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ColdStream® Life Sciences Services

Protecting the integrity of temperature-sensitive medicinal products

Our temperature-sensitive supply chain services help you protect the value, integrity, and efficacy of medicinal products by improving your cold chain performance. The Sensitech® Life Science Professional Services team has years of experience analyzing cold chains in the biological, pharmaceutical, chemical, and clinical sciences market, helping customers manage and improve their cold chain performance. Following a proven methodology and utilizing proprietary analysis tools, our team can identify cold chain inefficiencies and apply corrective actions. No matter what the challenge, our team knows how to translate data into actionable information.

Our services for the Life Sciences industry include:

ColdStream® Select

ColdStream® Select is an end-to-end global risk mitigation cloud solution, protecting validated data for in-transit product release decisions critical to product integrity and patient safety.

  • Validated data management for temperature-sensitive supply chains
  • Workflow automation
  • Global, secure, accessible cloud application
  • Tailored user experience by job role
  • Integrate with many systems
  • Data analytics, dashboards and best practice advice

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Continuous Improvement Programs

We can help develop a program to ensure consistent quality throughout a temperature-sensitive supply chain including full Corrective Action / Preventative Action (CAPA) management. By applying a disciplined, six-step methodology to cold chain analysis, we can identify weaknesses before they become systemic problems.

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Temperature-Sensitive Supply Chain Assessments

We perform a comprehensive evaluation of internal and external practices related to storage, handling, and distribution of temperature-sensitive medicinal products to identify gaps and opportunities for improving thermal compliance.

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Validation and Qualification Services for Storage and Transportation

Following the FDA's General Principals of Process Validation, we provide documentation confirming that processes, methods, and systems consistently produce results meeting pre-determined acceptance criteria—both in storage and in transit. As a global company, we take into account the guidelines of regulatory agencies for both the local country and for shipping locations.

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Thermal Mapping Kits

Prefer to perform your own thermal mapping? Our Thermal Mapping Kits make it easy and cost-effective. Once the mapping is complete, send the kit back to Sensitech and our Professional Services team will analyze the data and deliver a complete data analysis and a comprehensive summary report.

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Shipping Studies

Our Shipping Study is a cost-effective way to determine the thermal variability of a specific trade or shipping lane. Ambient Thermal Profiles evaluate temperatures across shipping lanes, and Performance Qualifications (PQ) evaluate whether a shipping system is performing to pre-determined criteria.

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ColdStream® Site Service

Automate temperature monitoring and documentation of storage facilities and equipment. Our easily deployed ColdStream® Site Service provides flexible, wireless temperature sensing of refrigerators, freezers and cold rooms with automated record-keeping and reporting. Eliminate manual processes while ensuring compliance with Good Manufacturing Practices (cGMP).

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Quality to the Patient for Temperature-Sensitive Specialty Pharmaceutical Shipments

Quality to the patient means having the right product in the right place, at the right time, and in the right condition based on the manufacturer’s cited label temperature requirements. An integrated cold chain encompasses every stage of logistics: in-transit, storage, and mid-cycle hand-offs. Care must be taken to safeguard that appropriate temperature ranges are maintained to ensure that manufacturers’ label requirements for stability, efficacy and quality are met to the patient. Sensitech Inc. provides pharmacies the capabilities needed to meet URAC Accreditation requirements for managing specialty pharmaceutical cold chain distribution.

View the Specialty Pharma datasheet
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