Pharmaceutical Cold Chain Distribution— Process Design & Validation

Cold Chain Management for Temperature Sensitive Products

The methods by which vaccines, parenterals, biologics, and human cell and tissue products (HCTPs) are moved from one place to another is a process that takes much consideration, design, validation, and supervision.

Typically referred to as "cold chain management", manufacturers must take into consideration such factors as the type of shipping containers to be used, the distribution carriers to be contracted, what refrigeration or humidity control equipment is required (if any), the types of environmental conditions expected at each location along the distribution chain, the length and time of the distribution route, and much more.

The goal, of course, is to ensure that the manufacturer's FDA-approved storage conditions be observed carefully at each destination along the distribution chain.

Challenges

Shippers need to know and understand the cold chain process as fully as possible to ensure the delivery of safe high quality products. Important factors in choosing recording devices to test and validate the cold chain process are:

1. High accuracy temperature (and, in some cases, humidity) sensing performance
2. Ability to operate without requiring an external power source
3. Large memory to handle lengthy processes without missing readings
4. Rugged performance to handle the knocks, bumps, and widely varying environmental conditions of the shipping process
5. Ability to measure and record both interior container temperatures and exterior conditions along the route
6. 21 CFR Part 11 compliance
7. The ability to measure and determine the effects of temperature excursions (such as through Mean Kinetic Temperature calculations)
8. Ability to accurately keep track of time and events across multiple time zones

Solution

Veriteq's VL-series validatable temperature and humidity data loggers are the ideal choice for cold chain design and validation. Each Veriteq data logger is equipped with the following key features:

• long life soldered-in 10-year battery
• large capacity digital memory capable of recording up to 21,500 time-based readings
• high accuracy to +/-0.10°C and to +/-1%RH
• wide operational temperature range ranging from -35°C to 85°C (VL-1000/1400, VL-2000) and to -90°C (with the VL-1000-VLT)
• tamper-proof files that meet 21 CFR Part 11 requirements
• automatic calculation of MKT values
• system displays local time based on UTC absolute time reference

For more information on Veriteq's cold chain monitoring solutions, please contact Veriteq.