Cold Chain Management for Taiwan's Pharmaceuticals Going Overseas

Globally Compliant Temperature Monitoring Solutions

Comply with FDA, EMA, WHO GDP/GMP certification requirements to ensure the quality and safety of pharmaceutical products in transnational transportation.

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Solutions

Case

Why should Taiwan's pharmaceuticals go overseas?

  • Decentralized risk: Expanding domestic and overseas markets to minimize the impact of single-market volatility

  • Enhancing Competitiveness: Strengthened brand image through GMP, GxP and other international certifications.

  • Creating New Business Opportunities: Meeting the demand for "high quality medicines" in the global aging and chronic disease markets

  • Driving technology upgrades: Accelerating R&D and Manufacturing Process Optimization

  • Expanding Global Impact: Enhancing Taiwan's Voice in the Pharmaceutical Supply Chain through Collaboration with International Partners

Industry Challenge: Temperature Monitoring Challenges for Pharmaceutical Exports

  • Sensitivity of drugs to temperature and humidity
  • Variability of the Transnational Transportation Environment
  • Complexity of real-time monitoring and data management
  • High standards of regulations and compliance in various countries.

API (API)

High temperatures may cause API degradation affecting efficacy. After 6 months of exposure at 40°C, the degradation rate ofKODAK 20%

Biological products (vaccines, antimicrobials)

Some vaccines are active after 1 hour of exposure to temperatures other than 2-8°C.Reduction of 10%-50% 

Blood Products (Plasma, Stem Cells)

Over -20° C may lead to degradation of plasma proteins.Losing bets

Solving Pain Points

  • Ensure pharmaceutical cross-border transportation and warehousing comply with GMP, GDP and other international regulations, and reduce the risk of scrap, return and compliance caused by unstable temperature and humidity. Enhance the transparency and management efficiency of the supply chain through an intelligent and traceable monitoring system to ensure consistent standards, meet European and US GxP compliance requirements, and guarantee audit approval.
  • In view of the sensitivity of drugs to temperature and humidity, a high-precision monitoring solution is adopted, which is integrated into the cold chain system to realize automated data collection and satisfy the requirements of FDA and EMA on data integrity, so as to avoid compliance problems affecting the marketing of drugs.
  • Comply with global cold chain standards to reduce the risk of transportation temperature control violations, respond quickly to anomalies through real-time monitoring and data tracking, optimize cost and service quality with efficient, integrable monitoring equipment, and reduce compliance risk by selecting suppliers with global certifications and success stories.
台灣藥品出海冷鏈管理｜全球合規溫度監測解決方案

Honghong ELPRO Solution: Full Process Temperature and Humidity Monitoring

Satisfy the strict requirements of temperature control in overseas markets, solve the difficulties in international transportation safety, help China's medicines to go overseas, empower the supply chain safety, and help provide patients with safe and effective medicines.

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Industry Experience

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Trusted by pharmaceutical companies worldwide

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GxP Compliance

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Application Solutions

Your medication is safe with us

A globally compliant temperature and humidity monitoring solution is at the heart of ensuring the quality and safety of pharmaceuticals. With end-to-end temperature and humidity monitoring throughout the supply chain, Honghong ELPRO can help you ensure the quality and compliance of every step of the process, making it a reliable partner for your international pharmaceuticals export compliance!

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Free Sample Trial

Swiss quality, stable and reliable

More than 30 years of industry experience, trusted by the world's top 50 pharmaceutical companies, including Novo Nordisk, GSK, Bayer, Sanofi.

High price/performance ratio, easy to operate

Multiple settings to avoid misuse and multiple combinations for all applications in the pharmaceutical supply chain.

Global compliance, quality and safety

Comply with FDA, EMA, WHO GDP/GMP certification requirements to ensure the quality and safety of pharmaceutical products in transnational transportation.

Localized services to assist in data analysis

Customized services: support for configuration assistance, free trials, and compliance consulting services.

Product Recommendation

Export Non-Recycling Application

Single-use
PDF Temperature Recorder

Disposable, low price, easy to operate, used for cold chain quality control to ensure that the data "does not break the chain". Suitable for temperature recording during cold chain logistics of vaccines, pharmaceuticals and other temperature sensitive products.
Product Details

Export Recycling Multiple Applications

Multiple use Bluetooth transmission
PDF Temperature Recorder

Supports Bluetooth transmission and cell phone reading of PDF reports for fully automated management. Suitable for cold chain logistics, clinical trials, and monitoring in a variety of environments (ambient, chilled, frozen, dry ice, liquid nitrogen, etc.).
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Export Real-time Transmission Application

Wireless Real-time Positioning
Temperature and Humidity Recorder

Embedded with IoT chip, real-time temperature and humidity tracking and location, safe air transportation. Ideal for cold chain transportation of high-risk goods such as high-value pharmaceuticals, cellular and gene therapy products, and global/clinical supply chain temperature and humidity monitoring.
Product Details

Warehouse Laboratory Monitoring

GxP Compliant Automatic Ambient Temperature and Humidity Monitoring System

Suitable for warehouse, laboratory and clean room GxP environment monitoring, support multi-parameter monitoring, software support data analysis, evaluation archiving and remote alarms, to help customers to comply, ensure quality and patient safety.
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Contact the Specialist for a complete catalog.

Applicable Scenarios

Ingredients

(API)

Biological products

(Vaccines, Antibodies, Cell Therapy)

Blood Products

(plasma, serum, stem cells)

Preparations

(solid oral, injectable, freeze-dried preparations)

Clinical Trial Drugs

(IMP)

Compliance Standards and Certifications

  • New Zealand button battery powered, IATA compliant, recognized by more than 100 domestic and international airlines, added to the Air Cargo Authorization List.
  • With the air and sea transportation authentication report of Shanghai Chemical Industry Institute and Beijing DGM, it can be directly put on the airplane.
  • Patented PDF/A technology, PDF data report is not modifiable and meets FDA 21 CFR Part 11 requirements.
  • WHO PQS pre-certified for direct temperature monitoring of vaccines during export transportation.
  • Strictly based on GAMP5 R&D, design and production, in compliance with international and domestic pharmaceutical industry regulations.
Airline Recognition List
Free Scanner and Pickup Request Form for Identification Reports

Temperature deviation = drug failure? Intelligent Temperature Control Compliance Programs for Multinational Pharmaceutical Companies

More Application Videos

Discover more solutions for temperature and humidity monitoring applications.

From multi-use and single-use USB temperature data loggers to real-time mobile IOT and wireless Bluetooth (BLE) capabilities, Hong Kong ELPRO offers solutions for any cold supply chain application in the pharmaceutical, life sciences, healthcare, and logistics sectors where regulated temperature control is required to ensure quality results and compliance.

Comprehensive Temperature and Humidity Monitoring - Multi-scene Adaptation and Intelligent Automation Management

Testimonials

Reputation proves quality, trust comes from excellence.

“ELPRO prepared us for better data management by providing us with the hardware and software solutions we had been looking for. We were impressed with their ability to listen to our needs and then customize a solution for us. We appreciated the open dialog about the available solutions, our specialized needs, and ELPRO's future development projects.”
JOHNNY TEO
JOHNNY TEOSenior Manager Regional Quality & Project Management, ZUELLIG PHARMA
"Purchasing new equipment is often time-consuming and involves a lot of effort from selection to implementation. That's why we value a long-lasting, stable solution, and ELPRO's team follows up with us to ensure that we have the right tools for the job, and ELPRO's solution provides us with a comprehensive approach to temperature monitoring for all of the processes that require high levels of compliance."
KONSTANZE AURICH
KONSTANZE AURICHProfessional Pharmacist, Faculty of Medicine, University of Greifswald

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