We can conduct climatic tests according to various standardized or customized protocols, including ISTA, ICH, ASTM, ISO, etc. We have the capability to record test conditions in compliance with 21 CFR Part 11.
These tests simulate extreme conditions such as cold, heat, humidity, and pressure. These constraints can be cumulative (e.g., humid heat) and cycled to assess the aging of products and the impact on their mechanical properties.
Climatic testing is performed on both products and packaging systems.
The main failure modes associated with these tests are:
- Loss of mechanical strength (e.g., loss of BCT, etc.)
- Oxidation or corrosion
- Bond detachment
- Formation of cracks
- Material swelling
- Increase in permeability
Temperature range: -70°C to +180°C
Humidity range: Up to 98% RH
We can also simulate the effects of altitude using a depressurized chamber/tank, for example, according to ASTM D6653.
Here are some applications of climatic tests:
Thermal qualification of packaging
We conduct thermal and climatic tests under specific temperature and humidity conditions, including extreme conditions. These tests assess the performance of your packaging and qualify it in relation to temperature and humidity profiles.
ASTM F2825 – Climatic Stressing of Packaging Systems for Single Parcel Delivery
ASTM F1980 – Accelerated Aging Testing
Sterile packaging undergoes accelerated aging, and its physical properties and integrity are measured to evaluate whether the product or packaging characteristics have been altered compared to the control. Mechanical tests such as ASTM F88 tensile tests and other tests (ASTM F2096, ASTM F3078, ASTM F1886; ASTM F1929, ASTM F3039, etc.) are conducted at regular intervals during the accelerated aging process.
Shelf Life Testing
ISO 11607 requires manufacturers of medical devices to demonstrate the effectiveness of their proposed sterile barrier packaging. Storage or usage environment conditions, accelerated aging, and distribution simulation are a controlled means of exposing a packaging system to predictable environmental and dynamic stresses that the packaging system may encounter during its shelf life. The packaging's strength and integrity tests are then performed to assess the packaging after such exposure.
We can perform real-time or accelerated storage tests to help ensure product safety.