check for acceptable handling and storage characteristics of unopened cartons of packs from receipt, through storage to use at sessions.
Checks to be performed by collection teams
Collection teams will follow routine procedures for recording pack faults, but additionally should comment on
ease of overwrap opening
integrity of overwrap
accuracy of instructions for use at time of collection
acceptability of needle characteristics
suitability of tubing (length and flexibility)
general suitability.
Checks to be performed by processing team
The processing team will follow routine procedures for recording pack faults, but may additionally wish to comment on
breakage rates following freezing
heat seal failures (in house seals)
suitability of tubing (length and flexibility)
ease of cannula breakage
ability to sterile dock (during secondary processing)
integrity of join, following local, current, procedure
compatibility with SCD instructions
assess packaging of frozen packs
inspection of packs after overnight storage at 4°C.
End users
Set up a process by which users will feedback information on acceptability of the packs for use. This would involve blood bank and ward/theatre staff. Obtain details on:
Blood bank issues:
acceptability to end users
acceptability of number and condition of bleed line samples
crossmatch/other label adherence
leak and breakage rates.
End user issues:
general acceptability
accessibility of ports for giving sets
leak and breakage rates.
When the minimum number of packs has been evaluated, the individual or group responsible for the trial will prepare and submit a Phase 1 report.
Phase 2: evaluation
A minimum of 2000 packs from each of two batches for whole blood collection processes or 300 sets for apheresis collection will be used in this phase to allow data on consistency of manufacture to be collected.
Relevant SOPs will be available before commencing Phase 2. Customer communication and any associated training will also have been done by this date.
Blood components produced during Phase 2 may be used therapeutically where they comply with the normal release criteria.
Goods inward inspection
Check that appropriate storage information is shown on the packaging
Check the condition of packaging on receipt. Document damaged cartons and examine contents to assess the extent of any damage.
QA pack conformance inspection
Unless otherwise indicated, the following inspection will be performed and documented for packs to be used in Phase 2 of the trial:
pack batch number (eye-readable and machine-readable)
pack type number (eye-readable and machine-readable)
base label integrity
seals, seams and welds satisfactory
absence of leaks
anticoagulant/additive free from turbidity, particulate matter and inclusions.
Checks to be performed by collection teams
Collection teams will follow routine procedures for recording pack faults, but additionally should comment on:
ease of overwrap opening
integrity of overwrap
accuracy of instructions for use at time of collection
acceptability of needle characteristics
suitability of tubing (length and flexibility)
general suitability.
Checks to be performed by processing team
The processing teams will follow routine procedures for recording pack faults, but may additionally wish to comment on:
breakage rates following freezing
heat seal failures (in house seals)
suitability of tubing (length and flexibility)
ease of cannula breakage
ability to sterile dock (during secondary processing)
integrity of join, following local, current, procedure