In the highly regulated field of medical device manufacturing, ensuring that every part and component meets rigorous quality standards is essential. One of the first and most critical steps in the Production Part Approval Process (PPAP) is Identifying Requirements. Performance Validation (PV), a leader in PPAP services for medical device manufacturers, emphasizes the importance of […]
Read More
Energy audits are an invaluable tool for identifying opportunities to improve energy efficiency, reduce operating costs, and enhance building sustainability. A comprehensive energy audit involves a systematic evaluation of a building’s energy consumption, efficiency, and performance. Today we will provide an energy audit checklist outlining essential steps for conducting a thorough and effective energy assessment. […]
Read More
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 […]
Read More
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 […]
Read More
Building commissioning plays a crucial role in ensuring that buildings operate efficiently, sustainably, and in accordance with their intended design. However, despite its importance, there are several myths and misconceptions surrounding the practice of building commissioning. In this week’s post, we will debunk some of the most common myths about building commissioning and shed light […]
Read More
Building envelope, also known as building enclosure, is a critical component of any structure. It serves as the primary interface between interior and exterior environments, providing protection, insulation, and structural support. We are going to explore the importance of building envelope for today’s blog. The goal will be understanding the role it has in creating […]
Read More
Digital transformation is more than a buzzword; it is a comprehensive journey that reshapes how organizations operate, innovate, and deliver value. In FDA-regulated industries such as pharma manufacturing and medical device production, digital transformation is not just about integrating new technologies but about rethinking processes, culture, and leadership to drive sustainable growth. Robert Perks, a […]
Read More
Commissioning is a critical component in ensuring that buildings operate efficiently, reliably, and in accordance with their design intent. While commissioning can generally be associated with new construction projects, it is also largely important for existing buildings and facilities. Today we will be exploring the strategies for retro-commissioning and continuous optimization of existing buildings, highlighting […]
Read MoreManufacturing 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 […]
Read More
In today’s evolving business landscape, commercial building owners and operators face increasing pressure to optimize energy usage, reduce operating costs, and minimize environmental impact. One powerful tool in achieving these objectives is an energy audit. It is a comprehensive assessment of a building’s energy performance. In this blog post, we will explore the importance of […]
Read More
Skip to main content