What is glass delamination?
Glass delamination – the appearance of visible flakes or glass lamellae – has contributed to regulatory recalls. Beyond patient risk, delamination can be costly for pharmaceutical manufacturers.
What are the USP required tests for glass containers?
USP and IP provide two tests to determine the chemical resistance of glass containers. From the glass containers, alkaline constituents (oxides of sodium, potassium, calcium, aluminum, etc.)…
- Leakage test: Fill ten container with water.
- Collapsibility Test: This test applicable to containers.
What is glass grains test?
The Glass Grains Test indicates the alkali content of the glass. container, while the Surface Glass Test provides information on the inner. surface durability of the glass container. The Surface Etching Test provides.
What is the limit for light transmission in light transmission test for colored glass?
The observed light transmission for colored glass and plastic bottles for preparations that are used for solid and liquid oral dosage forms should not exceed 10% at any wavelength in the range from 290 nm to 450 nm, irrespective of the type and the capacity of the glass and plastic bottles.
What causes window delamination?
WHY DOES GLASS DELAMINATE? Water immersion is the primary cause of glass delamination, so when using laminated glass in an external installation it is important to consider a water drainage solution for the channel.
In what types of glass are parenterals usually stored?
Type II glass containers are suitable for storing neutral aqueous preparations and acidic preparations whether they are parenteral or non-parenteral.
What is USP Type I glass?
borosilicate glass
Type I (borosilicate glass) is suitable for most products for injectable and noninjectable use. Type II is treated soda-lime glass, and Type III is soda-lime glass on the basis of the hydrolytic resistance of the glass.
What is USP Type?
There are four types of glass that are classified as USP glass. This glass is commonly found in Amber and Clear colors, but can also be produced in green and blue. The USP test methods that glass should comply with are USP <660, 661> and USP <671>.
What is powdered glass test?
A) POWDERED GLASS TEST : It is done to estimate the amount of alkali leached from the powdered glass which usually happens at the elevated temperatures. When the glass is powdered, leaching of alkali is enhanced, which can be titrated with 0.02N sulphuric acid using methyl red as an indicator .
Can you fix delaminated glass?
Re: Delaminating glass You will need to do this away from natural daylight to avoid premature curing. If this is successful, then allow it to cure and finish it by sealing the edge of the glass with silicon to deter water/moisture getting into the interlayer as this would turn the PVB interlayer white over time.
How do you prevent glass from delaminating?
Drugmakers could adapt their manufacturing processes in certain ways to reduce the risk of glass delamination. For example, treating the surface of the glass vials with materials, such as ammonium sulfate, can reduce the rate of glass erosion, says Shabushnig.
What is Type 1 and Type 2 glass?
Type II glass generally has a lower melting point than Type I glass so it is much easier to mould. Type II glass containers are suitable for storing neutral aqueous preparations and acidic preparations whether they are parenteral or non-parenteral.