Facilities & Equipment

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.

A Prescription for Success
iSpeak Blog
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.
A Prescription for Success
iSpeak Blog
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...