sensitech.com 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. 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. • Reduce the risk of delivering adulterated products to patients. • Identify opportunities to improve overall cold chain performance. • Meet URAC certification requirements for managing specialty pharmaceutical cold chain distribution. Ensure that every delivery maintains the appropriate temperature label claim. Assure the safety of direct patient deliveries. Reduce patient returns based on subjective patient assessments. Continuous Monitoring Assessment Performance Qualification (PQ) Packaging / Pack-outs Transportation Assess thermal packaging, handling, and shipping processes by conducting ambient temperature studies seasonally. Evaluate thermal packaging and pack-out design, instructions, and training. Gauge package process improvements. Analyze the performance of patient delivery services. Confirm that in-transit cold chain processes meet industry certifications. Comprehensive Cold Chain Methodology Assures Quality to the Patient
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sensitech.com
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.
Quality to the Patientfor 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.
• Reduce the risk of delivering adulterated products to patients.
• Identify opportunities to improve overall cold chain performance.
• Meet URAC certification requirements for managing specialty pharmaceutical cold chain distribution.
Ensure that every delivery maintains the appropriate temperature label claim.
Assure the safety of direct patient deliveries.
Reduce patient returns based on subjective patient assessments.
Continuous Monitoring Assessment
Performance Qualification (PQ) Packaging / Pack-outs
Transportation
Assess thermal packaging, handling, and shipping processes by conducting ambient temperature studies seasonally.
Evaluate thermal packaging and pack-out design, instructions, and training. Gauge package process improvements.
Analyze the performance of patient delivery services.
Confirm that in-transit cold chain processes meet industry certifications.
Comprehensive Cold Chain Methodology
Assures Quality to the Patient
sensitech.com
Quality to the Patient for Temperature-Sensitive Specialty Pharmaceutical Shipments
URAC Specialty Pharmacy Accreditation Version 3.0 PHARM-OP 7URAC certification requires the pharmacy to implement a well-documented process, under which the pharmacy will manage the cold chain distribution process.
The pharmacy’s policies, procedures, and documentation must address:• Criteria that guide the pharmacy’s selection of
packaging products
• Standards that guide the selection of appropriate transportation process of products
• Means for testing new packaging products
• Selection criteria for choosing the correct packaging
• Compliance with packing instructions
• Process to ensure that the product is maintained within the manufacturer’s guidelines throughout the entire shipping process
• Plan for the pharmacy to determine if extreme weather suggests that a delay in shipping would be appropriate
• Ability to determine whether a shipment should be held because of expected delays in delivery
• Decision tree for handling a product if there is a breakdown in the distribution process
• Mechanism for annually evaluating product packaging, in addition to anytime there is a modification made to a product’s packaging, to ensure that each package appropriately handles different temperatures for varied lengths of time
Annual review by the quality management committee of the following issues:• Validated distribution process (i.e., accuracy of the
results can be demonstrated)
• Monitoring system
• Patient or prescriber complaints regarding cold chain distribution
Sensitech’s Specialty Pharmaceutical Package Qualification Kit
Provides Pharmacies the Capabilities Needed to Meet the Requirements for URAC AccreditationCold Chain Risk Assessment of the current cold chain shipping processes; includes expert advisor to design and deploy a seasonal shipping study with 60 dataloggers across 30 lanes. Analysis addresses:
• Is package capable of maintaining the temperature requirements; i.e., meets the needs of a Package Performance Qualification (PQ)?
• Is process impacting temperature conditions?
• Possible cost reductions in package, weight, shipping costs, and dim weight?
• Do Risk Controlled Ambient Temperature Profiles (RCATP) indicate that package redesign is necessary?
• Are transportation modes (overnight, courier, etc.) and service levels appropriate?
Sensitech Inc., a global leader in supply chain visibility solutions, provides Pharmacies the capabilities needed to meet the requirements for URAC Accreditation• One-on-one engagements with experienced industry cold
chain advisors.
• Data collection, analysis and recommendations to achieve industry best practices, measure critical control points, reduce the risk of temperature excursions, and ensure high-quality product deliveries to patients.
• Selection criteria for packaging solutions to test and rationalize the robustness and cost effectiveness, in order to meet current specialty pharmacy requirements for certification.
• Thermal Mapping Kit for Storage to analyze, report, and assure the temperature stability of stand-alone refrigerators and freezers.
• Cost effective monitoring of temperatures for “direct to patient” shipments, along with “patient friendly” acceptance processes, that include customer training and support, to reduce product returns.
Process/Package Performance Qualification (PQ) Shipment Thermal Assessment
Analyze temperature conditions of packaging and shipping process; i.e., instructions, pre-conditioning of coolants and product, courier handling.
Reducing Temperature Variability Year over Year—Process/Package Improvements
The length of the box and vertical lines correspond to the level of variation among the averages from shipments along the same transportation lane. Longer boxes and lines indicate more variation. The median temperature by destination is displayed (bold red line). The graphs demonstrate that the variability in median temperature across all shipments by destination has been drastically reduced in Year 2.
sensitech.com@sensitech
04/18
Sensitech Inc. is focused on delivering supply chain visibility solutions that track, monitor and protect products for global leaders in the food, life sciences, consumer goods, and industrial markets. Our solutions are focused in three key areas: quality and compliance, supply chain security, and logistics performance management. Quality and compliance solutions address temperature-sensitive, complex supply chains focused on delivering the highest quality possible, while our supply chain security solutions help to mitigate risks associated with theft, diversion and chain of custody. Sensitech’s logistics performance solutions deliver origin-to-destination, real-time transparency to any in-transit journey. Sensitech Inc. is an ISO 9001:2008 company, headquartered in Beverly, Mass., with more than 35 sales, service and distribution locations around the world. Sensitech is a part of UTC Climate, Controls & Security, a unit of United Technologies Corp., a leading provider to the aerospace and building systems industries worldwide. Visit www.sensitech.com for additional information. © 2018 Sensitech Inc. All Rights Reserved. Unless otherwise indicated, all trademarks and service marks are the property of Sensitech Inc.
Quality to the Patient for Temperature-Sensitive Specialty Pharmaceutical Shipments
Sensitech Inc. • Global Headquarters • 800 Cummings Center • Suite 258X • Beverly, MA 01915-6197
1-800-843-8367 • +1-978-927-7033 • Fax: +1-978-921-2112 • [email protected]
Delivering Quality to the Patient for Specialty Pharmaceuticals
An Easy-to-Follow Process
ThermoAlertTM is a single use, cost-effective, reliable monitor that is easy for patients to understand
when temperature conditions have been exceeded. Provides peace of mind to the patient.
Additional Sensitech Services for Storage Best Practices
Refrigerator/Freezer Thermal Mapping StudiesStorage Monitoring Service: ColdStream® Site Facility Monitoring Systems
Post Corrective Action: controlled lane
Assure that every patient delivery meets the required temperature specifications by monitoring every shipment.
Control and document your shipping lane to meet regulatory requirements and reduce costs.
CONTROL2 3
Understand the true dynamics and robustness of your current packaging through cost-effective Shipping Studies by season and by lane.
UNDERSTAND ASSURE1
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