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 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 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:
The chemical industry
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 contact us 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
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’s screen tension tool for WP120+200 Pharma
Alexanderwerk’s screen tension tool for WP120+200 Pharma has been featured in an article in the May issue of Powder & Bulk Solids May 2021 Check it out on pg31.
Comments Off on First impressions from CIPM 2021 in QingDao (P.R. China)
Alexanderwerk exhibits at the 60th China International Pharmaceutical Machinery Exposition 5/10/2021 – 5/12/2021
Alexanderwerk is happy to have a base in Shanghai helping support our numerous partners and customers in China. Hence, it was no question for us at all to join this year’s CIPM in QingDao.
See some impressions from our booth N5-26 and feel free to visit us in QingDao. Our colleagues will be very happy to introduce you to the advantages of Dry Granulation and the Alexanderwerk portfolio.
CIPM is a large pharmaceutical machinery industry show held in China since 1991. It has been held since 1991.
Comments Off on 5 common questions about roller compaction and dry granulation 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 provide answers to five of the most commonly asked questions regarding the roller compaction process, including how it works, what advantages it offers, what the significance of parameter controls is, what a typical roller compaction operation and system look like, and what products it accommodates.
What is the science behind powder processing during roller compaction operations?
What powder processing techniques are there and what advantages does roller compaction have over other powder processing techniques and technologies?
What are the significant control parameters in roller compaction operations?
What does a typical roller compaction operation and system look like?
What products can be compacted, and how is material flow addressed?
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 Are you in need of more roller compaction and dry granulation capacity? Rapid roller compactor delivery program
Shown here are Alexanderwerk’s pharma and nutraceutical industry roller compactor and dry granulation workhorses WP120 and WP200
If for nothing else the Covid19 crisis has brought to light a greater sense of urgency for being able to boost local production of pharma and even nutraceutical products. Some of you may be struggling to keep up with production capacity in addition to a myriad of other manpower, supply chain, and logistics challenges.
One area where Alexanderwerk can assist you is with our rapid delivery program. Please see here Alexanderwerk rapid delivery inventory our inventory of our high quality Made in Germany roller compactors that can be at your site as fast as the freight providers can get it to you. Our technicians are able and willing to travel to your site helping commission the roller compactor and then also train your operators and maintenance folks so you can add more dry granulation capacity to your operation in record time.
Quality and performance of Alexanderwerk’s WP120 and 200 Pharma series roller compactors https://alexanderwerkinc.com/products/roller-compaction-pharmaceutical/ is legendary. Small size batches, up to 400Kg/hr production runs, and even continuous production is possible with the models Alexanderwerk has available. Remote trouble shooting is built into the controls come in handy when you are in a bind in today’s environment of complicated travel restrictions.
Not located in our geographic region, but you are looking for a rapid delivery for your plant? Check out your local representative here https://alexanderwerkinc.com/
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