TAKO Healthcare: ISO 11607 Certified 60gsm Medical Pouch

INTRODUCTION

The healthcare industry pays utmost importance to high-quality care, patient safety, and compliance with regulatory standards. As the industry continues to evolve, so does the demand for cutting-edge solutions that meet the highest standards of quality and compliance. To ensure that the healthcare products meet the required standards of quality, there is a set framework to comply that allows the products to be officially recognised and certified.

This article delves into the significance of ISO 11607 certification and explores the innovative features that make the 60gsm medical pouch an indispensable asset in TAKO’s Healthcare medical device packaging products.

ISO 11607 CERTIFICATION

ISO Certification is an international recognition for organizations that meet the standards set by the International Organization for Standardization (ISO). ISO 11607 stands as a globally acknowledged standard, focusing on the assessment of materials, pre-formed sterile barrier systems, and packaging systems.

Its scope encompasses products designed to preserve the sterility of medical devices subjected to terminal sterilization until they reach the point of use. These standards provide a framework for ensuring quality, safety, and efficiency in various industries, including healthcare.

THE ROLE OF ISO 11607 CERTIFICATION

In the high-stakes world of healthcare, even the smallest contamination can have dire consequences. ISO 11607 tackles this concern head-on with its comprehensive, risk-minimizing packaging rules, safeguarding patients from potential infections or complications.

Here are several critical reasons why medical device packaging products must be certified:

Safety and efficacy of medical devices: Packaging protects medical devices from damage and contamination during storage and transportation. ISO standards for medical device packaging help manufacturers design and produce packaging that meets stringent safety requirements, minimizing the risk of device failure or contamination that could harm patients.
Compliance with regulatory requirements: Different countries and regions have their own regulations for medical devices, including specific requirements for packaging. ISO certification can help manufacturers demonstrate compliance with these regulations, facilitating market access and reducing the risk of regulatory hurdles.
Quality and consistency of packaging: ISO standards establish clear guidelines for the design, manufacture, and testing of medical device packaging. This helps manufacturers ensure that their packaging is consistently high-quality and meets the specific needs of their devices.

BENEFITS OF ISO CERTIFICATION MEDICAL DEVICE MANUFACTURERS

ISO 11607 certification in medical device packaging, particularly for medical pouches, offers a range of significant benefits that contribute to the overall quality, safety, and compliance in the healthcare industry.

Here are some key advantages:

Compliance with International Standards: ISO 11607 certification ensures that the medical pouch packaging meets internationally recognized standards. This compliance enhances the credibility of the medical device manufacturer and facilitates market access across different regions.
Ensures Sterility: The primary purpose of ISO 11607 is to maintain the sterility of terminally sterilized medical devices until the point of use. Certification guarantees that the packaging is designed and validated to prevent microbial contamination, ensuring the safety of patients and healthcare professionals.
Reduces Regulatory Risks: Adhering to ISO 11607 standards reduces the risk of regulatory issues and non-compliance. Regulatory bodies often require medical devices to conform to established packaging standards, and ISO 11607 certification serves as a recognized proof of compliance.
Enhances Product Reliability: ISO 11607 certification involves rigorous testing and validation processes. As a result, the medical pouch packaging is more likely to be robust and reliable, providing assurance that the enclosed medical devices will remain protected and intact throughout their lifecycle.
Optimizes Packaging Processes: The certification encourages the implementation of best practices in packaging design, validation, and manufacturing. This optimization can lead to more efficient and cost-effective packaging processes, benefiting both manufacturers and end-users.
Facilitates Risk Management: ISO 11607 emphasizes risk management in packaging design. By identifying and mitigating potential risks, certification contributes to the development of packaging solutions that are better equipped to handle the challenges associated with transportation, storage, and usage of medical devices.
Global Market Access: ISO 11607 certification facilitates access to global markets by aligning with international packaging standards. This is especially crucial for manufacturers looking to distribute their medical devices across different countries with varying regulatory requirements.

THE ISO STANDARD

ISO certification is a valuable asset for medical device manufacturers in today’s competitive global market. By demonstrating their commitment to quality and safety, manufacturers can gain a competitive edge, improve their brand reputation, and ensure the safe and effective delivery of their medical devices to patients around the world.

Here are some specific ISO standards that are relevant to medical device packaging:

ISO 13485:2016: This standard specifies the requirements for a quality management system for the design and manufacture of medical devices. It includes requirements for packaging that ensure the safety and efficacy of the devices.
ISO 11607:2019: This standard specifies requirements for packaging systems for sterilized medical devices. It helps to ensure that sterile devices remain sterile after packaging and throughout their shelf life.
ISO 15378:2011: This standard specifies requirements for a quality management system for manufacturers of pharmaceutical and medical device primary packaging materials. It helps to ensure that the materials used in packaging are safe and suitable for their intended use.

WHAT IS A MEDICAL POUCH?

A medical pouch is a type of packaging specifically designed to hold and protect medical devices or supplies. It’s crucial for maintaining the sterility, safety, and integrity of the contents until they reach the point of use. These pouches often come in various sizes and materials to accommodate different types of medical equipment and instruments.

Medical pouches play a key role in complying with ISO 11607. The standard outlines specific requirements for the materials used in the pouch, its structure, sealing methods, and labeling to ensure it effectively protects the device from:

Microbial contamination: The material must be impermeable to bacteria and other microorganisms, preventing them from entering and contaminating the device.
Physical damage: The pouch must be strong and resistant to punctures, tears, and abrasions to protect the device from physical damage during transport and handling.
Chemical degradation: The material should not react with the device or its packaging components, causing any chemical degradation that could compromise its sterility or function.
Environmental factors: The pouch should withstand exposure to temperature fluctuations, humidity, and pressure changes that might occur during storage and transportation.

Therefore, medical pouches designed and manufactured in accordance with ISO 11607 play a crucial role in ensuring the safe and effective delivery of sterile medical devices to healthcare professionals and ultimately, to patients.

Examples of medical devices commonly packaged in pouches adhering to ISO 11607 include:

Surgical instruments
Catheters
Syringes and needles
Implants
Diagnostic tools
Blood bags

By adhering to ISO 11607 and using appropriate medical pouches, manufacturers can contribute significantly to patient safety and enhance the quality of healthcare delivery.

Customizable Medical Pouch Options:

Size and Format: Pouches come in various sizes and formats, from small individual pouches to large flat or gusseted options, accommodating diverse medical equipment and supplies.
Materials: Different materials cater to specific needs. Medical grade paper, coated Tyvek, grid lacquer coated paper, and PE-coated paper offer varying levels of barrier protection and tear resistance.
Sterilization Methods: Pouches can be pre-sterilized using methods like gamma irradiation or ethylene oxide sterilization to ensure sterility upon arrival at the healthcare facility.
Indicator Ink: Pouches can incorporate indicator ink strips that change color during sterilization, visually confirming the effectiveness of the sterilization process.
Printing and Labeling: Custom printing and labeling with logos, barcodes, and other information can enhance brand identity and facilitate inventory management.

Benefits of Medical Pouches:

Cost-effective: Compared to other packaging options, medical paper pouches offer an economical solution for sterile packaging.
Lightweight and Flexible: Pouches are lightweight and flexible, making them easy to handle and store.
Sustainability: Several pouch materials are recyclable or compostable, contributing to environmental sustainability efforts.
Tamper-evident: Sealing features ensure pouches remain intact, preventing contamination and tampering.
Ease of Use: Pouches are simple to open and close, facilitating efficient use in healthcare settings.

By choosing the right medical pouch and its customization options, medical device and disposable manufacturers can ensure the safe and effective delivery of their products, ultimately impacting patient safety and healthcare quality.

TAKO’S HEALTHCARE MEDICAL POUCH

Designed for medical devices and disposables, TAKO Healthcare offers a range of well-constructed paper pouches (with or without indicator ink) crafted from ISO 11607-certified materials like 60gsm medical grade paper, Tyvek (coated or uncoated), grid lacquer coated paper, and PE-coated medical paper.

The product materials:

ISO 11607 Certified 60gsm medical grade paper
Coated/Uncoated Tyvek 2FS/1059B/1073B
Grid lacquer coated paper
Medical paper coated with PE

The material specifications:

Custom size
pouches/roll
with/without printing
with/without indicator ink

The key points of TAKO’s medical pouch:

Effortless opening
Improve efficiency
Enhance Efficiency
Sustainable

TAKO’S MEDICAL POUCH SEALANT TYPES

CONCLUSION

Unlocking a new era in healthcare packaging, TAKO’s Medical Pouches for flexible packaging stands as a pinnacle of innovation, offering key benefits that redefine industry standards. With ISO 11607 certification, TAKO ensures uncompromised sterility and compliance on a global scale. The 60gsm material strikes an optimal balance between durability and flexibility, safeguarding medical devices throughout their journey.

Unmatched Protection:

ISO 11607-certified materials: Rest assured, your products are safeguarded by the highest standards for sterile packaging.
Tear-resistant and puncture-proof: From delicate instruments to bulky disposables, TAKO pouches keep everything secure.
Optional indicator ink: Visually confirm sterilization effectiveness for added peace of mind.

Unparalleled Versatility:

Wide range of sizes and formats: From single-use pouches to large rolls, we have the perfect fit for your needs.
Customizable materials: Choose from medical grade paper, coated Tyvek, and more, tailored to your specific application.
Sterilization compatibility: Pre-sterilized or ready for your preferred sterilization method – TAKO pouches adapt to your workflow.

Unbeatable Efficiency:

Cost-effective: Get reliable protection without breaking the bank.
Lightweight and flexible: Easy to handle and store, saving you valuable time and space.
Tamper-evident seals: Ensure product integrity and maintain sterility throughout the supply chain.

READY TO DISCOVER THE TAKO DIFFERENCE?

Explore our extensive range of medical packaging solutions: Visit our website to find the perfect pouch for your needs.

Unlock customization options: Let our experts help you tailor a pouch to your specific requirements.
Get expert advice: Contact us for a free consultation and discuss your unique packaging challenges.
Download our brochure: Learn more about the science behind TAKO’s superior sterile packaging solutions.

Don’t settle for anything less than the best. Choose TAKO Medical Pouches and experience the ultimate in flexible, reliable protection for your valuable healthcare products.