Web Analytics

Glass Delamination Testing

Glass Delamination Testing

Glass Delamination Testing of glass containers
Glass delamination can be identified as Separation of thin glass particles (lamellae) that shed from the internal surface of glass container. They appear as shiny, needle shaped crystals suspended in contact liquid product. Glass delamination is observed when glass-liquid interactions take place in which silica-rich layer poorly bonded to the substrate is the first stage for the initiation for delamination. In other words it is also known as leaching of ions into product.

Leaching of ions from the inner surface of glass container into the product will significantly affects the product quality while compromising the durability of glass container. As glass delamination is a serious quality issue, recently many pharmaceutical products have been recalled due to glass delamination.

When small glass particles are injected to systemic circulation, it will lead to serious health issues. NRPL serves investigation and propensity studies. We follow general guidelines referred by various regulatory authorities including USFDA (USP General; information chapter <1660>, “Evaluation of the inner surface durability of glass containers”) and European pharmacopoeia (EP, Chapter 3.2.1)

White Paper Download

Failure mode effects Investigation
Download
Risk and Failure analysis, Mitigation and Corrective services

Incidences of delamination

As per the information available there are 4 major incidences for glass delamination.

  1. Thermal stress during vial formation.
  2. Processing vials during product filling.
  3. Interaction of glass with formulation.
  4. During storage.
Why delamination studies are required?

Delamination analysis will be performed to achieve any of the below requirements.

  • Propensity (glass behavior) studies to evaluate glass delamination.
  • Assessment of glass quality
  • Pharmacopeial requirements to confirm the glass durability.
  • To confirm glass composition as per the requirement.
Controlled Product
Delaminated Product

Difference between controlled and delaminated product packed in glass container (Illustration)

Why NRPL for delamination studies?

NRPL has decades of experience in applications of instrumental techniques. We also have expertise in handling several projects related to delamination studies of pharmaceutical containers. We not only generate the required data but also perform assessment and advise to mitigate the risk of delamination.

Most of the times companies are interested in performing delamination studies only when product is failed during stability studies (appearance of opalescence, Foreign particles and suspended particles). But the fact is delamination studies has to be performed as a part of product development and as a propensity studies.

How NRPL can assist you?
Experts of NRPL will design appropriate protocols for evaluation of delamination studies. Delamination studies require multidisciplinary approach from early product development stage so as to avoid surprises post product development. Team of NRPL will synchronize with your team in designing the protocol for delamination studies.
Sampling techniques for delamination testing

Delamination is a slow process and it will take long time to reflect its manifestations, by the time the product is distributed to final point of sale or sometimes even consumed. Sampling for delamination studies is most critical aspect which is tricky as we need to assess the inner surface of glass container, which is in contact with product. Most of the times sampling process is compromised which will affect the physical attributes of sample. While sampling process sample may undergo deformation which may mislead to confirm delamination. During sample collection out most care has to be taken that it should not mislead the interpretation of delamination.

Nishka research has developed in house standard protocols for collection of samples. which are used in delamination analysis. These protocols will assure you that sample integrity and its internal structure is protected and will lead to trust worthy results.

Glass Container

Location of sample to be collected from glass container for delamination studies

Location of sample to be collected from glass container

3 inner surface areas of glass containers will be selected for evaluation of delamination studies.

Sl. NoArea
1Wall near shoulder
2Wall near to bottom
3Bottom
Controlled sample
Delamination
If you require an expert advice for delamination testing, we are more than happy to assist.

Nishka Research

NISHKA has been helping customers unlock their full potential and realize their true value for more than 13 years by providing innovative and bespoke solutions to ensure the highest standards.
View More

Nishka Research Pvt. Ltd.

Regus Business Center,
4th floor, Gumidelli Commercial Complex,
1-10-39 to 44, Old Airport Road, Begumpet,
Hyderabad-500016
India

Phone : +91 40 29303155

Mobile : +91 7842798518

Send Mail : [email protected]
Copyright © 2023 -NISHKA Research Pvt. Ltd. |
Privacy Policy
apartmentdatabasechart-barschevron-down
Sashi Kanth
Sashi Kanth

Left us a 5 star review

Sashi Kanth
October 12, 2020

I am a PhD scholar from Kaunas University at Lithuania, Europe. I have given a sample to perform SEM analysis of the organic tissue. The results are highly satisfactory and impressive. The service was really excellent, on time( even before the time schedule), consumer friendly. cost to the academic samples are very less comparing with others. Once again thanks to Nishka for providing me the service ontime as I am really in urgency...

Tejaswini Kulakarni
December 14, 2021
Ajay Gunti
December 14, 2021
sushma nampally
December 15, 2021
Sai teja Reddy
March 1, 2022
Narendar Vemula
December 14, 2021
Samiksha More
June 2, 2022

Great work done by nishka research. Thank you so much for your kind Co operation

M VENKAT M VENKAT
August 22, 2021
Shyamala Mudiraj46
December 14, 2021
akshay shriwas
December 14, 2021
Keyur Butani
May 10, 2022

Submitted the samples for my phd work . Great work and reports submited with 2 days of time . Also the image clarity and all data are clear .

Firdose Begum
December 14, 2021
KESHAMONI AKHILAGOUD
December 14, 2021
Divya Gaddam
December 15, 2021
Anita Raj Panigrahi
October 20, 2021

Thank you for your services.. Looking forward for more collaboration with your labs for my future projects..

Andem Jhansi
December 14, 2021
Yedukondalu Janapuram
December 14, 2021
VENKATESH PANTHIKI
December 14, 2021
Raviteja. Vathsavai
December 17, 2021
Abhijit Patil
October 30, 2020

A very good lab delivering acurate results. I must also mention about the very cordial staff that they have.

Chaithanya Reddy
December 30, 2021
Ramkumar Ganguly
April 25, 2022
Aishwarya Katrela
April 27, 2022
sai charan
April 30, 2022
linkedin facebook pinterest youtube rss twitter instagram facebook-blank rss-blank linkedin-blank pinterest youtube twitter instagram