Produced in Partnership with ERWEKAReviewed by Emily MageeAug 14 2024
In this interview, Kyle James from ERWEKA highlights the company's commitment to supporting pharmaceutical sciences through advanced equipment and continuous innovation.
Image Credit: Shutterstock.com/Photobank.kiev.ua
Can you provide an overview of ERWEKA's mission and how it has evolved since the company's founding, particularly in relation to its product offerings?
The company was originally founded with the goal to supply every pharmacy to enable pharmacists to create products for their local customers. This was the original “ERWEKA Method,” as the AR403 All Purpose Unit could be used to create salves, tablets, and powders for local customers.
Since the company was founded, ERWEKA has further developed product solutions for pharmaceutical sciences by developing dissolution testers and tablet hardness testers along with supporting equipment for pharmaceutical testing.
As the years have progressed, the equipment has constantly undergone upgrades via software, automation, and integration. For example, the DT series of dissolution testers are fully compliant with USP Methods 1/2/5/6 and can be offered as standalone systems or fully online systems with fraction collectors and the ability to integrate with a UV-VIS or HPLC for live measurements/analysis.
Can you discuss the importance of dissolution testing in the pharmaceutical industry and how ERWEKA's products support this process?
At ERWEKA, we have a passion for making best-in-class test equipment for the pharmaceutical industry for tablet testing that meet USP/EP/JP guidelines. ERWEKA is a technology and manufacturing leader, committed to innovation, with an extensive global network and an unrivaled offering in dissolution and hardness testers. With a comprehensive product range and a team of product experts, ERWEKA is established as company and brand focused on excellent product quality and support for all of our customers in the pharmaceutical industry, research and development laboratories, and universities around the world.
Dissolution testing is an integral part of the pharmaceutical industry as it is vital for quality control, formulation, research and development, and regulatory compliance. Since all Dissolution testers must be manufactured and supplied according to the USP Methods, all units and components are made with very strict requirements.
As ERWEKA follows the USP requirements, we also provide the user with enhanced features and options such as Test Assist, which allows the customer to use the integrated touch screen to walk through the entire process of product information programming, testing parameters, and user management. Additionally, as industry requirements progress, ERWEKA offers further software support and control that is fully 21 CFR 11 Compliant.
ERWEKA's Dissolution Tester is highly regarded in the pharmaceutical industry. Could you explain the key features and benefits of this product?
The DT 950 series is a true launching point into dissolution. The DT series is designed to be a modular system, so customers can start with a unit and use it as a standalone system that can be upgraded throughout its lifetime to add more options and automation.
We can offer the unit as a standalone, offline, online, or even offline/online system, so it is definitely a system that can grow with the company or lab. Additionally, as noted earlier, the integrated touch display provides the Test Assist software embedded in the interface for standalone operation. As the unit is upgraded, the DISSO.NET software can be used for this system to control additional equipment and programming for sampling and analysis, which is 21 CFR 11 compliant.
Erweka DT 950 Introduction
Video Credit: ERWEKA
The ERWEKA DT 956 is a popular choice for dissolution testing. How does this model ensure reliability and accuracy in pharmaceutical testing?
It all begins with the manufacturing of the unit according to the USP Methods. If the equipment cannot function and is not qualified to operate according to the USP, then any trust in the system must be abandoned.
Since DT956 meets these requirements and is available with a suite of documentation to corroborate this, ERWEKA ensures that the foundational checkbox is indeed checked. From this point, we focus on the DT956's reliability at the customer site. As most customers using the system are in regulatory environments, calibrations and qualification of the unit are standard service work/offerings that we provide.
With the increasing complexity of pharmaceutical formulations, how do ERWEKA's hardness testers adapt to meet the evolving needs of the industry, particularly in testing a wide range of tablet types and strengths?
The formulations of the tablets have not posed significant issues regarding hardness, but the shape of the tablets has been a notable challenge. Everyone is familiar with round tablets or oblong tablets, but there are manufacturers that are now making heart shaped tablets or star shaped tablets, and this has been one of the challenges that our team often tests.
When we have customers that are working with different shapes, we often ask for tablet examples to be provided to us, so our product and application specialists can work with the tablets to provide a solution that will yield reliable and reproducible data. Correct tablet positioning is essential for obtaining reliable hardness and measurement results. Therefore, our goal is to provide the customer with a product and solution that enables the equipment to handle these materials independently. This allows scientists to focus on other tasks without needing to intervene in the system for every test.
Image Credit: Shutterstock.com/Garan Julia
ERWEKA's products often come with comprehensive training and support. What specific resources are available for clients to maximize the use of equipment like the Dissolution Tester and All-In-One automated tablet tester?
For the Dissolution Testers and Tablet Hardness Testers, we offer installation and training. We provide document execution at time of installation as well as a full training session for the lab scientist and their team.
Should there be a requirement for additional training or a refresher course, we do offer these initially via Teams or other video conferencing software; however, depending on the complexity of the equipment or use-scenario, we will also provide on-site support. We also have a full team at the ERWEKA headquarters in Langen, Germany that is willing to jump on calls or go to meetings to provide an additional layer of support.
For someone considering a career in the pharmaceutical industry, how important is it to understand the technical aspects of equipment such as the TBH 425 tablet hardness tester and the ZT 730 disintegration tester?
We believe that for anyone considering a career in pharmaceutical science, it is essential to understand the complete journey. This journey encompasses everything from the initial development of the pharmaceutical ingredient to formulation studies, as well as quality control and production control.
ERWEKA touches each and every aspect of this process. Being able to supply equipment to the research and development and formulations team to design and work with a pharmaceutical product at the beginning stages is crucial.
Once the original formulation has been developed, disintegration, dissolution, and hardness testing are clear next steps to ensure that it will work for the product. It is here that the scientist can ascertain if the formulation is acceptable or if additional work must be done.
If the product is successful, it moves on to the production phase. At this stage, ERWEKA's disintegration, dissolution, and hardness testing units play a crucial role by providing essential data that demonstrates to quality control and production teams that the pharmaceutical product meets design specifications and complies with regulations. So, it is important to know all the steps from inception to the final product and at what stages certain equipment and techniques are required.
Looking ahead, what future developments or projects can we expect from ERWEKA that will further enhance the capabilities of products like the MultiCheck 6 and the Dissolution Tester?
Since all units have to comply with the USP manufacturing guidelines, we are constantly striving to improve the user experience with our equipment. This could be from software upgrades for control and database management or to automation features to remove potential user errors. ERWEKA is always looking at ways to help our scientists in the lab to be more efficient with their time and remove as many bottlenecks as we can in the various testing processes.
About Kyle James
Kyle James currently serves as the Business Manager at Erweka and brings over 18 years of expertise in sales, project management, and operations to the role. Throughout his career he has had a strong focus on developing and executing strategic plans that align with business objectives.
About ERWEKA
ERWEKA is a leading international manufacturer of test equipment for the pharmaceutical industry. We supply tablet test equipment for large pharmaceutical and life science companies, research and test laboratories, and universities all over the world. Founded in Germany in 1951, ERWEKA is the only manufacturer to offer a product for every required test for solid dosage form drugs. ERWEKA stands for excellent product quality, attractive design and bespoke customer support. Our clients have trusted us for more than 65 years.