An ultimate guide to biosafety during UN3373 transport
Since the rise in at-home testing, the biosafety of clinical and diagnostic samples during collection and transportation is an issue that has been repeatedly brought into the public eye.
Home testing kits have now become a commonplace household item. This means that safety assurance is crucial not only for laboratory staff but also for the public and postal workers who could handle the package at any stage of its journey.
Ensuring biosafety throughout the lifespan of a sample’s transportation time involves satisfactory UN3373 transport compliance of packaging, all whilst still meeting the commercial aims of the healthcare distributors and receptacle facilities.
In this blog, we’ll address the expectations of compliant packaging as well as how biosafety transport solutions can deliver on wider commercial requirements.
Biosafety in biological sample transportation
During sample transportation, biosafety involves the processes in place to minimise the risk of exposure to potentially infectious agents or hazardous materials. This includes all UN3373 Category B substances, such as our diagnostic and clinical trials samples.
Adherence to regulations, guidelines, and best practices is essential to prevent contamination, spills, or other incidents that could compromise the integrity of the samples or pose a risk to human health.
UN3373 regulations explained
Samples that are packaged and shipped under the remit of UN3373 Biological Substance Category B must contain a primary receptacle for the substance, encapsulated within a secondary package and then a rigid outer package.
There must be an absorbent material within the package to prevent spillage, and the rigid outer package must be clearly labelled with all the relevant information and security warnings. When the package reaches its destination, the cultures must be handled in a Biosafety Level 3 (BSL-3) lab and under BSL-3 practices.
Navigating the compliance pathways of biological specimen transportation is made simple with our tree diagram resource. Simply navigate through the various compliance steps of packaging here.
UN3373 transport compliance within the GMP framework
Biosafety is not just about meeting regulatory requirements, it’s about protecting the health and safety of those involved in sample transportation. This includes laboratory staff and couriers who may come into contact with the samples during transit.
This wider expectation is linked to Good Manufacturing Practices (GMP), whereby manufacturers can improve and maintain their product quality whilst the protection of consumers of such goods is unaffected.
GMP guidelines account for many aspects of quality and safety, including:
People, Premises, Processes, Products and Procedures
GMP is active in ensuring public safety, however, it further saves manufacturers money by embedding a series of strict development stages. These prevent businesses from going to market with unsafe goods.
The average annual cost of maintaining GMP is estimated to be around £33,000 for a small business of less than 20 employees. The cost of recalling a product, however, can be in the billions.
One example is the recall of Rofecoxib (Vioxx), an arthritis medication made by Merck off the back of a noted increased risk of heart attacks. This cost the company $4.85 billion!
Addressing overuse of bio-safe plastics
As one of the most bio-safe materials available, single-use plastics continue to dominate the healthcare market.
More and more businesses however are not only looking for compliant materials but are looking to meet commitments to sustainability, reduced carbon emissions, more efficient procedures and operations and many other factors outside of their typical commercial drivers.
RDi works closely with stakeholders and executives across a range of healthcare organisations to ensure that our services and products continue to evolve to align with internal discussions.
Addressing the plastic problem is a major example. Replacing the use of plastic materials within the healthcare sector, however, is unachievable. What is achievable, is the dramatic reduction of plastic.
At RDi, our packaging goes above and beyond traditional biosafety considerations. Through the strategic use of bio-safe plastic materials, we can help to address your wider commercial goals and meet industry targets.
Our safeTpouch helps meet sustainability ambitions with a reduced plastic concept being fundamental to the core design. The plastic pouch enclosing the specimen tubes is typically 1gm LDPE, far lower than the standard 13gm LDPE – 19gm LDPE utilised in other market products. This means that incorporating the SafeTpouch within our sample packaging could reduce your plastic use by up to 95%!
This secondary packaging not only reaches new heights in sustainability but also provides additional efficiency to our customers through reduced costs associated with contaminated waste which would otherwise require incineration at a fee.
Outperforming UN3373 transport with RDi’s innovative products
Anything that can make your job a little easier, by default, improves safety. At RDi, we’re here to help combat some of the problems faced by laboratory staff, end users, couriers and healthcare professionals when handling these samples.
We recognise that what is required is a guideline towards exceptional customer service to ultimately improve kit completion rates whilst maintaining acceptable UN3373 transport standards.
Our products have been developed by life sciences professionals with decades of expertise in understanding what is expected from a sample collection packaging provider.
Not only is our packaging portfolio compliant with all UN3373 transport regulations and GMP guidelines, but we also work to actively elevate costs, simplify ease of use, and eliminate safety concerns associated with sample packaging.
The SafeTFIT, for example, includes additional safety features within its compact pouch design, including additional lining, absorbency and curved-edge features. Our safe2Pcanter incorporates a flat-packed, reduced plastic design to lessen shipping costs, limit damage during transportation and improve sample return rates.
Visit our product page to see the full outline of features of each component of the UN3373 compliant packaging, including the outer packaging, primary receptacle and secondary packaging and complete assembled kits.
For ultimate biosafety, choose RDi
We recognise that biosafety goes beyond packaging compliance and GMP protocol embedment. By curating a portfolio that addresses broader commercial goals, such as sustainability, while prioritising the use of bio-safe materials, we establish ourselves as a forward-thinking packaging provider.
Through the kit assembly, return traceability, readily available production lines and much more, RDi provides ensured compliance as well as new heights in logistics and operations.
For assured biosafety during sample transportation, speak to RDi.