In the ever-evolving pharmaceutical manufacturing landscape, innovation is key to maintaining efficiency, safety, and compliance. One such innovation that has gained significant traction in recent years is the adoption of single-use technology (SUT). However, the successful implementation of single-use systems requires a thorough understanding of their unique characteristics and careful evaluation of their compatibility with […]
In pharmaceutical manufacturing, ensuring quality is not a matter of chance—it’s built into the process from the ground up. This is the core principle of Quality by Design (QbD), a systematic, proactive approach that focuses on integrating quality into the design and development stages of drug products. The QbD process begins with a clear target: […]
Drug delivery has always been a challenge in the development of new treatments, but what has truly transformed the landscape is how these challenges are being addressed with cutting-edge materials. This evolution in materials technology has significantly impacted both pharmaceuticals and medical devices. In the early days of solid oral dose (OSD) products, advanced materials […]
In the fast-paced world of pharmaceutical manufacturing, the need for efficient, reliable, and compliant systems is paramount. Traditionally, Stainless Steel Technology (SST) has been the cornerstone for ensuring product quality and maintaining sterility, requiring extensive cleaning, sterilization, and validation procedures. However, Single Use Technology (SUT) has emerged as a viable alternative that offers significant improvements […]
North Carolina leads the southeastern United States in research and manufacturing in the pharmaceutical and biotechnology spaces. The state has key manufacturing sites spanning from the mountains to the coastal plain, and ranging from small molecule to complex biotechnologies. What started in the state as typical pharmaceutical production and processing, has developed into advanced biotechnology […]
In pharmaceutical and medical device manufacturing, the qualification of equipment and systems is a critical component of ensuring that they operate as intended, consistently producing high-quality products. The qualification process is divided into three key stages: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Each stage plays a vital role in verifying that […]
Manufacturing drug products aseptically requires the utmost care to ensure that safe and effective products can make it to patients. It starts with the facility design and construction and is immediately followed by the manufacturing equipment selection, installation, and implementation. When choosing the correct equipment and systems for manufacturing, process scientists, process engineers, microbiologists, and […]
Advanced Aseptic Processing starts with the facility: To assure safety and efficacy of the medicines many rely on, the manufacturers must embrace advanced aseptic processing. To the regular person, this might sound like a fancy buzz phrase but to those in the industry and those creating the powerful therapeutics that patients rely on, this is a […]
Performance Validation, Inc. (PV) is thrilled to announce that Robert Perks has joined our team as the new Digital Solutions Director. This strategic addition to our team will significantly enhance our Automation and CSV services, including IT and OT CSV, Process Automation, Paperless Validation, and Digital Transformation initiatives. Robert’s extensive experience and expertise will undoubtedly […]
Automated Storage and Retrieval Systems (AS/RS) have revolutionized the landscape of material handling and storage, offering unprecedented efficiency and space optimization. However, the path to a seamlessly integrated AS/RS in a facility is fraught with challenges, especially during the validation phase. This critical stage is where theoretical designs and simulations confront the tangible realities of […]
Director of Technical Services - Donna has over 20 years of experience leading teams in Commissioning, Qualification, and Validation (CQV). Her focus has always been on pioneering equipment management, quality control, and embracing innovative practices, such as Paperless Validation.
