Biological risk management in the preanalytical phase
The essence of the Biological Risk Management in the Preanalytical Phase is the upkeep of the Biological Security Chain, which starts with the taking of the sample and concludes with its destruction. Thus, this chain includes rick prevention when taking the sample and during packaging, transportation, receipt and handling until its final destruction as waste.
Therefore, a strategic and integrated approach is required in order to analyze and manage the risks of contaminating agents on people and the enviorenment, as well as the adverse effects that such agents produce.
Transport Category A infectious materials
Transport Category A infectious materials:
1. Leakproof primary receptacle
2. Secondary packaging. Leakproof and certified 95 kPa between -40 ºC to + 55 ºC
3. Outer packaging. Rigid
Do you pack and/or transport properly and securely your clinical samples?
- Do you know whether or not it contains infectious substances?
- Have any pathogens been neutralized or inactivated, so that they no longer pose a health risk?
- May it contain microorganisms that are nonpathogenic to humans or animals?
- Is it in a state in which any pathogens that should appear have been neutralized or inactivated so that they no longer pose a health risk?...
Classification
The WHO*, depending on UN*, has developed a Guidance on regulations for the Transport of Infectious Substances. Those instructions are included in the ADR*, as well as in specific regulations of ICAO* and IATA*.
How should a container be?
| COMPONENTS | PACKAGING INSTRUCTION P620 | PACKAGING INSTRUCTION P650 |
ADR EXEMPTION (according to 2.2.62.1.5.6 ADR) |
| PRIMARY RECEPTACLE (test tubes / Petri dishes / Urine vials) | Leakproof / Capable of withstanding, without leakage, an internal pressure of not less than 95 kPa and temperatures in the range -40º to +55ºC (if secondary packaging does not) | Leakproof / Capable of withstanding, without leakage, an *internal pressure of 95 kPa in room temperature (if secondary packaging does not) | Leakproof |
| ABSORBENT MATERIAL | For liquid substances, if multiple primary receptacles, they should be individually wrapped and absorbent material should be placed between the primary receptacles and the secondary packaging | ||
| SECONDARY PACKAGING (bag, canister or box) |
Leakproof / Capable of withstanding, without leakage, an internal pressure of not less than 95 kPa and temperatures in the range -40º to +55ºC (if primary receptacle does not) | Leakproof / Rigid if outer packaging is not / Capable of withstanding, without leakage, an internal pressure of 95 kPa in room temperature (if secondary packaging does not) | Leakproof |
| OUTER PACKAGING | Rigid /The smallest external dimension shall be not less than 100 mm. | *Rigid if secondary packaging is not / Minimum dimension of 100 mm x 100 mm. | Strong enough to withstand usual carriage/ Minimum dimension of 100 mm x 100 mm |
What tests must a container pass?
| TEST | CATEGORY A PACKAGING (6.3 ADR) |
CATEGORY B PACKAGING | EXEMPT SAMPLE PACKAGING |
| Drop Test | From a height of 9 m | From a height of 1,2 m | NO |
| Water Spray Test | For fiberboard outer packagings | For fiberboard outer packagings | NO |
| Stacking Test | YES | NO | NO |
| Puncture Test | YES | NO | NO |
| Internal pressure (primary receptacle or secondary packaging) |
Internal pressure of not less than 95 kPa and temperatures in the range -40º to +55ºC | Internal pressure of 95 kPa in room temperature | NO |