|Infobox on Pharmaceuticals|
|Example of Pharmaceuticals|
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|Humidity / moisture||-|
|Risk factors||See text|
The pharmaceutical industry develops, produces, and markets drugs or pharmaceuticals licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices. They are subject to a variety of laws and regulations regarding the patenting, testing and ensuring safety and efficacy and marketing of drugs.
The world of pharmaceuticals continues to develop with new and improved products launched after expensive research and clinical trials. Many different pharmaceuticals are supplied worldwide, and some require temperature controlled storage and distribution to maintain their efficacy and other properties. Until fairly recently, long distance distribution of products needed without delay has been undertaken by air. In recent years, however, there has been a trend to move some of these products by sea in refrigerated containers. Clearly, products must have sufficient storage lives for the complete chain, and the carrier needs the required expertise and level of diligence to ensure successful outturns. The carriage of pharmaceuticals and intermediaries is already established on many trade routes with different transit times. Two examples are the increasing use of Ventolin (an aid to breathing) carried at chilled temperatures, and blood products moved as frozen cargoes. Some cargoes can give significant cold chain challenges if they are temperature sensitive or have a very high value. When both the sensitivity and high values of a pharmaceutical shipment combine, a careful and systematic approach to the planning and carriage must be undertaken.
Most people employed in reefer container shipping will only see, or be prescribed, a relatively small number of pharmaceuticals in their lifetimes. There is less knowledge of their needs than when moving large amounts of food on well-established routes. It may be helpful to consider the features of an equivalent class of food product in transit. A big difference is that many pharmaceuticals have a very much higher value than the equivalent volume of food products. They are also regulated by national or state medicines agencies that have several similar roles to foods standards agencies.
Shipment / Storage
Pharmaceuticals should be carried in integral containers with good refrigeration capacity, high internal airflow rates and an ability to provide the required temperature control.
Following the stuffing of the cargoes into containers, they require the capability to deal with the heat loads to which they may be subjected.
Pharmaceuticals are often transported in reefer containers, in nominated temperature zones. The shipper should understand that, in the chilled mode, the control point is the supply air sensor. The return air temperature at the return air sensor is the control point in the frozen mode. It is important that customers understand that cargo temperatures are not controlled directly by the refrigeration system.
Carriers are contracted to supply temperature controlled air to containers to meet shippers' (bill of lading) requirements and do not directly control product temperatures. The following are not exclusive but are given as a guide:
Many pharmaceuticals require an environment in the +2°C to +8°C range. These products must not freeze or become too warm in transit so that their potency, release potential, colloidal suspension or other properties are affected. They vary in their sensitivity, but the most sensitive could be considered somewhat similar to chilled meat for carriage. The container set point is normally in the above range and +4°C or +5°C are often used.
Temperatures colder than minus 18°C are specified for some products. They are often sensitive to temperature fluctuations as well as needing a cold base temperature. A temperature set point of minus 25°C for containers is often requested. Serious thawing can often be observed by eye, but changes in protein structure, or other changes, through invisible temperature fluctuations require laboratory assessment.
The shipper may request relatively dry air circulated in the containers. Many modern containers are fitted with a dehumidifier, so can offer a value-added service to reduce the relative humidity (RH). The RH is measured and controlled by a probe in the refrigeration unit. It does not represent the actual RH throughout the cargo space, which is difficult to measure accurately, and a tolerance of at least +/-5% over the available range should be expected.
Fresh air ventilation
Fresh air ventilation is not expected for chilled pharmaceutical cargoes, but the need should be checked before bookings are accepted. Ventilation volumes should be kept as low as is essential. This is to ensure that better temperature control is maintained (with evaporator coil defrosting kept to a minimum).
Some materials are hazardous and must be declared as dangerous under the International Maritime Organization (IMO) rules. These cargoes require a trained person to assess documents including Material Safety Data Sheets (MSDS).
European Union regulations require the services of a qualified dangerous goods safety adviser (DGSA) to be used by relevant distribution companies outside the shipping industry. Shippers are required to declare and label classified products correctly as they know the properties of the materials and packaging.