If your company transports or dispatches pharmaceutical products, medical tests, or biological samples, you will likely be well aware that these shipments need careful handling.
Whether fragile, temperature-sensitive, or with a narrow time window of viability, pharmaceutical storage standards are exacting.
Below, you will find the essential requirements involved in pharma shipping and storage. If you are a decision-maker in manufacturing, laboratory testing, or medical supply, please read on. Below, we offer time-saving advice and valuable tips.
Inevitably, all pharmaceutical shipping chains involve temporary storage locations and hubs between production and the end-user or the laboratory and healthcare facility. So what are the critical criteria for pharma shipping and storage sites?
If a warehousing company is to be a suitable business partner for a pharma manufacturer, it must provide written documentation regarding policies, distribution, inventory, and procedures.
In addition, the pharmaceutical storage facilities must meet the following requirements:
Fulfill GMP (good manufacturing practice) standards.
Have sufficient ventilation and lighting.
Be able to store drugs without specific environmental prerequisites at room temperature.
Have sufficient space for storage, maintenance, and inspections.
Have a dedicated quarantine area for drugs that are no longer usable.
Have indoor and outdoor security systems to prevent unauthorized entry and theft.
Know Your Supply Chain
Your company should check the environments that products will pass through to reach the end-user, be it a pharmacy, laboratory, hospital, or end-user in a Direct-to-Patient (DtP) application. Firstly, verify the quality and completeness of scientific knowledge and technical information about each product.
Next, to ensure that your pharmaceutical storage and distribution chain meets the specified requirements, you should audit proposed business partners in the sequence.
Then, where applicable, confirm that any subcontractors are qualified. At the same time, keep records and prepare the necessary documentation, taking the time to issue clarifications or organize staff training sessions if needed.
Finally, for effective management of temperature-controlled pharma shipping chains, it is helpful to ask yourself: what would an audit inspector or regulatory body want to know?
Self-auditing and checking compliance with regulations in advance will help prepare you for a successful formal audit.
LIBERO ITS Electronic Indicator
Collect all the data you need electronically: start, lowest temperature, highest temperature, alarms, stability budget, etc.
Turning to specific shipping requirements for the product, your preparations and approach may need to widen if the transport or logistics operator is separate from the warehousing company. In all cases, you should verify the transport company's credentials, badges of approval, reliable operating capacity, and pharma shipping procedures. Does their way of working take into account the nature of the pharmaceutical product(s) concerned and any special precautions necessary?
At this stage, you might find the following checklist helpful:
Is shipping to be by road, air, or sea? Perform a risk analysis of the route, including temperature monitoring and verification methods.
Choose the right packaging based on the product characteristics and anticipated environmental requirements: temperature, humidity, and exposure to light.
Determine the appropriate manufacturing process to meet the shipment size.
Identify how much you intend to ship in each consignment. Dividing the products between multiple shipments minimizes the risks of wastage and negative patient impact. It also mitigates the risk of loss if temperatures exceed limits during distribution.
Based on the step above, agree on a workable schedule of shipments.
Identify Packaging and Distribution Requirements
Packaging and distribution may vary considerably in line with the product, customer or patient, and best healthcare practices. For instance, is a dry ice or cryogenic refrigerated container required?
In cryogenic transport chains, the development of kit designs or product packaging has to take the dimensions of cold chain shippers into account. In addition to observing safety precautions, staff must remember to ensure that samples or products do not touch the liquid nitrogen directly because this could adversely affect the quality.
European pharmaceutical shipping guidelines state that the transport of pharmaceutical products should be such that it does not impair integrity. For temperature-controlled supply chains to be flexible and viable, management must plan clinical packaging at the earliest opportunity and with any product or kit complexities in mind.
In particular, glass vials are fragile and require protective packaging. Careful handling is essential, while movement limitations and correct package orientation often apply.
Apart from the heating effect and temperature implications, it is vital not to leave light-sensitive products exposed to the sun and bright daylight. Extreme temperatures and humidity can affect adhesiveness and package or consignment labels.
Logically, clinical trials with demanding or short timelines might leave little time available to customize labels. In contrast, with sufficient margin for planning and preparation, purpose-designed packaging solutions are possible.
Finally, the frequency with which expiry dates change will influence the supply chain and packaging. Including this detail at the planning stages should help to minimize waste.
Apply Box-Level Indicators to Shipments
Using kit-level environmental monitoring devices provides warnings of temperature excursions or proof that the products have remained within the specified conditions, thus guaranteeing the integrity of the goods. However, for best results, you should choose the right indicator for the consignment(s) in question and ensure proper positioning.
Electronic box or kit-level indicators are simple to apply and have an easily-visible quality status. Automatic communication of status and transfer of data is straightforward using smartphones, tablets, or computer devices.
Automatic Roll for ITS Application on Package by Dividella
Recently, the implementation and successful rollout of a pioneering packaging project saw ELPRO work in partnership with Dividella, an engineering automation company. The joint venture addressed a manufacturer's growing need.
In light of the constantly growing number of patients receiving personalized drugs and gene therapies, a leading pharma company needed to ramp up production volume and packaging speed. However, the manual attachment of box-level temperature recording labels was proving to be a bottleneck.
After automating the application of compact wireless LIBERO ITS temperature indicators, the manufacturer's production line can now attach and start up to 40 indicators per minute. The add-on robot module also sets the labels to start logging environmental data.
This quick, reliable, and consistent automation allows serialization, fast cataloging, and statistical reports. In turn, pharmacies and hospitals benefit from product protection and improved stock availability, while patients can count on their medicine(s) being safe to use.
LIBERO ITS temperature monitoring solutions are compliant with and certified under WHO PQS E006, an approval that confirms performance, quality, and safety. Additionally, certification of NIST-traceable calibration, GAMP 5 validation and IATA compliance all underline the impressive credentials and suitability for pharmaceutical shipping applications. Conveniently, no battery declaration or additional paperwork is necessary.
Low-Cost Kit Packaging Solution
Temperature Monitoring on the Box!
Automated application to square bottles: ITS by Faubel
ELPRO and Faubel now offer the Faubel-Compact® Label with an integral LIBERO ITS wireless temperature indicator to facilitate compliance with regulations and guidelines. In what promises to deliver considerable manufacturing efficiency savings, multi-language product labeling and protection is now swift to apply.
Simply apply the square-shaped LIBERO ITS indicator directly to the Faubel label to ensure it stays on the product. The device is straightforward to start through a corner tab. From filling via storage and transport to the patient, the state-of-the-art sensor then monitors temperature deviations.
The device logs data and provides status reports with downloadable documentation and statistics via a smartphone application. Usefully, the solution includes secure cloud archiving. As well as unmatched quality assurance, a long-life battery ensures reliable readouts for as long as four years during pharmaceutical shipping and storage.
Compared to conventional data loggers, LIBERO ITS is considerably slimmer and more compact. It is possible to apply product booklet labels, including the temperature indicator, in a single, efficient action during the packaging stage.
Above, you have reviewed the critical considerations of pharmaceutical storage and transportation at a kit level. To comply with regulations and guidelines, pharma manufacturers must apply labels directly to products at the manufacturing stage. There are ways to document pharmaceutical shipping and storage temperature conditions at kit or box level during the entire supply chain.
ELPRO is a global leader in environment monitoring solutions for storage and supply chains, with particular expertise in data monitoring and GxP services. With its three decades of experience, ELPRO enables you to boost efficiency, make medicine safe for patients and manage compliance throughout your pharma shipping chain. For more advice or to discuss your requirements, please contact us today.