In FDA-regulated pharmaceutical manufacturing, the formulation and filling process plays a critical role in ensuring that each dose delivered to a patient is safe, effective, and consistent. Whether manufacturing sterile injectables, biologics, or other complex drug products, errors at this stage can carry severe regulatory, financial, and—most importantly—patient safety consequences. Why Formulation and Filling Matter […]
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In pharmaceutical manufacturing, maintaining cleanroom integrity is essential to ensuring product quality and patient safety. Room Occupancy Testing is a key contamination control strategy used to assess the impact of personnel and equipment on controlled environments. People are the primary source of particulate contamination in cleanrooms, and as movement increases, so does the risk of […]
Read MoreThermal bridging occurs when heat transfers more willingly through certain parts of a building envelope, creating “bridges” that bypass insulation and minimize the overall thermal performance of the structure. These bridges can lead to increased energy consumption, increased costs of heating and cooling, in addition to discomfort for building occupants. This blog will explore how […]
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Attending a career fair can be exciting—and a little overwhelming. You’re navigating a crowded room, trying to make meaningful connections, and hoping to leave a strong impression that leads to your next opportunity. If you’re a new graduate preparing to attend a career fair, there are a few things that can help you stand out […]
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Data is everywhere—but turning that data into actionable insight is what sets top-performing teams apart. At Performance Validation, we’re continuously investing in tools and partnerships that give our clients the edge in operational efficiency, compliance, and innovation. One of the most exciting developments in this space is our partnership with Seeq, a powerful data analytics […]
Read MoreA building envelope is the physical barrier between the conditioned interior of a building and the external environment. This includes the walls, roof, foundation, windows, and doors of a building. A high-performing building envelope is essential for achieving energy efficiency, which is a critical component in sustainable building design and operation. This blog will explore […]
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Why CQV is Essential for Oral Solid Dosage Manufacturing Commissioning, Qualification, and Validation (CQV) play a crucial role in Oral Solid Dosage (OSD) pharmaceutical manufacturing, ensuring that facilities, equipment, and processes meet strict regulatory and quality standards. Without a structured CQV approach, manufacturers risk product quality failures, regulatory non-compliance, and operational inefficiencies that can impact […]
Read MoreAn air barrier system is fundamental in modern building construction to control airflow between the interior and exterior environments. Properly designed, installed, and tested air barriers significantly enhance the energy efficiency, indoor air quality, and overall performance of a building. This blog post will articulate the best practices for air barrier systems within building envelopes, […]
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Lyophilization is a cornerstone of pharmaceutical manufacturing, providing a reliable method to stabilize biologics, vaccines, and injectable drugs. For FDA-regulated facilities, ensuring that lyophilization systems are properly commissioned, qualified, and validated is essential—not only for compliance but also for maintaining product efficacy and stability. Inaccuracies or failures in these processes can result in contamination, product […]
Read MoreArtificial Intelligence (AI) has emerged as a transformative force across industries, and pharmaceutical manufacturing is no exception. With its capacity to analyze vast datasets, streamline operations, and provide real-time insights, AI is driving efficiency and innovation. This blog explores the current applications of AI in pharmaceutical manufacturing and offers a glimpse into its promising future. […]
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