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tests

Packaging / Transport Tests

International regulatory agencies put emphasis on compliance with ISO 11607 for highly sterilized medical devices. This standard defines the test requirements required to ensure that the terminally sterilized package / device maintains its design performance throughout the designed life of the product and does not deteriorate as a result of sterilization, shelf life, transportation, or storage.

TURCLAB is experienced in package tests that must meet the following standards:

  • ANSI - American National Standards Institute
  • AAMI - Medical Devices Development Association
  • ASTM - American Test and Materials Association
  • ISO - International Standards Organization
  • ISTA - International Safe Transport Association

Our expertise is drawn from the entire supply chain, with the driving forces and challenges of raw material providers, converters, packers / fillers, brand owners, logistics providers, retailers and waste management organizations.

our laboratories in Turkey, shipping, storage, handling and climatic conditions through its simulation of providing performance evaluation laboratory of packaged goods to customers we offer a wide package testing services.
We support customers addressing today's key issues:
Identify opportunities for cost reduction and avoid cost

  • Ensuring compliance with legal and legislation
  • Making progress against the sustainability requirement
  • Reducing damage at the point of sale and improving the appearance of products
  • Delivery against quality requirements and performance expectations in complex and global supply chains.

Test Method Development and Validation

Our experts have experience in designing and validating bespoke test methods. We conduct a verification test to determine test methods:

  • Repeatability
  • Reproducibility
  • Sensitivity and detection limits (for integrity tests)

Proficiency Test

TURC can test the product at every qualification stage:

  • Instrument Proficiency (IQ) - test to help identify critical process parameters.
  • Operations Qualification (OQ) - testing on upper and lower parameter limits to make sure the features meet the predefined requirements.
  • Protocol Proficiency (PQ) - testing to demonstrate consistent acceptable sterile barrier systems

certification

We work with you to prepare certified documents to provide proof of compliance with ISO, TS, FDA and EU regulatory submissions.

  • Test protocols and reports
  • Verification protocols and reports
  • Supporting documents such as calibration records.

Services