Temperature control is a fundamental element of pharmaceutical quality assurance. Whether your facility stores finished products, active ingredients, or in-process materials, maintaining validated environmental conditions is key to ensuring product safety, stability, and efficacy. Even minor temperature deviations can have outsized consequences. A single undetected hot or cold spot can lead to product degradation, investigation […]
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In Part 1 of our series, we explored what drew our long-tenured (10+ years) employees to Performance Validation and why they chose to stay. In Part 2, we continued their stories by highlighting how their careers have evolved over time. In Part 3, we focus on how Employee Ownership has made a meaningful impact on […]
Read MoreIn today’s day and age energy efficiency is often not just a goal, it is a critical necessity. With energy costs on the rise and environmental concerns at the forefront, industrial operators and developers are under pressure to optimize energy usage, reduce operating costs, and minimize their carbon footprint. Enhanced energy audits offer a powerful […]
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The pharmaceutical industry operates under some of the most stringent regulatory frameworks in the world. Every system, process, and technology that touches product quality or patient safety is subject to oversight. Increasingly, these processes rely on computerized systems, such as laboratory information management systems (LIMS), environmental monitoring systems (EMS), or manufacturing execution systems (MES). When […]
Read MoreThe Leadership in Energy and Environmental Design (LEED) certification is a universally recognized standard for sustainable building practices. Established by the U.S. Green Building Council (USGBC), LEED certification advocates for environmental responsibility, energy efficiency, and sustainable building design. For existing buildings, LEED certification is directly corelated with retrocommissioning, a process aimed at improving the performance […]
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In pharmaceutical manufacturing, lyophilization plays a critical role in ensuring product stability, efficacy, and shelf life. However, the complexity of freeze-drying processes makes them highly sensitive to variations in temperature, vacuum levels, and environmental conditions. Without a robust risk assessment strategy, manufacturers expose themselves to significant operational, quality, and compliance risks. Implementing a risk-based approach […]
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In Part 1 of our series, we explored what drew our long-tenured employees to Performance Validation (PV) and why they chose to stay. In Part 2, we continue their stories by highlighting how their careers have evolved over time. These journeys reflect not only personal growth, but also the opportunities and support that have shaped […]
Read MoreMaximizing return on investment (ROI) is a top priority for building owners, facility managers, and stakeholders, especially when it comes to optimizing performance and energy efficiency. One often overlooked yet highly effective strategy for achieving significant ROI is envelope testing. The building envelope is the physical barrier between the interior and exterior environments. By evaluating […]
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The pharmaceutical landscape is evolving rapidly, and Pharma 4.0 is more than a buzzword, it is a transformative, strategic shift. Coined by the International Society of Pharmaceutical Engineers (ISPE), Pharma 4.0 extends the principles of Industry 4.0—automation, AI, IoT, and advanced analytics—into the highly regulated world of pharmaceutical manufacturing and quality systems. For manufacturers, distributors, […]
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Completing a temperature mapping study is a big step toward compliance—but what you do with the results matters just as much. For 3PL providers serving the pharmaceutical and biotech industry, post-study action is where true operational value and regulatory assurance are demonstrated. Whether you are preparing for a client audit or striving to strengthen your […]
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