Josh Ciesiolka is a Senior Validation Engineer and certified project leader at Performance Validation. Josh has led a number of complex Lyophilization projects including retrofit of existing units, installation of new units and integration with automated loading and unloading systems. He is PV’s technical expert in regards to the commissioning, qualification, and validation of Lyophilization equipment and processes. Based on his interest in this field – Josh has joined ASTM E55 Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products and holds Performance Validation’s official vote for the subcommittee on Lyophilization. In October ASTM E55 will be holding its fall meeting at Purdue University, October 23-25, 2018 with a full day workshop on Lyophilization on the 23rd, presented by LyoHub. Have a question on the commissioning, qualification, and validation of Lyophilization equipment and processes email Josh.
Performance Validation has been serving the life science industries since 1988, and is a nationwide leader in providing validation, commissioning, and quality services for pharmaceutical, biotechnology, and medical device manufacturers.
ASTM Committee E55 on Manufacture of Pharmaceutical Products was formed in 2003. E55 meets twice each year, in May and November, with about 50 members attending three days of technical meetings (every 3rd to 4th meeting of E55 is held outside of the United States). This Committee addresses issues related to process control, design, and performance, as well as quality acceptance/assurance tests for the pharmaceutical manufacturing industry. Stakeholders include manufacturers of pharmaceuticals and pharmaceutical equipment, federal agencies, design professionals, professional societies, trade associations, financial organizations, and academia. The Committee, with a membership of approximately 200, currently has its standards published in the Annual Book of ASTM Standards, Volume 14.05. E55 has 4 technical subcommittees that maintain jurisdiction over these standards.