O laboratório Scitec oferece completa infraestrutura para ensaios de embalagens de produtos médicos, como por exemplo, ensaios de condicionamento acelerado e em tempo real, ensaios de integridade, resistência, e ensaios de ciclo de distribuição. Além desses serviços, também realizamos estudos de estabilidade de produtos acabados e validação de processos produtivos.
Normas
Ensaios de Ciclo de Distribuição
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
Embalagens em geral
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
ISO 11737-1: Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
ISO 11737-2: Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
