Professional Documents
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Stabilty Studies -
Ensuring product
reliability
Vincent RIETSCH
BU Manager – Medical Device Testing & Consulting
Sylvain DARONDEL
BU Manager – Storage & Logistics
29.02.2024
Introduction
Regulatory & normative framework
Study design & protocol
Data collection & analysis CONFIDENTIAL AND PROPRIETARY - © Eurofins Scientific (Ireland)
Ltd, 2022. All rights reserved. This document contains information that is
confidential and proprietary to Eurofins Scientific SE and / or its affiliates
Case studies and is solely for the use of the personnel of Eurofins Scientific SE and all
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Introduction
Definition of stability studies for Medical Devices
Safety
Efficacy
Reliability
Stability studies
(various environmental conditions)
4
Importance of stability studies for Medical Devices
5
Medical Devices, Combined MD and Sterile Barrier Systems
6
Regulatory
framework
MDR - Annex I: GSPR
8
MDR - Annex II: Technical Documentation
9
Regulatory Framework - ISO 13485 / FDA 21 CFR part 820
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Regulatory Framework - ICH guideline
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Normative
framework
ASTM F1980:2021 - Standard Guide for Accelerated Aging of
Sterile Barrier Systems and Medical Devices
Provide sufficient evidence for expiration date claims for medical devices and
sterile barrier systems (SBS), until data from real-time aging studies are
available
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ASTM F1980:2021 - Scope and goals
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ASTM F1980:2021 - Main concepts
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ASTM F1980:2021 - Accelerated aging theory
[1]: Hemmerich, K. J., “General Aging Theory and Simplified Protocol for Accelerated Aging of Medical Devices,” Medical Plastics and Biomaterials,
July/August 1998, pp. 16–23
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Study design &
protocol
ASTM F1980:2021 - How to design an accelerated aging study ?
Environment
➢ Access and video surveillance
➢ Anti-intrusion security system
➢ Temperature regulation
➢ Pest control
Methods
➢ SOPs in place (sample flow, metrology,
maintenance)
➢ Training support
Manpower
➢ Training
➢ Habilitation
Materials
➢ Stability study Protocol and Report
(ICH Q1D : bracketing and matrixing)
➢ Safety data sheet
Measurements
➢ Continuous monitoring (temperature and humidity) 21 CFR Part 11
➢ Alarm system with on-call system 24 hours a day, 7 days a week, 365
days a year
Eurofins Medical Device Testing France 26
Confidential & Proprietary
Shipment management
➢ Shipment condition
In operation for One hour from Paris Dedicated team to Dedicated building
20 years airports and storage and logistic 3,200m3 of storage
International train
station
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Case studies #1 - Accelerated aging
Surgical implants :
- accelerated aging of 2 boxes (30 x 10 L,
57 x 1.5 L)
- 55°C/50%HR
- 2-time intervals (T91 and T228, 1- and 5-
years simulation)
- boxes sent by carrier at the end of
aging (visual inspection and functional tests)
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Case studies #2 - Combined Medical Device
Dermal filler :
- combined stress, real-time and accelerated aging (4 batches)
- Precondition study : -20°C 7 days, 40°C 3 days, cycling (-20°C, 40°C) 12 days
- 25°C/60%HR (real-time) and 40°C/75%HR :
- 7-time intervals (T3, T6, T9, T12, T18, T24 and T36, + back-up)
- 2-time intervals (T3 and T6, + back-up)
- boxes sent by carrier to several testing sites (mechanical, chemical and
microbiological tests)
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Take-home
Message
Take-home Message
Mail: Vincent.Rietsch@bpt.eurofinseu.com
Any Questions?