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Delamination Controlled:

Spotlight on
Schott Pharmaceutical Packaging

Due to the increasing tightened regulatory demands of the Pharmaceutical Industry, containers have to meet the following requirements:
  • Compliance with international regulations, such as Ph:Eur., USP, and JP
  • Controlled manufacturing and packing processes (high quality production processes according to cGMP, ISO 9001 and ISO 15378)
  • Excellent performance through strict quality control and process capabilities
  • Following the FDA advisory, which results in avoiding delamination through appropriate risk management, including stability testing

Glass has many advantages when compared with other packaging materials. It is traditionally held in high regard when discussing barrier properties, but depending on the chemical composition of the product contained, the quality of the tubing, and the converting process, the inner glass surface can be harmed by delamination, resulting in flakes barely visible to the naked eye.

Recent advances in the field of glass processing technology allow for the development of Type I glass vials that can withstand the delamination process. The region near the bottom of Schott DC (delamination controlled) vials particularly show a unique surface homogeneity and chemical stability. As a result, the liability to delaminate is improved. Schott DC vials comply with all current standards, including the ones mentioned above.

  • sodium
  • silicium
  • oxygen
  • aluminium
  • boron

Schott's DC vials

The new line of vials produced by Schott ensure that a number of benefits are provided to companies seeking to improve the quality of the packaging in which their drugs are shipped.

High glass surface homogeneity and quality

The new processing technique maintains glass surface homogeneity, reducing the risk of delamination and ensuring formulae remain as pristine as possible.

Applicable to already registered products

Conventional vials can be replaced by DC vials that feature delamination control without the need to revalidate the pharmaceutical product.

Production quality control

Production quality is routinely checked by the Schott's Delamination Quicktest. The routinely conducted Quicktest monitors product quality and certifies that Schott DC vials do not exceed the set sodium limit, ensuring that the delamination tendency is reduced.

Confirmed in studies

Filled with a 15 percent potassium chloride solution or a 10 percent sodium thiosulfate solution, DC vials remained stable even after being exposed to a temperature of 60 degrees Celsius for twelve weeks.

Why is delamination a problem?

Na and B depletion

Detaching flakes

 

 

 

Why does delamination occur?

Volatile components like boron and sodium evaporate while the bottom of the glass vial is being formed. As the production process continues, these substances produce inhomogeneous spots on the glass surface that are generally more susceptible to delamination.

The consequences to business

Product recalls of numerous injectables over the last several years, have cost pharmaceutical and partnered packaging firms upwards of 50 million USD per recall.

The Schott Delamination Quicktest

SCHOTT is the first manufacturer capable of determining the risk of delamination based on threshold values, and then monitoring these values over the course of manufacturing. To achieve this, the company developed the patented SCHOTT Delamination Quicktest.  

  • The first step is to perform autoclaving with the bottom up for 4 hours at a constant temperature of 121°C.
  • A second autoclaving with extraction follows using highly purified water, for 2 hours at the same constant temperature of 121°C.
  • Analysis of the results follow, along with the quantification of sodium content. The volume of sodium extracted correlates with the probability that the vials will experience delamination at a later point in time.” By monitoring these values and adhering to certain threshold values, SCHOTT is now able to control the risk of delamination for the first time ever. Stereomicroscopy has now been made obsolete for production control.

Autoclaving
Empty head first

Time = 4 hours
Temperature = 121°

Autoclaving
Filled with H2O

Time = 2 hours
Temperature = 121°

AAS
(Atomic Absorption Spectroscopy)

The results of testing for delamination risks can be obtained in a few hours.

Schott DC vials are available now, click here for more information.

 

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  • Modified 15 Jan 2016
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