Emily Hough, PDA
Being at PDA for a little more than two years has given me multiple opportunities to learn about the challenges in production and delivery of drug products. But, when I was told there was another occasion to discover even more about the complexities of drug product transport and storage, I jumped at the chance and signed up for the PDA New England (NEPDA) Chapter event.
The meeting featured a facility tour of Masy Systems, Inc. and a dinner meeting with two speakers on the topic of shipping logistics. Masy provides validation and calibration services and controlled storage for biopharmaceuticals, pharmaceuticals and medical devices.
On March 10, I flew into Logan International Airport, where Chapter President Jerry Boudreault very graciously met me and drove me over 46 miles to the Masy plant in Pepperell, Massachusetts. Once there, I, along with other participants, was escorted to areas of the facility designed for the storage of temperature-sensitive product. Guides at the facility explained Masy’s calibration techniques and how the firm handles client notification when the system goes out of spec.
Next, visitors heard about Masy’s routine monitoring that involves thermocouples that test for temperature and produce a reading every ten minutes. The firm is currently converting to wireless sensors in place of the thermocouples.
A highlight of the tour was Masy’s new BioPharma Storage facility. There, participants were exposed to the innovative ways that the firm has improved temperature-controlled storage for biopharmaceuticals. For example, even though the new facility was on the same campus as Masy’s older facility, the BioPharma Storage warehouse operates with a different shipping code to ensure that the cold chain will not be broken by mistakenly going to the wrong building. Once a product has been received at the facility, it is unpacked into an environment that identically matches the temperature conditions in which it arrived. The facility is equipped with cryogenic, as well as reach-in and walkin cGMP storage. Storage temperature is also available at ambient and ICH stability conditions. To reduce the risk of product loss, the warehouse has two independent generators each capable of running the entire facility for 3 days, triple redundant HVAC system and a LN2 backup. According to Masy, there are only two other facilities like this in the world.
After the tour, it was time to go to the dinner meeting. The meeting opened with Jerry announcing the winner of the Chapter’s student scholarships. Four $1,000 scholarships were granted to members of the NEPDA student chapter who attend Middlesex Community College.
The first speaker, Anthony Rizzo, focused his presentation on recently released PDA Technical Report 46: Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User, which was developed because of the lack of guidelines from the handoff of a product from the manufacturer to the end user. Anthony noted that the task force was currently working on developing training documents from the technical report.
When in transit, products are dependent on available technology, weather conditions and the method of shipping. For example, when shipping by air, it is necessary to take into account pressure differences that can impact packaging. When moving temperature-sensitive product without protective packaging by truck, shippers need to ensure that the truck is maintained and qualified to be able to control a specified range of temperatures. During his presentation, I discovered that load planning is an extremely important task. When shipping, it is important to ensure that air flow within a refrigerated container can be moved around without any heaters, otherwise, its ability to hold temperatures will be greatly reduced.
The most common challenges, Anthony said, are when shipments are moved to different modes of transportation. For example, when a product is placed into a container with insulation and heating and cooling elements that rely on external power when shipping by sea and moved once the ship is docked to a truck, there is a chance that there would not be an external power source.
“Those handoffs are critical areas that really need to be focused on.” Anthony said contingency plans are important to reduce risks that can come up due to major weather events, lack of necessary equipment or malfunctions of equipment.
His talk drove home that the regulations and guidelines for wholesale distribution are incomplete. So even though manufactures are highly regulated, once a product is handed off, it is a “crapshoot,” Anthony asserted. For example, a patient orders a product that has gone through a temperature-controlled supply chain, but when it gets delivered from a pharmacy, it sits on the patient’s doorstep in the sun for hours.
The next speaker, Jim DiTolla, gave his account on how to avoid logistical nightmares pertaining to shipping. He has noticed that at every point of the chain of logistics, compliance issues have occurred.
The most important step, he said, is to properly classify and label the material correctly to avoid negative consequences like fines or rejection of the shipment by customs officials. I learned that understanding all of the relevant regulations and keeping abreast of changes is critical to maintaining the proper paperwork.
There are three categories of regulations:
• The IATA regulations: These are the regulations that are handed by a governing body that will allow you to put goods on an aircraft in a safe and proper manner to an airline to ensure safety is maintained. Jim said that if you bring a product to the airport that is not up to IATA code, it can get rejected on the spot and that will hurt your shipping times. He also mentioned that customs sometimes holds up products because of missing paperwork, which might result in a loss of product if cold chain is broken.
• Import/Export regulations: This varies by government, material you are shipping and where you are shipping to. For example, you can ship one product to Spain with one specific permit, but a different permit must be used if you are shipping to Italy. This is because every county has their own specific regulations. Jim reminded audience members to check countries regulations often, as they change frequently.
• Trade compliance issues: Every item that is imported to a country has a specific code on it that allows a government to determine a percentage of a tax to the importers material so that they can collect money when the shipment has been cleared based upon the commercial value of the product and percentage of the tax that was assigned to the product. Fines can occur if the price of a product has been misreported.
Jim reminded members to do as much front-end work as they could before they ship products to other countries. Use of an experienced customs broker in each specific country can be helpful, he said. It struck me, at the meeting, that the complexities to drug product transportation are truly numerous, and it is amazing that so few incidents do occur. Until the pharma industry solves the problems that arise from transporting product that are in the supply chain, contingency plans are still the best bet on avoiding the loss of a product.
PDA Who’s Who
Jerry Boudreault, President, Drug Development Resources and President of the NEPDA Chapter
Jim DiTolla, OPS Manager, Biocair
Anthony Rizzo, Strategic Account Engineer, Cold Chain Technologies
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