JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

4.7: Control of purchased material and services

4.7.1: Specification and inspection of blood bags

Blood collection shall be by aseptic techniques using a sterile closed system and a single venepuncture. The integrity of the system must be checked prior to use and measures must be taken to prevent non-sterile air entering the system.

Blood shall be collected into containers that are pyrogen free and sterile, containing sufficient licensed anticoagulant for the quantity and purpose of blood to be collected.

The container label shall state the kind and amount of anticoagulant, the amount of blood that can be collected and the required storage temperature.

Manufacturers’ directions regarding storage, use and expiry dates of the packs whose outer containers have been opened and resealed must be adhered to.

Batch numbers of the blood packs used shall be recorded.

The donation number on the pack and sample tubes should be checked at the end of the donation to ensure that those for a given donation are identical; that is, the donation number on the donor health and lifestyle questionnaire, the primary and secondary collection packs and the sample tubes must all be identical.

Prior to release from the blood collection session the pack and its associated tubing should be reinspected for defects and its integrity should be checked by applying pressure to the pack to detect any leaks. Any defective pack should be marked for disposal and held separately from intact packs. Details of the defect(s) should be recorded for future analysis and action (see section 5.11).

4.7.2: Specification of apheresis sets

Blood components must be collected by apheresis using sterile, single-use, disposable items that are licensed and CE marked. The apheresis set for collection of components for direct clinical use must have a preconnected access needle to ensure a sterile pathway, and incorporate a bacterial filter in all non-preconnected fluid lines (e.g. saline, SAGM, and the anticoagulant line [not required if the anticoagulant bag is preconnected]). For dual-needle procedures a preconnected needle is only essential for the access venepuncture.

A record must be kept of all lot and/or batch numbers of all the apheresis set components and injectable materials used, in accordance with local quality systems.

4.7.3: Specifications for automated donor apheresis machines (see also section 8.5)

Machines must be correctly installed and commissioned according to each manufacturer’s instructions. They must be CE marked.

The environment and operating area for each machine employed and the power supply available must conform to the manufacturer’s recommendations for satisfactory machine performance.

Machines must comply with the relevant aspects of the Health and Safety at Work Act 19743 and the Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture.6

Automated apheresis machines must have the following features:

  • A manual override system so that the operator can stop the automatic cycle at any time during the procedure.
     
  • A blood flow monitor, to monitor blood flow during blood withdrawal and return. The purpose is to ensure that the selected donor flow rate does not cause collapse of the donor’s vein and to monitor the venous pressure during the donor blood return cycle such that if any obstruction to flow occurs the blood pump will automatically reduce speed and/or stop. In either event a visual and audible alarm system should operate.
     
  • An in-line air detector to protect the donor from air embolism. In the event of air entering the extra-corporeal circuit a visible and audible alarm must be activated, the return blood pump must automatically stop and the venous return line must automatically be occluded.
     
  • A blood filter integral with the harness to prevent any aggregates formed during the procedure from being returned to the donor.
     
  • An anticoagulant flow indicator, providing a visible means of monitoring anticoagulant delivery throughout the procedure, and ideally an audible alarm if no anticoagulant is flowing.
     
  • A device for pre-setting the collection volume, monitoring the collection volume during the procedure and automatically ending the procedure. A system with a visual and audible alarm to notify the operator of the completion of the procedure may be provided.
     
  • In the event of a power failure the machine must automatically enter a standby mode once power returns.

Apheresis machines must be serviced in accordance with the manufacturer’s instructions.
A planned maintenance scheme should be followed. Machine maintenance and servicing must
be documented and be in accordance with the procedures outlined in the appropriate Medicines and Healthcare products Regulatory Agency publications: DB 9801, DB 9801 Supplement 1 and DB 2000(02).7

Apheresis machines must be routinely cleaned with a suitable decontaminating agent on a daily basis. A standard procedure for dealing immediately with blood spillage must be in operation.

4.7.4: Anticoagulant

A licensed citrate anticoagulant must be used at a ratio which achieves a final plasma citrate concentration of 15–25 mmol/L in the collected component (see Chapter 3, Appendix II).

The anticoagulant must be in date, with no evidence of particles or leakage. Any suspect unit must not be used. The batch number must be recorded on the session record and any defect reported in accordance with local quality systems.