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Testing Facilities at ZYNOR International

At ZYNOR International, we prioritize the highest standards of quality and safety. Our comprehensive testing facilities ensure that every product meets rigorous standards before reaching our customers. Our testing facilities include:

  • Triple-Testing: We conduct thorough testing at three stages – Incoming, In-Process, and Finished Goods – to ensure quality at every step.
  • Comprehensive Testing: Our testing includes visual, dimensional, functional, and microbiological assessments to ensure compliance with product standards such as ISO 10555-1 for IV Catheters, ISO 80369-7 for Luers and Stop Cocks, and US Pharmacopoeia for Sterility.
  • In-House Physical/Functional Testing Laboratory: Equipped with advanced apparatus for Tensile Testing, Pressure Leakage Testing, Flow Rate Testing, Penetration Testing, and more.
  • Microbiological Testing Laboratory: Capable of performing Product Bio-Burden assessments, Clean Room Monitoring, and 14-day Sterility Testing.
Quality at ZYNOR International

At ZYNOR International, we pride ourselves on our rigorous Quality Control measures, which include Triple-Testing at the Incoming, In-Process, and Finished Goods stages. Our team of dedicated and diligent QC and QA professionals conducts various visual, dimensional, functional, and microbiological tests to ensure compliance with product standards such as ISO 10555-1 and -5 for IV Catheters, ISO 80369-7 for Luers and Stop Cocks, and ISO 11070 for Hemodialysis Catheters and Vessel Dilators.

Our Key Quality Control Features:
  • Comprehensive Testing: Our Physical Testing Laboratory operates 24-hours to ensure samples are drawn for functional tests such as flow rates, leakage, and penetration force from each production shift.
  • Sterility and Microbiological Testing: Qualified microbiologists conduct Sterility Testing on all finished production lots as per US Pharmacopoeia, in addition to other microbiological evaluations for product and environmental bio-burden.
  • Validated Processes: All production processes and equipment are validated periodically to ensure highly reliable and repeatable manufacturing.
  • Regulatory Compliance: Our dedicated in-house QA and Regulatory team ensures that we meet and exceed stringent international standards. This enables us to register our products in multiple countries worldwide and satisfy documentary requirements of customers and regulators.
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Certifications and Approvals:
  • ISO 13485:2016 Certification
  • WHO
  • CE Certification
Core Values:
  • Empathy: Every Medicura Devices employee is committed to understanding and prioritizing the well-being of end-users.
  • Discipline: We maintain an uncompromising adherence to strict tolerances at every stage of quality control.
  • Standardization: Our automated and tightly controlled environment ensures consistency and standardization in all our products.