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ACCELERATED AGEING FOR BIOMEDICAL MEDICAL AND PHARMACEUTICAL
PRODUCTS

QRA Lab 1 at Jurong East

Test Lab I at Jurong East

QRA is the preferred laboratory services partner for many companies in the biomedical, medical devices and pharmaceutical industries in Singapore and around the region.


Our 2 Laboratories comprising close to 20 test chambers are running 24 hours a
day,7 days a week to provide accelerated ageing with controlled temperature and
humidity according to major international standards.


Before starting each test, QRA provides a comprehensive Calibration Report for each
chamber and also for the test sensors (temperature and humidity) with full ISO 17025
traceability.


Upon completion of these tests, or during the specified duration at regular intervals,
QRA provides detailed test reports with pictures and graphs to our clients.

QRA Lab at Jurong East
Accelerated Ageing Testing, what are they?

Accelerated ageing tests are commonly used to verify that a new product can be stored
for an extended period of time (2, 3 or even 5 years) without degradation of its

 

  • function

  • form

  • efficacy


for the duration of the expiry of the product (for example, 2 or 3 years).


To accelerate the effects of time, the products are subjected to higher temperatures and
humidity conditions that it would normally encounter during its shipping, storage and
operational life cycle.


The objective of accelerated ageing is to provide assurance that the product will meet its expected lifetime and reliability goals in as short as possible a time and tweak or
redesign the product at the factory level so that the level of quality and reliability will be
assured for its entire life. That would ensure that the product quality and brand is
maintained at its highest level.

2 such international standards which we run ageing tests in our Labs and comply with are:


(a) ASTM F 1980 - 21
Standard Guide for Accelerated Ageing of Sterile Barrier Systems for Medical
Devices.


(b) ISO 11607
Stability Testing (accelerated ageing and real time ageing)
 

QRA Lab 2 LIm Chu Kang

QRA Lab II at Lim Chu Kang

QRA can also provide (in close cooperation with our local partner), the following test
services (off site location).

 

  • Transport Simulation

  • Vibration

  • Impact Shock

  • Drop

  • Compression

  • Stacking

 

According to 2 other international standards:


(a) ASTM D 4169
(b) ISO 11607 Package Strength and Integrity Test

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Medical Device Performance and Safety Testing

Our performance and safety testing is designed to accommodate your needs for both healthcare products and laboratory equipment. Our global facilities allow us to provide efficient and custom solutions tailored to your product or facility’s requirements, and experts understand the changing market and how to best serve your business’ specific needs.

We can help you with:

  • Standards testing to help you bring compliant products to market quickly.


  • Customized on-site support and training


  • Convenient, localized testing in global facilities for electromagnetic compatibility (EMC), software validation and wireless security


  • Clearance of FDA 510(k) submissions for devices

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Medical Device Packaging Testing

Validation of packaging procedures, such as the forming and sealing of sterile barrier systems, as per ISO 11607-2 is one of our services. Sterilized and final-packed test devices are subjected to both thermal and regular ageing, as well as transport simulation, as part of a combined stability and packaging validation study, according to ISTA or ASTM standards.

The specific qualities of medical equipment and their packaging systems must remain stable during their shelf life, according to ISO 11607-1. Following that, products can be put through a series of testing to determine the packaging system's performance, aseptic presentation, and microbiological barrier qualities, as well as the performance of the enclosed medical device, functionality, and biocompatibility.

The following test systems may be applicable for the packaging system: 

  • Dye test for seal integrity 


  • Peel test, burst test and bubble test 


  • Air permeability test and test for microbiological tightness 


  • Qualification of packaging materials 


  • Validation of the forming, sealing, and assembly processes of packaging for terminally sterilized medical devices 


  • Validation of final packaging systems for sterile medical devices 


  • Evaluation of the shelf life of the sterile packed medical device 


  • Stressed medical devices are subjected to specific performance tests as well as to a biological evaluation test strategy


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