Safely Transport Products from 503B Compounding Facilities with Akuratemp Parcel Shippers
Why Parcel Shippers for 503B Compounding Outsourcing Facilities?
503B compounding outsourcing facilities face unique challenges when it comes to shipping pharmaceutical products as they require strict temperature control during transportation and these facilities often ship small quantities of products, making it challenging to find cost-effective and efficient shipping solutions. Pre-validated parcel shippers minimize the risk of temperature excursions during transportation, standardize the pack-out procedures and eliminate the requirement to monitor temperature in each shipment. Multi-use parcel shippers justify investment in high quality shipping systems, optimize the inventory required for packaging material, optimize the need of their storage space, eliminate the risk of unavailability at the time of need, and more importantly, substantially reduce the disposal cost attached to single use products.
The Challenge
Due to the strict regulations surrounding pharmaceutical cold chain, compounding outsourcing facilities are required to produce sterile and high-quality products, and ship these products in a strict temperature controlled environment. Failure to maintain traceability of proper temperature control during the entire cold chain can result in compliance issues and any break in cold chain can result in product spoilage, which can have serious health consequences for patients.
The Solution
ISTA7D pre-validated parcel shipper systems can eliminate these challenges by providing documentation for reliabity and effectiveness of temperature control during shipping. While the documentation meets the regulatory requirements, these systems bring standard operating procedures for preparing and packaking temperature sensitive products, and peace of mind that the products shipped will remain in acceptable conditions. These parcel shippers are designed to maintain a consistent temperature range, which is critical for ensuring product stability and efficacy during their supply chain. The validation per International Safe Transit Association (ISTA) recommended standards, ensure that the parcel shippers meet industry standards for performance.
