Technical

Mobile water treatment in an ISO container - ISPE Pharmaceutical Engineering
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...
A Strategy for the Analysis of Dissolution Profiles - ISPE Pharmaceutical Engineering
Technical
A Strategy for the Analysis of Dissolution Profiles
In this article, a new method for the analysis and comparison of dissolution profiles is proposed and illustrated with case studies. This useful strategy makes effective use of dissolution profile data by using all data in each profile to create two...
Article - ISPE Pharmaceutical Engineering
Technical
Inline Dilution: An Agile Capability for Downstream Manufacturing
As the global population demands faster and more affordable drugs, biopharmaceutical companies are continually trying to find ways to produce their drug products more economically and efficiently. Today, the competition and need for drugs are greater than ever before. Companies have been...
Article - ISPE Pharmaceutical Engineering
Technical
Sampling Considerations in Continuous Manufacturing
Sampling is the selection of a representative portion of the population to make inferences about the entire population. In pharmaceutical manufacturing, samples are drawn from different stages of the process for both controlling process parameters and assessing drug product quality. In the case of...
Article - ISPE Pharmaceutical Engineering
Technical
Inline Dilution: An Agile Capability for Downstream Manufacturing
As the global population demands faster and more affordable drugs, biopharmaceutical companies are continually trying to find ways to produce their drug products more economically and efficiently. Today, the competition and need for drugs are greater than ever before. Companies have been...
Automated Parts Washer Factory Acceptance - ISPE Pharmaceutical Engineering
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 - ISPE Pharmaceutical Engineering
Technical
Quality By Redesign of a Legacy Product Case Study
In recent years, the concept of quality in the pharmaceutical industry has evolved from the idea of testing the quality to designing the quality. The fundamental idea is very simple; it is necessary to understand the material and process variables that determine the final product’s quality from the...
Article - ISPE Pharmaceutical Engineering
Technical
Blockchain for Pharmaceutical Engineers
This article discusses how blockchain technology may disrupt the way we collect and manage data within regulated processes. The first section is a nontechnical summary of blockchain’s features, including a description of what it is (and what it is not). This sets the context for the next section,...
Article - ISPE Pharmaceutical Engineering
Technical
Continuous OSD 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.
Data - ISPE Pharmaceutical Engineering
Technical
Getting Ready for Pharma 4.0
The amount of data collected in a typical pharmaceutical manufacturing operation is staggering, yet research shows that much of this information is rarely used for anything more than compliance. New technologies such as big data, artificial intelligence, machine learning, and deep learning permit...
Experimental Conditions Define the ATP Inference Space - ISPE Pharmaceutical Engineering
Technical
Experimental Conditions Define the ATP Inference Space
This article illustrates the importance of experimental conditions to evaluate analytical methods. Italicized text is used throughout the article to emphasize key points and illustrate formula variables.
cyber security - ISPE Pharmaceutical Engineering
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 - ISPE Pharmaceutical Engineering
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...
testing - ISPE Pharmaceutical Engineering
Technical
Making CPV a Proactive Component of Process & Product Improvement
Change often takes years longer in the pharmaceutical industry than in others. Why can we not challenge that paradigm? The auto industry, for example, successfully forced changes to its supplier base within a couple of years. By benchmarking other industries that have dealt with similar problems,...
Article - ISPE Pharmaceutical Engineering
Technical
Evaluating In-line Volume Reduction During mAb Production
In-line concentration solves problems found in mAb production, including insufficient storage capacity and process tank volumes, extended processing times, and large hold-up loop volumes for ultrafiltration concentration. It optimizes the ion-exchange step following capture, reduces costs and...
Article - ISPE Pharmaceutical Engineering
Technical
A Holistic Approach to Production Control
This article presents the work of the newly formed ISPE Holistic Production Control Strategy Working Group, which has identified and summarized the need for a redefined control strategy implementation methodology.
Article - ISPE Pharmaceutical Engineering
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...
Article - ISPE Pharmaceutical Engineering
Technical
Defining the Analytical Target Profile
Analytical target profile criteria for judging the quality of results generated by analytical methods are framed in an optimization paradigm by illustrating the ATP criteria as a loss function. In the case where specifications are based on quality arguments and process capability, a...
Article - ISPE Pharmaceutical Engineering
Technical
Indian Serialization Mandate & The US Supply Chain
India is a worldwide leader in drug manufacturing, producing 10% of global pharmaceuticals, with 2016–2017 exports valued at $16.4 billion. 1 Indian generic manufacturers generate 20% of all global exports and more than 80% of antiretroviral drugs in the developing world. 7 India's pharmaceutical...
Article - ISPE Pharmaceutical Engineering
Technical
How Robust Is Your Process Capability Program?
ISPE's Process Capability team has developed an industry-specific maturity model that can help companies design a robust process-capability program and compare it to those of their peers. The model has been substantiated by surveying 15 companies.
Article - ISPE Pharmaceutical Engineering
Technical
Bowtie Analysis and Barrier-Based Risk Management
Every business has legal, economical, and ethical objectives that range from mandatory safety to commercial goals to corporate citizenship. Businesses undertake a certain amount of risk to achieve these objectives. The balance between risk and reward is an ongoing challenge regardless of the...
Article - ISPE Pharmaceutical Engineering
Technical
Effect of Low-Energy E-Beam Irradiation on Presterilized COC Packaging
Does electron-beam surface decontamination radiation damage COC syringes? Experimental investigations confirm that no measurable dose is delivered if irradiation parameters are selected correctly. Even a dose of a few kGy (equivalent to a few 0.1 Mrad) would not cause significant change.
Article - ISPE Pharmaceutical Engineering
Technical
Statistical Approach for CU Testing CPV Batches & Comparison with USP <905> UDU
The USP &lt;905&gt; UDU test, widely used for batch release since 2007, is no longer supported by FDA. We propose a two-sided tolerance interval method to alleviate this deficiency. The approach provides 50% confidence and 95% probability that future samples from the batch will conform to USP...
Article - ISPE Pharmaceutical Engineering
Technical
Manufacturing Excellence Utilizing a Life Cycle Approach
The emergence of “big data” has allowed pharmaceutical organizations to harness the vast amount of information they generate. By collecting equipment, facility, and manufacturing data (process parameters, calibration, qualification, environmental...
Article - ISPE Pharmaceutical Engineering
Technical
A Variable Sampling & Acceptance Polygon Approach for Content Uniformity
We propose a method for demonstrating content uniformity in the context of variables sampling and relate this to the acceptance criteria and probability of passing the USP CU test. We demonstrate that a variable sampling plan with 99.4% coverage between 83.5% and 116.5% of label content is...
Article - ISPE Pharmaceutical Engineering
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 - ISPE Pharmaceutical Engineering
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 - ISPE Pharmaceutical Engineering
Technical
An Introduction to Predictive Maintenance
Much has been published on advantages of predictive maintenance, yet many do not realize that it is a tool to help achieve their facility's goals and objectives. If you need to convince management of the need for PredM, this article contains information that you can use as an "elevator speech."
Article - ISPE Pharmaceutical Engineering
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 - ISPE Pharmaceutical Engineering
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.
Article - ISPE Pharmaceutical Engineering
Technical
EU Clinical Trials Regulation: The Application Process
One of the major changes introduced by the European Union (EU) regulation 536/2014 is an application procedure that will require sponsors to apply for authorization to conduct an interventional/low-intervention clinical trial (CT) via a new EU portal.3...
Article - ISPE Pharmaceutical Engineering
Technical
Continued Process Verification (CPV) Signal Responses in Biopharma
This paper was written by members of the BioPhorum Operations Group CPV and Informatics team and widely reviewed across the BPOG collaboration. As such, it represents the current consensus view of process verification subject matter experts in the biopharmaceutical industry, but does not represent...
Article - ISPE Pharmaceutical Engineering
Technical
Process & Product Contact Surfaces in Bioprocessing
As part of their quality risk management (QRM) programs, many biopharmaceutical manufacturers have made deliberate efforts to classify systems, equipment, and components by their potential to affect product quality. In assessing these risks, it is...
Article - ISPE Pharmaceutical Engineering
Technical
History of Quality & the Evolution of the Modern Leader
The Food and Drug Administration (FDA) report “Pharmaceutical Quality for the 21st Century: A Risk-Based Approach”14 was an introduction to quality by design (QbD), the concept that quality should be built into a product. According to the FDA report...
Article - ISPE Pharmaceutical Engineering
Technical
Balancing Pre and Post-Market Control of Health Supplements
Regulatory authorities (RAs) worldwide employ different terminologies to describe various medicinal and health products. According to the definition by the Association of Southeast Asian Nations (ASEAN), Health supplements (HS) are products used to...
Non-GMP or GMP Washers and Sterilizers: How to Choose - ISPE Pharmaceutical Engineering
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.