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Delamination Studies

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GTS provides analysis of a whole range of glass failures and defects - including the investigation of glass delamination and, in many cases mistaken for delamination, the analysis of naturally occurring minerals, metals and a range of other contaminantsWe provide analysis of a whole range of glass failures and defects - including delamination and stability studies, investigations, simulated accelerated attack, long term studies and the analysis of glass delamination cases. In many cases mistaken for delamination, we also provide foreign body analysis - including naturally occurring minerals, metals and a range of other contaminants.

Glass Technology Services Ltd offers both investigative analysis where delamination is suspected and delamination propensity studies. This includes the suggested approach detailed in the United States Pharmacopoeia (USP General Information Chapter <1660>, 'Evaluation of the inner surface durability of glass containers') and referred to in the European Pharmacopoeia/Pharmacopée Européenne (EP) Chapter 3.2.1.

Please note: if you are seeking information regarding analysis of the delamination of laminated flat glass , please see our product failure analysis services.

For further information, please see:

Laboratory Services and Studies

Glass Technology Services Ltd (GTS) offer a number of professional support services with respect to glass delamination including:

Delamination Analysis

SEM image showing surface attack of flame worked region on vial sidewall Initially, optical examination is carried out to ascertain the location and appearance of the suspect delamination, as this can be key information in determining the root cause.  If there are particles suspended in the liquid, then this can be filtered out and, if there are particles attached to the glass surface, the glass item carefully prepared to enable further examination. 

Using scanning electron microscope (SEM) the particles captured during filtration and particles from the glass surface are visually examined - as their appearance provides further information.

Energy dispersive spectrometry (EDS) is then carried out to analyse the composition of these particles.  The information gained is then used to determine whether the particles are delaminate lamellae or other forms of product or surface contamination, to assess how they were formed and identify possible options for eliminating the problem on future production runs.

In some cases further information may be required in order to determine the root cause of the suspect delamination, this may include:

Delamination Propensity Pre-screening and Accelerated Stiudies

Introduced into the USP in December 2013, propensity pre-screening assesses the probability of packaging to delaminate during its life-cycle under in-use conditions. This pre-screening package helps to evaluate differences in containers from different manufacturers, glass formulations, batch variations and post-forming processing and treatment conditions and includes the following assessments:

Long Term Delamination and Stability Studies

A number of studies can be conducted - depending on the nature of the drug product, client requirements, market territory and relevant regulatory and pharmacopoeia requirements.

We work with our clients to understand their needs and ensure that the programme of analysis and study conditions are appropriate to the product, storage and use conditions.

Studies can be carried out at pre-determined temperatures, relative humidity levels, and time periods to simulate actual or accelerated ageing of filled products, predict delamination propensity and investigate the suitability or compatibility of different primary glass packaging formats, suppliers or drug formulations. 

Further Information about Delamination Prevention

For all clients, we advocate a proactive approach to minimise the potential for delamination. This must always include: for pharmaceutical companies - the correct specification for the glass to ensure it's suitability for the pH of the product, the processing involved – including sterilisation and autoclaving processes – and both handling and storage conditions for the filled product; and, for glass manufacturers - ensuring that appropriate process controls are in place - including forming temperatures and correct annealing - and due diligence in the quality testing and assurance of their glass.

Quality assurance should dictate that glass quality, pharmacopoeia and durability analyses are conducted to assess the compatibility of the glass with the specific product that will be stored within the container - these are services that our team regularly provide on both an ad-hoc and contract basis. Glass quality can be assessed to assess the forming and annealing quality as well as mechanical performance, durability and migration testing can be provided using a range of simulants, of different pH, whilst pharmacopoeia testing will verify that the glass container meets the relevant international Pharmacopoeia Monographs, including USP and Ph. Eur, as required by the client. Each of these services are provided to a range of clients on a regular basis.

What is Delamination and why does it occur?

It is this enriched silica skin that can then detach, or ‘flake’, from the surface and be observed as thin shimmering particles, ‘lamellae’, now commonly referred to as delamination.

The video, embedded below, shows a sample of glass lamellae in suspension and their shimmering appearance. Note that this is a concentrated example, generated after prolonged, repeated, exposure to extreme conditions:

Further Information and Resources

A UKAS accredited testing laboratory No. 1994, Glass Technology Services Ltd is also registered with the FDA under the GDUFA regulation. Our teams employ a range of analytical techniques, including SEM-EDS (scanning electron microscopy - energy-dispersive X-ray spectroscopy); WDS-XRF (wavelength dispersive spectroscopy X-ray fluorescence); GRIM (glass refractive index measurement); FTIR (fourier transform infra-red) spectroscopy; ICP-OES (inductively coupled plasma optical emission spectroscopy); UV-Vis spectroscopy and FEA (finite element analysis).

In many cases the analysis from different analytical techniques can provide data enabling the team to determine the root cause and suggest possible solutions.

GTS provides testing to a range of international standards and pharmacopoeias, including:

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.

 

Further Related Services

Pharmacopoeia

Pharmacopoeia testing for all Type I, II and III glass packaging (containers, bottles, vials, ampoules) and parenteral delivery vessels for use across the pharmaceutical and medica…

Defects and Contamination

Analysis of solid, gaseous, contamination, forming and other defects, including stone, cord, bubbles, blisters, foreign materials, bloom and delamination.

Foreign Bodies and Fragments

Identification of the likely source of foreign bodies, contamination or fragments found within a product, or for comparative analysis (e.g. forensic evidence), through a range of a…

Quality Assessment

The quality and performance of a product once in market is a reflection of the brand, and suppliers, identity - should that product not be fit-for-purpose, cause injury, or not per…

Physical and Mechanical

Physical and mechanical testing for impact, thermal shock, internal pressure, vertical load, microwave, dishwasher and other requirements.

Technical Consultancy

Our technical experts provide support throughout the glass supply chain - providing clients with market advantage, knowledge and technical input to improve their manufacture, proce…

SEM-EDS Analysis

GTS provides specialist scanning electron microscopy services to the glass supply-chain.

Failure Analysis

Determining the true cause of failure can help to eliminate future problems and resolve disputes, whether between manufacturer and supplier, or when the end user has experienced gl…


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