GLASS PACKAGING: USP, EDQM AND ECA CONFERENCE COVERS CENTRAL ISSUES
Together with the industry, the pharmacopoeias are currently working on new approaches for the inner surface hydrolytic test and the light transmission test (for amber glass). Additionally, efforts are being made to develop a new description of the autoclave procedure for the glass grains and the surface tests to eliminate ongoing questions associated with the autoclave cycle and to establish a global standard.
The conference "Glass meets Pharma" - jointly organised by the USP, Ph.Eur. and the ECA - put the central issues around packaging materials made of glass in the centre of attention:
- Requirements and expectations of USP and Ph.Eur.
- Delamination & Glass Particles (Particle Contamination in Parenterals)
- Extractables & Leachables
- Glass Formulations with enhanced chemical Stability
- How to prevent breakage in filling lines using an innovative Technology
On both conference days in early June delegates and 13 speakers from FDA, EDQM, USP as well as from industry concentrated on the latest developments with regard to glass packaging.
In his presentation "ICG-TC12 advices for a proper autoclaving cycle to measure the hydrolytic resistance" Daniele Zuccato from the Ompi/Stevanato Group presented the work of the ICG (International Commission on Glass) for the description of the autoclaving process including sample preparation. The goal is to describe the autoclaving process in as much detail as possible to ensure that most of the current questions on the process are answered and that all Pharmacopoeias (USP and Ph.Eur.) and standards (ISO Standards) can adopt it. This is done i.a. in light of the fact that the currently described autoclaving process is considered to be the main cause for differences in hydrolytic resistance results: The autoclaving process as currently described in Ph.Eur. chapter 3.2.1. Glass containers for pharmaceutical use must be followed strictly and performed with the highest accuracy to obtain consistent (and correct) results. This was shown in a TC 12 ring trial. As a result, besides the request for a uniform procedure in USP and Ph.Eur., the following questions still have to be answered:
- Is the defined 10 min hold-times before heating really necessary?
- Are smaller variations allowed at the given 100-121°C heating rate with 1°C/min?
- Are smaller variations allowed at the 121-100°C cooling ramp?
- The point "Autoclave samples load uniformity" should be explained in more detail
- Delegates and podium discussed this presentation as well as the following issues intensively:
- An Update of USP General Chapters <660>, <1660>, including proposed revisions regarding the hydrolytic resistance test and the light transmission test
- An Update of Ph. Eur. Chapter 3.2.1 (specific topics: delamination / hydrolytic resistance)
- Glass Delamination (What is delamination - What's it like?) and Product Recalls caused by Delamination
- Glass Particles (Particle Contamination in Parenterals) including USP´s approach to glass particulates: Proposed New General Chapter <667> Sub-Visible and Visible Particulates in Packaging and Manufacturing Components and Systems
- Risk Evaluation of Elemental Impurities (EIs) from Glass in view of ICH Q3D and mitigation strategies to reduce extractables with surface treatment and coatings (for example by siliconization of the container inner surface)
- Glass formulations with enhanced chemical stability - for example Aluminosilicate glass (e.g. Valor Glass®) which is not covered by the pharmacopoeias yet.
- New approaches to prevent breakage in filling lines using an innovative technology (SmartSkin©) in regard to: - The identification of process steps with high (mechanical) stresses, - The optimization of process / filling line, - The increase in product yield through reduction of defect rates.
These topics were highly discussed by the audience and the participant´s comments will now be considered during the revision process of the pharmacopoeias regarding the chapters on glass packaging materials.
The provided comments will be considered in the revision process of the glass chapters in the pharmacopoeia.
Author:
Dr Andrea Kühn-Hebecker
... is Operations Director and organises and conducts courses and conferences on behalf of the ECA Academy in the area packaging, deveopment and Lifecycle Management.
