Packaging

The Scitec laboratory offers complete infrastructure for medical device packaging testing, such as accelerated, real-time conditioning tests, integrity, endurance tests, and distribution cycle testing. In addition to these services, we also conduct stability studies of finished products and validation of production processes.

Standards

Distribution cycle tests

ASTM D4169 – Standard Practice for Performance Testing of Shipping Containers and Systems

ASTM D4003 – Standard Test Methods for Programmable Horizontal Impact Test for Shipping Containers and Systems

ASTM D4728 – Standard Test Method for Random Vibration Testing of Shipping Containers

ASTM D5265 – Standard Test Method for Bridge Impact Testing

ASTM D5276 – Standard Test Method for Drop Test of Loaded Containers by Free Fall

ASTM D5277 – Standard Test Method for Performing Programmed Horizontal Impacts Using an Inclined Impact Tester

ASTM D5487 – Standard Test Method for Simulated Drop of Loaded Containers by Shock Machines

ASTM D6055 – Standard Test Methods for Mechanical Handling of Unitized Loads and Large Shipping Cases and Crates

ASTM D6344 – Standard Test Method for Concentrated Impacts to Transport Packages

ASTM D642 – Standard Test Method for Determining Compressive Resistance of Shipping Containers, Components, and Unit Loads

ASTM D6653 – Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method

ASTM D880 – Standard Test Method for Impact Testing for Shipping Containers and Systems

ASTM D951 – Standard Test Method for Water Resistance of Shipping Containers by Spray Method

ASTM D999 – Standard Test Methods for Vibration Testing of Shipping Containers

ASTM D6179 – Standard Test Methods for Rough Handling of Unitized Loads and Large Shipping Cases and Crates

Packaging test

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

Farmacopeia Brasileira, 5 ed.

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