Comments Off on Techceuticals and Natoli held Solid Dosage Manufacturing Process Seminar in Telford PA June 7-9, 2022
“When two exceptional training entities unite, you benefit!” was the motto of this seminar and it couldn’t have been more true. All the various processes helping push bulk material into pill form were covered. No wonder that all seats were sold out.
Our own Al Friedrich covered the #drygranulation via #rollercompactor. Theoretical training was followed up with practical demonstration using an #Alexanderwerk WP120 Pharma roller compactor.
Comments Off on Alexanderwerk will be presenting at the upcoming Techceuticals & Natoli Training: Tablet Development Process Training Seminar June 7-9, 2022
If you or your peers are in pharmaceutical, nutraceutical, CBD, or any other OSD related industry this is a great opportunity to learn about tableting. What is so great about our collaboration with this powerful training team is that experts as well as novices will be provided with powerful knowledge that can be put into action at home base right away. Your entire formulation, development, and manufacturing team can get on the same page. This type of training that incorporates fundamental theoretical knowledge and combining with practical hands on training in the lab is highly effective and might we say – fun! You get your questions answered on the spot and most importantly you get to network with other experts and people who are facing similar challenges as you.
Our Al Friedrich will be teaching the attendees about dry granulation using roller compaction. An Alexanderwerk WP120 Pharma will be featured in the lab for the live demonstration part.
Do not lose time and sign up right away and you may even get the early bird discounted rate.
Comments Off on How continuous monitoring and control of granulate PSD can be achieved
Granules are the basis of numerous products in the pharmaceutical and food sectors; they are subject to the strictest quality requirements.
Not all processes in the chemical and life science industries can be efficiently tested on a continuous basis. Especially in the area of dry granulation, in-process control is treated more as an afterthought. Although experience from the industry shows that continuous monitoring of a process in real time is not only economical, but also increases the quality of the end product. A new solution for continuous dry granulation has been developed by Alexanderwerk GmbH and Parsum GmbH in a recently completed joint research project.
The production of granules as a basis for chemical or pharmaceutical products is often carried out in a discontinuous batch process. In the pharmaceutical industry in particular, this procedure is also transferred to roller compactors to ensure the traceability of a production batch. At the same time, this means a lot of additional work for such companies. “The equipment has to be dismantled, cleaned and reassembled after every batch that has been processed,” explains Marcus Weidemann, process technology engineer at Alexanderwerk GmbH. “This increases the downtime of the machines and subsequently leads to an increase in production costs.” In addition, employees have to manually take random samples several times per batch and analyze them in the laboratory. Since the results are usually available after the completion of a production cycle, process parameters can only be adjusted for the following batch if quality defects are detected, while in many cases the quantity already produced has to be completely discarded.
Continuous granulate control can be economical and better for the environment
Improved process controls not only ensure an increase in the quality of the product, they also make it possible to detect defects at an early stage and thus avoid unnecessary costs. What is often forgotten, however, is that fewer rejects and more efficient processes always mean “material-saving” and thus “environmentally friendly” at the same time. Modern analysis options in real time are part of one of the twelve principles of Green Chemistry.
In order to design the process technology of the roller compactors with the corresponding measuring instruments and the associated control technology for continuous manufacturing, Parsum and Alexanderwerk worked out a solution in a joint development project. This is because the continuous manufacturing approach offers numerous advantages over the batch process: “Ideally, the measuring technology used not only monitors Critical Quality Attributes (CGA) in real time, but also provides the actual values in order to automatically counteract any deviations,” explains Stefan Dietrich, Managing Director of Parsum GmbH. “As a result, production no longer has to be interrupted to readjust parameters. Plant availability as well as close tolerance quality control is significantly increased, which both improves product quality and reduces manufacturing costs.”
From laboratory analysis to in-process measurements
The practical implementation of a Process Analytical Technology (PAT) process presented a major challenge in dry granulation. This is because while machine-side process parameters, such as the speed of the feed screw, the roll speed and the roll press force, can already be recorded online. Checking the particle size distribution, an important process variable for the processed material, was previously only possible offline. The reason for this was the lack of a suitable combination of sampling equipment (process interface) and measurement technology for this process. “In brief, in a roller compactor the very loose, powdery starting material is first compacted by mechanical force between two counter-rotating rollers to form a continuous solid ribbon, also called, flake. Subsequently, this is gently milled in a screen mill called a Rotor Fines Granulator (RFG), resulting in granules with a defined particle size distribution as the end product,” Weidemann explains. The challenge in measurement is that the granules produced do not consist of homogeneous particles, but of particles with size ranges from very fine to coarse within a given sample.
Relevant for the measurements are the two resulting fractions: the fines fraction and the granular fraction. “This is a bimodal distribution of the particle size,” reports Dietrich. In the past, various measuring probes and dispersers had been tested that had already proven their worth in other granulation processes, for example in fluid bed or high-shear granulation. In the special case of the dry granulation process, however, the in-process measurement results often differed significantly from those of the samples analyzed offline in the laboratory.
A joint research project
Parsum and Alexanderwerk finally took a closer look at the causes of the fluctuating measurement results as part of a joint research project. Based on these investigations, a measuring probe and a process interface to the roll compactor had to be developed. For a fundamental process simulation of roller compaction, they also called on the expertise of the Technical University of Hamburg (TUHH).
The project partners identified the Particle Size Distribution (PSD) of the granules as the most important critical quality attribute. Parsum’s task was therefore to develop an instrument for in-process measurement that would determine the PSD representatively and in real time, without major intervention in the process or machine design. In order to obtain meaningful data as a basis for process control, a suitable “process interface” for the Parsum probe had to be developed. Furthermore, it was important to extend the previous standard measuring range downwards so that the fines fraction can also be measured accurately.
The measurement location is decisive
For the illustration of process changes, it is important to carry out a differentiated evaluation of the measured data. It is not sufficient to look only at the median particle size (x50), as in other processes with “normal” PSD. Instead, the ratio of fines and granular fractions is decisive in this process. “In regular operation, however, this ratio fluctuates,” Dietrich explains. “The fines fraction passes unevenly through the outlet of the machine and in this way leads to measurement fluctuations.” The positioning of the measuring probe is therefore particularly important for representative sampling. There are striking differences in the ratio between fines and granule content depending on where and how it is positioned below the granulation screen. In order to develop an optimized method for a sample that is as representative as possible, four different approaches were tested. For this purpose, among other things, several test series were carried out in which samples were taken simultaneously at 40 different positions under the granulating screen which were then analyzed. A patent application was filed in early 2021 for the resulting method of representative in-process sampling.
The small particle size also posed a challenge. In order to enable continuous in-process monitoring, Parsum developed a PAT measuring probe with a lower measuring range especially for use in roller compactors, as well as special in-process dispersers with which particles in the size range of 20 – 2000 µm can also be reliably and consistently distinguished and measured.
The in-process particle probe has a newly developed process interface for representative measurement. Manual random samples no longer have to be taken and analyzed offline for quality assurance, but all measurements and analyses can already be carried out in-process and in real time. (Image: Parsum GmbH)
Monitoring of relevant process parameters in real time
On the basis of numerous test series and optimizations in measurement technology, it was finally possible to develop a market-ready roller compactor for dry granulation with an integrated PSD diagnostic tool. The particle measuring probe was placed in a strategically favorable location in the roller compactor so that manual random samples no longer have to be taken and analyzed offline for quality assurance, but all measurements and analyses can be carried out in-process and in real time. Nevertheless, Alexanderwerk GmbH paid attention to a space-saving design during integration, so that the roller compactor does not increase in size compared to previous models. Only 100 mm more overall height is required at the outlet of the roller compactor to install the PSD measuring probe with dispersion technology.
All relevant machine parameters, such as press force, roller gap, and roller speed, are combined in the machine control system and the actual and target values are recorded and compared. In addition, the complete PSD is now also measured and recorded. The characteristic values are both graphically processed in real time and stored in the batch log,” reports Weidemann. Thanks to this online monitoring process, the manufacturing process can be stopped at an early stage in the event of major deviations, or if predefined limit values are exceeded. This prevents unnecessary and costly material losses. In addition, the in-process measurement data can be used for direct release of a produced batch for the next processing step.
Please also see Mr Weidemann’s presentation on Alexanderwerks YouTube channel. Here is the link: YouTube Video
Based on numerous test series and optimizations in measurement technology, a market-ready roller compactor for dry granulation with integrated diagnostic tool has been developed. (Image: Alexanderwerk GmbH)
A look ahead
Following completion of the first phase of the research project, a market-ready solution has now been developed which can be offered as an option for the WP120 Pharma roller compactor from Alexanderwerk GmbH and is also to be adapted for other areas of application. For the project collaboration partners, however, the project is not yet complete. The success development of the roller compactor with in-process PSD measuring probe is getting the industry one step closer to a fully controlled continuous manufacturing process. Many more up- and down-stream process challenges still need further consideration. An evaluation in real time of the PSD measured in-process is already planned in order to draw conclusions about the ribbon density. Such an evaluation can intervene – if necessary – in the compacting process via a control loop. Therefore, an even more consistent granule quality could be produced. “Industry 4.0 is finding its way more and more into process technology, allowing continuous, cost-efficient, and error-free production,” concludes Weidemann.
Comments Off on How to Streamline Operations for Pharmaceutical CDMOs e-book released
At Alexanderwerk, we are the world’s leading provider of dry compaction and granulation solutions. We offer high-quality standard and custom machines that support critical processing applications in the chemical, pharmaceutical, food, life science, and nuclear fields. We just published an eBook in which we explore how to improve the value proposition a CDMO offers to its clients by taking advantage of our experience, process expertise, engineering, and test facilities. Among the topics covered:
If you have more specific questions chat with one of our subject matter experts in granulation development work, including roller compaction, blending, milling, drying and material handling, containment, continuous manufacturing and more use this link: https://alexanderwerkinc.com/contact-us/
Comments Off on Alexanderwerk will present Roller Compaction Scale Up De-mystified at the upcoming VP Pharma Expo February 22 10am-12pm ET
We are excited to examine the key parameters of roller compactor / dry granulation scale up and dispel prevalent myths and misconceptions with the international audience. Our Matt Walczer will be presenting and we will demonstrate the upscaling process with video feeds with a WP120 in our U.S. lab and a WP200 in our Remscheid, Germany lab. Do not miss the opportunity to attend this live presentation on Tuesday, February 22, 2022 from 10AM – 12PM Eastern Standard Time.
Comments Off on Alexanderwerk supports Natoli’s premier hands-on Cannabis Tablet Manufacturing Course – Jan 25-26 in Telford, PA
What you need to know for successful cannabis tablet production? That is the key question our partner Natoli Scientific will help answer during a 2-day-seminar on “Cannabis Oil, Powder Processing and Tablet Manufacturing Process”. Our experts from Alexanderwerk Inc. will support this premier hands-on training event covering #drygranulation of CBD powdered compounds.
Comments Off on Alexanderwerk roller compaction and dry granulation webinar with live lab feed will be held on 12/02/2021
Do not miss our webinar this Thursday 12/2/21 5pm EST intended for our customers, partners and friends in LATAM – organized by #Alexanderwerk and #PachecoYAndresen. The webinar will be held in English/ Spanish and will feature also a live demo from our lab in the US.
Comments Off on Alexanderwerk supports Natoli’s premier hands-on Cannabis Tablet Manufacturing Course – Dec. 7-8 in Telford, PA.
What you need to know for successful cannabis tablet production? That is the key question our partner Natoli Scientific will help answer during a 2-day-seminar on “Cannabis Oil, Powder Processing and Tablet Manufacturing Process”. Our experts from Alexanderwerk Inc. will support this premier hands-on training event covering #drygranulation.
Comments Off on Equipment Spotlight: The Alexanderwerk WP120 for Pharmaceutical Roller Compaction
As a global leader in compaction and granulation, Alexanderwerk develops industry-leading machinery for the pharmaceutical industry. We also provide testing facilities that provide our customers with state-of-the-art machinery in a quality-controlled environment.
Our new process testing suites allow our clients to expand their current production capabilities or test out our technology. Among the testing machinery and equipment we have available for onsite pharmaceutical roller compaction is the WP120. This blog post will go into detail about the WP120’s design features and capabilities.
The WP120 Pharma by Alexanderwerk
Alexanderwerk’s WP120 Pharma was designed to meet the stringent standards and requirements in pharmaceutical research and development. It works well in applications involving small batches and provides completely controlled production conditions when processing special products. It features a roller diameter of 120 mm and a standard roller width of 40 mm. It also has an optional MiniBatch production module with a roller width of 25 mm for amounts ranging from 50 grams to 8Kg as well as an optional MicroBatch module for small mounts (1-5 gramm). The WP120 supports a maximum roller speed of 15 rpm and is highly adaptable to the specifications of varying applications.
The WP120 is designed to process as little as 5 g up to a maximum of 40 kg/h into granules of different sizes. Due to its modular design, the process technology can be disassembled without the need for special tools, which allows for easy cleaning and replacement of rollers.
The WP120 features a mobile, compact design and was created as a portable unit to provide the highest degree of flexibility for the compaction process. Additionally, it allows previously determined process parameters to be easily scaled up to larger production machines. Machines such as the WP120 can be used for a wide variety of pharmaceutical roller compaction applications to produce products such as:
Tablets
Nutraceuticals
Capsules
Instant powders
Life science products
Functions & Features
The WP120 features an advanced interface for comprehensive control of the compaction process. This interface enables the operator to precisely adjust parameters such as flake density, throughput, and compacting pressure. Another key feature of the WP120 is Alexanderwerk’s patented Diagonal-Design two-stage granulation unit, which provides gentle granulation and can achieve the final size of the granules based on previously defined tolerances. Some additional features of the WP120 include:
cGMP design
Stainless steel construction
Throughput from 5 g to 40 kg/h
PLC control
Separation of the drives from the production area
Cantilever roller design ensures consistent compaction and granulation
Fast clean up and roller exchange
Feedback control loop for consistent processing
Reproducible scaleup and scale down capabilities
Compaction units are individualized with different roller combinations based on the application
The WP120 for pharmaceutical roller compaction has been updated with optional UL-rated controls in its interior. While previous models had been tailored for European markets, Alexanderwerk proudly supports reshoring initiatives in North American markets, as evident by our upgraded models. For additional information or questions regarding our machinery, please contact us today.
Comments Off on Alexanderwerk will be exhibiting at the 2021 ISPE Annual Meeting & Expo 31 Oct – 3 Nov
Alexanderwerk will be one of around 200 key expo exhibitors at the Hynes Convention Center, Boston, MA from Monday Nov 1 until Tue Nov 2. ISPE members are invited to stop by at booth #662 and speak to our Matt Walczer (see photo above). Come on out to collaborate with us to help solve your most difficult material flow, sustain, particle size distribution, and so many more challenges using Alexanderwerk’s #drygranulation and #rollercompaction solutions. Let’s talk!
It is not too late to register for this event. Please see also the event’s coordinators webpage here: https://tinyurl.com/b2hpbfy2 . This four day event offers business leaders to students a great opportunity to learn and collaborate with top industry leaders and companies. Please find the agenda using this link: https://tinyurl.com/3b3bdhph . If you have a time that works for you to speak with Matt, reserve your time slot to meet with him using this scheduling tool link: https://tinyurl.com/56jtyrb9
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