Understanding UN3373 Sample Transport Compliance Regulations Find out how to package and transport biological samples safely and in accordance with the UN3373 regulations. ■ Supporting Category B Sample Transport Compliance ■ Helping Meet Your Obligations for Safe Road (ADR) and Air (IATA) Transport ■ Convenient, Time-Saving and Cost-Effective Packaging Solutions to Ensure Your Compliance to the Legal Requirements ■ A Range of Options for Primary, Secondary and Outer Packaging
www.UN3373.co.uk 2 n freephone order 0800 387732 n buy online at www.alphalabs.co.uk Contents Contents Page Introduction 3 Understanding the Regulations - P650 Packaging Instruction for Road (ADR) 4 - P650 Packaging Instruction for Air (IATA) 5 UN3373 Compliance Resources 6 UN3373 Packaging Guide 7 Sample Collection Solutions - Faecal Collection 8 - Capillary Blood Sampling 9 - Urine Collection 9 - Swabs 10 Primary Containers for Sample Transport - for Air Transport 11 - for Road Transport 13 - Leak-Proof Tested 15 Secondary Packaging Solutions for Sample Transport - SpeciSafe® Complete Secondary Packaging 16 - for Air Transport 18 - for Road Transport 19 Outer Packaging Solutions for Air or Road Transport 20 Mailing Envelopes for Road Transport 21 Complete Kits for Sample Transport 21 Tailor-Made Sample Collection and Transport Kits 22
www.UN3373.co.uk 3 n email order sales@alphalabs.co.uk n freefax order 0800 614249 Introduction Introduction Whether for medical diagnostic purposes, clinical trials or research, collecting, storing and transporting patient and other biologically hazardous samples safely from their source to the laboratory can be problematic. Biological specimens fall under the Dangerous Goods Regulations since they may contain pathogens. Their transport is strictly controlled and it is a legal and mandatory requirement to comply with the regulations. This ensures that all such parcels, and their contents, reach their destination in good condition, whilst not endangering the environment or anyone who comes into contact with them during their journey. Samples such as blood, tissue, excreta, secreta etc. from humans or animals (which are not assigned to Category A, Infectious Substances), are considered to be Category B Biological Substances. These are assigned to UN3373 and must be packaged according to the Dangerous Goods IATA (air) or ADR (road) Packing Instruction 650 for transport. Alpha Laboratories provides a wide range of sample packaging materials that help make your regulatory compliance convenient, consistent and cost-effective. UN3373: Packaging with Confidence Scan the QR code to watch the new animated video that will help you to easily understand how to achieve compliance when transporting biological samples.
4 Pricing and Online Ordering at www.UN3373.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk Understanding the Regulations Understanding the Regulations Visit our dedicated website www.un3373.co.uk to access videos, brochures and guidelines, plus find out about our UN3373 training seminars. Here you will find a brief overview of the classification of infectious substances, and the key requirements for transporting UN3373 Biological Substance, Category B. Transport of any material which is considered hazardous in any way, can only be conducted in a manner which is compliant with the Dangerous Goods Regulations. This includes any materials derived from human or animal sources which has the potential to contain pathogenic organisms. There are 2 main classes of infectious material: Category A "An infectious sample which is transported, in a form that when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals. Infectious substances meeting these criteria which cause disease in humans or both in humans and animals must be assigned to UN2814. Infectious substances which cause disease only in animals must be assigned to UN2900.” Category A Infectious Substances are considered to be high consequence dangerous goods. Transport of these substances must only be carried out by fully trained and certified handlers. Please refer to the IATA or ICAO websites for further information. Category B An infectious substance which does not meet the criteria for inclusion in category A. Infectious substances in Category B must be assigned to UN3373 – Biological Substance, Category B. P650 Packaging Instruction Key Requirements for Road Transport (ADR) Infectious substances assigned to Category B (UN3373) can be transported by specialised couriers or the Royal Mail, provided they comply with packaging instruction P650 as specified within the dangerous goods manuals. Always check with your transport provider before shipping. The packaging must be of good quality and strong enough to withstand the shocks and loadings normally encountered during transport. It must prevent any loss of contents that could occur due to vibration or changes in temperature, humidity or pressure. The P650 packaging instructions for liquid substances state:- a) The primary receptacle(s) shall be leak proof; (see point e) b) The secondary packaging shall be leak proof; (see point e) c) If multiple fragile primary receptacles are placed in a single secondary packaging, they shall be either individually wrapped or separated to prevent contact between them; d) Absorbent material shall be placed between the primary receptacles(s) and the secondary packaging. The absorbent material shall be in quantity sufficient to absorb the entire contents of the primary receptacle(s) so that any release of the liquid substance will not compromise the integrity of the cushioning material or of the outer packaging; Key Requirements of UN3373 Regulations
5 Pricing and Online Ordering at www.UN3373.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 Understanding the Regulations P650 Packaging Instruction Key Requirements for Air Transport (IATA) The key differences compared to transport via road are highlighted for clarity a) The primary receptacle(s) shall be leak proof; (see point e) b) The secondary packaging shall be leak proof; (see point e) c) If multiple fragile primary receptacles are placed in a single secondary packaging, they shall be either individually wrapped or separated to prevent contact between them; d) Absorbent material shall be placed between the primary receptacles(s) and the secondary packaging. The absorbent material shall be in quantity sufficient to absorb the entire contents of the primary receptacle(s) so that any release of the liquid substance will not compromise the integrity of the cushioning material or of the outer packaging; e) The primary receptacle or the secondary packaging shall be capable of withstanding, without leakage, an internal pressure of 95 kPa (0.95 bar) in the range of -40C and +55C f) The outer packaging shall be rigid and the entire packaging solution will have passed the 1.2m drop test g) Suitable cushioning material shall be added to prevent too much movement within the package h) The packaging should be clearly marked with the UN3373 diamond adjacent to the words “BIOLOGICAL SUBSTANCE, CATEGORY B” i) The outer packaging must have one surface of minimum dimensions 10 x 10cm j) Maximum volume per primary is 1L k) Maximum volume per outer is 4L l) The outer packaging must contain an itemised list of contents e) The primary receptacle or the secondary packaging shall be capable of withstanding, without leakage, an internal pressure of 95 kPa (0.95 bar). f) The outer packaging or the secondary packaging shall be rigid and the entire packaging solution will have passed the 1.2m drop test. g) Suitable cushioning material shall be added to prevent too much movement within the package. h) The packaging should be clearly marked with the UN3373 diamond adjacent to the words “BIOLOGICAL SUBSTANCE, CATEGORY B”
6 Pricing and Online Ordering at www.UN3373.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk UN3373 Compliance Resources IATA The absolute rules for shipping Dangerous goods by air. http://www.iata.org/whatwedo/cargo/dgr/Documents/infectious-substance-classification-DGR56-en.pdf http://www.iata.org/whatwedo/cargo/dgr/Documents/packing-instruction-650-DGR56-en.pdf Government website A guide to the international regulations on the transportation of dangerous goods by air, sea, road, rail or inland waterway https://www.gov.uk/guidance/moving-dangerous-goods#regulations-for-transporting-dangerous-goods-by-air-sea-road-and-rail-transport International Civil Aviation Organisation (ICAO) Technical Instructions for the Safe Transport of Dangerous Goods by Air http://www.icao.int/publications/Documents/guidance_doc_infectious_substances.pdf Department for Transport, HSE, Maritime and Coastguard Agency and Civil Aviation Authority Transport of infectious substances UN2814, UN2900 and UN3373 https://assets.publishing.service.gov.uk/government/uploads/system/uploads/ attachment_data/file/527069/dangerous-goods-guidance-note-17.pdf World Health Organisation Transport of Infectious Substances https://www.who.int/publications/i/item/789240089525 Royal Mail IATA Guidance Document Infectious Substances http://www.royalmail.com/sites/default/files/Guidance-Document-Infectious-Substances-171012.pdf You can also refer to your courier’s website for advice. Alpha Laboratories advises all users to consult the official bodies responsible for safe transport of hazardous material. Visit our dedicated website www.un3373.co.uk to access these links online. Official UN3373 Regulation Resources
7 Pricing and Online Ordering at www.UN3373.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 Packaging Guide UN3373 Packaging Guide for Air and Road Transport Are You Transporting Biological Samples by Air or Road? Follow these Guidelines to Ensure Your Compliance and Find the Products You Need Air Road Is Your Primary Container Certified 95kPa at both -40C and +55C?1,2 Is Your Primary Container Certified 95kPa at Ambient Temperature? Yes No Yes No You need Leak-Proof Secondary Packaging with Absorbent3 using... You need a Secondary Pouch Certified 95kPa at both -40C and +55C with Absorbent3 (seepage18) You need Leak-Proof Secondary Packaging with Absorbent3 using... You need a Secondary Pouch Certified 95kPa at Ambient Temperature with Absorbent3 (seepage18) A Bag (seepage20) + Absorbent3 (seepage17) A Bag (seepage20) + Absorbent3 (seepage17) Rigid Outer Packaging Required4 (seepage19) Rigid Outer Packaging Required4 (seepage19) Note 1. The 95kPa pressure differential test is required for either the primary or secondary container. If the primary container does not have this certification, or you are unsure, you should use a 95kPa certified secondary container. Note 2. The required pressure differential test is different for air and road transport. For road transport the test is conducted at ambient temperature. For Air transport it must also be conducted at both -40C and +55C. Note 3. Absorbent material must be capable of absorbing the entire contents of the primary containers. Note 4. For air transport, you must use a rigid outer box. Note 5. For road transport the rigid element of the packaging can be either the secondary or the outer packaging. Note 6. Multiple primaries will need separating to avoid damage and cross contamination.. Important - Always check with your transport provider to ensure they do not have any additional special conditions for transport of Biological Substances.
8 Pricing and Online Ordering at www.UN3373.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk Faecal Collection Hygienic and Convenient for the Patient, Quality Samples for the Laboratory There are numerous assays now available that can diagnose clinical conditions from the biomarkers, analytes or pathogens found in faecal samples. However, collecting a faecal sample is difficult and unpleasant and the various methods used can cause erroneous results and additional work for the laboratories. Fe-Col®Papers Solve the Problem Fe-Col® is a unique, disposable stool collection paper, which is easily and securely placed on the toilet and can be flushed away entirely after use as it is completely degradable. Available on its own with clear pictorial instructions for use, or in a dispenser box for clinics to give to patients to use at home. NOTE: appropriate UN3373 packaging should also be provided for patients to return their sample. Features: n Made from wood-free paper n Flushable & biodegradable n No optical brightness additives (e.g. bleach) n Simple instructions for use n Flow-seal packaging n Small and compact n Recyclable material Perfect for: n Clinical Trials n Screening Programmes n Calprotectin and Faecal Elastase Testing n Fat content tests n Infectious disease tests etc. Sample Collection Solutions Fe-Col® Faecal Collection Papers Fe-Col® Faecal Collection Papers Catalogue Number Description Pack Size FC2010 Fe-Col Faeces Collection Paper with Instructions for Use (IFU) 1000 FC2031 Fe-Col Faeces Collection Paper with Instructions for Use in Dispenser Box. 5 boxes of 50 6 x 50 Fe-Col® is supplied in a discreet, flat flow-wrapped package.When unwrapped and unfolded it opens up to slip easily onto the toilet seat ready for use. It remains firmly in place whilst some of the sample is transferred into an appropriate vessel. A full range of sample collection containers and tubes are available from Alpha Laboratories, please see the website.
9 Pricing and Online Ordering at www.UN3373.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 Capillary Blood & Urine Collection Urine Sample Collection Device The urine sample collectiondevice is a discreet and handy pop-up urine collection cup. It is supplied flat-packed, which reduces postal costs and storage space, and makes it ideal for inclusion into home testing kits where patients need to collect their own samples. It is simple and quick to assemble, simply press with finger and thumb in the marked areas and the the 3D cup locks into position. The wide aperture makes it easier to collect the sample reducing spillages and the square design of the cup provides a natural and accurate pouring spout for decanting into the final urine storage or transport container. The design reduces the opportunity for crushing/cracking during the delivery and collection process, thus increasing the potential for return of usable sample. Ideal for Point of Care Diagnostic Kits, Clinical trials, Sample Collection Kits, or anywhere there is a need to collect a urine sample. Urine Sample Collection Device Catalogue Number Description Pack Size UC1000 Urine Sample Collection Device 1000 Tasso+ Capillary Blood Sampling Device Tasso+ is a high quality, patient centric Capillary sampling device, enabling users to collect clinical grade capillary blood samples, simply through the push of a button. Designed around patient experience, Tasso+, provides a user-friendly alternative to traditional lancets, allowing patients to collect quality samples at home or in point of care scenarios, without the need of a phlebotomist. Tasso+ can be used in conjunction with the following BD microtainers as a collection reservoir: 365968, 365975, 365993 and 365986. Tasso+ is sterile, and CE certified to European Medical Device regulations under Class IIa classifications. Tasso+ is single use device only. Tasso+ Capillary Blood Sampling Device Catalogue Number Description Pack Size K0021040-01 Tasso+ Capillary Blood Sampling Device Each
10 Pricing and Online Ordering at www.UN3373.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk Swabs & Primary Containers for Sampel Transport Swabs Primary Containers for Sample Transport Once collected, samples need to be stored and transported securely without the risk of contamination or leakage. The key requirement for primary containers to transport samples is that they are leak-proof. Here we offer a range of primary containers which are tested and certified to be leak-proof. However to meet the UN3373 P650 packaging instruction, either the primary or secondary container must have been tested specifically to withstand a 95kPa pressure differential test. For road transport this test should be conducted at ambient temperature, but for air transport, the test must also be conducted at -40C and +55C. This means a leak-proof container, which has not been demonstrated to pass the 95ka pressure differential test, can only be used for sample transport when combined with a secondary container which has passed the appropriate test. We have categorised the sample containers according to their certification, however tubes certified to the IATA standard may also be used for other forms of transport. Please refer to the UN3373 Packaging Guide for Air & Road Transport on page 7 for further guidance. Swabs Catalogue number Description Method of Sterilisation Pack Size SW1020 Plain Swab, Wooden Stick, Cotton Tip, Non-Sterile - 10 x 100 SW1030 Plain Swab, Wooden Stick, Cotton Tip, Sterile EO 100 SW1070 Plain Swab, PS Stick, Viscose Tip, Non-Sterile - 90 x 100 SW1040 Plain Swab, PS Stick, Viscose Tip, Sterile EO 10 x 100 SW1010 Transport Swab without medium, White Cap, PP Tube, PS Stick, Viscose Tip, Sterile IR 500 SW1050 Transport Swab with Amies medium, Blue Cap, PP Tube, PS Stick, Viscose Tip, Sterile IR 8 x 150 EO = Ethylene Oxide Sterilisation, IR = Irradiation, PS = Polystyrene, PP = Polypropylene A selection of plain and transport swabs for collection and safe transport of bacteriological, serological and cytological samples. Plain swabs are CE-marked for IVD and transport swabs as Class IIa in accordance with Medical Devices Directive 93/42/EEC. SW1020 SW1030 SW1070 SW1040 SW1010 SW1050
11 Pricing and Online Ordering at www.UN3373.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 Primary Sample Containers For Air Transport Blood Collection Tubes Cyto-Chex® BCT The Proof of Stability Light scatter profiles from a blood sample drawn into a K+ EDTA tube analysed at six hours compared to data from a blood sample from the same patient drawn into a Cyto-Chex® BCT tube analysed at seven days. EDTA – 6 hours Cyto-Chex® BCT – 7 days FSC FSC A vacuum tube for the collection, transport and retention of whole blood samples for immunophenotyping by flow cytometry. n Maintains cellular morphology and surface antigen expression n Samples are stable at room temperature for up to 14 days prior to analysis allowing for batch processing n Stabilises white blood cell panel antigens including those of the HIV panel of CD markers n Subsets of leukocytes can be distinguished by flow cytometry n Facilitates sample batching to reduce daily flow cytometry start-up costs n 2ml paediatric tube available Cyto-Chex® BCT Catalogue Number Description Pack Size 218980 Cyto-Chex BCT (glass) 100 x 2mL 213361 Cyto-Chex BCT (glass) 6 x 5mL 213362 Cyto-Chex BCT (glass) 25 x 5mL 213386 Cyto-Chex BCT (glass) 100 x 5mL Streck Cell-Free DNA BCT® Cell-Free DNA BCT® is a blood collection tube with a preservative stabilising nucleated blood cells. This unique stabilisation prevents the release of genomic DNA, allowing isolation of high-quality cell-free DNA. It also has been demonstrated to minimise the degradation of CTCs. Multiple Applications Recover high-quality cell-free DNA suitable for a wide range of downstream applications commonly used in clinical research studies, drug discovery and diagnostic assay development. Consistent Results Enhanced stability and recovery of cell-free plasma DNA minimises variability associated with cell-free DNA sample preparation. Improved Logistics Cell-Free DNA BCT reduces the need for immediate plasma preparation and CTC processing due to unique stabilisation properties. Cell-free DNA is stable for up to 14 days at 6 °C to 37 °C, while circulating tumour cells are stable for up to 7 days, at room temperature, allowing convenient sample collection, transport and storage. n Blood Draw Volume 10.0 mL n cfDNA/gDNA Sample Stability 14 days at 6 °C to 37 °C n CTC Sample Stability 7 days at 15 °C to 30 °C n Shelf Life 24 months from manufacture Cell-Free DNA BCT® Catalogue Number Description Pack Size 218996 Cell-Free DNA BCT CE (glass) 6 x 10mL 218997 Cell-Free DNA BCT CE (glass) 100 x 10mL 230244 Cell-Free DNA BCT CE (glass) 1000 x 10mL Streck All Blood Collection Tubes are certified 95kPa compliant for air transport. Primary Sample Containers Certified 95kPa Compliant for Air Transport To be used with a leak proof secondary, absorbent and outer rigid box.
12 Pricing and Online Ordering at www.UN3373.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk Primary Sample Containers For Air Transport Nucleic Acid BCT™ Nucleic Acid BCT™ Catalogue Number Description Pack Size 230637 Nucleic Acid blood collection tube (RUO) 6 x 5ml 230638 Nucleic Acid blood collection tube (RUO) 100 x 5ml 230639 Nucleic Acid blood collection tube (RUO) 1000 x 5ml 230644 Nucleic Acid blood collection tube (RUO) 6 x 10ml 230645 Nucleic Acid blood collection tube (RUO) 100 x 10ml 230646 Nucleic Acid blood collection tube (RUO) 1000 x 10ml Streck The new Nucleic Acid BCT™, is a game-changer in preserving nucleic acid concentrations, maintaining analyte levels at draw-time concentrations for up to 7 days at room temperature. This empowers laboratories to shift focus from degradation concerns to data analysis. n Stabilises sample for cfDNA, EVs and cfRNA n 7-day sample stability when stored at room temperature n Compatible with commercially available total plasma nucleic acid isolation kits n Compatible with standard low input RNA sequencing library prep kits n Isolated nucleic acids are suitable for downstream applications Nucleic Acid Plus BCT™ Nucleic Acid Plus BCT™ Catalogue Number Description Pack Size 230698 Nucleic Acid Plus BCT, 6 tube pack (RUO) 6 x 5ml 230699 Nucleic Acid Plus BCT, 100 tube box (RUO) 100 x 5ml 230700 Nucleic Acid Plus BCT, 1000 tube case (RUO) 1000 x 5ml Streck Nucleic Acid Plus BCT™ is a direct draw whole blood collection tube designed to preserve plasma integrity under real-world collection, shipping and processing conditions for workflows involving cell-free DNA, cell-free RNA, miRNA, extracellular vesicles (EVs), and select plasma protein workflows. n Stabilises cfDNA, cfRNA, EVs and select plasma protein markers n Limits ex vivo platelet activation and haemolysis n Compatible with mass spectrometry and immunoassay- based proteomic analysis n Minimises contamination of blood cell-secreted proteins into plasma, providing sample integrity during storage, shipping and handling of blood samples n Reduces the need for immediate sample processing and analysis n Allows for the batching of samples, optimising laboratory workflow
13 Pricing and Online Ordering at www.UN3373.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 Primary Sample Containers For Road Transport Primary Sample Containers Certified 95kPa Compliant for Road Transport To be used with a leak-proof secondary, absorbent and either flexible or rigid outer packaging (please refer to the UN3373 Packaging Guide for Air & Road Transport on page 7). Cryogenic Vials Alpha Laboratories has four ranges of CE marked cryogenic storage vials, all designed for safe, ultra-low temperature storage. All products in this range are certified free from RNase, DNase, pyrogens and DNA. The Classic Range : Internally Threaded – with Silicone Washer. Designed to improve safety compared with standard screw cap microcentrifuge tubes. ‘The Classic’ uses a square section washer that compresses tightly between the cap and top of the tube wall. Feel the Seal Range: Internally Threaded – with Silicone O-Ring. It’s true, you really can feel when the cap is securely closed. Ideal when storing important samples in large batches. Ultimate Security Range: Externally Threaded – with Flange/Washer Combination. This unique combination of square section sealing washer and internal cap flange provides the highest level of security for your most precious samples. High Capacity Vials: Externally Threaded – Our jumbo, freestanding, externally threaded cryovials have a working volume of 9.5ml. They are gamma irradiated and certified free from RNase, DNase, Pyrogens and Human DNA. Featuring volume graduations and a large labelling area, these tubes offer a high level of security for your valuable samples. Coloured cap inserts are perfect for colour coding and are compatible with all the ranges below with the exception of the High Capacity vials. The Classic Range of Cryogenic Vials Catalogue Number Description Pack Size LW3332 1.0ml Classic Cryogenic Vial Free Standing 100 LW3334 2.0ml Classic Cryogenic Vial Free Standing 100 LW3335 2.0ml Classic Cryogenic Vial Round Bottom 100 LW3336 3.6ml Classic Cryogenic Vial Round Bottom 100 LW3337 3.6ml Classic Cryogenic Vial Free Standing 100 LW3338 5.0ml Classic Cryogenic Vial Round Bottom 100 Feel the Seal Range of Cryogenic Vials Catalogue Number Description Pack Size LW3532 1.2ml Feel the Seal Cryogenic Vial Free Standing 100 LW3534 2.0ml Feel the Seal Cryogenic Vial Free Standing 100 LW3535 2.0ml Feel the Seal Cryogenic Vial Round Bottom 100 LW3538 5.0ml Feel the Seal Cryogenic Vial Round Bottom 100
14 Pricing and Online Ordering at www.UN3373.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk Primary Sample Containers For Road Transport Ultimate Security Range of Cryogenic Vials Catalogue Number Description Pack Size LW3432 1.0ml Ultimate Security Cryogenic Vial Free Standing 100 LW3434 1.8ml Ultimate Security Cryogenic Vial Free Standing 100 LW3435 1.8ml Ultimate Security Cryogenic Vial Round Bottom 100 LW3436 3.0ml Ultimate Security Cryogenic Vial Free Standing 100 LW3437 3.8ml Ultimate Security Cryogenic Vial Free Standing 100 LW3438 4.5ml Ultimate Security Cryogenic Vial Free Standing 100 Cap Inserts for the Ranges Above Catalogue Number Description Pack Size LW3339AS* Assorted Cap Inserts * Other colours available. Please see our website. 500 High Capacity Cryogenic Vials Catalogue Number Description Pack Size LW3439 10ml High Capacity Cryogenic Vial Skirted 2 x 50
15 Pricing and Online Ordering at www.UN3373.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 Primary Sample Containers - Leak-Proof Tested Primary Sample Containers - Leak-Proof Tested Leak-proof tested in accordance with BS EN 14254 Annexe D. Note: Require an appropriately certified secondary container dependent on mode of transport, plus absorbent and outer packaging (please refer to the UN3373 Packaging Guide for Air & Road Transport on page 7). Universal Containers Universal Containers - Polypropylene Tube Catalogue Number Description Material * (Tube/Cap) Label Sterility Pack Size Inner Pack 08-022-2004 15ml Universal Container with Spoon, Skirted Base PP/PE No Aseptic 1000 250 08-002-2004 12ml Universal Container with Spoon, Round Base PP/PE No Aseptic 1000 250 *PP = Polypropylene, PE = polyethylene Blood Collection Tubes Blood Collection Tubes Catalogue Number Description Pack Size 363705 BD Microtainer® MAP blood collection tubes K2EDTA (PP) 4 x 50 365968 BD Microtainer SST™ (400-600µl) 200 365975 BD Microtainer® K2EDTA (250-500µl) 200 365986 BD Microtainer® PST™ Lithium Heparin blood collection tubes (400-600µL) 200 365993 BD Microtainer® Sodium Flouride and Sodium EDTA tubes (400-600µL) 200 367839 BD Vacutainer® K2EDTA Tubes (PET) 4mL 100 368201 BD Vacutainer® Sodium Fluoride and Potassium Oxalate Plus Tube with BD Hemogard™ Safety Closure Tubes (PET) 5ml 10 x 100 362725 BD Vacutainer® HEMOGARD PLUS Plain EST PLH 3mL 1375 S E 1000 367895 BD Vacutainer® K2Serum Tubes (PET) 10.0mL 10 x 100 367956 BD Vacutainer® SST II Advance Tubes (PET) 3.5mL 10 x 100 363095 BD Vacutainer® Citrate Tubes (PET/PP) 2.7mL 1000 362781 BD Vacutainer® CPT Tubes (PET) 4.0mL 1 x 60 362780 BD Vacutainer® CPT™ Cell Preparation Glass Tubes for Collection and Separation of mononuclear Blood Cells 1 x 60 Urine Collection Tubes Urine Collection Tubes Catalogue Number Description Pack Size 365000 BD Vacutainer® Z (No Additive) Plus Urine Tube Conical 100
16 Pricing and Online Ordering at www.UN3373.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk Secondary Packaging Solutions for Air or Road Transport SpeciSafe replaces secondary packaging for mailing Category B samples contained in 95kPa vials. It combines the absorbent material, vial separation and rigid container within a single pre-moulded mailing pack You then only need to add a UN3373 labelled padded envelope or bag as your outer packaging when transporting by road, or a rigid box for air transport, saving you time and money. SpeciSafe packs are available in a range of designs to fit perfectly around commonly used 95 kPa sample vessels. When used with 95kPa primary containers, SpeciSafe meets all requirements of UN3373 for secondary packaging. Benefits of SpeciSafe Packs n Shock resistant primary container protection n Built-in ultra-absorbent Gel Block – absolutely no leaks! n Clear plastic enables sample details to be visible without unpacking n Visible spillage indication prior to opening protects users n User friendly, quick and intuitive use n The pre-moulded packs keep multiple primary containers separated from each other n Compliant flat-pack design minimises postage costs SpeciSafe® Provides a Safe, Convenient and Economical UN3373 Compliant Secondary Sample Packaging Solution Secondary Packaging Solutions for Air or Road Transport Road Transport If primary container is leak-proof and 95kPa certified at ambient temperature (ADR) – enclose into a leak-proof secondary specimen bag with appropriate absorbent. If primary container is leak-proof but NOT 95kPa ADR certified – secondary packaging must be leak-proof and 95kPa ADR certified with appropriate absorbent included. The outer or secondary packaging must be rigid for road transport, so popular options are flexible UN3373 outer mailing envelopes and UN3373 outer boxes for outer packaging. Air Transport If primary container is leak-proof and 95kPa differential tested at -40C and +55C (IATA) – simply enclose in a leak-proof secondary specimen bag with appropriate absorbent. If primary container is NOT 95kPa IATA certified but leak-proof – secondary packaging must be leak-proof and 95kPa IATA certified with appropriate absorbent included. The outer packaging must be rigid for air transport, so team up your primary and secondary packaging with our UN3373 outer boxes for complete compliance. Alpha Laboratories provides a range of sample packaging materials that help make your regulatory compliance convenient, consistent and cost-effective. Always check your packaging with your courier or postage provider before sending to avoid potential problems. SpeciSafe® Complete Secondary Mailing Packs for 95kPa Vials
17 Pricing and Online Ordering at www.UN3373.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 Secondary Packaging Solutions for Air or Road Transport Ultra-Absorbent Lining Eliminates Leakage The unique feature of SpeciSafe packaging products is an internally bonded ultra-absorbent lining which soaks up any leakage in seconds. The material is so absorbent that 1m2 can soak up as much as 20 litres of liquid. Once the lining has absorbed its maximum amount of liquid, it becomes a watertight barrier and effectively seals the SpeciSafe pack preventing any leakage from the secondary container. SpeciSafe® for Micro Blood Tubes or Serum Vials SpeciSafe for Micro Blood Tubes or Serum Vials Catalogue Number Description Pack Size SS1700 1-place SpeciSafe for Micro/Serum Tubes 450 SS0301 6-place SpeciSafe for Micro/Serum Tubes 300 SpeciSafe secondary mailing packs suitable for transporting micro blood tubes, serum type tubes or 0.5, 1.5 or 2.0ml microtubes. Package just one or up to six tubes with speed and ease. SS1700 SS0301 SpeciSafe® for Venous Blood Tubes Ensure safe and compliant transport of various types of evacuating blood collection tubes with this range of SpeciSafe secondary mailing packs. These packs also accommodate many other types of tube up to 10ml volume. SS0500 SS0701 SpeciSafe for Venous Blood Tubes Catalogue Number Description Pack Size SS0500 1-place SpeciSafe for Venous Blood Tubes 500 SS0401 2-place SpeciSafe for Venous Blood Tubes 300 SS0701 5-place SpeciSafe for Venous Blood Tubes 150 *Please request a sample to check the fit of the blood tubes that you use SpeciSafe® for Universal Containers These SpeciSafe secondary mailing packs are designed to fit standard 30ml Universal tubes commonly used as urine or faeces sample containers. There is a single or triple tube option available. Please note: The maximum volume per package which can be transported by Royal Mail is 50ml. SpeciSafe for Universal Containers Catalogue Number Description Pack Size SS0600 1-place SpeciSafe for Universal Containers 300 SS1400 3-place SpeciSafe for Universal Containers 160 SS1400 SS0600
18 Pricing and Online Ordering at www.UN3373.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk Secondary Packaging Solutions for Road Transport Absorbent Sheets These super absorbent sheets can be used with all types of packaging to help meet UN3373 regulations. Available in 4 sizes specified by the volume that they can absorb, simply choose the one that will absorb at least the total volume of your sample. More than one sheet can be added to any packaging if required, to ensure that it would absorb all the sample in the event of catastrophic leakage. A 1, 2, 4 or 6 bay absorbent pouch is also available, suitable for sending 1, 2, 4 or 6 blood type or similar tubes. This keeps the tubes separated from each other, without the need to wrap each one individually. Absorbent Sheets Catalogue Number Description Pack Size AB001-1000 Absorbent Sheet 46 x 85mm - absorbs 50ml 1000 AB001-0100 Absorbent Sheet 46 x 85mm - absorbs 50ml 100 AB002-500 Absorbent Sheet 93 x 85mm - absorbs 100ml 500 AB002-0100 Absorbent Sheet 93 x 85mm - absorbs 100ml 100 AB003-500 Absorbent Sheet 85 x 186mm - absorbs 200ml 500 AB003-0100 Absorbent Sheet 85 x 186mm - absorbs 200ml 100 AB004-500 Absorbent Sheet 185 x 186mm - absorbs 400ml 500 AB004-0100 Absorbent Sheet 185 x 186mm - absorbs 400ml 100 AB014-1000 Absorbent 1 Bay Pouch for up to 1 blood tube 100 AB015-1000 Absorbent 2 Bay Pouch for up to 2 blood tubes 1000 AB010-100 Absorbent 4 Bay Pouch for up to 4 blood tubes 100 AB013-100 Absorbent 6 Bay Pouch for up to 6 blood tubes 100 These handy, grip seal specimen bags comprise the main compartment plus an integral document wallet to ensure your paperwork stays with your samples. For use with appropriately tested 95kPa primary containers. These can also be used to separate multiple primary sample containers from each other. Supplied non-sterile. Specimen Bags Catalogue number Description Pack Size BS1422 Specimen Bag, Plain 22x15cm, with Wallet 18x15cm 100 BS1422P Specimen Bag, with Biohazard Warning 22x15cm, with Wallet 18x15cm 100 BS1414P Specimen Bag with Biohazard Warning 14x14cm, with Wallet 20x14cm 1000 BS1209 Bag Clear Grip Seal - Biodegradable 8.9 x 11.4cm 160 gauge - C7 1000 BS5200 Small clear grip seal bag made with 30% recycled content with a 50 micron thickness 20.3 x 28cm 1000 Specimen Bags Other Secondary Packaging Solutions for Air Transport 95kPa IATA Pouches Flexible Secondary Pouches are the ideal solution for transporting sample containers where the pressure resistance is either unknown or not certified to be 95kPa compliant. These IATA compliant pouches can be used as the secondary packaging option when combined with a rigid outer box. In this way the pouches can be used to meet the UN3373 regulations P650 packaging instruction for transport of category B biological samples by air. The IATA flexible secondary pouches have undergone much more rigorous testing at both -40C and +55C to ensure they are robust enough to withstand the changes in pressure and temperature they may encounter during air transport. 95kPa pouches carry full instructions. 95kPa IATA Pouches Catalogue Number Description Pack Size Please enquire Flexible Secondary IATA 95kPa Pouch
19 Pricing and Online Ordering at www.UN3373.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 Secondary Packaging Solutions for Road Transport Secondary Packaging Solutions for Road Transport 95kPa ADR Pouches Flexible Secondary 95kPa Pouches are the ideal solution for transporting sample containers where the pressure resistance is either unknown or not certified to be 95kPa compliant. These ADR pouches can be used as the secondary packaging option when combined with a rigid outer box. The rigid outer can be an individual one, or a hospital courier transport box designed to hold several samples. In this way the pouches can be used to meet the UN3373 regulations P650 packaging instruction for transport of category B biological samples by road. 95kPa ADR Pouches Catalogue Number Description Pack Size FS95-C4-500 Flexible Secondary 95kPa Pouch C4 500 FS95-C4-100-V2 Flexible Secondary 95kPa Pouch C4 100 FS95-C5-500 Flexible Secondary 95kPa Pouch C5 500 FS95-C6 Flexible Secondary 95kPa Pouch C6 500 FS95-C6-0100 Flexible Secondary 95kPa Pouch C6 100 95kPa ADR Pouches with Absorbent For added convenience these pouches come complete with the appropriately sized absorbent sheet. 95kPa ADR Pouches with Absorbent Catalogue Number Description Pack Size FS95-C5A-1000 Flexible Secondary 95kPa C5 50ml Absorbent 1000 n 95kPa pouches carry full instructions n Areas to write sender and recipient details n Check boxes for temperature requirements n Unique sequential barcoded number for easy package recognition(with the exception of FS95-C5-PLAIN-100, FS95-C4-500 and FS95-C4-100-V2) n C5 and C4 pouches have a document wallet on the reverse side n For security, the flexible secondary pouches include a tamper evident seal n Pouches can be purchased on their own or with appropriately sized absorbent in various pack sizes
20 Pricing and Online Ordering at www.UN3373.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk Outer Packaging Solutions for Air or Road Transport Outer Packaging Solutions for Air or Road Transport Labels and Seals Labels can be purchased to add to your own packaging solutions which comply with the UN3373 regulations. Save time and effort with labels directly from a roll. Also available is the tamper evident security seal. This has a special adhesive to ensure it cannot be removed without being torn so it becomes immediately obvious if the package has been previously opened. Labels and Seals Catalogue Number Description Pack Size LB001-500 Security Seal 500 LB001-1000 Security Seal 1000 LB002-500 UN3373 Label Small 50mm x 50mm 500 LB002-1000 UN3373 Label Small 50mm x 50mm 1000 LB003-500 UN3373 Label Large 100mm x 100mm 500 LB003-1000 UN3373 Label Large 100mm x 100mm 1000 Rigid Outer Boxes Use these boxes when you need to tailor the packaging to exactly suit your needs. All boxes are supplied flat packed to minimise storage requirements and have full instructions for assembly. They can be used with 95kPa pouches for either air or road transport. Rigid Outer Boxes Catalogue Number Description Pack Size RO-LL1 Rigid Box Outer Dimensions: 191 x 146 x 24mm 35 RO-LL2 Rigid Box Outer Dimensions: 173 x 117 x 23mm 50 RO-200G Rigid Box Outer Dimensions: 193 x 124 x 44mm 35 RO-330G Rigid Box Outer Dimensions: 193 x 124 x 69mm 35 RO-500G Rigid Box Outer Dimensions: 185 x 120 x 100mm 30 RO-1K-30 Rigid Box Outer Dimensions: 242 x 189 x 96mm 30 The outer packaging protects the secondary packaging and its contents from physical damage while in transit. Either the secondary or the outer packaging must be of rigid construction.
21 Pricing and Online Ordering at www.UN3373.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 Outer Packaging Solutions for Road Transport Outer Packaging Solutions for Road Transport Mailing Envelopes These flexible envelopes are made from lightweight polyethylene and together with RO-LL1 can help to minimise postage costs by enabling many sample packages to be mailed at large letter rather than parcel rates. They are available in C4 or C5 envelope sizes, supplied in packs of 500 or 100 envelopes and are pre-printed with appropriate UN3373 packaging instruction requirements. To comply with UN3373 regulations, these envelopes should be used with rigid secondary packaging and 95kPa primary containers. Mailing Envelopes Catalogue Number Description Pack Size FO117-100 Polyethylene Envelope C4 size 100 FO117-500 Polyethylene Envelope C4 size 500 FO118-100 Polyethylene Envelope C5 size 100 FO118-500 Polyethylene Envelope C5 size 500 SH1210 Polythene Envelope with bubble wrap liner Size 265 x 180mm 100 Off-the-Shelf or Customised for You Envelopes can even be customised with labels to include your required address. Ideal for clinical trials packs etc. Contact us to discuss your needs and obtain a quotation. Complete Kits for Sample Collection and Transport Complete Mailing Systems Complete Mailing Systems for Road Transport Catalogue Number Description Box Size (Internal) Pouch Size Absorbent Size Additional Items Pack Size RF95-LL1 Rigid Flexible 95 LL1 179 x 142 x 20mm C5 150 x 205mm 50ml 46 x 85mm Security Seal 25 RF95-200G Rigid Flexible 95 200G 181 x 120 x 40mm C5 150 x 205mm 100ml 93 x 85mm Security Seal 25 RF95-330G Rigid Flexible 95 330G 181 x 120 x 65mm C5 150 x 205mm 100ml 93 x 85mm Security Seal 25 RF95-500G Rigid Flexible 95 500G 173 x 116 x 96mm C4 205 x 300mm 200ml 85 x 186mm Security Seal 25 RF95-1K-25 Rigid Flexible 95 1K 230 x 185 x 92mm C4 205 x 300mm 200ml 85 x 186mm Security Seal 25 These convenient sample transport complete systems make UN3373 compliance simple. They contain absorbent material, a 95kPa pressure tested secondary pouch, a rigid outer box and a security seal. They can accommodate all types of primary sample container. Use when your primary is not certified 95kPa pressure resistant. Available in a range of sizes, simply pick the one which matches your requirements best. These sample collection kits are supplied flat packed to minimise storage requirements.
22 Pricing and Online Ordering at www.UN3373.co.uk n freephone order 0800 387732 n buy online at www.alphalabs.co.uk Tailor-Made Sample Collection and Transport Kits Tailor-Made Sample Collection and Transport Kits Designed for the collection and safe transport of blood samples for laboratory testing, Alpha solutions provide a range of bespoke and off-the-shelf sampling kits. As experienced providers of Category B UN3373, biological sample transport packaging products, we possess the expertise to develop kits compliant with IATA and ADR packaging instructions. These kits are assembled under an ISO 13485 quality management system, the gold standard for medical devices. Whilst working in partnership with healthcare providers to understand their requirements and challenges, Alpha Solutions also remains focused on patient experience to ensure ease of use. This helps to generate high return rates that increase proactive health management to improve patient pathways and the success of any health programme. At Home Capillary Blood Collection Kits Alpha Solutions: At Home Capillary Blood Collection kits are designed for the collection and safe transport of blood specimens for laboratory testing, diagnosis and follow up. Each component of this lancet based kit is thoughtfully selected, serving a clear, usability study tested function, with the aim of maximising safe and successful sample return. For instance, use of a 17G lancet, maximises blood flow whilst minimising sampling discomfort, whilst the provision of a tube holder encourages correct sampling practices. HBC-Kits utilise intelligent packaging solutions to both align with UN3373 packaging requirements and reduce environmental impact where possible, with components contained within a recyclable outbox, and reduced plastic sample return pouches. Alpha Solutions provide a range of Capillary Blood Collection kits based on the variant and quantity of Microtainers®, with further capillary blood tubes available upon request. Colour Code Product Code Product Description HBC-KIT-G1 At Home Capillary Blood Collection Kit (SST tube x 1) HBC-KIT-L1 At Home Capillary Blood Collection Kit (K2EDTA tube x 1) HBC-KIT-G2 At Home Capillary Blood Collection Kit (SST tube x 2) HBC-KIT-G1L1 At Home Capillary Blood Collection Kit (SST tube x 1 and K2EDTA tube x1) HBC-KIT-G2L1 At Home Capillary Blood Collection Kit (SST tube x 2 and K2EDTA tube x 1) HBC-KIT-G3 At Home Capillary Blood Collection Kit (SST tube x 3) HBC-KIT-LG1 At Home Capillary Blood Collection Kit (Lithium Heparin tube x 1) HBC-KIT-GR1L1 At Home Capillary Blood Collection Kit (K2EDTA tube x 1 and Na2 EDTA tube x 1) HBC-KIT-G1GR1L1 At Home Capillary Blood Collection Kit (SST tube x 1, K2EDTA tube x 1, Na2EDTA tube x 1)
23 Pricing and Online Ordering at www.UN3373.co.uk n email order sales@alphalabs.co.uk n freefax order 0800 614249 Complete Kits for Collection and Transport Bespoke Blood Collection Kits for Clinical Trials At home or professional use sample collection kits enable clinical trial research to become decentralised, expanding expand your potential pool of participants by sampling remotely. Understanding the limitations of a one-size-fits all approach, Alpha Solutions will work in partnership with your organisation to develop bespoke kits, tailored to your unique specifications. Whether you require a branded sleeve design, sleek box layout, or a specific requirement and function of components, Alpha Solutions can assist. To streamline logistical process, Alpha also provides solutions for Stock Holding, Despatch and Return of samples to laboratory. We work with leading manufacturers to offer a niche range of high-quality sample collection products, including swabs, transport media, tubes, urine and faeces collection. For instance, Alpha Solutions supports clinical trial research into the significance of Circulating free DNA in cancer diagnosis, by offering Sample Transport kits containing Cell-Free DNA BCT tubes, allowing blood taken by a phlebotomist, to be safety transported back to laboratories, whilst maintaining sample quality and integrity. 9Bespoke Blood Collection Kits for Clinical Trials Catalogue Number Description Pack Size CFD-VBT-KIT-RUO Venous Blood Transport Kit Streck Cell-Free DNA BCT tubes x 2 - RUO Each For further information, please enquire at solutions@alphalabs.co.uk to discuss your requirements.
Alpha Laboratories Limited 40 Parham Drive Eastleigh Hampshire SO50 4NU United Kingdom Tel: 023 8048 3000 Email: sales@alphalabs.co.uk Web: www.alphalabs.co.uk JBN193A 05.26 Custom Designed to Your Exact Specifications and Branding From a bespoke Pastette® to deliver your specific sample volume, to a complete patient pack to transport quality samples to the laboratory, we will work with you to custom design and build just what you need. Pastette® - disposable transfer pipettes in any format UN3373 Compliant Packaging - for clinical trials, diagnostics and screening kits Complete Patient Packs for Sample Collection and Transport Building Solutions Let us help with our personalised, flexible and fast bespoke service. Find out more at www.alphalabs.co.uk/customdesign or contact us to discuss your specific requirements and join our long list of satisfied customers.
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