Peer-Review Research

Dec 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The industry lacks an accepted method for establishing a minimum incubation time (MIT) of less than seven days for biological indicators (BIs). The authors propose an MIT method that provides a means for reproducible determination of BI grow-out time.
Nov 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Predicting long-term storage stability of a given protein and formulation is desirable for effective screening and optimization early in the development process. Multiple routes to aggregation during storage to suggest that multiple measurement types should be made to probe different aspects of protein behavior.
Oct 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors discuss a strategy for developing a risk-based approach for testing of elemental impurities in leachable studies.
Oct 02, 2013
Pharmaceutical Technology
The authors evaluated a variety of materials of construction (MOCs) and found that visible residue limits (VRLs) were higher on some MOCs than on stainless steel. The optimal viewing conditions were dependent on the MOC and the viewing background. The risk of a cleaning failure due to visual failure for different MOCs can be mitigated or eliminated using complementary cleaning validation studies.
Sep 02, 2013
Pharmaceutical Technology
Vaporous hydrogen peroxide, used for sterilization and decontamination, is highly potent but presents implementation challenges.
Sep 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The advantages of using an automated powder dispensing system in a ventilated balance enclosure for efficient handling and effective containment of potent compounds are discussed.
Aug 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors examine alternative solvents for extractables and leachables screening evaluation of process components that provide extraction equivalence and do not interfere chromatographically.
Jul 02, 2013
Pharmaceutical Technology
The author discusses the purpose of analysis and testing and the implications for specifications and their underlying statistical distribution.
Jun 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors report on the range and distribution of grow-out times for biological indicators exposed to sublethal sterilization processes.
Jun 02, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors discuss three methods for identification of out-of-trend (OOT) results and further compare the z-score method and the tolerance interval in OOT analysis for stability studies.
native1_300x100
lorem ipsum