With our expansive industry knowledge and engineering expertise, Custom Powder Systems provides groundbreaking solutions in the pharmaceutical industry that redefine how companies handle complex processes, save time, cut costs, and optimize labor resources. We are an industry leader in containment and powder handling equipment, and offer designed, fabricated, tested, and validated equipment and systems to meet anyone’s needs.

In the dynamic landscape of manufacturing, efficiency is paramount for the success of companies and their products. However, the trend of downsizing in recent years due to cost considerations has led to a deficit of in-house resources such as labor and equipment, resulting in a need to outsource services to fill those gaps. So, companies that lack the necessary technology and experience for continued growth and improvement have turned to equipment manufacturing companies for additional support.

Case Study: Upscaling Production of Injectable Pharmaceuticals

In 2017, Custom Powder Systems was approached by a custom manufacturer of injectable pharmaceutical products to help them significantly upscale their production capabilities. While the company had an innovative scientific approach of using two identical lines to manufacture liquid and lyophilized sterile products in tubular glass vials of different sizes and volumes, they lacked the facilities and expertise to initiate and execute the project. In the end, CPS played a crucial role in bridging this gap, saving the company large amounts of time and resources on the front end.

For this project, CPS was tasked with supplying a high-capacity fully-automated aseptic system for filling, lyophilization, and capping of glass vials to complement their low-capacity manually-operated clean room vial-filling process, thus increasing production from a few hundred vials per day to thousands of vials per day.

Over the course of the project, CPS took center stage as the single point of contact for the design, integration, fabrication, testing, installation, and validation of the specialized equipment.

Using the detailed user requirement specifications, such as how they visualized the system to operate and where it would fit, CPS helped the customer define their needs and adapt their ideas to the allotted space and confinements. CPS’ experiences with and knowledge of Current Good Manufacturing Practices (cGMP), aseptic design, and the FDA validation process were instrumental during the design phase, as was the ability to work with the customer and site contractors during the installation and commissioning phases.

Building the system itself involved incorporating six pieces of manufacturing equipment for each line (twelve total) as well as five subsystems and a SCADA control system. This was followed by assuring that the different suppliers’ equipment successfully worked in unison to wash, depyrogenate, fill, and transport vials to either be lyophilized or processed as liquid-filled vials.

The end result was a system boasting fourteen different vial paths, simultaneously running batches from Line 1, Line 2, or a combination of Line 1 and 2 in aseptic isolator gloveboxes and a controlled environment that safeguarded the vials and material from contamination. Accomplishing this took not only knowing how to integrate different pieces of manufacturing equipment but also understanding how the equipment functions and how their operations interface with and affect the overall approach.

Utilizing expansive industry expertise, CPS also acted as an integrator during the validation efforts, eliminating the need for an additional service from an external source, therefore conserving even more time and costs for the customer. Because of familiarity with the equipment and how it worked, CPS was able to ensure each part of the system functioned properly according to the outlined specifications and provided the necessary documentation.

Throughout this process, CPS became a crucial partner for both meeting the customer’s needs and actively contributing to defining them, consequently saving substantial time and resources. CPS had not only the ability to integrate just one or two pieces of equipment but also the experience to handle an entire project of this magnitude and the knowledge required to understand the intricacies of handling complex containment systems.

Oftentimes, pharmaceutical companies face added challenges due to the intricacies of handling complex processes and materials. Throughout this endeavor, Custom Powder Systems was not only able to formulate a solution, but also supply the knowledge, technology, and equipment to make it work, as well as site support to install, test, and validate the system, saving the customer valuable time and ensuring a smooth process.

For more information, contact us, and let us know what problems we can help you solve.

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