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James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.
February 02, 2018
The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.
January 24, 2018
The revised Annex 1 on sterile manufacturing includes incorrect and ambiguous statements that must be fixed before implementation.
November 15, 2017
Alternatives to time-consuming, error-prone operations promise to reduce vaccine manufacturing costs and improve facility flexibility.
November 02, 2017
The revised Akers-Agalloco aseptic risk assessment and mitigation method includes two sub-methods that can be used independently for risk assessment.
May 15, 2017
Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.
November 15, 2016
The half-cycle method for validating sterilization can have adverse effects on materials if used for steam sterilization.