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)
Failure mode effects Investigation
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Risk and Failure analysis, Mitigation and Corrective services
As per the information available there are 4 major incidences for glass delamination.
Delamination analysis will be performed to achieve any of the below requirements.
Difference between controlled and delaminated product packed in glass container (Illustration)
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.
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.
Location of sample to be collected from glass container for delamination studies
3 inner surface areas of glass containers will be selected for evaluation of delamination studies.
| Sl. No | Area |
| 1 | Wall near shoulder |
| 2 | Wall near to bottom |
| 3 | Bottom |
Need help or Have a question?
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
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