Ensure Pharmaceutical and Medical Supply Integrity with Temperature Monitoring That Meets Stringent WHO Certification Guidelines

Thermax 40C removes the guesswork – see at a glance if temperatures have been exceeded. Key Takeaways: Temperature has a significant role in maintaining the…

Thermax 40C removes the guesswork – see at a glance if temperatures have been exceeded.

Key Takeaways:

  • Temperature has a significant role in maintaining the integrity and efficacy of drugs, medical supplies, and equipment, many of which are susceptible to environmental conditions.
  • The Thermax 40C, which meets World Health Organization (WHO) certification standards, is a pivotal tool for ensuring that medical supplies are stored and transported within safe temperature ranges.
  • Utilizing SpotSee’s proprietary color change technology, the Thermax 40C labels provide an easy-to-read, permanent record by changing color when temperatures exceed defined limits, making them essential for ensuring compliance and maintaining the integrity of medical products.

Temperature control plays a pivotal role in maintaining the integrity of medical supplies and equipment, many of which are highly sensitive to environmental conditions. Effective monitoring ensures that these vital products retain their efficacy from manufacture to use. Thermax® 40C, a precise temperature monitoring tool, is essential – its World Health Organization (WHO) certification aligns with global medical standards and underscores its reliability.

WHO Good Manufacturing Practices (GMP) guidelines provide standards for pharmaceutical product manufacturers to ensure product quality, safety, and efficacy. Certification guarantees that a manufacturer has systems and procedures that ensure quality standards, protecting public health by reducing the risk of contaminated or ineffective products. 

WHO Guidelines and Certification

While certification is issued by national and regional authorities globally, WHO provides uniform guidelines around production and quality control, as well as international regulatory standards that include:

  • Stability
  • Packaging
  • Storage

The guidelines require that active pharmaceutical ingredients remain stable under all conditions, including packaging, storage, and transport. Certification indicates that a product has undergone extensive testing to verify its accuracy, ensuring it performs as intended and meets its stated claims.

Meeting these standards for many modern medications requires a robust monitoring solution in the cold chain.

How Thermax 40C Supports Medical Supply Chain Compliance

Ensuring proper handling, storage, and transport is vital to meet WHO certification standards, making Thermax 40C an essential tool in cold chain compliance. Thermax 40C is a simple monitoring tool based on SpotSee’s proprietary color change technology:

  • Inexpensive and easy to use.
  • Provides an immediate response with a distinct color change from clear to black when the temperature has been exceeded. 
  • Provides a permanent record of the highest temperature reached.
  • Oil, water, and steam resistant.
  • Accuracy tolerances of +/-1°C at less than 100°C.

These conveniently sized self-adhesive labels – 12mm x 13mm – consist of temperature-sensitive elements sealed between heat-resistant substrates with a transparent window that changes color distinctly as the rated temperature is exceeded. The irreversible changes will not de-laminate when removed for reference and can be attached to an inspection report to serve as a permanent record.

Thermax 40C labels can be placed on packaging or directly on a product to ensure proper storage and handling.

Best Practices to Use Thermax 40C in Your Cold Chain

Implement Thermax 40C to integrate a WHO-certified temperature monitoring solution into supply chain operations. Easily integrated into current processes, this tool optimizes compliance and enhances efficiency. 

Organizations must maintain consistency across global operations, ensuring all facilities adhere to the same high standards of temperature management. You’ll know with a single glance if the required temperatures have been exceeded for pharmaceuticals and medical equipment. 

Improve Your Cold Chain with Temperature Monitoring from SpotSee

Emphasizing the importance of WHO-certified temperature monitoring tools like Thermax 40C is essential for reinforcing reliability and compliance in medical supply chains. Procurement teams can easily integrate these solutions into their operations to safeguard the quality of medical supplies globally.

For more information or to inquire about Thermax 40C, contact SpotSee to discuss how this crucial tool can be implemented in your supply chain to enhance and ensure medical supply safety and efficacy.