May 24, 2007 Lehigh Valley, Pa.
A new range of high grade compressed gases, developed by Air Products especially for the pharmaceutical industry, is helping manufacturers to achieve compliance and improve efficiency.
The recent introduction of directives 2004/27/EC and 2004/28/EC (amendments of former directives 2001/83/EC and 2001/82/EC), concerning the use of Active Product 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 research and development, through to production and analysis. As part of this requirement, manufacturers must use high grade specialty gases, which have been produced according to ‘Good Manufacturing Practice’ (GMP) part II.
By upgrading their gas supplies to ensure compliance, some pharmaceutical companies are finding that they have an opportunity to improve process efficiency.
Lieve de Paepe, Air Products’ European Product Manager Analytical and Laboratories, explains:
“By choosing high grade gas products that come with a fully traceable Certificate of Analysis and compliant with the European Pharmacopoeia, manufacturers are finding that they can minimise the need for internal controls and improve efficiency.”
The first of the new range, Air Products’ Pharma grade Nitrogen is produced using analytical methods and analytical equipment specified in the corresponding monograph of the European Pharmacopoeia. Other gases, including carbon dioxide and oxygen, will be produced in the same way. In each case, the Certificates of Analysis are signed by a qualified person and the production process and analytical system are fully validated. The aim is to delegate the responsibility for a traceable Pharma grade gas to the gas supplier and release pharmaceutical companies from additional analysis requirements.
Lieve de Paepe concludes:
“Using Air Products’ Pharma grade gases brings peace of mind - allowing the manufacturer to focus on optimising the production process, safe in the knowledge that its gases and equipment are fully compliant and meet the highest standards of quality.”
For more information about Air Products’ Experis® range of gases and gas handling equipment, including the new pharma range of gases, ring 0845 777 8800 or email email@example.com.
About Air Products
Air Products (NYSE:APD) serves customers in industrial, energy, technology and healthcare markets worldwide with a unique portfolio of atmospheric gases, process and specialty gases, performance materials, and equipment and services. Founded in 1940, Air Products has built leading positions in key growth markets such as semiconductor materials, refinery hydrogen, home healthcare services, natural gas liquefaction, and advanced coatings and adhesives. The company is recognized for its innovative culture, operational excellence and commitment to safety and the environment and is listed in the Dow Jones Sustainability and FTSE4Good Indices. The company has annual revenues of $9 billion, operations in over 40 countries, and over 20,000 employees around the globe. For more information, visit www.airproducts.com.
Christine Smart or Sara Jenkins
Phone: 0121 456 3199