Article: Q&A with Chris Berry about the Environmental Isolation Chamber

Smithers environmental isolation chamber is designed to allow the functionality of medical devices and packaging to be evaluated while being exposed to controlled test conditions. Chris Berry, Manager of our Medical Device Physical Testing, talks us through the equipment's capabilities and what it means for the clients we help.

Chris Berry, Medical Device Testing ManagerThe temperature and humidity within the chamber can be set within a tight tolerance while an operator is able to reach into the chamber and directly manipulate the device through a pair of isolation gloves.  The large window and interior lighting allow the operator to interact with the device in the comfort of the laboratory environment while the test device is exposed to the required test conditions.  The chamber is typically used to assess the performance or function of devices at high or low temperatures, or at a specific level of humidity; it is particularly suited to evaluating device functionality during or after exposure to condensing conditions.

Q: Can you talk us through the equipment?

The chamber consists of a 600 litre work space which can achieve temperatures below -40°C and above 55°C.   An access panel in the side of the chamber allows samples or test consumables to be transferred into and out of the chamber with minimal effect on the test conditions.  The chamber’s conditions are monitored throughout testing to provide an accurate record of the controlled exposure. 

Q: What types of medical devices can this new equipment help validate?

The equipment can be used to assess any devices which are likely to be used or stored at conditions above or below normal room temperature.  This is particularly applicable to devices which contain electronics or components which are effected by temperature or humidity.

Q: How do these specific tests fit into a wider testing programme?

Testing performed in this manner can be used to simulate in-use conditions which are known to present a risk to a product.  For example exposure to damp heat, dry heat, cold and condensation.  Testing allows potential performance issues to identified and corrected.

Q: What standards or regulations will these help clients meet?

This is testing approach is useful for clients following ISO 14971 “Application of risk management to medical devices” who have identified the potential for device use during expose to specific conditions.

Q: In addition to standard testing, what bespoke test services will these facilities enable you to perform?

This equipment allows us to evaluate the general functionality of devices and equipment during exposure to controlled environmental conditions.  Our test operators are able to mimic product usage to identify any potential issues associated with use at the specified conditions.