How do the tests work?
With the objective of analyzing the performance of the packages, as well as guaranteeing that they meet the respective normative requirements, the tests performed by SCiTec aim to evaluate the integrity, resistance, and stability of the packages, as well as the products, in such a way as to supply data that allows the industries to guarantee greater quality and safety to their clients.
- Migration Tests
- Shelf Life
- Mandatory requirements
- Resistance to transportation
- Packaging optimization
- Accelerated conditioning
- Suitability for the distribution cycle
ASTM D4332 – Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
ASTM F1140/F1140M – Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
ASTM F1929 – Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F1980 – Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F2054/F2054M – Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
ASTM F2096 – Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
ASTM F3039 – Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
ASTM F88/F88M – Standard Test Method For Seal Strength Of Flexible Barrier Materials
RDC 51/2010 and RDC 105/1999;
The SCiTec laboratory offers a complete infrastructure for packaging tests, such as accelerated and real time conditioning tests, integrity and resistance tests, and distribution cycle tests. Besides these services, we also perform stability studies of finished products and validation of production processes.