Peer-Review Research

Apr 02, 2016
Pharmaceutical Technology
Visible residue limits have been shown to be a valuable tool in validated cleaning validation program.
Apr 02, 2016
Pharmaceutical Technology
The authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union’s current good manufacturing practices.
Apr 01, 2016
Pharmaceutical Technology
A strengths, weaknesses, opportunities, and threats analysis for an Eco-Friendly Pharmaceutical Production Facility in Malta.
Mar 02, 2016
Pharmaceutical Technology
A statistical approach determines when a statistically significant relationship between a process parameter and a critical quality attribute is large enough to make a practically meaningful impact.
Feb 01, 2016
Pharmaceutical Technology
A novel method, based on differential calculus, was used to calculate the maximum potential error associated with the drug concentration in pharmaceutical mixtures composed of an infinite number of ingredients measured on an infinite number of balances with different sensitivities. The method was further applied to calculate the ingredients’ least allowable quantities. This approach ensures that the pharmaceutical formulation is prepared within a given maximum permissible error in drug dose.
Jan 02, 2016
Pharmaceutical Technology
The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.
Dec 02, 2015
Pharmaceutical Technology
Microorganism lethality requirements for process validation must always be balanced with the need to protect product integrity and patient safety.
Nov 02, 2015
Pharmaceutical Technology
Delamination of glass packaging is a source of particulates in parenteral drugs, but identifying the root cause allowed the design of an improved manufacturing process for glass vials.
Oct 02, 2015
Pharmaceutical Technology
An integrated approach can improve the efficiency of cleaning validation studies.
Aug 06, 2015
Pharmaceutical Technology
A study of root cause in stability samples suggests the need for tighter control of the sodium lauryl sulfate manufacturing processes.
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