JVT Journal Articles
Vol. 20, Issue 1, Mar 2014

Bench-scale methods for assessing the relative cleanabilities of process soils are useful tools for applying a risk-based approach to full-scale cleaning validations, troubleshooting cleaning issues, and developing cleaning strategies. In this study, the authors explored a coupon soiling method, referred to as the “spreading method,” that controls soil size and shape during sample preparation.
Shelly J. Asmussen, Ph.D.
,
David G. Stroz, M.S.
,
David LeBlond
,
Dennis A. Stephens, Ph.D.
This manuscript translates the USP Pharmacopeial Mean Kinetic Temperature (MKT) into an approach that can be applied to temperature excursion management. It also describes and justifies the use of a two-tiered model that is a conservative estimate of product stability, and it is simplified through the creation of standardized evaluation tables...
Nathalie Hertzog
,
Thierry Muller
,
Emmanuelle Silva
Plastic parts are commonly used in the regulated industry: as consumables in laboratories, as critical components in manufacturing areas for packaging as well as for single-use products, and, of course, they can be major parts of medical devices. The plastic part and its injection process are the subject of this paper. From product development to...
Keith Bader
,
Kelly Scalva
While considerable attention has been given to the development of visual residue limits (VRLs) in a laboratory setting, translating the bench scale values to the assessment of process surfaces has not yet been thoroughly assessed. However, knowledge of both the critical parameters that impact the determination of VRLs and the influence of those...
Mary Sexton
The validation of a pharmaceutical water system for the active pharmaceutical ingredient (API) industry will depend on the type of API process (e.g., intermediate API, final API) and the Grade of Water (i.e., Municipal Water vs. Purified Water) required: Final API: The final product manufacturing step in the process; it is the substance in a...
Jane Weitzel
Clarity, confidence, probability, prospective, and fit-for-intended-use are all characteristics and outcomes of the analytical target profile (ATP). As discussed in the previous column, the ATP is analogous to the quality target product profile (QTPP), which is a prospective summary of the quality characteristics of a drug product. For an...
Tim Sandle
Biological indicators (BI) are routinely used within the pharmaceutical, food, and medical devices industries to monitor the efficacy of various sterilization processes. These processes include dry heat, ethylene oxide, hydrogen peroxide, moist heat (steam sterilization), chlorine dioxide, and peracetic acid.
Paul L. Pluta, Ph.D.
The recent US Food and Drug Administration Process Validation Guidance has provided clear statements on the need for statistical procedures in process validation. FDA has redefined validation to include activities taking place over the lifecycle of product and process—from process design and development through ongoing commercialization. New...
John E. Lincoln
The UDI Final Rule is FDA’s first step towards requiring regulated device manufacturers to implement a consistent way to identify medical devices throughout their distribution and use. This is part of a continuing effort to improve patient safety by making it harder to distribute counterfeit product and better facilitate the identification of...

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