Please read through some clips of articles written for the Thermal Packaging Industry. Full versions of each are available in pdf format. If you do not have Adobe Acrobat Reader please download it for free at www.adobe.com .
Part 1. Wholesaler/Distributor: Missing Audit Assurance
“Pharmaceutical Cold Chain: A Gap in the Last Mile”
By Sanford Cook, Joseph Villa, and Teri Magennis, RN Thermal Packaging Solutions LLCIt is well known in the industry that many biologics and other pharmaceutical compounds can be damaged with excessive heat or freezing, as evidenced in pharmaceutical manufacturer’s stability studies, resulting in reduced efficacy. Unless authorized by the pharmaceutical manufacturer on a formula and packout basis, distributors delivering medications to the hospital, clinic, or retail pharmacy must maintain the label temperature; therefore, the packaging needs to maintain product temperatures and accommodate ambient temperature/humidity and weather changes
Full Article – click here
Part 2. Closing the Assurance Gap: Temperature Monitors: When To Use What; Latest Technology vs. Misinformation
“Pharmaceutical Cold Chain: A Gap in the Last Mile”
By Sanford Cook, Joseph Villa, and Teri Magennis, RN Thermal Packaging Solutions LLCAccording to USP Chapter <1079> Good Storage and Shipping Practices, “a drug can take a variety of paths from the manufacturer to the patient. In the simplest form of the distribution system, the manufacturer ships directly to the customer, such as a doctor’s office, clinic, or hospital. However, more often, the article leaves the manufacturer’s chain of control and enters a complex system of handoffs that involve the distribution chain to the patient.”
In a recent study conducted by Thermal Packaging Solutions (TPS; Ocean, NJ) and Brigham and Women’s Hospital (B&W), shipments from a major wholesaler/distributor (W/D) were delivered to the hospital in a packaging condition that left the drugs highly vulnerable to temperatures below the drugs’ labeled temperature limits. This study revealed an audit gap in the last mile between the manufacturer and the hospital. The same condition exists between the W/D and retail pharmacies.
read online: http://www.pmp-digital.com/pmpmag/201012#pg22
Developing Controlled Temperature Tunnels
“Pharmaceutical & Medical Packaging News, Nov. 2008”
By Sandy Cook, Teri Magennis, and Joe VillaThe perfectly controlled ambient atmosphere for temperature-sensitive products during cold chain distribution from the shipping dock to final destinations, known as the temperature tunnel, has been elusive, since shippers must deal with various modes of transportation.
One If by Land, Two If by Sea
“Pharmaceutical & Medical Packaging News, Apr. 2008”
By Sandy Cook, Teri Magennis, Joe VillaCargo shipping costs can be reduced through safe, stable ocean freight companies in the cold chain.
EDITORIAL – Filling Gaps in the Cold Chain
“Pharmaceutical & Medical Packaging News, Nov. 2006”
by Daphne Allen; Editor
If you are sending products out into the cold chain, you’ve got to be thinking about more than just the package. Sure, your role is to ensure that your shipper maintains temperatures under extreme conditions during travel by land, air, or sea. But have you searched for any gaps in your solution? The FDA just might be looking for them, warns Sanford Cook, CPP, Thermal Packaging Solutions LLC (Ocean, NJ).
Operational Considerations of Thermally Sensitive Healthcare Products
“ISPE Pharmaceutical Engineering, Jul. 2006”
By Sanford L. CookThis article discusses the need for special procedures starting at receipt of sensitive components/ingredients, through operations and cold chain distribution, including requirements and new packaging supplies for temperature sensitive medical products.
‘Cold Chain’ Packaging for Health: New Products and Coming Visions
“Package Design Magazine, Apr. 2005”
By Sanford L. CookThe pharmaceutical industry relies on accurate, reliable temperature recorders that might be equally valuable to consumer goods and food product manufacturers. Thermochromic inks can be a reassuring indicator that sensitive products haven’t been exposed to harmful temperatures.
Thermodynamics of Packaging
“Pharmaceutical Technology Europe, Mar. 2000”
By Sanford L. CookThe possibility that pharmaceutical products may be exposed to hazardous temperatures during cold chain shipping and storage is a concern. This article describes the role of packaging in protecting products from hazardous temperatures, discussing the mechanics of phase changes.