GDP, DPD mapping

The COCH laboratory is accredited for testing in accordance with PKN-DIN SPEC 91323:2019-08 “Temperature-controlled commercial vehicles used for distribution of pharmaceutical products (for human or veterinary use) — Qualification guidelines“.

PKN-DIN SPEC 91323:2019-08 applies to temperature-controlled commercial vehicles that are used to distribute pharmaceutical products, both for human and veterinary use. The guidelines in this standard cover the qualification of such vehicles to ensure that the pharmaceutical products being transported are stored under appropriate temperature conditions throughout the period of transportation.

• Testing of temperature distribution inside the body without loading;
• Testingof temperature distribution inside a loaded body.

Technical Specifications of COCH Climatic Chamber for Pharmaceutical Transport Evaluation

Geometric Dimensions of the Climatic Chamber:

• Length: 22 meters
• Height: 4.6 meters
• Width: 4 meters

Range of Climate Parameter Control:

Temperature:

• Control Range: from -20°C to +40°C
• Enables simulation of extreme summer and winter conditions, crucial for assessing cooling and heating system performance in vehicles.

Relative Humidity:

• Control Range: from 20% to 90%
• Adjustment of humidity allows simulation of various atmospheric conditions, important for evaluating the impact of humidity on pharmaceutical product quality.

Air Velocity:

• Control Range: from 0 m/s to 4 m/s
• Air velocity regulation facilitates analysis of air circulation inside the vehicle, directly influencing temperature distribution uniformity.

Significance of Climatic Chamber Technical Parameters:

The COCH Laboratory’s climatic chamber, with its wide range of parameter adjustments, enables highly precise and realistic testing. This capability allows for:

Realistic Simulation of Transport Conditions:

• The chamber simulates diverse climatic conditions encountered during pharmaceutical product transport.

Versatile Testing:

• Facilitates testing of various scenarios and operational conditions, aiding in identifying potential issues and optimizing temperature and humidity control systems.

Enhanced Safety and Quality:

• Detailed tests under varied climatic conditions ensure pharmaceutical products are transported safely and under suitable conditions, crucial for maintaining their quality and effectiveness.

COCH Laboratory, equipped with its advanced climatic chamber, plays a pivotal role in ensuring that commercial vehicles used for pharmaceutical distribution meet the highest standards of quality and safety, in accordance with PKN-DIN SPEC 91323:2019-08.

COCH Laboratory Additional Tests for Pharmaceutical Transport Evaluation

1. Impact of Door Opening on Temperature Distribution Inside Vehicle Body:

   • Description: This test assesses how opening doors affects internal vehicle temperature, crucial for understanding thermal stability during loading and unloading.
   • Objective: Identify heat/cold loss potential and develop strategies to minimize door-opening impact on transport quality.

2. Simulated Refrigeration Unit Failure or Power Outage:

   • Description: Simulates scenarios where refrigeration unit failure or power outage causes uncontrolled temperature changes.
   • Objective: Evaluate emergency system response time and duration for maintaining safe pharmaceutical transport conditions.

3. Time to Reach Desired Internal Temperature (Set on Controller):

   • Description: Measures time for cooling/heating systems to stabilize the set temperature inside the vehicle.
   • Objective: Assess vehicle thermal system performance in achieving and maintaining ideal transport conditions.

4. Other (Customizable with Client):

   • Description: COCH Laboratory offers flexibility for additional tests tailored to specific client needs.
   • Objective: Ensure adaptability to unique requirements and challenges in pharmaceutical transport.