| As the drive for quality continues, regulatory framework surrounding emissions control tightens. Lieve de Paepe at Air Products urges the pharmaceutical industry to foster close partnerships with suppliers to achieve compliance and improve efficiency
Generally used for only the most demanding industrial applications, pharmaceutical manufacturers use speciality gases for a wide range of specialist applications. These applications range from environmental monitoring and control, to using the gas as a key component of the production process itself. For example, many manufacturers use nitrogen as an inerting gas to prevent chemical reactions during production and packaging processes. At other times, pure gases, such as oxygen, are used to create the required reactions or to encourage microbe culture growth. Speciality gases are commonly used in the laboratory and in the area of R&D, and can even be used to carry out specific production processes, such as chemical synthesis. With such critical uses in mind, demand for quality has never been higher, and manufacturers need to be sure that the gas products they are using will deliver the highest standards of accuracy and consistency.
SOURCING HIGH GRADE GASES
When sourcing the highest grade speciality gases, first and foremost manufacturers tend to select those that fulfil the requirements of the monographs of the European, US and Japanese Pharmacopoeias. These standards are widely recognised by manufacturers and gas suppliers alike. In addition, the recent introduction of directives 2004/27/EC and 2004/28/EC (amending directives 2001/83/EC and 2001/82/EC), concerning the use of active pharmaceutical ingredients (API) for human and veterinary use, requires manufacturers to provide an assurance of quality and traceability at every stage of the production process – from R&D, through to production and analysis. As part of this requirement, manufacturers must use high grade speciality gases, which have been produced according to good manufacturing practice (GMP) part II. |
