USP 660

An Automated Autoclave Process for Use in Determining Glassware Quality [USP 660]

Amit Gupta
Written by: Amit Gupta

MS Mechanical Engineering, Vice President of Engineering

Glass containers for pharmaceutical use are intended to come into direct contact with pharmaceutical products. The glass container manufacturing process directly results in the quality of glass produced. Certain types of glass are less durable than others and are therefore more susceptible to delamination of the interior of the glass container.

If delamination occurs on the interior surface of the container, it can contaminate the product inside, leading to product recalls. This is especially problematic with injectable drugs because, according to Desmond G. Hunt, principal scientific liaison of the United States Pharmacopeia (USP):

“There is potential for drugs administered intravenously that contain these fragments to cause embolic, thrombotic and other vascular events; and when administered subcutaneously, to lead to development of foreign body granuloma, local injection site reactions, and increased immunogenicity.”

Due to this risk, the USP has defined a set of quality, purity, strength and identity standards for glass containers used in pharmaceutical products. The Packaging and Distribution Expert Committee made further revisions to these standards in the interest of security and in order to clarify their intent; these revised standards fall under USP General Chapter 660.

Under USP 660, the USP defines three types of glassware used in the packaging of pharmaceutical products:

Glass Type Composition Intended Use
Type I Borosilicate glass This type of glass — also known as neutral borosilicate glass — contains a significant amount of boric oxide, aluminum oxide and alkali and/or alkaline earth oxides. Due to its chemical composition, borosilicate has high hydrolytic and thermal resistance and can be sterilized before or after filling. Type I glass containers are ideal for any preparation with acid, neutral and alkaline pH, whether or not for parenteral administration.
Type II Soda-lime-silica glass with high hydrolytic resistance This type of glass contains a significant amount of alkaline metal oxides (mainly sodium oxide) and alkaline earth oxides (mainly calcium oxides). Type II glass has a higher hydrolytic resistance than Type III glass despite having the same composition because it has undergone special treatment (typically with ammonium sulfate) to achieve the same hydrolytic stability as Type I glass on its surface layer. Type II glass containers can be sterilized before or after filling and are suitable for most acidic and neutral, aqueous preparations, whether or not for parenteral administration.
Type III Soda-lime-silica glass with low hydrolytic resistance This type of glass is identical to Type II with the exception that it has a significantly lower hydrolytic resistance. As a result, Type III glass containers should be sterilized by dry heat before filling. Type III glass containers are best suited for non-aqueous preparations for parenteral administration, powders for parenteral administration and for preparations for non-parenteral administration.

Glass in any of these categories can be either colored to provide light protection or colorless; colorless glass can be made light resistant through the use of an opaque enclosure.

According to USP General Chapter 660, you can determine which type of glass you are working with by conducting a Glass Grains Test in combination with a Surface Glass Test. Together, these tests evaluate the hydrolytic resistance of glass by determining the quantity of alkali released under the prescribed conditions of the test. You can also conduct a Surface Etching Test to figure out whether a glass container’s hydrolytic resistance is the product of its natural chemical composition or surface treatment. All three of these tests require using an autoclave to heat the container and its contents in a controlled method. The key requirements of this process include ramping the temperate from 100°C to the hold temperature of 121°C at 1°C/min and ramping the temperature down to 100°C at 0.5°C/min after the hold temperature is complete.

Consolidated Sterilizer System’s USP 660 cycle adapts the autoclave procedure laid out in USP General Chapter 660 for an automated laboratory steam autoclave.

For additional queries concerning USP 660 or other USP glass standards, as well as practical autoclave applications for the pharmaceutical industry, contact the specialists at Consolidated Sterilizer Solutions today.

With over 70 years of experience manufacturing state-of-the art steam sterilizers for laboratories around the world, we have the necessary expertise to assist with any autoclave-related project.

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