Cómo realizar pruebas de cadena de frío para productos farmacéuticos en 2025
Actualizado 20 Noviembre 2025 - Cold chain test procedures ensure that vaccines, biologics and emerging cell therapies remain safe and potent throughout storage and transport. With the biopharma cold chain market projected to exceed 65 mil millones de dólares en 2025 and regulations such as the Ley de seguridad de la cadena de suministro de medicamentos (DSCSA) requiring interoperable electronic tracking by 2025, effective testing is no longer optional. This comprehensive guide explains why cold chain tests matter, how to perform them, and what trends will shape compliance in 2025 y más allá.
¿Por qué son cold chain tests essential for pharmaceutical productos? – learn about product integrity, market losses and the high failure rate of untested shipments.
Which regulations and standards govern cold chain testing in 2025? – understand DSCSA, FSMA, I GDP, USP <659> and ICH stability guidelines.
How do you perform temperature mapping and stability testing? – get step by step insights into mapping hot and cold spots, using ALCOA+ principles and scheduling tests.
¿Qué son los DQ?, coeficiente intelectual, OQ and PQ validation phases? – discover how packaging, equipment and processes are qualified under real world conditions.
How do you handle temperature excursions and implement best practices? – explore root causes, corrective actions and emerging technologies for continuous monitoring.
What innovations and trends will shape cold chain testing in 2025? – examinar el crecimiento del mercado, celúla & gene therapy demands, digitalisation and sustainability.
Why cold chain tests matter for pharmaceuticals
Protecting product integrity and patient safety
Cold chain testing safeguards the quality of temperature sensitive pharmaceuticals by verifying that storage and transport conditions stay within validated ranges. Los estudios estiman que alrededor 20 % of temperature sensitive healthcare products are damaged or degraded during distribution por mala gestión de la cadena de frío. Another report notes that acerca de 30 % of cold chain shipments experience temperature excursions. These failures translate into degraded products, pérdidas financieras, regulatory penalties and, lo más importante, patient harm.
Key therapeutic categories depend on strict temperature control:
Vacunas y biológicos: Most vaccines and monoclonal antibodies must remain between 2 °C y 8 °C, while some require –20 ºC or cryogenic storage at –70 °C o menos. La OMS estima que cerca de 50 % de las vacunas se desperdician en todo el mundo debido a una gestión inadecuada de la temperatura.
Terapias celulares y genéticas.: Advanced therapies like CAR T treatments often demand storage at –150 °C in liquid nitrogen vapour and are forecast to grow from US$6.31 billion in 2024 to US$74.03 billion by 2034. Failure to maintain ultra cold conditions can render these treatments ineffective.
Peptide and protein drugs: Diabetes and obesity medications (Agonistas del GLP 1) and coagulation factors require refrigeration and generate demand for specialized logistics.
Without robust testing, even brief exposures outside the approved range can degrade potency and lead to batch rejection. The global biopharmaceutical cold chain market is projected to exceed 65 mil millones de dólares en 2025, and yet the industry continues to lose billions due to temperature excursions. Cold chain testing provides the evidence needed to demonstrate that systems maintain required conditions, thereby protecting product integrity, ensuring patient safety and reducing waste.
Economic and operational drivers
Más allá de la seguridad del paciente, testing protects revenue streams and reputation. When products are compromised, companies face direct costs (destroyed goods), indirect costs (delayed treatments, rescheduling clinical trials) y daño de reputación. Regulatory penalties can include fines, shipment quarantine or licence suspension. With regulatory scrutiny increasing globally, documented evidence of cold chain performance is a competitive advantage for manufacturers, contract development and manufacturing organisations (CDMO) y proveedores de logística.
The market for pharmaceutical cold chain services illustrates the growth potential. The global cold chain market for pharmaceuticals was valued at 6.400 millones de dólares en 2024 y se prevé que alcance 6.600 millones de dólares en 2025. Roots Analysis forecasts growth to 9.600 millones de dólares por 2035, reflecting increasing adoption of biologics and advanced therapies. Mientras tanto, healthcare packaging demand is expected to grow encima 30 % por 2028. En este contexto, rigorous cold chain tests serve not only as a compliance requirement but also as a strategic investment.
Regulatory requirements and standards for 2025
Global frameworks and deadlines
Regulators worldwide require proof that temperature sensitive products are stored and transported within validated ranges. En los Estados Unidos, el Ley de modernización de la seguridad alimentaria (FSMA) emphasises preventive controls and supply chain traceability. El Ley de seguridad de la cadena de suministro de medicamentos (DSCSA) mandates interoperable electronic tracking of prescription drugs; dispensers with more than 25 pharmacists must comply by 27 Noviembre 2025, while large distributors have deadlines in mayo y agosto 2025. El Regla final de trazabilidad de alimentos de la FSMA originally scheduled for 2026 may be extended to 20 Julio 2028, requiring companies handling foods on the FDA’s list to provide key data elements within 24 horas.
de Europa Buena práctica de distribución (PIB) Pautas y Anexo GMP de la UE 1 demand validated equipment, Monitoreo ambiental e integridad de datos.. The World Health Organization’s Model Guidance on Good Storage and Distribution Practices (WHO TRS 961 Anexo 9) y ISO 14644 3 Proporcionar puntos de referencia internacionales para mapeo térmico y pruebas de salas limpias.. El International Council for Harmonisation (ICH) Q1 guideline sets out principles for stability testing, stating that the purpose is to provide evidence on how the quality of a drug varies with time under environmental factors such as temperature, humedad, light or agitation and to establish a re test period or shelf life and recommended storage conditions.
In pharmacy practice, el Farmacopea de los Estados Unidos (USP) General Chapters <659> Packaging and Storage Requirements, <1079> Good Storage and Transportation Practices for Drug Products, y <1079.2> Temperatura cinética media outline requirements for cold chain shipping and call for routine validation and documentation. Accreditation bodies such as URAC y el Accreditation Commission for Health Care (ACHC) include cold chain compliance in their standards; failing to meet them can jeopardise accreditation status.
Data integrity and ALCOA+ principles
Regulators increasingly expect electronic records to comply with ALCOA+ principles—data must be Atribuible, Legible, Contemporáneo, Original y preciso. Electronic record systems must have audit trails, secure user authentication and validated e signatures (21 Parte CFR 11). Failing to ensure data integrity can lead to sanctions even when temperature ranges were maintained. When designing cold chain tests, plan for secure data capture, redundant storage and robust access controls.
Temperature mapping and environmental monitoring
Understanding temperature mapping
Mapeo de temperatura, also called thermal mapping or temperature characterisation, measures how temperature is distributed within a controlled space and how it fluctuates over time. Even in a well designed cold room or vehicle, temperature is not uniform—it can vary by height, airflow and the presence of equipment. Mapping studies involve placing multiple sensors (típicamente 9–15 sensors) throughout the area to record temperature data over a defined period. The collected data are analysed to identify the warmest and coldest zones, which then inform the placement of permanent monitoring probes.
The objectives of temperature mapping are to:
Guarantee product quality and storage stability by verifying that the environment stays within validated limits.
Identify hot and cold spots that could compromise product integrity.
Define the best locations for permanent monitoring probes to ensure continuous compliance.
Demonstrate regulatory compliance during audits by providing documented evidence of environmental behaviour.
When and how to conduct mapping
Temperature mapping should occur at several key moments: before initial use of a storage or production area, after significant changes (p.ej., HVAC upgrade or equipment replacement) y periodically (often twice a year to account for seasonal variations). Hospitals also map new refrigerators and vaccine storage rooms. Perform mapping both vacío (at rest) y loaded to simulate real world conditions; some teams include stress tests such as door openings and power outages to evaluate system resilience.
Following a mapping study, equip the identified hot and cold points with permanent monitoring probes connected to an integrated Environmental Monitoring System (EMS) that collects, víveres, visualises and analyses data in real time. This approach eliminates manual transfers and ensures immediate alerts for deviations.
Data integrity and sensor calibration
To meet ALCOA+ requirements, calibrate sensors against recognised standards (p.ej., NIST o UKAS) and document calibration certificates. Use sensors capable of recording temperature, humedad, eventos de luz y shock; these should transmit data via secure cellular, satellite or low power networks for real time visibility. Regularly verify sensor placement during mapping and operational phases to avoid blind spots.
Stability testing and shelf life determination
Stability testing evaluates how the quality of a drug substance or product varies with time under the influence of environmental factors and defines its shelf life. ICH Q1 emphasises that stability testing should establish a re test period or expiry period in the proposed container closure system under recommended storage conditions. Para productos de cadena de frío, stability data not only support label claims but also inform excursion assessments—knowing how long a product can withstand elevated temperatures helps determine whether a shipment remains usable after a deviation.
Stability studies fall into two categories:
Development studies under stress or forced conditions: These characterise degradation pathways and identify critical quality attributes. They may include exposure to elevated temperature and humidity, freeze–thaw cycles and thermal cycling. The results inform analytical methods and help design formal studies.
Formal stability studies (largo plazo, intermediate and accelerated): These generate data that support shelf life claims and regulatory submissions. Para productos de cadena de frío, formal studies often include multiple temperature conditions—e.g., 2–8 ° C for refrigerated products and –20 ºC o –80°C for frozen and ultra frozen products. Continuous monitoring and backup power systems are essential to prevent temperature excursions during studies.
Stability tests should be conducted in validated chambers set to ICH stability conditions, and results should be documented according to ALCOA+ principles. Companies often perform additional excursion impact studies to evaluate whether a brief deviation outside the label range affects product quality. These studies allow for science based release decisions when real world excursions occur.
Validation phases: DQ, coeficiente intelectual, OQ y PQ
Cold chain validation is a structured process comprising four phases—Design Qualification (DQ), Calificación de instalación (coeficiente intelectual), Calificación operativa (OQ) y calificación de desempeño (PQ). Each phase builds on the previous one and collectively demonstrates that equipment, packaging and procedures perform as intended under real world conditions.
Calificación de diseño (DQ) – Evaluate whether the system’s design—vehicles, packaging and monitoring devices—meets the requirements for protecting specific products. Consider materials, espesor de aislamiento, refrigerant type and sensor placement early to avoid costly redesigns.
Calificación de instalación (coeficiente intelectual) – Verify that all equipment is installed correctly and functions as intended. Para transporte, Esto incluye garantizar que las unidades de refrigeración, Los contenedores aislados y los registradores de datos están configurados y calibrados correctamente.. Documentation should include serial numbers, installation diagrams and calibration certificates.
Calificación operativa (OQ) – Test the system under various operating conditions to confirm it performs within specified temperature ranges. Simulate worst case scenarios such as high ambient temperatures, extended transit times or power failures; verify that alarms trigger at the right thresholds and that the system maintains temperature stability. Temperature mapping is often performed during OQ to identify hot and cold spots.
Calificación de desempeño (PQ) – Evaluate the system’s performance under actual transport conditions. Conduct pilot shipments along representative routes across seasons and vehicle types. PQ confirms that the system maintains temperatures during storage, cargando, tránsito, descarga y almacenamiento final. PQ data provide the confidence needed for commercial deployment.
Validation is not a one off exercise. Continuous reassessment is required whenever there are changes in routes, estaciones, products or equipment. A validation master plan should outline responsibilities, protocolos, criterios de aceptación, contingency plans and re qualification schedules. Clear documentation of test protocols, resultados, deviations and corrective actions is critical—without documentation, regulators may deem the test as never having occurred.
Packaging qualification and test planning
In addition to transport systems, el embalaje itself must be qualified through the same DQ/IQ/OQ/PQ framework. Qualification testing exposes packages to external forces such as temperature, presión, humidity and light to ensure they protect contents over the intended transit time. A robust plan should define the test procedure, tamaño de la muestra, test frequency, method justification, aging conditions and acceptance criteria. Only after verification at each level can you progress to the next stage.
Test planning should align with product requirements (p.ej., storage time, clima de destino, transportation mode) and incorporate ambient temperature profile analysis to select appropriate phase change materials, aislamiento y refrigerantes. Some packaging suppliers provide off the shelf operational qualifications, but you still need to perform performance qualifications in your own shipping lanes.
Mesa: Temperature categories and validation focus
| Categoría de temperatura | Rango | Productos típicos | Enfoque de validación | Importancia práctica |
| Refrigerado | 2 °C – 8 °C | Vacunas, insulina, anticuerpos monoclonales, Agonistas del GLP 1 | Verify that passive cooling elements (paquetes de gel, Materiales de cambio de fase) and insulation maintain the 2–8 °C range throughout the distribution route. Utilice mapas de temperatura para localizar puntos calientes. | Garantiza la potencia y el cumplimiento normativo.; failure leads to product degradation and safety risks. |
| Congelado | Por debajo de –20 °C | Vectores virales, intermediarios biológicos a granel, some plasma derivatives | Confirm that packaging and refrigeration units can maintain sub zero temperatures during loading/unloading; perform drop and vibration tests to ensure physical integrity. | Critical for biologics requiring long term frozen storage; prevents potency loss during transit. |
| Ultrafrío/criogénico | –70 °C a –150 °C | Vacunas de ARNm, terapias celulares y genéticas | Validar contenedores especializados (congeladores criogénicos, transportistas de hielo seco) and sensors for extremely low ranges; include real time tracking and alarm systems. | Esencial para terapias de próxima generación; failure results in rapid degradation and high financial loss. |
| Temperatura ambiente controlada (CRT) | 15 °C – 25 °C | Many oral drugs, active pharmaceutical ingredients | Pruebe que el embalaje modera los cambios de temperatura y protege contra condiciones ambientales extremas.; validate monitoring devices and allow broader excursion ranges supported by stability data. | Enables distribution of CRT products without cold chain infrastructure, reducing costs while ensuring safety. |
| Categorías especiales | 8 °C – 15 °C or other narrow bands | Ciertas vacunas, reactivos de diagnóstico | Validate packaging for narrow ranges, ensure sensors and alarms provide timely alerts; may involve custom containers and real time monitoring. | Addresses niche products with specific requirements, preventing quality loss in intermediate temperature zones. |
Managing temperature excursions and best practices
Understanding excursions and their sources
A excursión de temperatura occurs when a time–temperature sensitive product is exposed to temperatures outside its validated storage or transport range. The WHO defines excursions accordingly. Industry data suggest that 20 % of temperature sensitive products are damaged during distribution, highlighting the prevalence of excursions. Common sources include:
Retrasos en el transporte: Traffic congestion, weather disruptions and customs backlogs can prolong transit times.
Fallos de embalaje: Inadequate insulation or depleted phase change materials lead to rapid temperature changes.
Mal funcionamiento del equipo: Faulty refrigerators, reefer trucks with inconsistent cooling and inaccurate data loggers cause unexpected deviations.
error humano: Improper loading, doors left open and incorrect configuration of monitoring equipment remain preventable causes.
Regulatory expectations for excursions
Regulators expect a risk based approach to managing excursions. Los EE. UU.. FDA’s GDP guidelines require validated storage and transportation systems capable of maintaining temperature integrity. La Agencia Europea de Medicamentos (EMA) emphasises structured impact assessments and well documented responses. The WHO GDP model calls for ongoing monitoring, corrective and preventive actions (CAPA) and robust stability data to support decisions.
Best practices for excursion management
Implementing a comprehensive excursion management strategy involves the following steps:
Develop clear Standard Operating Procedures (Sops) – SOPs should define every step to take when an excursion occurs, including quarantining affected items, recording temperature and duration, notifying quality assurance teams and conducting root cause analysis. Consistent procedures facilitate audits and regulatory inspections.
Use real time monitoring and GPS tracking – IoT enabled sensors provide instant alerts for temperature breaches and integrate with GPS to track high risk shipments. Real time visibility reduces blind spots and allows rapid corrective actions.
Validate packaging systems and conduct impact studies – Effective packaging reduces the likelihood of excursions. Validate solutions using phase change materials, vacuum insulated panels and active or passive containers. Perform stability and excursion impact studies to determine whether excursions affect drug quality and to inform release decisions.
Strengthen workforce training – Human error is a leading cause of excursions, so training should emphasise correct loading/unloading methods, proper use of monitoring equipment and escalation procedures. Regular refresher sessions aligned with GDP changes help maintain competency.
Apply root cause analysis and CAPA – Following an excursion, analyse whether it was caused by equipment failure, embalaje, process errors or human error, and implement corrective actions to prevent recurrence.
Aprovechar las tecnologías emergentes – Innovations such as blockchain for immutable records, AI based predictive analytics to anticipate risks (p.ej., clima, Retrasos aduaneros) and smart packaging capable of adjusting thermal profiles are transforming cold chain compliance. Digital dashboards integrate global monitoring, enabling holistic oversight.
Ejemplo del mundo real: COVID 19 vaccine distribution
Durante el lanzamiento de la vacuna COVID 19, el Pfizer–BioNTech mRNA vaccine required storage at –70°C. To mitigate excursion risks, the company used Transportadores térmicos habilitados para GPS, routine dry ice replenishment during transit and continuous digital monitoring from origin to destination. This case underscores how advanced monitoring, validated packaging and proactive risk management ensure safe delivery of ultra cold products.
Building a cold chain compliance toolkit
Core risks to address
Según tecnologías de la cadena de frío, a compliant cold chain must mitigate three core risks:
Risk to patient safety: Protect product efficacy, quality and safety.
Risk to total cost of ownership: Avoid the financial and reputational costs of damaged products, recalls and client loss.
Risk to accreditation status: Maintain compliance with URAC, ACHC and other regulatory or accreditation audits.
Risk mitigation checklist
To build your toolkit, start by answering the following questions adapted from industry checklists:
Capacitación: Are your employees and partners trained in URAC and ACHC standards? Do they follow supplier guidelines for pack outs? Document training sessions and competencies.
Process review: How often do you review SOPs and packaging procedures? Periodic audits help identify gaps and ensure alignment with current regulations.
Uso de tecnología: What temperature monitoring and communication tools are in place? Are you leveraging IoT sensors, blockchain or cloud dashboards to collect and analyse data?
Calificación de embalaje: Have your packaging systems been qualified to maintain the required temperature range? Do you have performance qualification data for your specific shipping lanes?
Blind spots: Where are the blind spots in your processes, and what are you doing to prevent them?
Educación del paciente: Have patients received correct information about storage, handling and delivery timeframes? Patient communication reduces the risk of exposure to extreme temperatures post delivery.
Mantenimiento de equipos: When were your freezers and refrigerators last serviced and verified for correct temperature and humidity levels?
Protocol understanding: Do employees understand how refrigeration protocols affect stability and efficacy timelines?
Compliance manual essentials
Crear un compliance manual that serves as the blueprint for cold chain success. This manual should include:
Historical testing data: Temperature monitoring and control tests of refrigerators, congeladores, performance qualification shipments and real time product visibility.
Pack out diagrams: Seasonal packaging configurations, proper placement of insulation, paquetes de gel, data loggers and other components.
Test summaries: Proof of performance qualification tests conducted in actual shipping lanes, including protocols and results.
Training audits: Summaries of training programs, schedules for refreshers and audits of employee packing and handling procedures.
Performance qualifications: Data and reports submitted to accreditation bodies, along with acceptance criteria and corrective actions.
Procedimientos operativos estándar: Cover regulatory compliance, facility and equipment maintenance, gestión de inventario, prescription processing, patient consultation and procedures for detecting and responding to excursions.
Maintaining both physical and digital versions of the manual ensures accessibility and preserves institutional knowledge.
2025 innovations and trends in cold chain testing
Crecimiento y diversificación del mercado.
The global healthcare cold chain logistics market is projected to grow from 59.970 millones de dólares en 2024 to US$65.14 billion in 2025, with forecasts reaching 137.130 millones de dólares por 2034. The pharmaceutical cold chain services market stands at 6.600 millones de dólares en 2025, and healthcare packaging demand is expected to increase by over 30 % por 2028.
Drivers include the rapid expansion of biologics and biosimilars—more than 85 % de los productos biológicos requieren gestión de la cadena de frío—and the rise of cell and gene therapies requiring cryogenic storage. The number of peptide based treatments and specialty pharmaceuticals continues to grow, further increasing cold chain complexity.
Digitisation and real time visibility
En 2025, digital technologies enable unprecedented visibility across the cold chain. sensores de iot integrated into packaging and vehicles continuously measure temperature, humedad, eventos de luz y shock. Unlike traditional data loggers that only record data for later analysis, Estos sensores transmiten información instantáneamente a través del celular., Redes satelitales o de baja potencia., allowing immediate corrective action when deviations occur.
cadena de bloques solutions offer tamper proof records of temperature measurements and custody transfers, enhancing traceability for high value products. Análisis predictivo impulsado por IA evaluate factors such as weather patterns, customs delays and carrier reliability to anticipate risks and suggest alternative routes. gemelos digitales simulate shipments under different conditions, helping to optimise packaging and routing before goods are dispatched.
Sustainable and reusable packaging
Environmental considerations are shaping cold chain innovation. Manufacturers are adopting materiales biodegradables y reciclables para reducir el desperdicio, and reusable insulated containers are gaining popularity. Paneles aislados al vacío (VIP) and advanced phase change materials offer high thermal performance with lower weight, Reducir el consumo de combustible y las emisiones.. Sustainability commitments also drive investments in renewable energy and low carbon refrigeration systems.
Regulatory evolution and traceability
Los marcos regulatorios seguirán evolucionando. The DSCSA’s package level electronic tracking requirements become fully enforceable in 2025, and the FSMA Food Traceability Final Rule may shift compliance deadlines to 2028. The EU’s revised GDP guidelines emphasise environmental sustainability, and WHO guidance increasingly integrates risk based approaches and digital monitoring. Companies must stay current with global standards and harmonise practices across regions.
Integration of quality and supply chain functions
Cold chain testing is no longer solely the domain of quality assurance. En 2025, cross functional integration es esencial: calidad, operaciones, logística, ÉL, sustainability and regulatory teams must collaborate to design, implement and monitor end to end cold chain solutions. CDMOs with specialised cold chain capabilities are becoming indispensable partners; their integrated infrastructure, specialised equipment, real time monitoring systems and validated processes support complex biologics and advanced therapies. Supply chain integration ensures seamless coordination from manufacturing to distribution, including clinical trial sites and commercial channels.
Preguntas frecuentes
Q1: What temperature range do most vaccines require?
Most vaccines and biologics must remain between 2 °C y 8 °C. Keeping products within this controlled cold range preserves potency and meets Good Distribution Practice requirements. Deviations can degrade the active ingredient and lead to batch rejection.
Q2: How often should temperature mapping be performed?
Temperature mapping should occur before initial use, after any major change (p.ej., HVAC upgrades) y periodically, típicamente twice a year to account for seasonal variations. Additional mappings are recommended after changes in product load or room layout.
Q3: What are the main phases of cold chain validation?
Cold chain validation consists of Calificación de diseño (DQ), Calificación de instalación (coeficiente intelectual), Calificación operativa (OQ) y Calificación de desempeño (PQ). These phases evaluate design suitability, proper installation, operational performance under stress and real world performance across transport lanes.
Q4: ¿Por qué es importante el monitoreo en tiempo real??
Real time monitoring provides instant alerts for temperature breaches and integrates GPS tracking for high risk shipments. Unlike traditional data loggers, Los sensores de IoT transmiten datos continuamente, enabling rapid corrective action and enhancing regulatory compliance.
Q5: How do you handle a temperature excursion during transport?
Poner en cuarentena inmediatamente el producto., record temperature and duration, notify quality assurance and perform root cause analysis. Use stability and excursion impact studies to assess whether the product remains within acceptable quality parameters. Document the event and corrective actions thoroughly for regulatory review.
Q6: What innovations are emerging for cold chain testing?
Las innovaciones emergentes incluyen cadena de bloques para registros a prueba de manipulaciones, Análisis predictivo impulsado por IA to anticipate risks, embalaje inteligente that adapts to environmental changes and digital dashboards that integrate data from sensors across global supply chains. Estas tecnologías mejoran la visibilidad, traceability and risk management.
Conclusion and recommendations
Control de llave
Testing protects product integrity and patient safety. Alrededor 20 % de los productos sensibles a la temperatura están dañados durante la distribución, y La mitad de las vacunas se desperdician. debido a una gestión inadecuada de la temperatura.
El cumplimiento normativo no es negociable. 2025 brings DSCSA deadlines, evolving GDP guidelines and stricter electronic record requirements. Understanding these frameworks is essential.
Temperature mapping and stability studies are fundamental. Mapping identifies hot and cold spots and informs monitoring probe placement, while stability testing establishes shelf life and supports excursion assessments.
Validation requires a phased approach. Diseño, instalación, operational and performance qualification ensure systems meet design specifications and perform under real world conditions.
Excursion management and digital tools reduce risk. Sops, monitoreo en tiempo real, embalaje validado, training and CAPA processes prevent and mitigate excursions, while IoT, blockchain and AI improve visibility and decision making.
Próximos pasos viables
Develop or update your validation master plan. Include DQ/IQ/OQ/PQ protocols, evaluaciones de riesgos, acceptance criteria and re qualification schedules. Ensure that all sensors and equipment are calibrated and that data integrity controls meet ALCOA+ standards.
Perform comprehensive temperature mapping. Map storage areas and transport vehicles both empty and loaded, twice per year and after major changes. Use the findings to reposition sensors and adjust packaging strategies.
Strengthen excursion management. Crear SOP para excursiones, invest in real time monitoring and conduct stability and excursion impact studies. Capacitar al personal sobre la carga adecuada., packaging and response protocols.
Build a compliance toolkit. Develop a compliance manual with historical test data, pack out diagrams, test summaries, training audits and SOPs. Use a digital dashboard to centralise documentation and monitor regulatory changes.
Manténgase a la vanguardia de las tendencias. Monitor emerging regulations, invest in sustainable packaging and adopt digital innovations such as blockchain and AI. Collaborate across quality, logistics and IT functions to integrate cold chain testing into your broader supply chain strategy.
Acerca de Tempk
Tempk is a leading provider of thermal packaging and monitoring solutions for the life sciences industry. We design and manufacture insulated shippers, Materiales de cambio de fase, cryogenic freezers and IoT enabled data loggers that help pharmaceutical companies, CDMOs and logistics providers maintain strict temperature control. Our solutions are validated to meet global GDP and GMP requirements, and our digital platforms integrate real time monitoring, blockchain traceability and predictive analytics. Al asociarse con Tempk, you gain access to cutting edge technology, expert guidance and a commitment to sustainability that ensures your cold chain stays compliant and reliable.
Ponte en contacto to discuss how our cold chain testing and packaging solutions can help you achieve 2025 compliance and beyond.
