On April 23rd 2014, the ISPE LA chapter held a meeting at the Amgen Conference Center about the generation, specifications, and testing of process gases.
In the first part of the meeting, speakers Phil Bowes, Director or Engineering at Amgen and Nick Haycocks, Senior QA Associate at Amgen, presented the ISPE good practices guide on process gases and process gas specifications. As there is no risk based approach for process gasses defined for the industry, the expertise within the ISPE is key in designing cost-effective engineering practices and efficient systems for process gases used in pharma manufacturing. The gases talked about in this guide, such as N2, O2, Ar, CO2 and compressed air, are in direct contact with the product and require practical, cost-effective systems for intended purposes.
This guide, in line with accepted industry practices, defines system parameters important to product quality and patient safety, management of facility installation and operational costs and provides a scientific risk-based approach to demonstrate compliance. The guide will overview the design development process flow, encompassing the user requirements, the generation and supply systems, distribution systems, control and monitoring, use of risk assessments, construction and its records, commissioning and verification and finally operation and maintenance. The guide defines a risk based approach to the design and operation of process gas systems, including the identification of risk controls, means of detection and an assessment of the resulting risk level.
In the second part of the meeting, speaker Ruby Ochoa, owner of Trace Analytics LLC, talked about process gas compressed air testing, sampling and analytical methods. Sampling methods for particles, water and oil (oil vapor, aerosol and liquid oil) were covered. For particle sampling, a laser particle counter is used to perform a background test and sampling tips were presented. For water measurement, devices such as hygrometers, psychrometers, electrical sensors or spectroscopic methods can be used. For oil, measurements can be taken for total or condensed hydrocarbons, oil mist or aerosols through various methods including spectroscopy, gas chromatrography and filtration through membranes.
In the third part of the meeting, speaker Andrew Castiglione, Account Manager, at Westair Gases and Equipment, discussed the methods for generation of gases and the control of quality parameters for pharmaceutical gases. The gases overviewed included atmospheric gases such as N2, O2, Ar, weird gases like CO2, pharma gases like H2, He, and other gases. Gas packaging methods such as single cylinders, liquid cylinders and other automated processes were discussed, along with methods to accurately track, categorize and date such cylinders via barcoding. Concerns of contamination and methods to analyze and verify the quality of the gas were also examined. To conclude, applications for each gas were covered: N2 for blanketing and preservation of biological samples, O2 for cell growth, fermenters and bioreactors, Ar for inerting, and CO2 for incubators and dry ice shipping.