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Guide

Guidelines for temperature monitoring of pharmaceutical air freight

Adam Hartmann-Kruckow
|CCO & co-founder

Get the complete guide to pharmaceutical aircargo temperature monitoring, covering GDP and IATA requirements, technologies, risk assessment, and excursion investigation.

Download a air freight temperature monitoring checklist

Get a compete framework for implementation of thermal monitoring in your pharmaceutical air fleet.

Introduction

Temperature excursions during air cargo cost the pharma industry an estimated $35 billion annually (Robert, 2025). Products moving by air pass through aircraft cargo holds where temperatures swing from –50°C at cruise altitude to +40°C on summer tarmacs. Tarmac exposure, multiple handoff points, and limited environmental control create risks that proper monitoring has to address.

This guide explains how pharma air cargo temperature monitoring works, which regulatory standards apply, and how to implement monitoring that meets GDP, IATA TCR, and GMP.

Also read: Temperature monitoring best practices and how to choose systems in GxP

What is pharmaceutical air cargo temperature monitoring?

Pharmaceutical air cargo temperature monitoring is the practice of documenting and verifying that temperature-sensitive medicinal products maintain required temperature conditions throughout air transport from departure to arrival.

How temperature monitoring works: Monitoring devices are activated before shipment, travel with the pharmaceutical product through all transport segments (origin facility, ground handling, aircraft, destination facility), and provide temperature data demonstrating that conditions remained within product specifications throughout the journey.

Why air freight requires temperature monitoring: Temperature excursions during air transport are estimated to cost the pharmaceutical industry billions each year. Products moving by air pass through aircraft cargo holds, tarmac exposure during loading and unloading, multiple handoff points between carriers, and varying climate conditions across airports and regions. Each segment presents temperature control challenges that monitoring must capture.

What monitoring documentation must show: Temperature records must demonstrate continuous compliance with product-specific temperature ranges (commonly 2–8°C for biologics, 15–25°C for controlled room temperature products, or –20°C and below for frozen materials). Records must include accurate timestamps, be attributable to specific monitoring devices with valid calibration, and meet electronic record requirements under FDA 21 CFR Part 11 or equivalent standards.

Why air freight temperature monitoring differs from warehouse monitoring

Air freight creates temperature control challenges that warehouse and ground transport do not face. Understanding these differences shapes effective monitoring strategies.

  • Aircraft cargo holds are not precision-controlled environments. Unlike GDP-qualified warehouses with validated uniformity, aircraft cargo holds use climate systems designed primarily for crew comfort and equipment protection. Temperature ranges vary by aircraft type, cargo zone location, and flight phase. At cruise altitude, exterior temperatures reach -50°C. Climate systems must balance these extremes, but control is never absolute.
  • Tarmac exposure represents the highest-risk segment in most air shipments. The time between leaving a temperature-controlled facility and boarding the aircraft – and the reverse at destination – typically involves outdoor exposure. Loading operations happen on tarmac where summer surface temperatures exceed 60°C and winter conditions risk freezing. Even with thermal protection, this segment introduces variability that monitoring must capture.
  • Multiple handoff points complicate temperature accountability. A typical air shipment passes through the shipper's warehouse, origin airport ground handling, the airline, destination airport ground handling, and receiver's facility. Each handoff transfers temperature control responsibility. Without continuous monitoring across segments, determining which party caused an excursion becomes difficult.
  • Regulatory frameworks treat air transport distinctly. GDP and GMP principles apply but air cargo adds IATA Temperature Control Regulations, aviation equipment requirements, and time-and-temperature-sensitive labeling that other modes do not require. CEIV Pharma certification provides additional standards for pharmaceutical air cargo handlers.

Also read: Pharmaceutical warehouse monitoring: How to stay GDP compliant

Which regulations apply to pharmaceutical air cargo temperature monitoring?

Multiple regulatory frameworks govern temperature monitoring for pharmaceutical air transport. QA and compliance teams must understand which requirements apply and how they interact.

Also read: What are the key regulations of temperature compliance?

EU Good Distribution Practice for air transport

EU GDP Guidelines (2013/C 343/01) establish baseline expectations for pharmaceutical distribution including air freight segments.

Key GDP requirements for air transport:

  • Written procedures covering storage and dispatch of temperature-sensitive products during air freight operations
  • Monitoring data loggers that is calibrated to provide accurate data
  • Documented evidence that temperature remained within acceptable limits throughout transport
  • Temperature excursion investigation and reporting procedures
  • Risk assessment addressing transport routes, seasonal conditions, and handling procedures

GDP does not mandate specific monitoring technologies. It requires evidence demonstrating temperature control was maintained. This evidence requirement drives monitoring decisions for air freight.

Also read: Temperature excursion investigation guide

IATA Temperature Control Regulations (TCR)

Airlines and freight forwarders handling pharmaceutical cargo follow IATA's Temperature Control Regulations, which establish operational standards complementing GDP requirements.

IATA Time and Temperature Sensitive labels: Shipments requiring temperature control must display labels showing required temperature ranges. Standard ranges include +2 to +8°C (refrigerated), +15 to +25°C (controlled room temperature), and –20°C (frozen). Labels alert handlers at every touchpoint that cargo needs special attention and controlled conditions.

When labels are mandatory: IATA requires Time and Temperature Sensitive labels whenever pharmaceutical cargo needs maintained temperature during any transport segment. This includes products shipped in passive packaging even if external monitoring is not attached.

Handling procedure expectations: IATA TCR outlines minimum standards for cargo acceptance checks, facility storage conditions, loading procedures, and transfer protocols at each stage. Airlines must follow documented procedures, though IATA does not mandate continuous automated monitoring of facilities or aircraft.

Documentation obligations: Carriers must maintain records demonstrating appropriate handling procedures were followed. However, this often means procedural checklists rather than continuous environmental temperature data.

CEIV Pharma certification for air cargo operators

Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma) certification demonstrates that airlines, freight forwarders, and ground handlers meet pharmaceutical handling standards.

What CEIV certification covers:

  • GDP compliance throughout air cargo operations
  • Staff training on pharmaceutical handling requirements
  • Risk management processes specific to temperature-sensitive shipments
  • Quality management systems aligned with pharmaceutical expectations
  • Facility and equipment standards for pharmaceutical cargo

What CEIV does not eliminate: CEIV certification confirms an operator has pharmaceutical-appropriate processes but does not validate specific environmental conditions or eliminate the need for shippers to monitor individual shipments. Certification addresses procedural compliance, not environmental qualification of facilities or aircraft.

Evaluating CEIV-certified carriers: CEIV certification indicates investment in pharmaceutical capabilities and should be a selection criterion. However, shippers must still verify actual facility conditions, review excursion data, and implement appropriate shipment monitoring based on route risk assessment.

USP <1079> and WHO TRS 961 guidance

United States Pharmacopeia chapter <1079> provides guidance on good storage and distribution practices for drug products. Section 7.3 addresses transportation and specifically covers temperature monitoring expectations during shipment.

Also read: USP <1079.2> explained: How to evaluate temperature excursions with MKT

WHO Technical Report Series No. 961, Annex 9 provides internationally recognized guidance on storage and transport of time-and-temperature-sensitive pharmaceutical products. Many regulatory authorities outside the EU reference WHO TRS 961 as their baseline standard.

Key principles both frameworks emphasize:

  • Risk-based approaches where monitoring intensity matches product sensitivity and route risk
  • Validation of transport containers and packaging systems for intended routes
  • Temperature mapping of transport equipment when feasible
  • Continuous temperature monitoring or recording during shipment
  • Documented procedures for responding to temperature deviations

Neither USP nor WHO guidance carries regulatory force, but both represent pharmaceutical industry consensus on best practices. Regulatory inspectors often reference these standards when evaluating company practices.

Also read: What are the WHO’s guidelines for temperature mapping?

FDA 21 CFR Part 11 for electronic temperature records

When temperature monitoring generates electronic data used for product release decisions or regulatory submissions, records must comply with FDA requirements for electronic records and signatures (21 CFR Part 11).

Part 11 requirements applicable to monitoring data:

  • Systems must generate secure, tamper-evident records with complete audit trails
  • Temperature readings must include accurate timestamps
  • Data must be attributable to specific monitoring devices (serial numbers, user IDs)
  • System access must be controlled to prevent unauthorized modifications
  • Any changes to original records must be documented with reason and auditor identity
  • Electronic signatures (if used) must be linked to specific individuals and dates

Implications for monitoring technology selection: USB data loggers, wireless monitoring systems, and cloud platforms all generate electronic records subject to Part 11 if data supports batch release. Systems must have built-in controls preventing post-collection editing. Export to Excel or manual data transcription creates compliance vulnerabilities unless properly controlled.

What happens to temperature during pharmaceutical air freight

Most pharmaceutical shippers transport products by air without understanding actual temperature conditions in aircraft cargo holds or during ground operations. This knowledge gap forces conservative approaches and expensive per-shipment monitoring instead of risk-based strategies.

Also see: Aircraft temperature mapping: What it is all about – and why do it?

Aircraft cargo hold temperature characteristics

Aircraft cargo holds are pressurized, climate-controlled compartments, but they are not pharmaceutical-grade temperature chambers with validated uniformity.

Temperature ranges during normal operations: Main-deck cargo areas on freighter aircraft typically maintain 15–25°C during cruise operations, though this varies by aircraft type. Lower deck compartments often run cooler, sometimes 5–10°C, because they sit further from insulated cabin areas and closer to extreme skin temperatures at -50°C ambient at altitude.

Temperature distribution within cargo holds: Floor-level positions typically measure cooler than ceiling areas due to cold air settling and proximity to aircraft skin. Areas near cargo doors experience greater variability during loading cycles. Positions adjacent to galleys or lavatories (on passenger aircraft carrying pharmaceutical cargo in belly holds) may experience heat transfer from these systems.

How long temperature stabilization takes: When cargo boards at ground temperature and aircraft climbs to cruise altitude, interior cargo spaces require time to equilibrate as climate systems counteract extreme exterior cold. Limited aircraft mapping data suggests pharmaceutical-appropriate temperature stabilization can take 2–3 hours of cruise flight, and short-haul routes under 4 hours may never achieve fully stable conditions throughout cargo zones.

Why tarmac exposure creates the highest excursion risk

Temperature excursions documented in pharmaceutical air freight occur most frequently during ground operations, not in flight. The period when cargo exists outside controlled environments – moving from facility to aircraft or aircraft to facility – accounts for the majority of recorded deviations.

Where tarmac exposure happens: Ground crews build Unit Load Devices (ULDs) or prepare bulk cargo in airport cargo areas that are typically not temperature-controlled warehouses. Even covered facilities maintain ambient conditions rather than validated pharmaceutical storage temperatures. Cargo then moves outdoors to the aircraft position, sits while loading operations proceed, and reverses this process at destination.

How long exposure typically lasts: Well-organized operations at pharmaceutical-specialized facilities complete loading in 30–60 minutes. Less efficient operations, particularly at airports without pharmaceutical infrastructure, may expose cargo to tarmac conditions for 2–4 hours. Flight delays, weather disruptions, or operational issues can extend exposure significantly beyond planned durations.

Temperature ranges during exposure: Summer operations on southern US, Middle East, or equatorial tarmacs can expose cargo to surface temperatures exceeding 60°C. Direct sunlight adds radiant heating to packaged products. Winter operations at northern airports risk exposing products to sub-zero temperatures. Even spring and fall operations can see 25–35°C ranges in temperate climates.

Why mitigation tools are not universal: Cool dollies (refrigerated transport carts), thermal blankets, and covered loading areas all reduce tarmac exposure risk. However, these tools add cost and are not standard at all airports. Shippers cannot assume protective measures will be available unless specifically contracted and verified.

How cargo handoffs introduce temperature control gaps

Each party transfer during air transport creates potential for temperature control lapses and accountability gaps.

Shipper facility to ground handler: Product leaves the shipper's GDP-compliant, mapped warehouse and enters airline or freight forwarder custody. Ground handler facilities may not maintain equivalent environmental standards. Some handlers operate GDP-certified facilities, but many use general cargo areas with minimal climate control.

Ground handler facility to aircraft: Cargo moves from holding areas to tarmac to aircraft cargo hold. This segment typically involves longest outdoor exposure and highest temperature variability. Responsibility for environmental conditions during this phase is often unclear in standard freight contracts.

Aircraft to destination ground handler: After landing, cargo must be offloaded, transported through destination airport facilities, cleared through customs (for international shipments), and prepared for final delivery. Destination airports vary significantly in pharmaceutical handling capabilities. Major hubs may have dedicated pharma facilities; smaller airports may use standard cargo warehouses.

Ground handler to final receiver: Last-mile delivery from airport to customer facility completes the chain. This often involves local courier services with varying cold chain capabilities, particularly for deliveries to smaller cities or rural areas.

Why gaps in temperature records create problems: If a temperature excursion is discovered after delivery, continuous monitoring across all segments is needed to identify which party and which segment caused the problem. Gaps in temperature records make root cause determination difficult and complicate responsibility assignment under freight contracts and insurance claims.

Monitoring strategies should either provide continuous temperature coverage across all handoff points or ensure overlapping coverage eliminates gaps where excursions could occur undetected.

3 approaches to pharma air freight temperature monitoring

There are three primary technology categories are used for air freight temperature monitoring. Each offers different visibility levels, cost structures, and operational complexity.

USB data loggers: Post-delivery documentation

USB temperature data loggers are battery-powered devices that record temperature at preset intervals throughout shipment transit. Users download data after delivery by connecting the logger to a computer.

Key limitations: Temperature data is unavailable until product delivery. If excursions occurred, product may already be in distribution, and no intervention opportunity exists during transit. At the same time, manual download and data review for each logger creates labor-intensive processes at scale.

When USB loggers are appropriate: Potentially, for lower-value shipments on established routes with historical performance data.

Wireless data loggers: Real-time monitoring with intervention capability

Wireless data loggers with cellular or satellite connectivity transmit data throughout transit, enabling real-time visibility and automated alerts when readings exceed specification. Data is available in real-time during transit with intervention possible if alerts are received.

Key advantages: If an alert indicates temperature deviation while product is at an intermediate airport or immediately after landing, teams can request transfer to other climate-controlled storage, adjust handling procedures to account for budgets, or in extreme cases reroute or return product. This intervention capability can prevent product loss.

Key limitations: Operations teams must maintain device inventory, process returns from destination locations, track devices through logistics networks, and maintain calibration certificates for all units. Higher per-deployment costs make universal monitoring expensive at scale.

When wireless monitoring justifies the cost: For high-value, high-sensitivity products, such as cell and gene therapies, biologics, etc. with narrow temperature specifications.

Smart labels: Single-use indicators and monitors

Smart Labels range from simple chemical indicators to sophisticated single-use electronic monitors with limited connectivity. They provide temperature status or recorded data without requiring device returns and reuse logistics. Data availability varies by type from post-delivery only to limited real-time capability. The devices are discarded after single use.

Key limitations: Single-use construction often means lower sensor accuracy than reusable instruments. Battery capacity limits use on very long routes or if shipments experience unexpected delays, and Bluetooth-only versions require proximity for data retrieval, creating similar post-delivery access patterns as USB loggers. Environmental impact is higher due to single-use construction generating electronic waste at scale.

When Smart Labels are appropriate: Moderate-value products on established routes where some level of monitoring is desired but cost and convenience favor disposable over reusable hardware. Smart Labels also eliminate device management complexity that challenges some logistics organizations.

Why all current approaches monitor shipments instead of environments

USB loggers, wireless monitors, and Smart Labels share a fundamental characteristic: They monitor individual packages or pallets, not the aircraft holds, tarmacs, and facilities through which products move.

This shipment-level focus exists because:

Pharmaceutical companies lack environmental performance data. Without temperature mapping showing what conditions actually exist in cargo holds, on tarmacs, and in handling facilities, monitoring the product becomes the only way to document that temperature remained within specification.

Regulatory standards require shipment-level proof when environments are not validated. GDP states that temperature monitoring is required during transport. Without validated environmental control of the transport environments themselves (aircraft, ground handling facilities), regulators expect proof that each shipment maintained appropriate conditions throughout its journey.

This creates a self-reinforcing cycle:

  • Environments are not mapped or validated as pharmaceutical-appropriate spaces
  • Therefore shipment-level monitoring is required for each package
  • Therefore companies invest in shipment monitoring rather than environmental qualification
  • Therefore environments remain unvalidated, requiring continued shipment monitoring

Breaking this cycle requires environmental mapping and continuous monitoring of facilities and aircraft, demonstrating that the environments themselves maintain appropriate conditions. When aircraft holds and facilities are proven compliant, the need for universal shipment-level monitoring decreases.

Also see: Aircraft temperature mapping: What is it all about - and why do it?

How to assess temperature risk for different air freight routes

Air routes present different levels of temperature risk. Matching monitoring intensity to actual route characteristics creates better cost-risk tradeoffs than applying identical monitoring to all shipments regardless of conditions.

What factors influence air freight temperature risk

Flight structure and duration: Direct flights between major pharmaceutical logistics hubs minimize handling operations to origin and destination airports only. Routes requiring connections add intermediate ground handling, each introducing tarmac exposure and handoff risks. Long-haul routes (8+ hours) provide more time for aircraft temperature stabilization, while short flights may never reach stable conditions.

Seasonal and climate conditions: Summer months (June–September in Northern Hemisphere) create elevated risk on routes through warm regions where tarmac temperatures regularly exceed 50°C. Winter operations through northern regions (December–March) introduce freezing risk for products that cannot tolerate cold exposure. Equatorial routes face year-round heat exposure. Historical weather data for specific airports quantifies these risks.

Airport infrastructure and pharmaceutical capabilities: Major pharmaceutical logistics gateways (Frankfurt FRA, Singapore SIN, Miami MIA, Brussels BRU, Copenhagen CPH) maintain dedicated GDP-certified pharmaceutical handling facilities with climate-controlled areas and often covered or climate-controlled aircraft loading zones. Smaller regional airports typically lack specialized infrastructure, forcing reliance on standard cargo facilities and outdoor tarmac operations.

Aircraft type and hold characteristics: Purpose-built cargo aircraft (Boeing 747-8F, 777F, 767-300F; Airbus A330-200F) are designed for freight operations with cargo hold climate systems optimized for cargo protection. Passenger aircraft carrying pharmaceutical cargo in belly holds were designed primarily for passenger comfort, with cargo temperature control as secondary consideration. Temperature mapping data (when available) reveals performance differences between aircraft types and specific cargo zone locations within each aircraft.

Product temperature requirements and stability: Biologics requiring 2–8°C storage present higher risk than products stable at 15–25°C controlled room temperature. Products with narrow stability windows (±2°C) are more vulnerable than products tolerating wider ranges (±5°C). Ultra-cold products (–70 to –80°C for some cell and gene therapies) require specialized handling and packaging regardless of route characteristics. Product value also factors into risk tolerance – a $1 million gene therapy shipment justifies protection levels that would be excessive for moderate-value products.

Historical route performance data: Temperature data from previous shipments on specific routes provides the most accurate predictor of future performance. Routes with documented excursion history require different monitoring and protection strategies than routes with consistent compliance records. Seasonality should be considered – a route with clean winter performance may show excursions during summer months.

Building a risk matrix for pharmaceutical air freight routes

Structured risk assessment creates consistent, defensible monitoring decisions rather than subjective judgment or blanket policies that may over-protect some shipments while under-protecting others.

High-risk route characteristics:

  • New routes without historical temperature performance data
  • Routes through airports lacking GDP-certified pharmaceutical handling infrastructure
  • Operations during seasonal temperature extremes (summer in hot climates, winter in freezing climates)
  • Multiple connections requiring 3+ separate handling operations
  • Short-haul flights (under 3 hours) where temperature never stabilizes
  • Products with narrow acceptable temperature ranges (±1–2°C) or ultra-high value
  • Routes with documented excursion history on similar shipments

Moderate-risk route characteristics:

  • Established routes with occasional documented excursions
  • Single-connection routes through airports with adequate pharmaceutical handling capability
  • Operations during temperate seasons (spring, fall in most regions)
  • Products with reasonable stability margins (±3–5°C acceptable variation)
  • Direct flights or single connections on routes with generally good performance
  • Adequate but not exceptional airport infrastructure

Lower-risk route characteristics:

  • Direct flights between major pharmaceutical logistics hubs with proven infrastructure
  • Carriers with CEIV Pharma certification and strong performance records
  • Routes during temperature-stable seasons with minimal climate extremes
  • Products with wide stability windows or high tolerance for brief excursions
  • Extensive historical data showing consistent temperature compliance
  • Long-haul routes (8+ hours) allowing temperature stabilization during cruise

Risk classification drives monitoring strategy: High-risk routes may require reusable real-time monitoring data loggers, active ULDs with powered cooling, redundant monitoring (both facility and shipment level), and designated personnel monitoring conditions during transit. Moderate-risk routes might use Smart Labels with recording capability or USB loggers with regular route re-validation. Lower-risk routes can sometimes justify reduced monitoring frequency (statistical sampling rather than 100% coverage) when supported by extensive historical performance data.

Document risk assessment methodology: Regulatory inspectors increasingly expect risk-based approaches to monitoring supported by documented rationale. Risk matrices showing how route characteristics drive monitoring decisions demonstrate thoughtful compliance strategy rather than arbitrary choices or simple "monitor everything" approaches.

Matching monitoring strategy to classified route risk

Once routes are assigned risk classifications, monitoring and protection strategies can be optimized to provide appropriate oversight without unnecessary cost.

For high-risk routes:

  • Deploy reusable wireless data loggers with real-time alarm capabilities and defined escalation procedures
  • Use active ULDs with powered cooling or enhanced passive packaging with significant thermal mass and insulation
  • Consider redundant monitoring approaches (facility monitoring where available plus shipment monitoring)
  • Establish monitoring coverage with clear responsibility assignments for alert response
  • Pre-qualify contingency procedures with carriers for intervention if alerts trigger
  • Maintain frequent re-validation (quarterly or seasonal) to verify continued route suitability

For moderate-risk routes:

  • Smart Labels with electronic temperature recording or USB data loggers provide adequate documentation
  • Passive ULDs with appropriate insulation and thermal mass typically suffice
  • Focus monitoring on highest-risk segments (verify coverage during tarmac operations especially)
  • Implement sampling-based re-validation on defined schedule
  • Review excursion data regularly to identify if risk classification should increase

For lower-risk routes:

  • USB data loggers meet regulatory documentation requirements
  • Standard pharmaceutical packaging often sufficient without specialized ULDs
  • Consider risk-based statistical sampling rather than 100% monitoring coverage (requires strong historical data justification)
  • Focus intensive monitoring on seasonal high-risk periods (summer months on warm-climate routes)
  • Periodic route re-validation when performance remains consistent

Continuous risk reassessment: Route risk is not static. Carrier changes (airlines switch aircraft types, ground handlers change), airport infrastructure improvements, seasonal shifts, and operational modifications all affect risk profiles. Implement periodic risk review incorporating recent performance data. Routes showing degrading performance require risk classification increases and monitoring adjustments.

How to implement temperature monitoring for pharmaceutical air cargo operations?

Effective monitoring requires more than device selection. Implementation must address carrier qualification, written procedures, staff training, documentation systems, and quality improvement processes.

Questions to ask air freight providers before carrier selection

Airline and freight forwarder capabilities vary dramatically. Due diligence before awarding contracts prevents quality problems and compliance gaps that are difficult to correct after operations begin.

Infrastructure and facility questions:

  • What temperature-controlled storage facilities do you maintain at origin and destination airports for pharmaceutical cargo?
  • How are these facilities qualified (GDP certification, mapping, monitoring systems)?
  • What is typical tarmac exposure duration during loading operations at airports we will use?
  • Do you have covered loading areas or climate-controlled aircraft positioning?
  • What procedures protect pharmaceutical cargo during extreme weather (heat waves, freezing conditions)?

Environmental control and monitoring questions:

  • Do you have mapping data for aircraft types and cargo zones used on our routes?
  • What temperature ranges do cargo holds maintain during cruise operations?
  • What monitoring systems operate in your facilities and during aircraft operations?
  • How quickly can you provide temperature data and compliance documentation after flights complete?
  • In what format do you deliver temperature records, and are they FDA 21 CFR Part 11 compliant?

Handling and operational questions:

  • What training do ground handlers receive on pharmaceutical cargo requirements?
  • What is your standard operating procedure for building ULDs with temperature-sensitive products?
  • How do you prioritize pharmaceutical cargo during operational disruptions or delays?
  • What is your process for notifying shippers if operational problems affect temperature-sensitive cargo?
  • Can you accommodate specific handling requests (expedited loading, enhanced monitoring, active ULD management)?

Quality and compliance questions:

  • Do you hold CEIV Pharma certification or equivalent pharmaceutical logistics accreditation?
  • What percentage of pharmaceutical shipments experience documented temperature excursions?
  • What is your investigation and CAPA process when excursions occur?
  • Can you provide customer references from pharmaceutical manufacturers using your services on similar routes?
  • What GDP or GMP audit findings have you received in the past two years, and what corrective actions were implemented?

Contract and liability questions:

  • How are temperature excursions handled under your standard contract terms (liability limits, investigation responsibility)?
  • What insurance coverage applies to pharmaceutical cargo, and what documentation is required for claims?
  • What temperature data and documentation do you provide as standard service versus available at additional cost?
  • What are your notification requirements and timelines if we need to file a claim?

Carriers unable to provide clear, documented answers present elevated risk. Inadequate infrastructure, poor monitoring capabilities, or weak quality systems often correlate with higher excursion rates and more difficult regulatory compliance.

Also read: GDP requirements for pharma logistics

Download an air freight temperature monitoring checklist

Get a step-by-step checklist for establishing new air freight routes, qualifying carriers, or reviewing existing monitoring procedures.

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Standard operating procedures for air cargo temperature monitoring

Written procedures ensure consistent monitoring practices and facilitate training for personnel managing temperature-sensitive air shipments. Key procedure elements include:

Pre-shipment preparation: Verify product specifications and stability data, select monitoring devices based on route risk assessment, retrieve devices from calibrated inventory, activate and test devices, document serial numbers and alarm configurations, prepare packaging with appropriate thermal protection, complete IATA Time and Temperature Sensitive labels, and photograph packaged shipments for documentation.

Real-time monitoring (if applicable): Designate responsible personnel for alert monitoring, define escalation procedures and response expectations, establish carrier communication protocols, document all alarms and interventions, calculate cumulative temperature exposure using Mean Kinetic Temperature if multiple excursions occur, and make release decisions based on product stability data.

Post-delivery procedures: Inspect packages immediately, download monitoring devices promptly, review complete temperature profiles, compare readings against specifications, quarantine product if excursions occurred, return reusable devices following established procedures, and archive complete documentation with batch records.

Selecting Unit Load Devices and packaging appropriate for route conditions

ULDs and thermal packaging systems work with monitoring to maintain product temperature. Selection should be based on demonstrated route requirements rather than maximum protection approaches that add unnecessary cost.

Active ULDs: Powered temperature control

Active ULDs contain battery-powered refrigeration or heating systems that actively maintain internal set temperature regardless of external environmental conditions. Units include temperature monitoring and often provide real-time data transmission.

When active ULDs are necessary: Routes with documented temperature instability where passive protection has failed validation, ultra-sensitive biologics requiring 2–8°C with narrow tolerance throughout transit, very long routes (12+ hours) where passive thermal mass cannot maintain temperature, routes through extreme climate regions during peak seasonal conditions, or products where cost of loss dramatically exceeds active ULD costs.

Operational requirements: Airlines require advance notification for active ULD shipments. Not all aircraft or routes accommodate active units due to weight distribution or power availability constraints. Specialized ground handling may be required at some airports. Companies using active ULDs need tracking systems ensuring unit returns after delivery to control inventory costs.

Passive ULDs and insulated packaging

Passive thermal protection relies on insulation materials and phase-change thermal mass (gel packs, water bottles, dry ice) to maintain temperature during transit without powered systems.

When passive solutions meet requirements: Routes with proven stable aircraft temperatures based on mapping data or extensive shipping history, products with controlled room temperature specifications (15–25°C) offering wider acceptable ranges, shorter flight durations (under 8 hours) where pre-conditioned thermal mass can bridge entire journey, routes where tarmac exposure is minimized, or products with sufficient stability margins to tolerate brief excursions.

Design and validation: Insulation quality (VIP panels, polyurethane foam, expanded polystyrene) determines heat transfer rates. Thermal mass quantity and phase change temperature selection must be calculated based on expected ambient conditions, package volume, and transit duration. Pre-conditioning thermal mass to target temperature is critical. Both active and passive systems require performance qualification demonstrating they maintain product within specification under actual route conditions, including worst-case scenarios.

Protective measures for tarmac operations: Cool dollies (refrigerated carts), thermal blankets or reflective covers, expedited loading procedures during extreme weather, and climate-controlled cargo staging areas all reduce tarmac exposure risk. Availability varies by airport. Major pharmaceutical hubs provide these services; smaller airports often do not. Contract terms should specify required protection, particularly for high-risk routes during seasonal extremes.

Documentation and data management for regulatory compliance

Temperature monitoring generates electronic records subject to regulatory requirements. Proper data management ensures compliance and enables quality decision-making.

Electronic record requirements (FDA 21 CFR Part 11): Monitoring systems must create tamper-evident records with complete audit trails showing all data access and modifications. Temperature readings must include accurate timestamps traceable to recognized time standards. Data must be attributable to specific monitoring devices using unique serial numbers. System access must be controlled through user authentication. Electronic signatures (if used) must be linked to specific individuals. Backup and disaster recovery procedures must prevent data loss.

Also read: Guidelines for 21 CFR Part 11 in pharma

Integration with quality management systems: Temperature data should flow into existing quality and document management platforms rather than existing as isolated records. Batch record systems should reference temperature documentation for product lots. Deviation management processes must capture temperature excursions for investigation tracking. CAPA systems should link corrective actions to temperature monitoring findings.

Regulatory inspection preparation: Inspectors will request temperature records for randomly selected shipments to verify monitoring occurred as procedures describe, complete temperature profiles are available, excursions were investigated, and product disposition decisions were appropriate and documented. Systems must enable rapid retrieval of records for any shipment based on product batch number, shipment date, or destination.

Well-organized monitoring data demonstrates control and builds inspector confidence, while missing records or slow retrieval creates concerns about overall quality system effectiveness.

How to investigate and respond to temperature excursions

Temperature deviations occur even with careful monitoring and appropriate packaging. Air freight excursions typically stem from tarmac exposure, cargo hold performance, or handling transitions between controlled environments.

Also see: Temperature excursion investigation guide

Responding to real-time temperature alerts during transit

Real-time monitoring systems enable intervention before product damage becomes irreversible, but only when clear response procedures exist and responsible personnel can act quickly.

Alert receipt and initial assessment: Designated personnel must receive and acknowledge alerts within defined timeframes per your quality system. Verify the alert represents genuine temperature deviation rather than sensor malfunction. Determine shipment location using flight tracking – identify whether product is at origin airport, in flight, at intermediate connection, or at destination. Identify which party currently has custody (your facility, ground handler, airline, destination facility).

Calculating cumulative temperature exposure: Review complete temperature history since shipment departure. Calculate Mean Kinetic Temperature (MKT) incorporating current excursion with any previous deviations. Compare cumulative exposure against product stability data. Determine remaining "stability budget" – how much additional exposure product can tolerate before exceeding studied conditions.

Possible corrective actions during transit: Contact carrier immediately requesting transfer to climate-controlled holding area if product is at an intermediate airport. Request adjusted handling (expedited loading to minimize tarmac time, covered dolly use, priority positioning in climate-controlled cargo zone). For extreme situations, consider rerouting to alternate airport with better pharmaceutical handling facilities or returning product to origin if remaining flight segments will exceed acceptable limits.

Document complete timeline including alert timestamp, flight number and segment, assessment findings, parties contacted, actions requested, carrier responses, and ultimate outcome.

Investigating temperature excursions discovered after delivery

USB data loggers and delayed data availability mean many excursions are discovered only after product reaches destination. Air freight investigations must determine which segment caused the excursion.

Correlate excursions with flight segments: Download complete temperature profile from activation through delivery. Generate graphs showing temperature versus time with specification limits marked. Identify all excursion events noting start time, end time, duration, maximum/minimum temperature reached, and area under curve for MKT calculation.

Correlate temperature events with flight timeline to identify which segment caused each excursion:

  • Origin handling: Temperature deviations during warehouse-to-aircraft transfer or tarmac exposure during loading
  • Takeoff/climb: Brief temperature fluctuations as aircraft climbs to cruise altitude
  • Cruise: Sustained deviations indicating cargo hold environmental issues or ULD failure
  • Descent/landing: Temperature changes during descent and approach
  • Destination handling: Tarmac exposure during unloading or delays in transfer to climate-controlled facility
  • Intermediate connections: Extended exposure during aircraft changes or layovers

Root cause determination: Common air freight excursion causes include extended tarmac exposure during loading/unloading (check weather conditions, ground operations delays), inadequate aircraft cargo hold temperature control (verify aircraft type, cargo zone location, cruise duration), active ULD refrigeration failure during flight, passive ULD insufficient thermal mass for route duration, or ground handling delays at intermediate airports.

Collect supporting evidence including carrier handling documentation, facility temperature records if available, weather conditions at relevant airports during tarmac operations, packaging examination after opening, ULD inspection reports if applicable, aircraft type and cargo zone assignment, and monitoring device calibration verification.

Product impact assessment: Compare cumulative temperature exposure (MKT calculation for entire journey) against product stability studies documented in regulatory submissions. If excursion is within studied conditions, documented stability data supports product release. If excursion exceeds studied conditions, consult pharmaceutical development or regulatory affairs to determine whether product must be rejected.

GDP-compliant investigation documentation: Complete investigation reports must include executive summary stating excursion details and disposition decision, chronological timeline correlated with flight segments, temperature data plots with specification limits, root cause analysis identifying which segment caused deviation, stability impact assessment with supporting stability data references, and disposition decision (release or reject) with documented scientific rationale.

Corrective and preventive actions (CAPA) for air freight excursions

Individual investigations should feed systematic quality improvement rather than ending with disposition decisions for affected shipments.

Identifying patterns requiring systemic correction: Compile excursion data across multiple air shipments to identify trends by route, carrier, aircraft type, airport, season, cargo zone placement, and packaging system. Patterns requiring CAPA include specific routes showing elevated excursion rates (particular seasonal periods, specific airports with inadequate pharmaceutical handling), particular carriers or aircraft types with recurring cargo hold issues, tarmac exposure problems at specific airports, or packaging/ULD designs with inadequate performance for actual flight durations.

Developing effective preventive actions: If investigations reveal tarmac exposure as primary cause, preventive actions might include changing to carriers with covered loading facilities or climate-controlled aircraft positioning, scheduling shipments to avoid peak temperature periods, or switching to airports with better pharmaceutical infrastructure. If cargo hold performance is inadequate, actions might include requesting specific cargo zone placement based on aircraft mapping data, upgrading to active ULDs for routes with documented temperature instability, or selecting different aircraft types with proven cargo hold performance. If packaging performance is inadequate for actual route conditions, redesign with increased thermal mass, improve insulation specifications, or validate seasonal packaging configurations.

Measuring CAPA effectiveness: Compare excursion rates before and after CAPA implementation by route, carrier, and season. Calculate financial impact of prevention versus cost of recurring excursions. Regular review of air freight temperature monitoring data, excursion trends by flight segment, and CAPA effectiveness by cross-functional teams drives systematic reduction in excursion rates and continuous improvement in air cargo cold chain performance.

Calibration and qualification for air cargo monitoring equipment

Regulatory frameworks require that temperature monitoring equipment provides accurate, reliable data with traceability to recognized measurement standards. Inadequate calibration and qualification create compliance vulnerabilities regardless of monitoring technology selected.

Also read: Guidelines and best practices for calibration in GxP

Calibration requirements for temperature monitoring devices

All temperature sensors drift from their original calibration over time. Periodic calibration ensures devices continue providing accurate measurements.

Calibration frequency standards: Annual calibration is minimum requirement for most pharmaceutical monitoring applications. High-use devices deployed on hundreds of shipments may require semi-annual calibration. Devices showing drift approaching specification limits should be recalibrated more frequently. Any device exposed to physical damage, extreme conditions, or suspected malfunction requires immediate recalibration before returning to service.

ISO 17025 accredited calibration: Calibration should be performed by laboratories holding ISO 17025 accreditation demonstrating technical competence and quality system compliance. Accreditation must cover temperature calibration in the relevant ranges (2–8°C for refrigerated logistics, 15–25°C for controlled room temperature applications).

What calibration certificates must document: Device serial number and identification, calibration date and due date, calibration points tested throughout measurement range (minimum 3 points), measured values compared to reference standard readings, calculated correction factors, measurement uncertainty values, and traceability statement showing reference standards are traceable to national standards (NIST in US, PTB in Germany, NPL in UK, or equivalent recognized authority).

Calibration data management: Maintain database linking each device serial number to current calibration certificate. Implement automated alerts before calibration expiration. Clearly label devices with calibration due dates. Quarantine and remove from service any devices found out of calibration. Investigate any shipments monitored with devices later found to have invalid calibration status.

On-site calibration options: Traditional approach sends devices to calibration laboratories resulting in turnaround time and unavailable devices. Some service providers offer on-site calibration where accredited technicians calibrate devices at customer facilities, reducing downtime. Verify on-site providers maintain same ISO 17025 accreditation and traceability as laboratory-based services.

Also read: On-the-wall calibration - how does it work?

Monitoring system qualification (IQ/OQ/PQ)

Beyond calibration, monitoring systems used in GMP or GDP environments require formal qualification demonstrating they function as intended and meet user requirements.

Also see: Complete guide to IQ, OQ, PQ in pharma

  • Installation Qualification (IQ): Verify monitoring devices and associated software are installed correctly according to specifications. Document device serial numbers, firmware versions, software versions, and system configuration details. Verify data storage location, security controls, backup systems, and disaster recovery procedures function properly.
  • Operational Qualification (OQ): Test monitoring devices across their full operating temperature range. Verify alarm functions trigger at correct temperature setpoints. Confirm data transmission and storage work reliably under various conditions including varying network connectivity at different airports. Test battery life meets manufacturer specifications for intended route durations. Verify electronic records meet 21 CFR Part 11 requirements with proper audit trails, accurate timestamps, and access controls.
  • Performance Qualification (PQ): Demonstrate monitoring devices perform correctly under actual air freight conditions during representative shipments. Verify real-world conditions (vibration during transport, varying environmental conditions at different airports, handling by ground personnel) do not compromise device performance.
  • Qualification maintenance: Maintain qualification protocols and reports in quality system following document control procedures. Requalification is required after significant system changes. Minor updates may not require full requalification if change control procedures determine existing qualification remains valid.

Continuous aircraft monitoring with Eupry

Eupry's aircraft temperature monitoring solution provides continuous validation that enables faster product release, reduces costs, and supports risk-based compliance strategies.

How it works

  • Permanent installation: Aircraft-approved wireless sensors installed throughout cargo holds transmit data via Bluetooth to gateway devices.
  • Automatic flight mode: Gateways detect takeoff and switch to airplane mode (cellular off, Bluetooth active), then automatically restore 5G connection upon landing.
  • Continuous measurement: Sensors collect temperature data throughout the entire flight while gateways aggregate data locally.
  • Instant upload: Complete flight dataset transmits to Eupry's cloud platform immediately after landing.
  • Immediate compliance reports: Dashboard are available within minutes of landing, enabling you to authorize product release or calculate cumulative exposure against stability budgets.

Results: Complete cargo hold visibility from takeoff to landing. Compliance confirmation within minutes rather than days. Immediate issue detection to reduce product loss risk.

Frequently asked questions

FAQ about pharmaceutical air freight temperature monitoring

How do you monitor temperature for pharmaceutical air cargo?

Temperature monitoring uses data loggers traveling with shipments (USB download loggers or wireless real-time monitors) or Smart Labels with temperature recording. Devices are activated before shipment, travel with product, and provide temperature data after delivery or during transit depending on technology used.

What temperature range is required for pharmaceutical air freight?

Required temperature ranges are product-specific based on approved storage conditions. Common ranges are 2–8°C for refrigerated biologics, 15–25°C for controlled room temperature products, and –20°C or colder for frozen materials. Each product's labeling defines its specific requirements.

When is the IATA Time and Temperature Sensitive label required?

IATA requires Time and Temperature Sensitive labels on any pharmaceutical shipment needing maintained temperature during air transport. Labels display required temperature range (2–8°C, 15–25°C, etc.) and alert all handlers to special handling needs.

How long does tarmac exposure last during air freight operations?

Tarmac exposure typically ranges from 30 minutes to 2 hours at efficient operations. Less capable airports or operational delays can extend exposure to 4+ hours. Pharmaceutical-focused logistics hubs generally achieve shorter exposure through dedicated facilities and procedures.

What causes most temperature excursions in pharmaceutical air freight?

Tarmac exposure during loading and unloading accounts for majority of excursions. Extended time in uncontrolled outdoor conditions during hot or cold weather causes most documented deviations. Inadequate packaging, equipment failures, and procedural errors contribute additionally.

What temperature is maintained in aircraft cargo holds for pharmaceutical products?

Aircraft cargo holds are not precision-controlled pharmaceutical storage. Main deck areas typically maintain 15–25°C during cruise but with significant variability by aircraft type, cargo zone location, and flight phase. Lower deck compartments often run cooler at 5–15°C.

What is CEIV Pharma certification for air cargo?

CEIV Pharma is IATA certification demonstrating airlines, freight forwarders, and ground handlers meet pharmaceutical logistics standards including GDP compliance, trained personnel, quality management systems, and appropriate facilities and procedures for pharmaceutical cargo.

Learn more about achieving CEIV pharma certification

How does GDP apply to pharmaceutical air transport?

EU Good Distribution Practice requires documented procedures, temperature monitoring, calibrated equipment, excursion investigation, and risk assessment for all pharmaceutical transport including air freight. Air operations add IATA-specific requirements beyond base GDP expectations.

What is the difference between active and passive ULDs for pharma?

Active ULDs contain powered refrigeration or heating systems maintaining set temperature regardless of external conditions. Passive ULDs rely on insulation and thermal mass (gel packs) without power. Active units provide stronger protection but cost significantly more and weigh more affecting fuel costs.

How do you investigate a temperature excursion in air freight?

Investigations require reviewing complete temperature data, correlating deviations with shipment timeline to determine which segment caused the problem, determining root cause (environmental, packaging, procedural), assessing product impact against stability data, and documenting disposition decision with supporting rationale.

Also read: Temperature excursion investigation guide

What documentation is needed for temperature-controlled air freight?

Required documentation includes temperature records (complete profile from departure to arrival), monitoring device calibration certificates, product stability data, investigation reports for any excursions, shipping documentation with IATA labels, and carrier handling records.

Learn more

GDP thermal compliance product catalog

From automated monitoring to specialized validation services and 5-second ISO 17025-accredited calibration: See how Eupry's automated temperature compliance solutions work in our catalog.

Aircraft temperature mapping guide

What is aircraft mapping all about - and why do it, if it is not required? Learn how temperature mapping works and how it can unlock smarter ULD use and lane qualification.

Talk to a specialist

Eupry's full cold chain services (including air freight) provides continuous validation that enables faster product release and reduces costs. Talk to one of our specialists about how it could work for your operations.