Pharmacopoeial verification

Leading experts in pharmaceutical glass verification

Glass Technology Services provide pharmacopoeial testing and a range of analytical, quality assessment, mechanical testing and specialist services and consultancy for glass used throughout the pharmaceutical industry.

These include pharmacopoeial verification of Type I, II and III glass containers for pharmaceutical use as primary packaging (containers, bottles, vials, ampoules) as well as parenteral delivery vessels (cartridges and syringes) to a number of worldwide pharmacopoeial monographs. This includes most commonly Hydrolytic Resistance against the European Pharmacopoeia/Pharmacopée Européenne (EP Chapter 3.2.1) and United States Pharmacopoeia (USP <660>).

We provide regular batch testing of pharmaceutical glass ware for a wide range of global pharmaceutical manufacturers, importers and suppliers in order to verify pharmacopoeial compliance, dimensional specifications and mechanical performance properties.

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Pharmacopoeia Testing

This suite of testing verifies that the glass packaging container provides adequate protection to its contents from the environment, minimises loss of constituents and the container itself does not interact physically or chemically with the contents such that their quality or function is degraded. Analysis and verification is provided against the United States Pharmacopoeia (USP), European Pharmacopoeia/Pharmacopée Européenne (EP) and international (ISO) standards.

Tests available include:

  • Hydrolytic Resistance: sometimes referred to as Alkalinity Test, including:
    • Hydrolytic resistance of the inner surfaces of glass containers: Surface glass test (USP <660>) and surface test (Test A - EP Chapter 3.2.1); also referred to as the Whole article test;
    • Hydrolytic resistance of glass grains: Powdered glass test (USP <660>) and Glass grains test (Test B - EP Chapter 3.2.1);
    • Surface etching test (Test C - EP Chapter 3.2.1) - to determine whether the containers have been surface-treated;
    • ISO 4802, 'Glassware - Hydrolytic resistance of the interior surfaces of glass containers';
    • ISO 719, 'Glass - Hydrolytic resistance of glass grains at 98 degrees C';
    • ISO 720, 'Glass - Hydrolytic resistance of glass grains at 121 degrees C';
  • Arsenic Release; applies to containers for aqueous parenteral preparations;
  • Spectral transmission for coloured glass containers - light transmission and UV resistance (applies to coloured containers);
  • USP <1660>, Delamination and ICHQ3D Studies;

Additional support, including chemical composition quality assessment physical testing, failure analysis, delamination investigation, foreign body analysis and consultancy services, is also available.

Pharmaceutical Glass Types

There are three types of glass containers for pharmaceutical use and a glass is designated a particular type only where it complies with the requirements of the specified pharmacopoeia. Glass Technology Services verifies glass against a range of international pharmacopoeias, including the United States Pharmacopoeia (USP <660>), European Pharmacopoeia (Ph. Eur. Ed Chapter 3.2.1) and British Pharmacopoeia (BP).

The three types of pharmaceutical glass are:

  • Type I - a 'neutral' glass with very high level of hydrolytic reistance. Type I containers are considered suitable for most preparations - whether or not for parenteral administration.
  • Type II - high level of hydrolytic resistance, but this can be achieved through surface coating of a soda-lime-silica glass. These are generally suitable for most acidic and neutral preparations or for aqueous preparations including parenteral administration.
  • Type III - moderate hydrolytic resistance, usually uncoated soda-lime-silica glass. These are generally suitable for non-aqueous preparations for parenteral administration, powders intended for parenteral administration (excluding freeze-dried preparations) and preparations for non-parenteral administration.

Delamination and Propensity Prescreening

Please see our delamination investigative services for further information regarding delamination analysis and propensity prescreening, as outlined in USP <1660>.

In addition to delamination screening and propensity studies our analytical laboratory now provides full migration studies against the ICH Q3D guideline for elemental impurities.

Failure Analysis

Please see our glass fracture and failure analysis service if you are experiencing unexpected failure of your glass. This service can be further supported with quality assessment and technical consultancy where required.

Standards and Methods

We provide testing to a range of international standards and pharmacopoeias, including:

  • USP 38-NF 33 - Chapter <660> and <1660> - The United States Pharmacopoeia (USP);
  • Ph. Eur Ed - Chapter 3.2.1 - European Pharmacopoeia/Pharmacopée Européenne (EP);
  • BP-Vol IV - The British Pharmacopoeia (BP);
  • GOST 13905 - Russian Water Resistance Test;
  • JP16 - Japanese Pharmacopoeia 16th Edition (JP);
  • ISO 4802, Glassware - Hydrolytic resistance of the interior surfaces of glass containers;
  • ISO 719, Glass - Hydrolytic resistance of glass grains at 98 degrees C;
  • ISO 720, Glass - Hydrolytic resistance of glass grains at 121 degrees C.

Please contact us, or make an enquiry using the form above, if you have any bespoke requirements, require further information, or would like a quote for analysis.

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