4.6 Biological Samples & Hazardous Goods: Collection, Storage, Disposal & Shipment

Biological Samples & Hazardous Goods

Quick Reference: The laboratory manual is the operational source of truth for samples. It specifies tube types, volumes, processing steps, timing, storage temperatures, labelling and shipping conditions. Where the laboratory manual and a coordinator's habit disagree, the laboratory manual wins; where the protocol and the laboratory manual disagree, that is a discrepancy to escalate to the sponsor, not to resolve locally.

Why this is tested

The ACRP-CP Exam Content Outline carries two knowledge statements on this material: 2D, "Standards for handling hazardous goods, materials, and biological samples (e.g., International Air Transport Association (IATA))" in Domain 2, and 4I, "Sample collection, storage, disposal, and shipment requirements" in Domain 4. It is one of the few places where the outline names an external standards body by name.

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The sample lifecycle

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Classification: the decision that drives everything else

Is the material known or reasonably expected to contain a pathogen?
   │
   ├── NO, minimal likelihood pathogens are present
   │      └─► EXEMPT HUMAN SPECIMEN
   │          Triple packaging still required; mark "Exempt human specimen"
   │
   └── YES ──► Is it capable of causing permanent disability, or
               life-threatening or fatal disease in otherwise healthy
               humans or animals?
                  │
                  ├── YES ──► CATEGORY A
                  │           UN2814 (affecting humans)
                  │           UN2900 (affecting animals only)
                  │           Packing Instruction 620
                  │
                  └── NO  ──► CATEGORY B
                              UN3373 "Biological Substance, Category B"
                              Packing Instruction 650

Most routine clinical trial samples — serum, plasma, urine, whole blood for pharmacokinetics or safety chemistry from participants with no suspected high-consequence pathogen — travel as Category B (UN3373) or as exempt human specimens.

Category A versus Category B side by side

Triple packaging, in every case

1. Primary receptacle — leakproof, holding the specimen itself.
2. Absorbent material — between primary and secondary, sufficient to absorb the entire liquid contents.
3. Secondary packaging — leakproof.
4. Outer packaging — rigid, with an itemised list of contents placed between the secondary and outer layers.

Either the secondary or the outer packaging must be rigid.

Category B specifics worth remembering

• Primary receptacles for liquids must withstand a 95 kPa internal pressure differential.
• For liquids, no more than 1 litre per primary receptacle and no more than 4 litres per outer package; for solids, no more than 4 kg per outer package.
• The UN3373 diamond mark must be at least 50 mm on each side, with lines at least 2 mm wide and characters at least 6 mm high, and the words "Biological Substance, Category B" adjacent to it.
• The smallest external dimension of the outer packaging must be at least 100 mm.
• Full name, address and telephone number of both shipper and consignee on the outer packaging.

Dry ice

Dry ice is not merely a coolant — it is a dangerous good in its own right.

• Shipped as UN1845, proper shipping name "Dry ice" or "Carbon dioxide, solid", Class 9, Packing Instruction 954.
• The package must permit release of carbon dioxide gas. A sealed airtight outer container is a rupture and asphyxiation hazard, not a better package.
• The net weight of dry ice in kilograms must be marked, along with the Class 9 label and the UN1845 identification.
• Dry ice goes outside the secondary packaging, and interior supports must keep the secondary packaging in position after the dry ice sublimates.

Exam Watchout: A UN3373 shipment needs no Shipper's Declaration — but if it travels on dry ice, the dry ice component still carries its own Class 9 marking and air waybill entry. Candidates who memorise "Category B needs no paperwork" get this wrong.

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Training and responsibility

The shipper — in practice the site staff member who packs and releases the package — bears responsibility for correct classification, packaging, marking and documentation. The courier does not assume it.

• IATA requires competency-based training and assessment for personnel who prepare dangerous goods shipments, with recurrent training within 24 months.
• Only individuals who hold current certification and are on the delegation record for the activity may pack and release shipments.
• Training certificates are essential records and are reviewed at monitoring visits and inspections.

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Chain of custody

Every transfer of a sample must be traceable, because an unexplained gap makes the result unusable:

• Requisition form identifying participant code, visit, sample type, collection date and time.
• Collection and processing log at the site, recording who drew, who processed and when.
• Shipment manifest listing each sample in the box, plus courier airway bill number and dispatch date/time.
• Receipt confirmation from the laboratory, including condition on arrival — temperature indicator status, integrity, whether any sample was rejected.
• Reconciliation: the site checks that every sample shipped was received and analysed, and follows up gaps. This is a close-out activity as well as an ongoing one.

Exam Watchout: Sample receipt confirmations are frequently filed unread. If a laboratory reports a sample as haemolysed, insufficient or thawed on arrival, that is a finding requiring action — repeat collection where the protocol allows, a deviation record, and a root cause analysis if it recurs.

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Consent defines the boundary

A sample is not simply a site asset. What may be done with it is bounded by what the participant agreed to:

• Protocol-specified analyses — covered by the main consent.
• Retention beyond the trial and future unspecified research — require the participant to have positively agreed, usually via separate optional tick boxes.
• Genetic or genomic analysis — commonly a distinct consent element with its own disclosures.
• Export to another country — must be described in the consent and be permitted by the applicable framework and any required import/export permit.
• Withdrawal — a participant may withdraw permission for future use of stored samples; the site must have a route to have the remaining samples destroyed and to document that destruction.

Disposal of samples and of contaminated consumables follows the protocol, the laboratory manual and institutional biohazardous waste procedures, and is documented.

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Realistic exam scenario

Scenario: A coordinator prepares a Friday afternoon shipment of frozen plasma aliquots to a central laboratory two time zones away. She packs the cryovials in a foam shipper with dry ice, seals the outer box with tape all around to keep the cold in, writes the participants' initials and dates of birth on the vials so the laboratory can match them, applies a UN3373 diamond mark, and books a standard courier for Monday morning collection.

Evaluation — five separate failures:

1. Sealing the box airtight violates the venting requirement for dry ice (UN1845, Class 9). Subliming carbon dioxide must be able to escape or the package can rupture.
2. No dry ice marking. The Class 9 label, UN1845 identification and the net weight of dry ice in kilograms are missing.
3. Participant initials and dates of birth on the vials breach confidentiality — samples are labelled with the participant code, never with identifiers.
4. Friday dispatch for Monday collection means the dry ice will largely sublimate before the samples move, and the laboratory may be closed on arrival. Shipping days must be coordinated with the laboratory's receiving schedule.
5. Chain of custody is incomplete if no manifest accompanies the box and no receipt confirmation is chased.

Correct actions: repack in a vented dangerous-goods-compliant shipper with the required dry ice quantity for the transit time; apply the UN3373 mark, the Class 9 dry ice label with net weight, and both shipper and consignee details; relabel the vials with participant codes only; hold the shipment until a day that matches the laboratory's receiving window; enclose the manifest; confirm receipt and condition on arrival; and document the near-miss with a CAPA covering shipper training and a shipping-day schedule.