In today’s fast-paced pharmaceutical industry, ensuring the safety and efficacy of medications is of paramount importance. While much attention is given to the development and manufacturing processes, it’s equally crucial to focus on pharmaceutical packaging testing to safeguard the integrity of the products.
When a pharmaceutical product is ready to be distributed after leaving the laboratory, it encounters new circumstances that jeopardize its integrity. Factors such as extreme temperatures or shocks during transportation can potentially impact the product’s quality and lead to financial losses.
Stability studies for pharmaceuticals are conducted with the aim of anticipating potential issues that may arise throughout the entire journey of a pharmaceutical product, starting from its departure from the laboratory to its ultimate destination – the end user. Among the various testing methods available, pharmaceutical packaging testing holds significant importance.
These tests aim to predict how the transportation process will influence pharmaceutical products and play a crucial role in assessing the durability and resilience of the packaging. All of these efforts have a singular objective: to ensure that the products reach their destination in impeccable condition.
Why conducting pharmaceutical packaging testing is recommended
Keeping pharmaceutical products safe during transport is extremely important. Therefore, it’s vital to make sure these medicines keep their quality, which is necessary for their safety and effectiveness, as proven by lab tests.
Today, the pharmaceutical distribution system is complicated, with many people involved. To maintain the quality of medicines, it’s crucial to closely oversee the distribution process and be ready for any potential issues.
Transporting any item involves careful planning, including choosing the right packaging and transportation method. When it comes to medicines, this planning has to be especially thorough because pharmaceuticals are unique.
That’s why, during the distribution process, we must be careful to avoid certain risks that could harm the quality of pharmaceuticals:
- The pharmaceutical cargo may experience vibrations, accelerations, decelerations, and shocks.
- All of these factors have the potential to result in breakages, deformities, or changes in the cargo, which could endanger the quality of the medications.
Ensuring Product Safety
To ensure that pharmaceuticals reach their destination in pristine condition, identical to their state when they departed from the laboratory, it is imperative to conduct pharmaceutical packaging testing as a component of a pharmaceutical product stability protocol.
In simpler terms, besides the usual tests that check the physical, chemical, microbiological, and toxicological aspects of medicines, it’s also crucial to run simulation tests that mimic the conditions medicines will face during shipping. These tests help us figure out the difficulties the medicines might face.
- The distribution conditions a shipment will encounter can be replicated using purpose-built machines. This approach enables the anticipation of potential risks and the implementation of appropriate measures to identify the most suitable packaging for the specific product.
- Through the execution of pharmaceutical packaging testing and packaging engineering procedures, it becomes possible to optimize the product-packaging system. This optimization helps in avoiding unnecessary expenses, such as excessive packaging that could increase costs for the company, and insufficient packaging that could compromise the safety of the goods.
- When applied within the pharmaceutical sector, packaging tests constitute just one element of stability testing for pharmaceutical products. This comprehensive testing ensures the safe and intact arrival of medications at their intended destination.
How to prevent issues in the transportation of pharmaceutical products
Pharmaceutical stability studies serve the purpose of determining how long a medication can maintain its suitability for consumption when stored and transported under specified conditions in its original packaging. This proactive approach aims to mitigate any potential issues that could occur throughout the distribution process.
In alignment with this objective, several actions can be implemented concerning the packaging and transportation of pharmaceutical products:
- The packaging for pharmaceutical products should include details enabling the identification of the medicinal item, such as its components, recommended dosage, and expiration date. Additionally, it should provide guidelines on the optimal practices to maintain the product’s quality.
- To ensure the safe delivery of medicinal products, it’s vital to conduct pharmaceutical stability tests that consider factors like expected external temperatures during transport and potential delays in the distribution process, including 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.
The establishment of a pharmaceutical product stability protocol provides insight into the essential procedures required for the storage, distribution, and transportation of pharmaceuticals. This includes identifying appropriate equipment and facilities for the distribution process, as well as selecting the most suitable packaging, with the assistance of experienced and trained personnel.
What is the legal framework that regulates the transportation of pharmaceuticals?
To ensure the preservation of pharmaceutical products throughout the distribution process, a legal framework is in place to govern their transportation.
Conducting a stability study on pharmaceutical products also ensures compliance with these regulations during the storage and transportation of medicinal products.
On November 6, 2001, the European Commission put in place Directive 2001/83/EC. In this directive, articles 84 and 85(3) talk about how to keep medicines safe during transport. It’s a rule that emphasizes the importance of protecting medicines during transportation.
In addition, following Directive 2014/47/EU is vital to make sure cargo stays safe and in good condition when it’s moved on European roads. This rule applies to all companies and logistics firms that transport goods on roads within the European Union.
Regulations ensuring cargo security and road transportation safety
Cargo securing regulations have been established to address the vital need for ensuring the safety of goods transported on our roads. These regulations are not just about paperwork; they’re about safeguarding both products and people. Specifically, they highlight the critical importance of securing freight in a way that can withstand the forces of acceleration and deceleration.
Inadequate cargo securing poses a double threat. Firstly, it can lead to deformations or damage to the goods being transported, resulting in financial losses. Secondly, and more alarmingly, it contributes to a significant number of accidents on the road. In fact, an estimated 25% of truck accidents can be traced back to improperly secured cargo.
To combat these issues, Spain introduced a regulation as a proactive measure to prevent such accidents. This regulation, known as Royal Decree 563/2017, came into effect recently. It assigned the Directorate General of Traffic (DGT) the responsibility of inspecting vehicle loads, a task they’ve been carrying out since May 2018 to ensure compliance with the law.
Here’s a closer look at what the regulation entails: visual inspections will be conducted by police officers, while more comprehensive inspections will be performed by trained agents. These inspections are scheduled to occur annually and will affect at least 5% of vehicles traveling on Spanish roads.
Furthermore, the regulation recommends the use of a specific test called EUMOS 40509:2012 to assess the stability and safety of cargo through packaging testing. This test is a game-changer when it comes to evaluating real-world conditions that cargo will encounter during transport. It helps us anticipate potential issues and develop effective solutions.
In the context of cargo safety, pharmaceutical packaging testing and transport simulations are especially significant. They allow us to replicate the conditions that cargo faces during transit, helping us fine-tune our approach.
The EUMOS 40509:2012 test is primarily intended for use by packaging laboratories and experts in freight safety, particularly those in the field of packaging engineering. Notably, only a select few specialized machines, like Safe Load’s Stability Tester, have the capability to conduct this crucial test.
Stability Tester by Safe Load: the essential equipment for conducting pharmaceutical packaging tests.
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
- Performs stability tests in accordance with the EUMOS 40509 method, ensuring compliance with European and national regulations.
- Helps avoid potential delays and increased distribution costs due to roadside inspection tests.
- Provides reliable, real results to protect and secure the pharmaceutical products during transportation.
- Ensures products arrive at their destination intact.
- Offers the flexibility to design personalized machine models specific to each project’s requirements.
- Suited for the unique demands of pharmaceutical product transportation.
- Allows for personalized tests, such as simulating forces experienced during roundabout maneuvers and other relevant scenarios.
- Intuitive machine operation for easy use.
- Simple system maintenance to facilitate accessibility to pharmaceutical product packaging testing results.
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.