PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
News|Articles|October 17, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
- PTSM: Pharmaceutical Technology Sourcing and Management-11-01-2017
- Volume 12
- Issue 11
Temperature-Controlled Shipping Service Solution
Author(s)Pharmaceutical Technology Editors
Almac Group’s Almac Pod, a temperature-controlled shipping solution service for biologics and other temperature-sensitive products, is available in the United States.
Almac Group, a contract development and manufacturing organization, has expanded availability of the Almac Pod, a temperature-controlled shipping solution service for biologics and other temperature-sensitive products, to the United States as part of the company’s end-to-end, global supply chain management solution. Originally released in Europe, the service is compliant with good distribution practices, and comes in three models: protected, optimized, and dynamic.
The protected model is qualified for up to 96 hours against thermal challenges by the International Safe Transit Association, and is available in -15°C to -25°C, +2°C to +8°C, and +15°C to +25°C temperature ranges. The optimized model is also qualified for up to 96 hours of protection, eliminates temperature excursions, is suited for reuse with no shippers left at the clinical site, and requires no disposal. The dynamic model features upgraded operational processing capacity and flexibility and uses a phase-change material to offer increased thermal protection. It can be immediately placed into appropriate storage at each point of packing and in-transit. For this model, Almac has the ability to perform a year-round pack out of clinical shipments.
Articles in this issue
almost 9 years ago
A Potential Downside to the CDMO M&A Frenzyalmost 9 years ago
Early Efforts Identify Unstable APIsalmost 9 years ago
Setting Safety Processes for Potentially Potent APIsalmost 9 years ago
CordenPharma Invests in Small Molecule API Development Capacityalmost 9 years ago
Piramal Plans Large-Scale Expansion of API Manufacturing Facilitiesalmost 9 years ago
SGS and Bavarian Nordic Form Vaccine Pactalmost 9 years ago
MediLedger to Explore Use of Blockchain for DSCSA ComplianceRelated to this article
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This article explores the historical use of silicone oil in the performance of primary drug product packaging; design of experiment test results for selection of the cleaning agent and CCPs; assessment of visible residue limits and Fourier-transform infrared spectroscopy surface analysis; and setting health-based exposure limits for silicone oil using a non-uniform distribution model, and a previously published permitted daily exposure.