Articles should discuss process equipment, the design of facilities, and utility systems that support the critical physical and chemical requirements of drug products, in addition to other aspects of the product specification. Topics include design and construction/installation, commissioning and qualification, operation and maintenance, and controls and automation.

Choosing the Right Industrial Mixer
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Choosing the Right Industrial Mixer
The Industrial Mixers Handbook provides information and considerations for choosing an industrial mixer for food, pharmaceutical, chemical, biomass and mineral applications.
Large-Scale, Ultra-Fast-Track Project Challenges Zeta’s Automation Team
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Large-Scale, Ultra-Fast-Track Project Challenges Zeta’s Automation Team
In 2019, a global pharmaceutical company approached ZETA with a significant challenge. The goal was to implement a major development-based EPCM (Engineering, Procurement, and Construction Management) project in Vienna, Austria, in just 24 months. ZETA accepted and successfully managed the general...
ATMP Facilities: Adapting to a Multimodal Future
Features
ATMP Facilities: Adapting to a Multimodal Future
In a recent advanced therapy medicinal products (ATMPs) innovator survey, two-thirds of respondents reported that they are developing multiple drug platforms.CRB Group. Cell and Gene Therapy Report. 2020. http://go.crbgroup.com/2020-horizons-atmp Without a guarantee of commercial success for any...
Choosing the Right Industrial Mixer
Sponsored Content
Choosing the Right Industrial Mixer
The Industrial Mixers Handbook provides information and considerations for choosing an industrial mixer for food, pharmaceutical, chemical, biomass and mineral applications.
Large-Scale, Ultra-Fast-Track Project Challenges Zeta’s Automation Team
Sponsored Content
Large-Scale, Ultra-Fast-Track Project Challenges Zeta’s Automation Team
In 2019, a global pharmaceutical company approached ZETA with a significant challenge. The goal was to implement a major development-based EPCM (Engineering, Procurement, and Construction Management) project in Vienna, Austria, in just 24 months. ZETA accepted and successfully managed the general...
ATMP Facilities: Adapting to a Multimodal Future
Features
ATMP Facilities: Adapting to a Multimodal Future
In a recent advanced therapy medicinal products (ATMPs) innovator survey, two-thirds of respondents reported that they are developing multiple drug platforms.CRB Group. Cell and Gene Therapy Report. 2020. http://go.crbgroup.com/2020-horizons-atmp Without a guarantee of commercial success for any...
FOYA Winners Share Lessons Learned in Facilities Development
Features
FOYA Winners Share Lessons Learned in Facilities Development
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...
Moving From Cleanroom to Isolation Technology for ATMPs
Technical
Moving From Cleanroom to Isolation Technology for ATMPs
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...
Viral Vector Platforms: Intersection of Facility and Program
Features
Viral Vector Platforms: Intersection of Facility and Program
Realizing the promise of any novel viral vector therapeutic depends on the innovator’s ability to constantly meet evolving program requirements set in the product’s preclinical; clinical; chemistry, manufacturing, and controls (CMC); and market strategies. A key enabler to success is establishing a...
Industrial Mixers: Processing with Precision for Every Application
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Industrial Mixers: Processing with Precision for Every Application
The Industrial Mixers Handbook provides information and considerations for choosing an industrial mixer for food, pharmaceutical, chemical, biomass and mineral applications. Given the cost and lifetime of industrial mixers, most manufacturers want to get a detailed education on their options before...
Scale-up in Granulation
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Scale-up in Granulation
A scale-up can be compared to a weather forecast. It is usually correct for the next two days, but the forecast for the next week becomes increasingly imprecise due to the many influencing parameters. The same applies to development processes in granulation. However, with a careful scale-up, the...
Figure 1: Points to consider when designing the media fill study.
Technical
Validation of Aseptic Processes Using Media Fill
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...
Kason - Fluid Bed Dryers, Coolers and Moisturizers
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Fluid Bed Dryers, Coolers and Moisturizers
Kason fluid bed dryers, coolers, and moisturizers employ an innovative circular processing unit which is inherently stronger, lighter, and less costly to build—and finish to sanitary standards—than rectangular units having equivalent surface area.
Figure 3: AUC used as the metric evaluator for models 1 to 5 (2020 data) and model 1 (2018 data, bottom right).
Technical
Case Study: Water for Injection Plant AI-based Maintenance
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...
Figure 2: Setting a risk-based CQV plan
Features
Today’s Pharma and Biotech Projects: A Phased Approach
This article revisits the concept of phased engineering, procurement, and construction (EPC) and updates it with risk-based considerations specifically regarding the commissioning, qualification, and validation (CQV) of general life-cycle principles for pharma and biotech projects. Enhancing the...
Figure 1: Seasonal comfort (temperature and RH). ©ASHRAE, www.ashrae.org. Used with permission from 2017 ANSI/ASHRAE Standard 55 [4].
Technical
Temperature & Humidity Requirements in Pharmaceutical Facilities
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,...
Figure 1: A HEPA fi lter without a di user (left) and a HEPA fi lter with a di user (swirl di user; right).
Technical
Pharmaceutical Cleanroom Design & ISO 14644-16
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...
Master soil (Browne soil) applied to laboratory glassware.
Technical
Master Soil Selection for Cleaning Validation of Parts Washers
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...
A dance floor facility design showing static buffer tanks and minimized tubing lengths
Online Exclusives
Biopharma Facility Design: Lessons Learned on the Dance Floor
In 2014, Pharmaceutical Engineering® published an article, “Lessons Learned in the Ballroom,”Wolton, D. A., and A. Rayner. “Lessons Learned in the Ballroom.” Pharmaceutical Engineering 34, no. 4 (2014). which presented for the first time an alternative to the then-popular ballroom concept adopted...
Figure 1: Cell therapy life cycles.
Features
Flexible Facility Design for Multiple Cell Therapy Processes
In many critical ways, the design of facilities for multiple cell therapy processes is unlike the design of conventional pharmaceutical facilities. This article surveys several of the key issues to consider when designing facilities capable of manufacturing multiple cell therapies, including...
HVAC and Cleanroom Design: ZETA is Expanding its Service Portfolio
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HVAC and Cleanroom Design: ZETA is Expanding its Service Portfolio
The highest quality and safety standards are key criteria in the planning and development of production facilities for pharmaceutical and biotech companies. However, building services engineering is no less important and demands in this field have been increasing steadily over the past few years....
FOYA Category Winners & Honorable Mentions for 2020
Special Reports
FOYA Category Winners & Honorable Mentions for 2020: Examples of Excellence
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...
Special Section: 2020 ISPE Annual Meeting & Expo
Special Reports
Special Section: 2020 ISPE Annual Meeting & Expo
2020 ISPE Annual Meeting & Expo: Driving the Future of Pharma The 2020 ISPE Annual Meeting & Expo will be ISPE’s first completely virtual Annual Meeting. As always, there will be great learning and networking opportunities—in fact, the digital...
Architecture building ceiling
Online Exclusives
Sustainability: Where Is LEED Leading Us?
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,...
Sustainability: Toward Zero Carbon in the Pharmaceutical Industry
Online Exclusives
Sustainability: Toward Zero Carbon in the Pharmaceutical Industry
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...
Company A energy audit summary (annual carbon savings by utility category).
Features
Two Real-World Experiences in Global Sustainability
The article appraises the real-world experiences of two pharmaceutical companies approaching the rollout of energy- and water-reduction programs to selected facilities around the world. It is the result of more than two years of collaboration between the company corporate teams, individual site...
Figure 2: Energy Venn diagram (per I.S. 399) and filter dryer example.
Features
Implementation of a Formal Energy-Efficient Design Process
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.
Chlorine dioxide gas sample readings (mg/L) charted over time
Technical
Chlorine Dioxide Gas Decontamination vs. Liquid Disinfection
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...
Biotech Industry’s Quest for Optimized Manufacturing Facility Design
Features
Biotech Industry’s Quest for Optimized Manufacturing Facility Design
Since the early 1990s, when the “upstart” biotech industry realized that its future success would be heavily influenced by the ability to manufacture multiple products within the same facility,Hill, D., and M. Beatrice. “Biotechnology Facility Requirements, Part 1, Facility and Systems Design.”...
Industrializing New Platforms
Features
Industrializing New Platforms
Moving platforms from development to the delivery of more biopharmaceuticals to more patients is reality, not just a concept, for Moderna, Inc. Juan Andres, the company’s Chief Technical Operations and Quality Officer, presented on “mRNA Medicines—Industrializing a New Platform” at the 2019 ISPE...
Comparison of electricity consumption at the main distribution board
Technical
Airflow Reduction in Cleanrooms after Closing Hours
Cleanrooms and laboratories can save a significant amount of energy by reducing airflow of air handling units (AHUs) after closing hours. Although challenging, airflow reduction is a successful energy reduction measure and has been implemented within the energy reduction program of Janssen Vaccines...
A Prescription for Success
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A Prescription for Success
How CMOs keep conditions controlled and reduce costs with temporary power, climate control, 100% oil-free air
Mobile water treatment in an ISO container
Technical
A New Qualification Approach for Mobile Purified Water Systems
The unavailability of a backup pharmaceutical water system has been a severe limitation for pharmaceutical manufacturers. Until recently, qualification concepts that adhered to current Good Manufacturing Practice (GMP) guidelines hindered the rapid setup of a water system. A new, tailor-made...
Automated Parts Washer Factory Acceptance
Technical
Automated Parts Washer Factory Acceptance Test
It is a common practice in the pharmaceutical and biopharmaceutical industries to execute a factory acceptance test (FAT) for equipment involved with various drug manufacturing processes. The FAT is a project milestone in purchasing good manufacturing practice–compliant equipment.
Article
Technical
Continuous Oral Solid Dosage in the Field - A Status Update
Although it includes some background material, this article is based predominantly on a series of interviews with SMEs at Eli Lilly, Janssen, Hovione, C-SOPS, and Patheon from October to December 2017. The comments and observations that follow are theirs.
cyber security
Technical
Bringing Cybersecurity to GxP Systems
Recent cyberattacks like WannaCry and Petya have affected GxP computerized systems, prompting questions on how to address risk from cyberspace using traditional computerized systems validation according to GAMP® 5. This article explores life cycle management of GxP computerized systems and...
underground system
Technical
Surrounding & Controlling Underground Leaks
Double-wall containment: an answer to unsafe piping systems While most in the pharmaceutical industry understand the need for double-wall containment piping systems, our field observations indicate that many companies do not. We frequently see pipes that should be (but are not) double-wall...
The Advent of Continuous Manufacturing - ISPE Pharmaceutical Engineering
Features
The Advent of Continuous Manufacturing
Spurred by pressure from governments and consumers to curb rising drug prices, pharmaceutical manufacturers are increasingly willing to look beyond traditional batch processing to cut costs and increase efficiency. One of the industry's most dramatic innovations on this front is continuous...
Article
InTouch
2018 ISPE Facilities of the Future Conference Highlights
ISPE's 2018 Facilities of the Future Conference highlighted emerging technologies that are driving change in pharmaceutical manufacturing. Topics included virtual reality, robotics, artificial learning, machine learning, and 3D printing. Education sessions were divided into Industry 4.0 and...
Article
Technical
Parenteral HEPA Filter PM Interval
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...
ISPE Pharmaceutical Engineering
Special Reports
Prepare for Regulatory Audits with Your Supplier
Data integrity continues to be a very hot topic for both regulators and the pharmaceutical industry. With the increased observations about data integrity in laboratories, could it be that analysts have changed how they do science in the laboratory? Are...
Article
Technical
Performance & Validation of Ozone Generation for Pharma Water Systems
Despite the advantages of ozone technology as a powerful commercially available oxidant and disinfectant, this technology has not been adopted broadly by the pharmaceutical industry. This article contains the rationale for applying ozone technology in a packaged system, which offers greater...
Article
Technical
Applying QRM to Air Change Reduction
The following is an example of an evaluation of room air change rates for potential reduction using QRM, providing more detail on engineering considerations.
Article
Technical
Extractables & Leachables: Not the Same
With the integration of single-use systems (SUS)* into downstream processing and thus closer to the final drug product, considerations of extractables and leachables (E&L) have become a critical issue within the industry. Lack of standardization,...
Article
Technical
Corrosion Investigation of Pharma Clean Steam Systems
This article presents current research on the problem of rouge in clean steam generators and their distribution systems, as well as possible deleterious effects on capital equipment and final drug products.
Non-GMP or GMP Washers and Sterilizers: How to Choose
Technical
Non-GMP or GMP Washers and Sterilizers: How to Choose
This article presents the standards and guidelines typically used by manufacturers to design and build GMP washers and sterilizers. It describes the characteristics that differentiate GMP from regular laboratory equipment.
Transitioning To Multicolumn Chromatography
Features
Challenges & Results: Moving to Multicolumn Chromatography
Although pharmaceutical manufacturing is traditionally a change-averse industry, the benefits of continuous processing demonstrated in other industries are beginning to drive interest in its application to bioprocessing. This article reports on...