BUSINESS
Pharmaceutical cold chain is a supply chain system that manages the entire distribution process of temperature-sensitive bio-pharmaceuticals while maintaining a stable temperature range required for their safety and efficacy.
Bio-pharmaceuticals are temperature-sensitive and can be affected in terms of efficacy, effectiveness, and safety, making cold chain distribution crucial. The pharmaceutical cold chain in South Korea is governed by comprehensive distribution quality standards outlined in regulations such as the [Regulations on the Manufacture and Sale of Biological Products], [Standards for Quality Control of Pharmaceutical Distribution], and [Guidelines for Vaccine Storage and Transport]. HLB Therapeutics leads the standards for these regulations and is at the forefront of advancing global pharmaceutical cold chain distribution.
Specialized Pharmaceutical Cold Chain Company
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- Importance of Pharmaceutical Cold Chain
- The preservation of pharmaceuticals during transport, particularly maintaining the correct storage temperature, is the most critical factor. To address temperature deviations and potential risks, it is essential to preemptively identify risk factors, establish preventive plans, monitor temperature throughout the entire delivery process, and respond swiftly to emergencies. Pharmaceutical cold chain logistics services require the highest logistics technology and management capabilities to ensure that the inherent functionality and safety of the products are never compromised, with independent refrigerated transportation being a crucial safety component
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- Expertise and Differentiation of HLB Therapeutics’ Cold Chain Division
- Bio-pharmaceuticals are essential for extending human life, maintaining health, and preventing diseases, and require an optimal supply system to ensure stable quality. HLB Therapeutics' pharmaceutical cold chain division has secured expertise through significant investment and management, focusing on cold chain distribution with double safety assurance through refrigerated transport containers and vehicles, exceeding standard management levels.
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- Current Status of Bio-Pharmaceutical Cold Chain Distribution
- Established in 2008 as a vaccine-specialized distribution company, HLB Therapeutics' cold chain distribution division recognized the importance of pharmaceutical cold chain from its inception and has been operating a cold chain system since then. In response to the COVID-19 pandemic starting in December 2019 and the disruption caused by room-temperature exposure of influenza vaccines in 2020, we have applied high standards to enhance the stability of our cold chain system and have established an optimal system. We are recognized by the government for handling nationwide cold chain distribution of bio-pharmaceuticals, including vaccines requiring 2°C to 8°C storage conditions and COVID-19 vaccines requiring -20°C and -70°C storage conditions, as well as cold chain distribution of numerous NIP (National Immunization Program) bio-pharmaceuticals.
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- Considerations for Selecting Pharmaceutical Cold Chain Logistics Service Providers and Strategic Business Partnerships
- Pharmaceuticals directly affect human life, so stability is the most critical factor, and reliable operation is necessary to ensure product safety. Particularly for pharmaceutical cold chain distribution, the process must be based on thorough and accurate procedures that guarantee product safety and quality during storage and transport, and this must be demonstrable. HLB Therapeutics' cold chain distribution business provides proven, specialized cold chain services and is a trustworthy, open company that reflects customer needs and operates reliably.
Cold Chain Distribution Process
Inspection for received products
SKU Classification
Inventory Registration
Dedicated Space Location Storage
Receipt of Shipping Orders
System Upload
Dispatch-System Upload
Printout Transportation-Related
Picking & Packing
Affixing Printouts Transportation-Related and Categorizing
Shipping
Sending Delivery Confirmation Records
Operation Systems
Operation Systems
- Dedicated Storage for Pharmaceuticals
- Dedicated Storage Spaces by Client (e.g., High-Value Vaccines, Cryogenic Vaccines, Controlled Substances, Defective Pharmaceuticals)
KGSP Equipment Operation
- Security/Safety Systems, Pest Control/Prevention
- Emergency Power Supply Equipment
- Separate P&P Work Areas by Product
Validation
- Storage
- Refrigerated Transport Containers
- Refrigerated Delivery Vehicles
- Automated Temperature Recording Devices with KOLAS Certification and Calibration
Digital Solution
- TMS
- WMS
Contingency Response System
- Formation of Response Committee
- Immediate Response by Systems for Accidents
- Development and Operation of Contingency Response Manuals
Cold Chain Training System
- Regular KGSP Job Training by Departments
- Vaccine Handling Training
- Safety Training
Document Management Systems
- KGSP
- SOP
- DATA Integrity Storage System Development and Operation