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 article provides guidance on these topics, with supporting rationales. READ MORE
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 non-unidirectional airflow against energy consumption with known sources of contamination and type of air diffusion used. It proposes alternative cases to compare potential economic savings from applying energy-saving measures proposed by ISO 14644-16: International Standardization Organization and ISO 14644-16:2019: Cleanrooms and Associated Controlled Environments—Part 16: Energy Efficiency in Cleanrooms and Separative Devices. READ MORE
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 aspect of the operation by quality assurance; and microbiological monitoring by quality control. READ MORE
For a multiproduct facility where equipment is shared, there is always a risk from cross-contamination. The correct calculation of the cleaning validation limits from maximum allowable carryover (MACO) of a marker compound to the next product is vital for the integrity and success of the cleaning validation program. However, the process yielding those limits often involves cumbersome, error-prone manual calculations. This article describes an innovative yet simple tool that uses a combination of spreadsheet software and a statistical platform to fully automate science- and risk-based MACO calculations in pharmaceutical cleaning validation. READ MORE
ISPE’s GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) maintains the principles and framework of the first edition and updates their application in the modern world, including the increased importance of service providers, evolving approaches to software development, and expanded use of software tools and automation. The Second Edition highlights the use of critical thinking by knowledgeable and experienced subject matter experts to define appropriate approaches. READ MORE
For companies focused on producing lifesaving treatments, the positive effects of employee health, well-being, and satisfaction can be easily overlooked, but those positive effects are real. An investment in people results in better research, testing, and manufacturing processes, which leads to more efficient delivery of therapies and treatment to patients worldwide. READ MORE
Out-of-trend (OOT) data results should be limited and scientifically justified, but historically, there have been different approaches to identify OOT. These approaches are easy to understand and implement. They also do not require different limits for each time point. The major disadvantage of these approaches is that they lack statistical basis, which raises questions about the reliability of these approaches to clearly and precisely detect OOT. READ MORE
Large engineering companies specializing in the industrial production sector have increasingly been adding process architects to their teams to address the need for expert designers in this specialized field. Process architects play a key role in designing industrial plants, particularly for pharmaceutical production facilities. READ MORE
The European Commission GMP Annex 1 “Manufacture of Sterile Medicinal Products” and the equivalent Annex 2 from the World Health Organization (WHO) triggered a discussion in ISPE’s Germany/Austria/Switzerland (D/A/CH) Aseptic Processing Community of Practice Steering Committee about where to qualify air speed: “at working position” versus “at working level.” This article provides background knowledge from literature and data from experiments to enhance the discussion. READ MORE
The pharmaceutical industry faces significant challenges in rapidly expanding production capacity to meet the needs of patients. Traditional centralized manufacturing models are increasingly seen as inflexible and slow to adapt to the dynamic demands of modern healthcare. This article proposes a regulatory framework for distributed manufacturing using the concept of fleet management to address these challenges. READ MORE
About Pharmaceutical Engineering
ISPE members receive an annual subscription to ISPE’s award-winning Pharmaceutical Engineering magazine as part of their membership benefits. Published six times yearly, each issue features contributions from expert authors and technical articles highlighting the latest industry trends and innovations.
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