ColdStream^® Life Sciences Services

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.

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.

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.

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.

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.

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).

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.