Technical

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.
Article
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
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...
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...
testing
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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&amp;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.
Article
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
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
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
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...