Achieving compliance in biological sample transportation
For a substantial timeframe, national research corporations, hospitals, major universities and military departments with forensic responsibilities have dominated the market in regard to the transportation of biological materials.
That was until the market was saturated with an influx of IROs, CROs, private healthcare facilities and other providers, all bringing ‘compliant’ and seemingly safety-assured sample transportation packaging solutions to market.
With a list of regulatory expectations and lengthy sources to navigate, it can become difficult to identify a reliable, truly compliant supplier who can meet your biological sample transportation needs.
What does compliance mean to the customer?
The government’s transportation regulations put the onus on the packaging manufacturer to ensure that delivery gets to its intended destination in an acceptable condition. They are therefore responsible for using sufficient, high-quality packaging to ensure its safe arrival.
This is particularly critical when it comes to the challenging nature of biological sample transportation and the regulations surrounding biological materials. Compliance is crucial for both preservation and safety assurance, with a lot of boxes that need to be ticked for your packaging to comply with regulations.
Transport packaging must be constructed well enough to prevent product loss from variations such as temperature, humidity, or pressure. Biological sample transportation packaging must also be strong enough to withstand manual and mechanical handling that takes place when loading pallets or shocks encountered during transport.
It is required that any packaging solution that handles biohazards must consist of at least three components:
- A primary receptacle
- A secondary packaging
- Outer packaging
Further regulations are implemented depending on the mode of transport used, for example:
Air transport
Packaging must have a proven capability of withstanding varying pressure conditions, with either your primary container or secondary packaging certified at 95 kPa for both -40°C and +55°C temperatures.
The secondary packaging must be leak-proof, with full absorbent capabilities that could absorb the entire contents of the primary containers. The packaging and its contents should be contained within a rigid outer box.
Road transport
Packaging must have a proven capability of withstanding varying pressure conditions, with either your primary container or secondary packaging certified at 95 kPa for both -40°C and +55°C temperatures.
The secondary packaging must be leak-proof, with full absorbent capabilities that could absorb the entire contents of the primary containers. The packaging and its contents should be contained within a rigid outer box.
What does compliance mean to the customer?
It is essential that the transportation of any possible pathogenic organism from either human or animal sources adheres to the Dangerous Goods Regulations. Such regulatory standards are orchestrated by official bodies, such as IATA and ICAO. It’s their responsibility to organise the global regulatory standards for safe biological transportation.
Biological materials can be categorised into two types:
Category A
Category A pertains to any infectious sample that has the capabilities to cause permanent disability, life-threatening or fatal harm. As a result of the high-risk nature associated with category A contamination, there are strict regulations for its transportation. Category A substances are either assigned to UN2814 or UN2900.
- UN2814: Infectious Substance affecting humans
- UN2900: Infectious Substance, affecting animals only
Category B
Category B comprises of all remaining biological substances for the purpose of diagnosis or investigation only.
These substances do not have the same high-risk nature as Category A and do not pose the same threat severity. Samples within category B are assigned as UN3373 samples.
Compliancy requirements for Category B packaging
To ensure the integrity and safety of your UN3373 Category B samples, packaging must adhere to regulations such as the
Dangerous Goods by Road (ADR) and the IATA Packaging Instruction 650 guidelines. Category B packaging should confidently meet the following expectations:
- Drop Proof from 1.2 meters
- Absorbent (30ml capacity)
- Strong Outer packaging
- Leak-proof secondary package
- UN3373 labelled (minimum 50mm wide)
- Sender and contents identified
- 95 kPa compliant (primary tubes)
Cost How can a customer recognise a compliant product?
You can be confident in the compliancy of a UN3373 Category B packaging product if they have been examined against the above tests.
One issue that customers will often face, however, is that several industry leaders opt for in-house testing on their own products. This poses a significant issue for customers due to predisposed biases, making it difficult to verify their results as dependable and trustworthy.
Assured product compliance is better achieved via product testing through an accredited independent laboratory. Certified laboratories are the only true facilities that can objectively and reliably perform independent Category B packaging testing in line with regulatory expectations.
We understand the importance of ensuring our products are of the best quality and compliance, certifying that our product range adheres to the strict regulatory demands for safe sample delivery.
Take our UN3373 Category B packaging solution, safeTpouch, as an example. This secondary packaging solution is independently tested by an ISO 17025 accredited lab, with certification of independent testing supplied to you upon request.
Opting for uncertified products, whether it’s unknowingly or not, can pose a significant risk to your secondary Category B packaging. You increase your sample’s susceptibility to leaking, with compromised safety, and increased costs, all of which can cause delays in your supply chain.
How to choose a complaint Category B packaging partner
It’s difficult to try and navigate the current market and understand which companies to trust, and which to avoid. There are a few key factors to consider when assessing the package integrity, these include:
Streamline your specimen packaging and transportation with RDi
Compliance accreditation
If a product has passed all compliance requirements through an independent laboratory test, then the business will be provided with certification, which should be available for all customers to view upon request. Certification is the easiest way to feel assured that a company has adhered to the strict regulations testing that is required to be P650 approved.
Assessing provider reputation
Get to know the company you’re working with. Understanding their reputation as a provider, their environmental awareness, their history within the industry and the experience they have, can all provide a good indication as to whether they’re a business you want to use.
Accolades such as industry awards and contributions can be tell-tale signs for the type of company they are. At RDi, we have always been proud of our 2021 UK packaging award, which champions our innovative secondary packaging design through its substantially reduced plastic usage.
Assessing provider capabilities
We understand the importance of finding a quality provider, who is not only compliant with regulations, but also has a sound reputation within the industry.
Our purpose-built facilities allow for cost-effective, compliant, bespoke solutions for our healthcare clients. We focus on innovative designs that use minimal plastic to diminish environmental impact as well as being optimised for both safety and usability.
Ensure safe biological sample transportation with RDi
Given the ambiguous compliance conformity within the market, it’s highly valuable to partner with a provider that you can trust. At RDi, we are so confident in our capabilities and testing, that we offer a 100% compliance guarantee to our customers.
With our award-winning Category B packaging solutions, we are able to ensure safe transportation of any UN3373 biological substances. Our range of secondary packaging, outer packaging and end-to-end medical kitting services involves strict QC manufacture that is overseen by our Compliance team to the highest possible quality.
Our safeTpouch is not only independently tested, but it can also offer a standard or 95 kPa solution for secondary packaging via road or air, helping to provide customer reassurance and confidence for safe biological sample transportation.
Looking for an end-to-end sample packaging provider? Get in touch with our team today to qualify a fully compliant solution fit for your business needs.