of “highly active substances” or “containment”, in particular for solid forms. The weighing of active substances and excipients for highly active drugs is a special challenge. The non-critical excipients are increasingly dispensed in a central weighing department, while the active substances are weighed in the spatial environment of the mixing/granulating containment.
Dosing powders
Höfliger has considerable experience of dosing extremely small quantities of powder. On its stand, the company presented possible solutions for automatic dosing of active substances directly into the mixing/granulating vessel. The dosing method used is also able to process precisisely active substances with poor flow properties, in multiple partial quantities where appropriate, to improve homogeneity in the mixing equipment. The interesting thing about this is that the loss-in-weight scale is positioned at some distance from the mixing device, which means that the scale is not exposed to vibrations.
Wet granulation
The trend in the manufacturing of tablet masses of “returning to conventional wet granulation” with “high-shear mixer” and “fluid bed drier” is continuing. While “single pot” granulators with or without microwave drying were still being presented a few years ago, these have virtually disappeared now. Dry granulators of the roller-compactor type are experiencing a revival for highly active products, as fluid bed processes are less suitable for this (safety, environmental protection, cleaning). Compactors in the containment design were thus in evidence at the show.
Split valve
Bohle presented a “split valve” for use with highly active substances, which is said to offer advantages over the valves currently on the market thanks to the vacuum between the active and passive valve.
Washable presses
Almost all manufacturers of tablet presses have now included washable presses (CIP/WIP) in their product range. These are also required for processing highly active substances. The peripheral equipment such as deduster/deburrer, metal checking and online checking equipment (weight/thickness/diameter/hardness) must be washable and thus included in the containment. Fette demonstrated a holistic solution on its stand, including a contained dust extraction system. In addition, a double rotary press with a single sided discharge chute was also on display. With this, only one peripheral as described above is sufficient for a double rotary press.
PAT is the word
Still with Fette, the subject of “PAT” (Process Analytical Technologies) was highly topical. The two new features here were the extension of the 4-parameter “Checkmaster” unit with a transmission NIR device, to determine content uniformity as well. Fette calls this system “Online PAT”, as opposed to “Inline PAT” which was also on show. The latter measures the content uniformity of every individual tablet on the press immediately before discharge by means of a reflection NIR unit from the Uhlmann subsidiary, Visiotec. This provides a monitoring performance of up to 200,000 tablets per hour.
Probe taking system
GEA subsidiary, Niro Pharma Systems, introduced its “Lighthouse Probe” system. A joint development with J & M, this probe-taking system for powder and granulate provides spectroscopic (IR, NIR, Raman; UV-Vis) tracking of processes, with an integrated cleaning and calibrating function, even in extreme conditions, without the risk of measurement errors due to a dusted-up window.
Film-coating
Niro also had its “Supercell Coater” on show for coating extremely small tablet quantities (20 to 120 g) within one to two minutes. It makes the unit attractive for the development and optimization of coating processes.
Film-coating is also a theme for the contract manufacturer, Cardinal Health. At the moment, they’re installing a new type of machine for the coating of tablets using electrostatic powder coating. Similar to laser-printing, it will be possible to “printcoat” tablets with multi-colored patterns and symbols. In these times of rampant product piracy, this is indeed a step in the right direction.
Single-Use
In other areas of pharma production, disposable items are increasingly being used, the latest headliner being a “Single-Use Bioreactor” (spotted on Hyclone’s stand). Niro Pharma Systems are also inline with the trend and offer disposable containers for tablets, e.g. for the transfer from the press to the coater using their “Hicoflex” system as dust-free docking technology.
Containment
Glatt introduced its innovative “Containment Lab”. Here again, the trend towards highly active substances had been taken on board. In uniform-sized inter-connected isolator modules, tablet batches of two to six kilograms can be manufactured for development purposes from weighing to coating.
Weight measuring
Under the hard gelatine capsules banner, Bosch exhibited a contactless inline weight measuring unit for filled mass which uses “soft X-rays”. In addition, an inline NIR sensor can provide content uniformity assessment for every filled capsule, albeit with the limitation of the reflection system. Both techniques exemplify the need to take the trend towards PAT seriously.
Wallets are coming
Bosch Packaging Technology also introduced its “SmartWallet”, a new, easy-to-produce form of external packaging for solid medicines. Wallet packs offer a market-oriented packaging solution and promote differentiation from the competition. They’re user-friendly, tamper-proof, reclosable and value for money. The equipment needed for the production of “SmartWallets” requires a lower level of investment and less production space than conventional wallet packaging machines, as in principle it’s a slightly modified horizontal cartoning machine. It’s said to have a working capacity of up to 500 packages per minute.
Faster packaging
Uhlmann exhibited their “Blister Express Center 500”, the fastest single-lane packaging line in the world. Solids in batches of between 30,000 and 150,000 blisters can be packed at optimum efficiency. The line’s fully continuous and self-regulating processes are provided by the inline stations, while quick and easy format changes and an output of up to 500 packages per minute demonstrate its superiority.
Conclusion: If you were looking for real innovations at Achema, this year would have been a struggle. Ultimately, “Real Innovation” differs from product improvements and developments in optimization in that fundamentally new approaches and technologies have to be applied. However, the examples quoted demonstrate that suppliers are working on improving the detail. The giant leap is still to come.