AIRFROSTER® for pharmaceutical logistics
The Good Distribution Practice (GDP) guidelines require seamless, documented temperature control throughout the entire pharmaceutical supply chain. The AIRFROSTER® conditions cooling packs in a GDP-compliant manner to defined target temperatures – reproducible, validated, and fully documented.
Validated temperature control
Supports GDP-compliant processes
Over 95 years of cooling expertise
GDP requirements in pharmaceutical logistics: Highest standards for the last mile
Pharmaceutical wholesalers and mail-order pharmacies are required to maintain medicines within defined temperature ranges throughout delivery. The GDP guidelines require continuous temperature control, low-risk handling, complete documentation, and validated processes across the entire supply chain.
Temperature-sensitive pharmaceuticals – including live vaccines and protein-based active substances – require continuous storage at +2 °C to +8 °C from manufacturer to administration. Already around 20% of all medicines require cold chain logistics – with a rising trend.
The challenge
The last mile determines the effectiveness of medicines
Temperature deviations during the last mile compromise the product quality of temperature-sensitive pharmaceuticals – with potentially serious consequences for patient safety, especially for protein-based active substances.
GDP audits require proof of validated, reproducible, and fully documented cooling processes. Process-reliable conditioning of cooling packs is a key prerequisite for this.
Specific risks on the last mile
The final stage of transport from wholesaler to end customer is typically carried out in small quantities – one individual transport box per customer. Nevertheless, the same GDP requirements for temperature control, documentation, and process reliability apply as for centralized storage structures. The following risk factors are particularly critical:
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Fragmentation
Each transport unit must be individually conditioned in a GDP-compliant manner – with high delivery frequency and varying transport durations.
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Process complexity
Changing transport modes and delivery methods make continuous temperature monitoring more difficult.
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Time variability
Traffic-related delays and unforeseen events extend transport times and increase the risk of temperature deviations.
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Limited monitoring
Compared to centralized storage, monitoring and control systems on the last mile are more limited.
The solution
AIRFROSTER®: Two cooling chambers, precise temperature control, GDP-compliant processes
The AIRFROSTER® has been specifically developed to meet the challenges of GDP-compliant pharmaceutical logistics. With its two independently controllable cooling chambers, cooling packs can be conditioned in parallel to different target temperatures – validated, reproducible, and with complete temperature documentation up to the point of pack removal.
This ensures perfect passive cooling for the last mile and guarantees that recorded temperature values are accurate and reliable. All without compromising efficiency or sustainability: as an alternative to dry ice, the AIRFROSTER® reduces CO₂ emissions by around 90% – GDP compliance and environmental responsibility are not mutually exclusive, but complementary.
Two independent cooling chambers
Parallel conditioning of cooling packs to different target temperatures (e.g. +5 °C for temperature-sensitive pharmaceuticals and −20 °C for specialty medications) – two GDP requirements, one system.
Precise temperature control
Adjustable target temperature range from −35 °C to +15 °C covers all common GDP requirements. Uniform pack temperature at removal ensures reproducible conditioning and minimizes temperature fluctuations during transport.
GDP-compliant validation & process reliability
Includes documented process qualification for quality management – carried out as a real-world test prior to commissioning. Continuous monitoring, programmable control with time stamps, and complete documentation ensure audit-ready validation and guarantee that recorded temperature values are accurate and reliable.
Energy-efficient & sustainable
Precise conditioning to GDP-compliant target temperatures eliminates energy-intensive overcooling. Reusable cooling packs replace dry ice – reducing CO₂ emissions by up to 90% while increasing process reliability.
Ergonomic & user-safe
Magnetically locking pack basket trolley enables low-effort loading and unloading. A 4.3-inch LCD touchscreen with intuitive controls minimizes user errors.
Plug-and-play system
Integrated solution consisting of shock freezer, pack basket, and transport trolley. Operates on 230 V – no installation required, ready for immediate use.
Remote maintenance & full service
Ongoing device data available online, with remote troubleshooting in case of issues. Optional full-service contracts ensure continuous operational readiness for GDP-compliant pharmaceutical shipping.
GDP-compliant cold chains on the last mile
GDP guidelines place the highest demands on temperature control, documentation, and process reliability in pharmaceutical logistics – while at the same time increasing pressure to design cooling processes in an energy-efficient and sustainable way. The AIRFROSTER® meets both requirements.
The AIRFROSTER® ensures process-reliable conditioning of cooling packs for GDP-compliant passive cold chains on the last mile.
✓ Supports GDP-compliant processes
✓ Quality management documentation included
✓ Audit-ready validation
✓ Risk minimization in the cold shipping process
✓ Energy-efficient conditioning to target temperature
Precisely adjustable target temperatures (−35 °C to +15 °C)- Two independently controllable cooling chambers
- Uniform pack temperature at removal
- Reproducible conditioning for shipping profiles (e.g. 2–8 °C)
Parallel batches
Downtime risk ↓
- Ongoing device and process data available online
- Programmable control with time stamps
- Seamless integration into pharmaceutical QM systems
Traceability
QM-compliant
- Real-world test with customer-specific cooling packs before purchase
- Complete QM documentation included
- Determination of the optimal configuration for the customer
QMS proof
Testable without obligation
- 2-chamber system (independently controllable)
- Remote maintenance with troubleshooting
- Minimization of process risks and downtime
Remote support
Stable supply chain
- Plug-and-play system (230V)
- Full-service and maintenance contracts available
- Integrated defrost water management & easy cleaning
GxP-compliant
Maintainable
- 4.3″ touchscreen with user-friendly control
- Ergonomic, magnetically locking pack basket trolley
- Automated process control – minimal training required
User errors ↓
Consistent
- Replacement for dry ice – 90% less CO₂
- Reusable cooling packs instead of single-use dry ice
- Minimal energy consumption (3 kW nominal power)
Cost-efficient
Reliable supply
- QM documentation prior to purchase for DQP/DUA, URS
- Adaptable in case of process changes
- Qualification as critical equipment within the customer’s QMS
Flexibly adaptable
QMS-integrable
Cooling solutions by Kramer
With our ideas, products, and projects, we help secure resources across Europe.
KRAMER has been developing solutions every day for over 95 years that conserve resources and create added value for customers.
As a specialist in energy-efficient cooling solutions, we support our partners in the food, gastronomy, and medical / pharmaceutical sectors in establishing reliable cold chains.
Project process
From the first introduction to a tailored proposal
Initial consultation & process assessment
We discuss your process and already calculate an initial estimate of cooling time and the maximum number of cooling packs per AIRFROSTER®.
Practical process test with your cooling packs
We refine the initial estimate through a real-world test, including documented process qualification for your quality management system.
Preparation of a tailored proposal
Upon request, we prepare a proposal tailored to your specific requirements.
More information, or have the process calculated without any obligation:
Your contact for information on AIRFROSTER®
Human Tavasoli and his team are specialists in the planning and realisation of AIRFROSTER® system solutions.
