Posted by Admin Alexanderwerk on | Comentarios desactivados en Upcoming seminar at Techceuticals with Natoli: Solid Dosage Manufacturing Process July 19-21, 2022
Whether you are new to the industry or want additional functional knowledge, this course consists of a well-balanced combination of presentations, group discussions, Q&A sessions, and live demonstrations with hands-on exercises. During the training, you will enhance your knowledge of setup, operation, and maintenance procedures for manufacturing processing equipment, while learning other tooling options. With our help, your company can effectively reduce downtime and increase productivity.
Our Al Friedrich will cover #drygranulation foundational knowledge using #Alexanderwerk’s #rollercompactors.
Posted by Admin Alexanderwerk on | Comentarios desactivados en 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.
Posted by Admin Alexanderwerk on | Comentarios desactivados en 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.
Posted by Admin Alexanderwerk on | Comentarios desactivados en Alexanderwerk helped co-author article featuring “Effect of deaeration on processability of poorly flowing powders by roller compaction” – link to article included
Our Al Friedrich helped co-author the article Effect of de-aeration on process ability of poorly flowing powders by roller compaction, we are pleased to let you know that the final version – containing full bibliographic details – is now available online for free for the next 50 days until June 30, 2022.
Dry granulation using a roller compactor is an important granulation technique for manufacturing pharmaceutical products as well as other materials. This study carried out at our academic research partner University of MN led by Prof. Sun focused on roller compaction (RC) of extremely cohesive powders. They can present a problem in roller compaction because they cannot be consistently fed into the slip and nip region of the rollers.
The use of a vacuum de-aeration mechanism, which is a standard offering on the Alexanderwerk roller compactors, can facilitate feeding of such difficult powders. This research was carried out using colloidal silica.
Cohesive pharmaceutical materials (low bulk density and cohesive powders) prepared by spray-drying, micronization, and freeze-drying are expected to benefit from the vacuum-aided powder feeding in RC.
Do you have such a challenging material and would like giving RC with vacuum de-aeration a try? We can offer our lab services and rental machines to you. Let’s talk! Please feel free to contact one of our local and global dry granulation experts where we can help you choose the best suitable granulation right from the beginning of your formulation process. https://alexanderwerkinc.com/contact-us/
Posted by Admin Alexanderwerk on | Comentarios desactivados en 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.
Posted by Admin Alexanderwerk on | Comentarios desactivados en 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.
Posted by Admin Alexanderwerk on | Comentarios desactivados en 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.
Posted by Admin Alexanderwerk on | Comentarios desactivados en 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.
Posted by Admin Alexanderwerk on | Comentarios desactivados en Why Does Your Product Need Dry Granulation?
At Alexanderwerk, we partner with leaders across a range of industries, including pharmaceutical and chemical. Our expertise in dry granulation enables us to provide our customers with solutions for even the most complex powder handling processes. While we are headquartered in Germany, we efficiently serve our customers in Canada, the USA, and Mexico from our 17,000 square-foot facility in Pennsylvania. Offering extended services such as commissioning, calibration, training, and repair services, we consistently help our global customer base reap the many benefits of dry granulation.
The Process
To produce granules, there are two types of granulation processes: wet and dry. Wet granulation requires the addition of a liquid binder to form the granules, joining each individual particle together in a process known as agglomeration. Typically, wet granulation also necessitates a drying process to reduce the moisture within the granules. This can slow down the granulation process and may have a negative impact on the quality of the granules.
Dry granulation, on the other hand, does not require the manufacturer to add a liquid binder. This method utilizes a two-step process; first compacting and then milling the initial powder to create granules with the desired particle size distribution, and density. Most often, manufacturers will utilize roller compaction equipment, which functions by compressing the initial powder between two counter-rotating rollers.
While dry granulation is advantageous across an array of industries, there are some sectors that rely on it particularly heavily. These include:
La Industria Química
The pharmaceutical industry
The food and beverage industry
When or Why Is Dry Granulation Required?
Due to the fact that it does not require a liquid binding agent, dry granulation is highly beneficial for applications that utilize active pharmaceutical ingredients (APIs). This is because the addition of liquid and a heated drying process may reduce the efficacy of certain APIs. Furthermore, there are many products in the food and chemical industries that are also very heat sensitive. There are two types of material in particular that require the dry granulation process.
Moisture Sensitive Materials
Certain bulk materials, e.g APIs in the pharma industry, react negatively when they come in contact with moisture. This means that the API is at risk of losing vital chemical properties, thus rendering it ineffective. As these types of materials will not function after undergoing wet granulation, manufacturers must opt for dry granulation instead.
Temperature Sensitive Materials
Once a material has undergone the first step of the wet granulation process, the manufacturer must then put the material through a drying process. Even if a material can handle exposure to moisture, it must also be able to withstand high temperatures if it is to maintain its efficacy after it is dried. If the API in question is sensitive to temperatures, dry granulation is required.
Overall, regardless of the initial properties of the powder blend, the goal of dry granulation is to increase both the particle size and the bulk density of the powder. Both of these outcomes serve to improve the flow of distributed material, thus increasing the efficiency of the manufacturing process.
However, increased efficiency is just one of the advantages of dry granulation. A manufacturer or pharma CDMO may opt for dry granulation due to the fact that dry granulation machinery is smaller and requires minimal amounts of floor space. This process is also very flexible, as it functions well for both large and small volume runs. Additionally, dry granulation is significantly less likely to result in any type of alteration in drug morphology when compared to wet granulation.
Other advantages of dry granulation may include:
Improved blending and a fixed blend uniformity
Improved tablet disintegration time
Dense compaction
Reduced friability
Dust reduction
Reduction of material volume during handling and storage
Partner With Alexanderwerk for Your Dry Granulation Needs
Dry granulation is an efficient and reliable process with a variety of advantages. At Alexanderwerk, our specialists are well-versed in this process, and we work closely with our customers to find the appropriate solution and ensure optimal results for each unique application. Learn more about our dry granulation equipment, or contáctenos to discuss your project and schedule a consultation.
Let’s talk and collaborate with us helping solve your most difficult granulation challenges.
WP120 and WP200 Pharma in Alexanderwerk Inc’s Chem Lab
Posted by Admin Alexanderwerk on | Comentarios desactivados en 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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