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home > pmps > spring 2009 > ensuring glass container quality
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Pharmaceutical Manufacturing and Packing Sourcer

Ensuring Glass Container Quality

Glass containers for parenteral drugs continue to show good growth due to several factors, including the emergence of new drugs from the biotechnology industry, and the increasing use of insulin and vaccines in the developing world. With the exception of X-ray contrast media and some oncology drugs, the injection volume of parenteral drugs is usually below 20ml, with subcutaneous or intramuscular injections being less than 1ml. The glass containers for these small volume parenteral drugs include ampoules, cartridges, pre-fillable syringes and vials, all made from tubing glass, although vials can also be made by moulding glass. In terms of tubing glass containers for pharmaceuticals, ampoules still lead with 40 per cent global market share, but overall growth is flat, while vials (27 per cent), cartridges (20 per cent) and pre-fillable syringes (13 per cent) are all growing in sales (1).

TUBING GLASS PRODUCTION

The manufacture of tubing glass containers is a two-step process that begins with the glass manufacturer producing the glass itself in a large furnace and then forming a tube of the required diameter by either the Danner or Vello processes. There is a limit to the diameter of glass tubing that can be reliably formed by these technologies, so large diameter glass bottles, (those over 100ml), are formed by moulding. The type of glass used to produce tubing for pharmaceuticals is neutral borosilicate, which has a high resistance to hydrolytic attack due to its chemical composition. The quality of this glass is controlled by the European and US Pharmacopeias, and is designated as Type I glass. The working point for Type I glass is relatively high: between 1,145ºC and 1,165ºC for clear glass, with an annealing temperature range of between 535ºC and 575ºC. The glass tubing is produced in a continuous process and is cut into standard lengths (canes), placed in bundles and wrapped to protect from abrasions, breakage and dirt. The canes can then be shipped to the glass converting plant that will form the containers.


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Dr Michael N Eakins is the Founder and Principal Consultant of Eakins & Associates, a consulting company that provides experience and advice on parenteral drug development, particularly in the use of plastic primary packaging and in the application of anti-counterfeiting strategies. Michael joined the Squibb Research Institute in the US in 1980, becoming Director of Diagnostics Development with Bristol-Myers Squibb before moving to Bracco Research USA, where he was Senior Director responsible for the strategic development of new packaging within R&D, and then Senior Director of the International Packaging Center for Bracco’s Corporate Worldwide Sales and Marketing Group. Michael is Vice-Chair of the USP Packaging and Storage Expert Committee for the 2005 to 2010 cycle. He holds a PhD from the University of London, has contributed to 52 publications and eight US patents.
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Dr Michael N Eakins
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