Protecting What Matters

PharmaTuff Qualification

Qualification is a crucial step in the cold chain packaging process. Without proper testing there is no way to know if your products are arriving to their destination in the desired temperature range. Pharmaceuticals and food can melt, freeze, or become too hot during transit. This can go unnoticed if your product has returned to its desired temperature range by the end of its journey. The result can be food that has spoiled or drugs that are now inactive or sometimes dangerous due to unforeseen changes during transportation.
 
Temperature range

The Qualification process performed by the Center of Excellence can solve this problem before it occurs. PharmaTuff shippers are qualified to accepted ISTA temperature profiles using inert liquid payloads. Cold chain qualification is typically associated with pharmaceutical shipping systems, but this compliance standard is also used in life sciences, biological specimens, blood, fresh produce, meats, fish, poultry, adhesives and other temperature sensitive materials. Our design, quality, and manufacturing teams produce a molded EPS thermal shipper that stands up to ISTA (International Safe Transit Association) temperature testing. Most sizes have already been tested against ISTA 7D, 7E, 1A and 2A standards for small parcel shipping and provide durable product protection without the need of an outer corrugated cover.
 
ISTA temperature profiles


EFP developed the PharmaTuff line of molded EPS shippers to be a pre-qualified cold chain packaging system for high volume users. The PharmaTuff kits are simple and economical, with the pedigree to satisfy your compliance needs. EFP can help you qualify PharmaTuff standard shippers for use with your product. These qualified systems will guarentee your product will stay in temperature range from distribution, through transit, and at the final destination.
 
Pre-qualified Cold Chain Packaging Systems


The Center of Excellence lab is completing its ISTA Lab Certification in 2018. After completion we will be able to provide third party testing of your existing shippers and provide documentation of your ISTA Qualification along with a full lab report.

 
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J.B. Pointdexter EFP Corp

Will Your “Pre-Qualified” Cold Chain Packaging Pass Performance Testing?

Specialty Pharmaceutical Distributors are being tasked with proving their cold chain packaging will stand up to real time temperature protection.

The accepted method of pre-qualification of parcels used to deliver prescriptions to patients or providers is static testing in thermal chambers. These tests expose the package to various, sometimes extreme external temperatures with the goal a surviving a minimum of 24 hours within label claim temperature ranges.

This testing is also subjective. The products are typically simulated using bottles of water. Probes are placed at the technician’s discretion.

URAC and other accreditation services are asking for “shipping lane testing” as further qualification of cold chain parcels. If you want to be ahead of the compliance curve, EFP can help you confirm the performance of your current cold chain packaging. Contact PharmaTuff to learn more.