Since we have implemented the system, we are able to verify the blend uniformity in real-time.
Saint Louis, Missouri (PRWEB) May 05, 2013
Pharmaceutical manufacturing companies around the world have been working for years to achieve greater production efficiencies by improving quality, reducing waste and reducing time-to-market, while maintaining regulatory compliance and strict manufacturing practices. In these efforts, organizations have turned toward PAT (Process Analytical Technology) tools and systems to reduce production cycle times, increase automation, improve operator safety, improve efficiency, manage production variability, increase capacity, and ultimately facilitate continuous processing. In pharmaceutical manufacturing, the most prized goal is real-time release, where drug manufacturers are able to seamlessly go from production to packaging to distribution.
PMRS is blazing the trail for the next generation of comprehensive pharmaceutical production services and is leveraging PAT as the silver bullet. PMRS has built a company culture that is based upon continuous improvement and a deep-seated mindset to achieve superior outcomes through people, technology and process. The company boasts custom-built processes and systems that meet and exceed cGMP requirements, and is fully committed to advancements in manufacturing and scientific services.
Recently, PMRS implemented the Prozess 602 Blend Monitoring PAT system to measure and control the uniformity of pharmaceutical powder blends. The Prozess 602 offers a wide wavelength range with exceptional measurement speed in a system that is purpose-built for manufacturing. The system uses a 21 CFR part 11 compliant software and data analysis package. Communication and data integrity are assured through the use of embedded electronics with onboard buffering. Communication and data integrity are maintained through the use of embedded electronics with both wireless and wired Ethernet links to the plant network. The system supports the OPC protocol which enables it to be interfaced to data historians, for example, or controlled remotely.
“We are thrilled at the results of Prozess’ Blend Monitoring technology on our production processes,” says Edwin Thompson, President & CEO of PMRS. “Since we have implemented the system, we are able to verify the blend uniformity in real-time and significantly increase the efficiency of powder blending resulting in a shorter time to market for the products. What’s more, the technical integration to our enterprise systems has been seamless.”
Prozess is a leading supplier to the highly-regulated pharmaceutical manufacturing industry and counts 16 of the largest 20 global pharmaceutical manufacturers as customers.
Prozess’ growth has been fueled, in large part, by leading manufacturing movements PAT (Process Analytical Technology) and QbD (Quality by Design). With pressure from the FDA (United States Food and Drug Administration), manufacturers are looking to Prozess solutions to enable them to produce products with consistent quality in a shorter production window, while shrinking waste and reducing overall production costs.
“PMRS is at the forefront of the continuous process movement in pharmaceutical manufacturing and is truly leveraging the real-time control capabilities of our systems,” says Stefan Beck, Vice President of Worldwide Operations for Prozess. “We are excited about our partnership with PMRS, and look forward to being a key enabler for them to achieve real-time release.”
ABOUT PROZESS TECHNOLOGIE
Prozess Technologie enables its customers to understand and control their manufacturing processes in real-time. The company creates intelligent process analytical systems to increase quality, yield, and productivity while reducing risk and downtime in the manufacturing environment. Customers can gather, process, and interpret data in milliseconds while viewing the data securely from wherever they are as part of an enterprise-wide continuous process system.
Prozess Technologie integrated hardware and software solutions are in use across the world by manufacturing customers in the pharmaceutical, food and beverage, and petrochemical sectors. The Company is a closely held, private organization, owned by investors and employees, operating out of Silicon Valley, California and Saint Louis, Missouri.
Incorporated by Edwin R. Thompson in September, 1994, Pharmaceutical Manufacturing Research Services (PMRS, Inc.) is a privately held company headquartered in Horsham, Pennsylvania, that has grown into a world-class supplier of pharmaceutical services. PMRS is committed to providing manufacturing and scientific services to the healthcare industry that exceed customer expectations and surpass industry standards. The company is committed to long-term investment in the brightest minds, the most advanced technology, and state-of-the-art facilities. These pillars have enabled PMRS to produce superior pharmaceuticals for the lowest possible cost.
PMRS works with a diverse range of products and has a depth of expertise in tablet, capsule, liquid and cream manufacturing processes. Working with domestic and international customers, the company provides Analytical and Microbiological Services, including method development and validation, raw material ordering and testing, in-process testing, batch release, stability testing, microbiological testing, and residual detection analysis.