Now there is a new integrated end-to-end solution for all processes in the laboratory involving solids — Anyone looking to bring innovative pharmaceutical products onto the market quickly needs future-proof scalable solutions for laboratory systems that meet the growing demands on performance, safety and process efficiency — like the new Multilab, which can do everything from laboratory applications and feasibility studies right through to process development.
Any manufacturer of pharmaceuticals in solid dosage forms who is engaged in development and/or process optimization will be familiar with the situation: many different active agents, changing experiment situations, small quantities. And yet the process is supposed to be fast and deliver reproducible results and, if successful, be capable of being ramped up to production scale. Efficiency and safety need to be reconciled — after all, more and more drugs are highly potent and require protective finishes and appropriate measures.
Clinical sample production processes face similar challenges and place even higher demands on GMP standards. The situation in order flow is aggravated even further, with changing customers increasing the risk of cross-contamination and with contracting bodies also casting a keen eye over equipment and safety standards in their auditing procedures. Containment is therefore on the rise, as are flexible and easily configurable systems which are as multifunctional as possible.
Glatt has developed the Multilab to cater precisely to these needs, meeting the requirements of manufacturers of original and generic drugs or contract manufacturers. Besides granulation, drying and coating, it combines the other processes in one machine on a laboratory scale and represents a groundbreaking achievement on the part of the process engineers.
Configurable for Any Application
The machine can therefore be configured as an end-to-end batch granulation line for the laboratory, from weighing to emptying, with seamless flow and shortest paths from powder to coated tablet, all in one safe and contamination-free process. There is currently a choice of twelve processes, allowing the operator to assemble the system to suit the application in any given case. The Twinpro, the winner of the Innovation Award at Achema 2018, is now also available as the Twinpro Lab. The machine combines two batch processes in one high-shear granulation and fluidized-bed drying line.
In addition to the tangential spray, top spray and bottom spray process modules, the Multilab offers various designs of rotor systems. Wet and dry screening equipment rounds off the range of batch processes. The Multilab also closes the gap to the successful modular continuous system Modcos.
New Filter Technology Brings Flexibility
The new patent-pending filter technology is designed as a modular system enabling simple and flexible configuration with a choice of three variable filter designs and two different filter housings. The design significantly reduces the surface area in contact with the product by half compared to conventional exhaust filter systems which also results in a 50 % lower air-to-cloth ratio, improving process control while at the same time reducing wear and lowering the overall height.
Variable Containment Level and Cleaning Cycle
Depending on the safety requirements and production parameters in any given case, operators can choose between three containment levels and the relevant cleaning systems.
“Containment and the required cleaning were integral to the development and can therefore be used at any level as needed,” said project manager R&D Dr. Adrian Kape. “Everything is possible, from low protection requirements right through to high containment at the highest risk level. The system can be easily retrofitted.” This complete package increases flexibility in the laboratory and allows varying degrees of freedom.
Importance was also attached to the quality of the design. A GMP-compliant mix of safety glass and stainless steel is used. In the process of developing the new mix of materials, Dr. Adrian Kape was keen that it would not only look good, but also offer advantages in terms of cleaning and durability. As a pioneer in innovative process solutions, the Glatt brand has always been synonymous with professional design with all the benefits of integrated technology, as Kape emphasized.
Intelligent System for Efficient Handling
Speed is not exactly rocket science with frequent product changes but it is the result of a sophisticated design. Form follows function — and this premise underpinning the Glatt philosophy has been built on in every respect in the new Multilab. The focus is always on the operator who benefits from improved modular capability, straightforward transport thanks to the slim, space-saving design, and optimized cleaning and maintenance. The assembly process is based on the poka-yoke principle.
The all-rounder can be reconfigured in just a few simple steps. Smooth surfaces without gaps reduce contamination and facilitate the cleaning process. This reduces the amount of time required for cleaning until the system is reused. The Multilab is truly lightweight and fits through any door. Thanks to its low overall height, it can easily be moved or transported at any time. The compact design also saves space and minimizes the work involved if the operator wants to extend the laboratory equipment.
This is a real advantage in laboratories where space is often limited. Stand-alone machines take up much more space than the compact Multilab. It is also true in many cases that process lines cannot be linked together to keep the transfer lines as short as possible. A smaller number of components and the use of durable, recyclable materials also reduce the ecological footprint.
Control Along the Lines of the Large-Scale Plant
The path to Industry 4.0 requires new groundbreaking solutions for full process flexibility and expandability for future options. Short system response times mean accelerated processes, and the intuitive operating system with Glatt View control guarantees full control of all process options.
The multi-port facility and sufficient computing power allow flexible connection to different PAT systems and their integration. “We have taken the control unit from the pilot systems and production lines,” explained the project manager R&D, adding that this enables the complete integration of PAT systems and reduces the need for training enormously.
It is easier for users who are familiar with the large-scale systems. What is more, the Glatt View batch process control unit has already undergone several optimization stages and has been thoroughly tried and tested over time. The modular design allows simple integration of future processes.
Intuitive Operation and Self-explanatory Interfaces
The touch control system is intuitive and the configuration of the human-machine interfaces is self-explanatory. Flow charts with optional animation are displayed on a large 19" HD monitor which is also available in an explosion-proof (Ex) design.
A recipe management function for batch processes is of course also available. Process data can be evaluated and the entire system is fully compliant with 21 CFR Part 11.
The Glatt View system can be integrated into the customer network via Ethernet and into MES or ERP systems via an OPC/XML interface. Adaptations to the MES system operated by the customer are possible at any time.
As summed up by project manager R&D Kape: The more process modules are purchased by a pharmaceutical laboratory, the more the investment in the Multilab pays off due to the clever distribution of components within the pharmaceutical installation.
* * The author is Head of marketing at Glatt, Binzen/Germany.