JVT Journal Articles
Vol. 15, Issue 3, Sep 2009

The biotechnology industry assumption in the cleaning of product contact equipment is that both acidic and caustic solutions and high temperatures effectively degrade residual active pharmaceutical ingredients. The necessity of conducting research to qualify such assumptions is relevant when considering the cleaning of equipment between batches...
Bernard McGarvey
,
Brian K. Nunnally
,
John McConnell
Before analytical error can be reduced, it must be understood The pharmaceutical industry has a history of confusing compliance with good quality When outsourcing analytical tests to a vendor laboratory, not only must compliance aspects be covered in the outsourcing protocols, but also minimum standards for analytical variation must be...
This article discusses various types of column chromatography that are used for purification in the biotech industry. These include affinity chromatography, ion exchange chromatography, gel filtration chromatography, hydrophobic interaction chromatography, and reversed phase chromatography.
Scott Sutton, Ph.D.
This article discusses the finalized harmonization of the Microbial Limits Tests. Changes to the respective tests and the ramifications of these changes are addressed. Specific key points discussed include the following: The final versions change the requirement for validation to “verification of suitability of the method” The Microbial...
Ed White
High efficiency particulate air (HEPA) filters and ultra-low penetration air (ULPA) filters are used in almost every aseptic process HEPA filters have an efficiency of at least 99.97% for 0.3-micrometer particles.
A previous series in this column on cycle development and validation for cleaning shows how design space and control space are established for cleaning processes (1). The series also shows how small-scale models can be used to determine worst-case operating conditions within the control space of the cleaning process (2). These models were used to...
Definition of amorphous solid Meaning of long-range and short-range order in solids Disorder (amorphous nature) accelerates the rate at which the solid degrades, absorbs water, dissolves, etc. Small amounts of amorphous content can affect the properties of individual batches of drug The glass transition temperature (Tg) is a characteristic...
Frank Houston
What validation problems are you likely to see over and over? When tackling complex validation challenges, you’ll save time, money, and headaches when you know the most common problems and where to find them. The following analysis is based on validation work performed for a large US Food and Drug Administration-regulated company. The goal...
Deliang Zhou
Stability of pharmaceutical products, including physical and chemical stability, is a core quality attribute potentially impacting efficacy and safety Phase transformation is a common form of physical instability. Polymorphic transition; solvation and desolvation; salt and parent conversion or salt and salt exchange; and amorphization and...
“Validation Strategy and Planning” previously published three articles on various components of validation master plans (VMPs). “Validation Master Plans—Defining a Quality System,” published in the Journal of Validation Technology (JVT), Volume 14, #5 (Autumn 2008), discusses the overall strategy and content of a VMP including planning, policies...
Brian K. Nunnally
After determining the analytical variability using the stability data for a vaccine drug product, a screening variance components study was performed on the vaccine content assay and related substance assays. For the content assay, the design included analyst, standard lot, mixing style, heater type, and container as factors. One significant...