The versatility of a Portable TOC Analyzer provides users ultimate efficiency gains in cleaning validation and product changeover

The 2026 ISPE Facilities of the Future (FOF) Conference will be held 2–3 February in San Diego, California, United States, and virtually. Lindsey Daniel, the conference’s Executive Chair, offers advice and shares what attendees can expect at the upcoming conference.

Sustainability principles can be effectively integrated into commissioning and qualification (C&Q) projects to support environmental goals without compromising compliance, quality, or patient safety. By positioning C&Q as both a verification tool and an enabler of sustainable intent, this article outlines a practical path for the pharmaceutical sector to enhance operational efficiency,...

Water and steam are essential in the pharmaceutical industry. Both are used for multiple purposes, including cleaning and sterilizing equipment, laboratory activities, and as an ingredient.

Across the country, data centers are being constructed at incredible speed. Pharmaceutical manufacturers should take notice. Despite complex MEP systems, on-site power generation and large site footprints, data centers are being designed and delivered in less than two...

As artificial intelligence (AI) technologies mature, their application in commissioning, qualification, and validation (CQV) is becoming not only more practical, but increasingly necessary.  

Many are exploring automation to meet their medical manufacturing goals, but sometimes full-scale automation isn't practical or justified.  In this article, JR Automation’s Chief Engineer for Life Sciences outlines the possibilities and advantages of using a lean cellular approach when designing your manufacturing process.

A leading BioPharma manufacturer specializing in life-sustaining proteins faced challenges with cleaning validation in its advanced production facility. To reduce costs, the company replaced a specific HPLC method with a more cost-effective Total Organic Carbon (TOC) method for routine cleaning verification and product changeovers. During a four-week pilot study, they found that their current...

In this case study, discover how G-CON partnered with IPS and NIIMBL on Project Blackhawk, transforming a 50-year-old warehouse into a GMP-like plasmid production facility using prefabricated POD® Cleanrooms. This innovative POD®-based approach integrated all utility systems, allowed renovation and construction to happen in parallel, and drastically accelerated the project timeline. The...

Pharmaceutical manufacturers often accept avoidable limitations of ULT freezers, such as temperature fluctuations, large footprints, and reactive maintenance. They should be demanding ULT freezers that are engineered to break the status quo.

Pumping systems are often an overlooked opportunity to make a significant impact on an operation’s energy usage. Grundfos has found that there simple, cost-effective changes that can yield significant energy cost savings. This whitepaper will explore four topics that can help a pharmaceutical facility reduce their carbon footprint while reducing costs.

Advancements in technology—such as process intensification, continuous manufacturing, and 3D printing—are enabling transportable and point-of-care (PoC) medicines manufacturing, especially with the rise of personalized medicine. Modular, small-scale production systems are particularly well-suited for cell and gene therapies and other advanced therapy medicinal products (ATMPs) designed for...

Defining requirements for calibration and routine testing of weighing equipment in the laboratory and production remains a complex endeavor for pharmaceutical companies. Applying sound, risk-based metrological strategies across the entire pharmaceutical value chain will help manufacturers ensure compliance, consumer safety, and commercial success.

Effective containment systems in a pharmaceutical manufacturing facility are essential to protect the health of workers, the environment, and patients receiving the medications. Particles released into the facility can cause adverse side effects to facility employees, and particles released outside the facility can harm the atmosphere and nearby waterways.

Controlling contamination in environments where biological medicinal products are handled is of paramount importance to ensure the safety of personnel, sterility of drug products, and protection of the surrounding environment. The application of vaporized hydrogen peroxide (vH₂O₂) has emerged as a promising method for postproduction decontamination due to its ability to...

Massimiliano Cesarini, MEng, was named CEO of Biogenera SpA, Bologna, Italy in 2024. He began his career at Duferco Engineering in energy generation, then moved to Comecer Group, holding roles as project and product manager, and global sales manager for the pharma and advanced therapy medicinal product (ATMP) division. He eventually joined Omnia Technologies Group establishing the Omnia Life...

At first glance, ready-to-use (RTU) primary packaging material (tub systems) give production lines more flexibility and reduce container preparation complexity for aseptic fill/finish operations. However, the aseptic introduction of RTU tub systems requires a thoroughly designed transfer process to avoid contamination of the sterile RTU items and the aseptic core.

Many organizations are on the right path to sustainability, but more can still be done— especially for setting and meeting net-zero targets. Although a commitment to net-zero operations is important for all industries, it’s particularly necessary for the pharmaceutical industry, with its high energy consumption, high water demands, and the use of solvents for manufacturing.

The decision to pursue net-zero facility design in manufacturing is complicated. There are significant challenges related to initial project costs, physical space constraints, and project site considerations—but also substantive benefits from operational savings, environmental impact, building brand trust, and working toward a more sustainable future.

Welds used in biopharmaceutical manufacturing must meet critical criteria to maintain a defined level of purity and bioburden control. One highly debated area of concern is the level of discoloration allowable on the product contact surfaces in the welded condition and secondary finishing methods. This article addresses the studies commissioned by the American Society for Mechanical Engineers...

The expectations for room differential pressures to maintain air quality in pharmaceutical facility design are consistent and well defined from a regulatory perspective. However, there is no common approach to the design, monitoring, or alarming of area differential pressures. This article explores differential pressure concerns in aseptic manufacturing, or cleanroom classes B, C, and D.

Growing up on a farm, Allen Koester thought he would design farm equipment after earning his degree in mechanical engineering.

In 2019, ISPE released the Second Edition of the ISPE Baseline® Guide Vol 5: Commissioning and Qualification. This guide mirrors the industry’s evolution toward harmonizing with latest...

Rod Freeman started his career in the pharma-ceutical industry as an analytical chemist.

Discover a comprehensive plan for life science decarbonization, from enhancing energy efficiency and electrifying heat to managing refrigerants and adopting renewable energy solutions.

The 2024 ISPE Facilities of the Future Conference opened on 29 January in San Francisco, California, with a series of six keynote presentations on innovations that are leading to advanced...

The ISPE Baseline^® Guide Volume 5: Commissioning and Qualification (Second Edition) framework has gained significant attention, use, and adoption since the...

Pharmaceutical manufacturing facilities produce a variety of products, including highly potent products that require safety measures to prevent adverse health effects on patients and operators. To ensure safety, these facilities use containment equipment to minimize the risk of contamination. This article presents criteria for selecting containment equipment, considering both...

Pharmaceutical critical utilities are typically built of 316L stainless steel; nevertheless, surface degradation has been reported due to the occurrence of different phenomena. This article aims to explain how field electrochemical techniques using a portable tool can be an effective method for surface inspection, qualification, and monitoring. The surface finish assessment considered...

The biotechnology and pharmaceutical sectors have pledged to reduce greenhouse gas (GHG) emissions as the climate concerns of consumers, investors, and regulators continue to grow. In seeking to benefit from this demand for sustainability and the potential for cost-saving opportunities, life science product manufacturers have started to evaluate the climate impact of their own labs and...

Cell therapies have been used to treat thousands of patients worldwide ever since the CAR T cell medication Kymriah was the first cell therapy approved by the FDA in 2017.  Yet significant manufacturing challenges continue to hamper patient access to life-saving cell therapies, particularly the high cost of these treatments. Kymriah can cost as much as $475,000 per dose and an allogeneic...

Since 2005, ISPE’s Facility of the Year Awards (FOYA) have recognized state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality...

The adoption of continuous manufacturing (CM) in the pharmaceutical industry is increasing because of the advantages and opportunities it offers, including the ability to handle hazardous reactions, a higher degree of process integration, and improved sustainability. This article discusses the considerations and approaches adopted by Pfizer, Eli Lilly, GSK, and Amgen in designing and...

To improve the energy efficiency of cleanrooms, the Roche Global Engineering and Oceanside facilities and Engineering team collaborated to implement a risk-based approach to achieve lower air changes during operation without adversely impacting the facility, equipment, or reliability, while meeting environmental requirements.

The expected FDA approval for a Treprostinil dry powder inhaler revealed a need for the manufacturer to expand its warehousing and logistics capabilities to support its growing operations. The company’s senior leadership wanted to ensure this expansion came with as minimal an impact on the environment as possible, so a key priority was to provide a net zero energy facility. With a vision for...

Computational fluid dynamics (CFD) can reduce or eliminate the uncertainty associated with a cleanroom facility as the planned design can be simulated to predict performance to a high degree of accuracy. This article discusses the use of CFD for the purpose of predicting and optimizing the performance of a cleanroom facility in terms of steady-state airborne particulate levels and for...

Chlorine dioxide has been shown effective in decontaminating various types of chambers and volumes such as rooms, isolators, processing tanks, and entire facilities, but its use to decontaminate compressed gas piping systems has not been documented. This article discusses using dry gaseous chlorine dioxide (ClO₂) to decontaminate an oxygen (O₂) feed piping system in a...

Two sessions at the 2022 ISPE Facilities of the Future Conference in early February captured varied views of emerging technologies in the pharmaceutical industry, and the industry’s work to embrace...

What do recipients of ISPE’s prestigious Facilities of the Year Award (FOYA) know that has helped their projects succeed? What are the lessons learned from achievements in facilities development, including forward-looking projects that encompass and inspire changes in the industry? Pharmaceutical Engineering® spoke with nine FOYA winners from recent years about the lessons they learned and...

Advanced therapy medicinal products (ATMPs) pose specific manufacturing challenges beyond those typically addressed by pharmaceutical chemistry. Often in current ATMP applications, a change in approach is introduced at some point in the development process out of convenience or necessity, which then results in a change in technology. This article analyzes the possibility of transferring a cell...

Aseptic process simulation (APS) is essential for validation of an aseptic manufacturing process and is required by regulators to demonstrate the aseptic capability of such processes. A successful program of APS and aseptic manufacturing requires significant operator training, skills, and supervision; thorough maintenance; effective cleaning and disinfection; significant oversight of every...

This article presents the results of applying artificial intelligence (AI), such as machine learning algorithms, to identifying and predicting anomalies for corrective maintenance in a water for injection (WFI) processing plant. The aim is to avoid the yearly stoppage of the water for injection plant for preventive maintenance activities, common in the industry, and use a more scientific...

Defining room temperature and humidity limits is a frequent topic of debate when designing and operating pharmaceutical and biotechnology facilities. What are appropriate alarm limits and acceptable durations for an alarm condition? Understanding the source of temperature and humidity requirements, and strategies for setting limits, can ensure both compliance and optimum use of energy. This...

Cleanrooms and controlled contamination environments are increasingly being used across many industrial sectors, including the pharmaceutical industry. An important issue is the operating cost associated with cleanroom energy consumption and, consequently, the identification of applicable energy containment measures. This article reviews pharmaceutical cleanroom calculations for...

The ISPE OSD Community of Practice Continuous Manufacturing Subcommittee is planning a Good Practice Guide to capture information developed over several years by the team to establish equipment requirements, identify opportunities for harmonization and flexible integration, and suggest where current equipment may be enhanced to work with continuous manufacturing platforms of the future.

One of the goals of the cleaning validation design phase is to define critical process parameters (inputs) and acceptance criteria (outputs) of the cleaning process. This article explores the selection of a master soil as part of the cleaning validation design phase for automated parts washers. The selection and qualification of a master soil through laboratory testing and during factory...

Robotic process automation (RPA) software automatically handles manual, repetitive, time-consuming, and highly structured tasks such as data entry and back-office functions. Certain processes specific to the pharmaceutical industry represent strong candidates for RPA implementation, with significant potential savings and the possibility of ensuring compliance.

In 2014, Pharmaceutical Engineering® published an article, “

Computational fluid dynamics (CFD) can reduce or eliminate the need to perform bioreactor scale-up studies because full-scale manufacturing bioreactors can be simulated to predict performance. This article discusses the use of computational fluid dynamics for that purpose, to predict the performance of a manufacturing-scale bioreactor under various operating conditions.

Each year, ISPE celebrates innovations and advances in pharmaceutical manufacturing technology with its Facility of the Year Awards (FOYA) program. This year, we added a new category, Social Impact, to recognize companies that developed new standards and practices to prevent drug shortages and increase patients’ access to medicine, designed new tools or techniques that reduced the cost of drug...

In 2000, the U.S. Green Building Council (USGBC) introduced Leadership in Energy and Environmental Design (LEED) to create a methodology to promote sustainability-focused practices in the building industry. This article reviews the earliest protype that we know of for a LEED manufacturing facility, presents a real-world case study of a pharmaceutical manufacturing facility achieving LEED Gold,...

We have some clarity over the desired end point of zero carbon within the next 30 years (or sooner for some pharma companies), but our industry is uncertain how we will achieve this objective. As pharma engineers, we will all play a role in delivering this end point through the continuous improvement of existing facilities and by designing, equipping, and building new facilities that will be...

Sustainability is a key principle for pharmaceutical companies in 2020. However, translating corporate goals into meaningful improvements can be a challenge, particularly when competing factors such as complex technical requirements or ambitious project schedules are involved.

Manual decontamination procedures are laborious processes and can be costly, requiring significant time and resources to complete. Manual procedures also may need to be repeated if initial efforts do not fully kill pathogens. To reduce failures and potentially reduce cost, chlorine dioxide gas decontamination was investigated as an alternative solution.

This article shares a process used to evaluate terminal HEPA filter maintenance programs serving a parenteral manufacturing plant. The evaluation determines whether maintenance history data supports extending preventive maintenance frequency.

Terminal HEPA filters in HVAC applications serving Grade B, Grade C, Grade D, CNC, and unclassified areas are...