BIOLOGICAL SUBSTANCES AND INFECTIOUS SUBSTANCES
Tecnisample takes care of the entire process of logistics and transport of biological and/or infectious substances, complying with European regulations.
PACKAGING FOR BIOLOGICAL SUBSTANCES OR INFECTIOUS SUBSTANCES
We manage all types of biological substances or infectious samples.
Tecnisample’s biomedical packaging solutions, for biological or infectious substances, consist of a wide range of approved components or kits conceived, designed, manufactured and rigorously tested to follow packaging and transport safety protocols.
Biological substances must be subject to the regulations and standards of biomedical transport when dealing with biological substances, infectious substances. It also requires specialised temperature-controlled logistics to guarantee the cold chain and preserve the integrity in transit of temperature-sensitive products composed of sugars, proteins, nucleic acids or living entities such as cells and tissues.
Packaging for biological substances and/or infectious substances
Classification of infectious substances
Classification of infectious substances
Infectious substances are divided into two categories:
- Category A infectious substance: any infectious substance which is carried in a form which, on exposure, is capable of causing permanent incapacity, endangering life or constituting a fatal disease in previously healthy humans or animals.
– UN 2814: infectious substances that cause disease in both humans and animals.
– UN 2900: infectious substances causing disease only in animals.
- Category B infectious substance: Any infectious substance that does not meet the criteria for inclusion in Category A. Category B infectious substances shall be assigned to UN 3373, except that cultures, being the result of a process by which pathogens are intentionally propagated, depending on the micro-organism cultured, may be classified as Category A or Category B and assigned to UN 2814 or UN 2900, as appropriate).
Standards that our packaging for biological products complies with
Our packaging line complies with UN2814 and UN2900 for infectious or potentially infectious samples (included in the P620 packaging guidelines) and UN3373 for diagnostic substances or samples (in the P650 guidelines).
Depending on your specific requirements, separate accessories or components can be used that will ensure compliance with the regulations for biological substances or infectious substances, categories A and B, or pre-qualified kits according to the required temperature range to keep infectious substances stable:
Biological packaging services
Our services are especially aimed at hospitals, laboratories, research centres and any life science requiring the management of:
- Petri dishes
- Patient samples
- Organs or tissues
- Biological products
- Micro-organisms and genetically modified organisms
- Medical or clinical waste, among others.
Discover our range of pre-qualified kits according to temperature range:
- Biomedical packaging at ambient temperature
- Refrigerated temperature biomedical packaging
- Frozen temperature biomedical packaging
- Cryogenic temperature biomedical packaging
Thanks to our extensive experience in the design and distribution of packaging with specific content and handling requirements, Tecnisample develops customised kits to meet the characteristics requested by our customers.
We also offer our services of dry ice supply and validation of temperature-controlled kits.
Biomedical packaging for transport of stem cells and other biological materials
The boom in the cryopreservation of umbilical cord blood for therapeutic purposes requires solutions for the transport of biological material at controlled temperatures.
Our kit for the transport of stem cells, umbilical cord blood and other biological materials such as corneas, bone marrow, etc. consists of an outer box in micro cardboard and a high performance injected polyurethane foam insulation and a practical detachable handle for easy handling.
These kits are fully customisable in terms of image and dimensions in order to cover the most varied sample transport needs depending on transit time and/or variable environmental conditions.
- Tailor-made projects in terms of dimensions and insulation thickness for longer transit times or adverse environmental conditions.
- Our exclusive injected polyurethane technology allows more flexibility in terms of shapes and sizes (even in short runs) as it does not require moulds or dies that make the final product considerably more expensive.
- Customisable in terms of image
- Complies with regulations for the transport of biological material.
We can complete the kits with the following accessories:
- Rigid or flexible thermal accumulators.
- Transit temperature recording systems
- Approved safety bags for the transport of biological material
Homologation UN 3373
Approval for Category B biological substances. Samples of human or animal origin such as urine, blood or tissues that may or may not be infected with a disease or virus.
Packaging for the transport of vaccines and pharmaceuticals
We also have specific solutions and temperature-controlled packaging specifically for the transport of vaccines, pharmaceuticals and insulin-type products, among others.
As the required temperature ranges differ depending on the vaccine, Tecnisample offers several approved solutions covering different temperature ranges: down to -70°C, down to -20°C and between 2°C and 8°C, so that manufacturers and distributors can choose the right transport solution for their needs.
Depending on the requirements of the supply chain, the thermal boxes maintain the required temperature for up to 12, 48 or 72 hours.
Biomedical packaging solutions
Our products comply with current regulations and standards.