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USP <660> Surface Glass & Glass Grains Testing

by Constantine on August 5, 2015

Surface Glass & Glass Grains Testing per USP <660>

As of May 2015, the United States Pharmacopoeia (USP) changed the requirements for general chapter <660> entitled “Containers – Glass”.  This is the chapter that covers the testing required for glass containers used for pharmaceutical purposes that are intended to come into direct contact with pharmaceutical products.  Specifically, this general chapter deals with the Glass Grains Test and the Surface Glass Test.  The Glass Grains Test, combined with the Surface Glass Test for hydrolytic resistance, determines the type of glass being used in the packaging of pharmaceutical preparations. There are three different glass types that are used for various purposes:

Glass Type Composition Use
Type I Borosilicate Glass Suitable for most parenteral and non-parenteral uses.
Type II Soda-Lime-Silica Glass but with a suitable treatment on the inner surface to increase the hydrolytic resistance Suitable for most acidic and neutral aqueous products for parenteral and non-parenteral uses. Can be used for alkaline parenteral products if there stability data to demonstrate suitability.
Type III Soda-Lime-Silica Glass Usually not used for parenteral products or for powders that will be reconstituted and used parenterally, except where suitable stability test data indicate that Type III glass is acceptable.

The Surface Glass Test can distinguish between Type III glass and Types I/II.  The Glass Grains Test can distinguish between Type I glass and Type II glass.  The tests work by determining the quantity of alkali released from the glass after going through the testing procedures specified by general chapter <660> of the USP.

This procedure involves preparing the glassware appropriately, cleaning the glass surfaces, immersing the glass grains or filling the glass surface with water, and then running through an autoclave with very specific performance characteristics.  The autoclaved solution is then titrated while being compared with glass standard reference materials and appropriate blank samples to ultimately determine and/or confirm the type of glass that one is dealing with.

Why Choose Nucro-Technics?

Nucro-Technics has many years of experience running the Surface Glass Tests & Glass Grains testing as per USP <660> and has routinely completed these tests for many clients.  As of May 2015, the USP changed the requirements for the general chapter that covers this testing, and Nucro-Technics continues to be compliant with these new requirements.  Testing can be completed as per Nucro-Technics’ standard 10 business day turnaround.

For further information about these services, a complete list of services available, to receive a quotation, schedule a test, or if there is something specific that you require, please contact NUCRO-TECHNICS.

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