When a pharmaceutical product leaves the laboratory for distribution, it faces new conditions that put its integrity at risk. Extreme temperatures or shocks during transportation may affect the product’s quality and cause economic losses. Stability studies of pharmaceuticals are performed with the purpose of foreseeing possible issues that may emerge during the process, from the moment a pharmaceutical product leaves the laboratory until its final destination: the user. Among the many available tests, pharmaceutical packaging testing is of vital importance.
These tests forecast estimate how the transportation process will affect pharmaceutical products, and help determine the strength and stability of the packaging. All of this with a single purpose: for the goods to arrive in perfect state to its destination.
Index hide4 Which legal framework governs the transportation of pharmaceuticals?5 Safe Load’s Stability Tester: the key for pharmaceutical packaging testing
Why it is advisable to perform pharmaceutical packaging testing
When transporting pharmaceutical products, product conservation is paramount. It is therefore essential to ensure that the medicinal products maintain the characteristics that ensure their safety and effectiveness, as certified by the laboratory.
The pharmaceutical distribution network is nowadays highly complex, with a great number of players involved. In order to maintain the quality of pharmaceutical products, the distribution cycle needs to be comprehensively controlled, taking into account any issues that may arise.
The transportation of any item demands a contentious research process: the package to be used and the best transportation method are some of the subjects to be addressed.
In the case of medication transportation, this research process must be particularly thorough due to the special nature of pharmaceuticals.
It is for this reason that, during the distribution process, there are certain risks that need to be avoided, which might endanger the integrity of pharmaceuticals:
- On one hand, the pharmaceutical load may be subjected to vibrations, accelerations, decelerations and shocks.
- All of this may lead to breakages, deformations or alterations in the load, which might put the quality of the medications at risk.
In order to guarantee that the medications will arrive at their destination in perfect state, just as they were when they left the laboratory, pharmaceutical packaging testing needs to be performed as part of a pharmaceutical product stability protocol.
In other words, in addition to the qualitative and quantitative physical, chemical, microbiological and toxicological tests, transportation simulation tests are also essential to discover the conditions that the pharmaceuticals will withstand during the distribution cycle:
- The conditions that a load will be subjected to during distribution can be reproduced through the use of machines created for this purpose. In this way, it is possible to foresee risks and act accordingly, finding the most appropriate packaging for the product in question.
- The product + packaging system may be optimized through the performance of pharmaceutical packaging testing and packaging engineering processes, preventing unnecessary costs. This will allow for over-packaging – which would result in higher costs for the company – and under-packaging – which would affect the safety of the goods – to be avoided.
- When applied to the pharmaceutical sector, packaging tests are just one aspect of stability testing in pharmaceutical products which will ensure that medications arrive at their destination intact.
In order to guarantee that the medications will arrive at their destination in perfect state, pharmaceutical packaging testing needs to be performed as part of a pharmaceutical product stability protocol.
If pharmaceutical packaging testing were omitted, the consequences might go beyond incurring losses for the company, since the medication might be compromised and suffer alterations.
In light of this, it will be up to the wholesaler to protect the medications from hazards that might endanger the quality and integrity of the product.
How to avoid problems during the transportation of pharmaceutical products
Stability studies of pharmaceuticals allow to establish the period that a medication remains in conditions suitable for consumption in its original packaging, as per the storage and transportation conditions established for a product, thus preventing any problems that may arise during the cycle of distribution.
In line with this, there are certain measures that can be taken in regard to the packaging of pharmaceutical products and their transportation:
- On one hand, the packaging of pharmaceutical products should contain information that allows the medicinal product to be identified: its components, posology and expiration date. The best practices to keep it in perfect state should also be stated.
- In order to ensure that the medicinal products arrive at their destination without being compromised, pharmaceutical product stability tests related to situations that might affect the stability of the medicinal product should be performed, including factors such as the expected external temperatures during transportation, or the effect that the distribution time may have (including, among others, customs clearance times).
- The medicinal products should be transported in containers that guarantee their safety. These containers should, additionally, contain more information about the right conditions for storage of the goods, in addition to the necessary precautions to be taken when handling and securing the load.
- The use of specific medicinal product transportation vehicles would be most appropriate. If non-specific vehicles are to be used, procedures should be put in place to guarantee the safety of the medicinal products during transportation.
In summary, setting up a pharmaceutical product stability protocol will allow you to know which processes are necessary for the storage, distribution and transportation of pharmaceuticals. Among others, the right equipment and spaces for the distribution cycle may be determined, in addition to the most suitable type of packaging, with the support of qualified, trained personnel.
Which legal framework governs the transportation of pharmaceuticals?
In order to guarantee that pharmaceutical products remain free from alterations during the distribution cycle, a legal framework governs their transportation.
A stability study of pharmaceutical products will, therefore, also ensure that these regulations are complied with during medicinal product storage and transportation processes.
On November 6, 2001, the European Commission published Directive 2001/83/EC, whose articles 84 and 85(3) regulate the good practices for the distribution of medicinal products for human consumption. Among others, this regulation establishes that the conservation of medicinal products should be a priority during transportation.
Directive 2014/47/EU, which guarantees the safety and rigidity of the freight during road transportation, must also be complied with. This regulation affects all corporations and logistic companies that transport goods by road in intra-community countries.
These regulations are the result of the need to regulate the securing of cargo and, thereby, guarantee the safety of road transportation
These regulations are the result of the need to regulate the securing of cargo and, thereby, guarantee the safety of road transportation. More specifically, it states that freight should be secured so as to withstand accelerations and decelerations.
- An inappropriate cargo securing may lead not only to deformations or damages in the products being transported, but also in serious problems: it is estimated that 25% of accidents involving trucks are the result of improper and hazardous cargo shifts.
- This regulation emerged as a means to avoid preventable accidents, and is incorporated to Spanish regulations starting this year by means of Royal Decree 563/2017. It is established that the DGT will be in charge of inspecting vehicle loads since May of 2018 to certify that they comply with the laws in effect.
- More specifically, it specifies that police officers are to make a visual inspection, and qualified agents are to perform a more accurate inspection. These inspections will take place yearly and affect at least 5% of vehicles travelling on Spanish roads.
In addition, the regulation proposes the use of a specific test known as EUMOS 40509:2012, for the purpose of evaluating the rigidity and safety of a load by means of a packaging test.
This test allows for the observation of the real conditions that a load will face during transportation, in order to foresee possible problems and find solutions:
- In this regard, pharmaceutical packaging testing and transport simulations are of great importance, since they allow for the conditions that the cargo will be subjected to during transportation to be reproduced in a real way.
- This test is aimed at packaging laboratories and freight safety experts, in the context of packaging engineering. Only a few specialized machines, such as Safe Load’s Stability Tester, are capable of performing it.
Safe Load’s Stability Tester: the key for pharmaceutical packaging testing
Safe Load Testing Technologies’ Stability Tester is a transportation simulation tool that mimics the real conditions that a load will be subject to during transportation:
- The horizontal stability machine is used to foresee and simulate the possible scenarios in which a load might be compromised during transportation.
- It thereby allows you to ensure that the packaging of a pharmaceutical product is adequate in regard to safety, costs for the company, and regulation compliance.
By using the Stability Tester it is possible to perform tests that simulate horizontal accelerations (acceleration, slowdown and braking) and decelerations.
In addition, these tests are carried out in environmental chambers that simulate the temperature and humidity that the medicinal products will be subject to during transportation. This guarantees that the tests are as close as possible to the real situations that the pharmaceuticals will face.
The horizontal stability machine is used to foresee and simulate the possible scenarios in which a load might be compromised during transportation
The advantages of using Safe Load Testing Technologies’ Stability Tester
Using Safe Load Testing Technologies’ horizontal stability machine implies a number of advantages in the transportation of pharmaceutical products, both in regard to regulation compliance and in guaranteeing product safety.
- On one hand, the Stability Tester is designed in a way that allows it to perform a stability test in accordance with the EUMOS 40509 method. This means that all players involved in the distribution of the medicinal products will be guaranteeing the compliance with European and national regulations.
By using this machine, the company ensures the readiness for roadside inspection tests that might delay or increase the cost of the distribution cycle.
- On the other hand, the horizontal stability machine goes one step further: not only can it be used to comply with regulations, but it also offers reliable, real results to secure the load and protect it, so that it arrives intact at its destination.
In this regard, the machine aims to accommodate the needs of each project, which means that it is possible to design an ad-hoc, personalized machine model, suited to the needs of each project.
- When used for the purposes of pharmaceutical stability testing the horizontal stability machine can be tailored to the special needs of the transportation of pharmaceutical products.
It is also possible to perform personalized tests, such as simulating the forces undergone by loads when entering a roundabout, among other tests.
The machine is also intuitive and its system is easily maintained, to make obtaining pharmaceutical product packaging testing results easy and accessible.
What are pharmaceutical product packaging tests like on the Stability Tester?
Safe Load Testing Technologies’ horizontal stability machine performs transportation simulations for pharmaceutical product packaging testing as per the EUMOS 40509 standard.
For its tests, the machine has an anti-skid steel platform and side protectors that prevent any load from falling off. It also has a steel basket that slides on the platform.
The pharmaceutical product load is placed in the basket, in order to determine the possible motions and hazards that it will have to face during transportation. During the process, the basket is pushed in a way that it performs the accelerations and decelerations involved in the test, allowing the behavior of the load to be observed under similar conditions to those found during transportation.
If you want to know more: Maximize cargo securing during transport with EUMOS 40509
In this way, the machine evaluates the rigidity and stability of the load in compliance with the laws in effect on the matter of goods transportation. More specifically, as per Royal Decree 2017/47/EU, a load should be able to withstand 0.8G in the direction of travel and 0.5G perpendicularly to the direction of travel.
Using Safe Load Testing Technologies’ horizontal stability machine, pharmaceutical product packaging testing will allow you to determine whether the load is ready for transport, or if more research is needed to optimize the packaging.
At Safe Load Testing Technologies we can help you manage your packaging research processes related to the study of stability in pharmaceutical products.
Get in touch with us and we will work together to find a solution tailored to your packaging needs.