Component specification

A3.11: Dried Plasma, Leucocyte Depleted

Plasma that has been obtained from whole blood or by apheresis (as defined in chapter 7.3). The starting plasma must be suitable for the production of FFP. The plasma contains less than 1×106 leucocytes per component and has been dried using a validated system demonstrated to maintain the activity of labile coagulation factors.

---

A3.11.1: Technical information

• Dried Plasma, Leucocyte Depleted (LD) is intended for the treatment of major haemorrhage currently only as part of clinical studies.
• Dried Plasma, LD should be manufactured from group A donations that are negative for high-titre anti-B antibodies.
• Donations of whole blood where the bleed time exceeded 15 minutes are not suitable to produce plasma components for direct clinical use.
• Plasma should be selected from male donors or consideration should be given to screening female donors for HLA/HNA antibodies, as a TRALI risk reduction measure.
• The plasma should be separated before the red cell component is cooled to its storage temperature. Greater FVIII:C yields will be obtained when the plasma is separated as soon as possible after venepuncture and rapidly frozen to -25°C or below.
• The method of preparation should ensure the component has the maximum level of labile coagulation factors with minimum cellular contamination. The production process should be validated to ensure that components meet the specified limits for FVIII:C concentration.
• Component samples collected for the quality monitoring assessment of FVIII:C should be representative of the distribution of ABO groups issued for clinical use.
• Dried Plasma, LD should be administered through a CE/UKCA/UKNI marked transfusion set.

---

A3.11.2: Labelling

For general guidelines, see chapter 6.6.

The following shall be included on the label:

(* = in eye-readable and UKBTS approved barcode format)

• Dried Plasma, Leucocyte Depleted* and volume
• the blood component producer’s name*
• the donation number and, if divided, sub-batch number*
• the ABO group*
• the RhD group stated as positive or negative*
• the date of collection
• the expiry date of the dried component*
• the temperature of storage
• the blood pack lot number*
• a warning that the component must be used within 6 hours of rehydration if maintained at ambient temperature
• the name, composition and volume of the anticoagulant.

In addition, the following statements should be made:

INSTRUCTION
Always check patient/component compatibility/identity
Inspect pack and contents for signs of deterioration or damage
Risk of adverse reaction/infection, including vCJD

---

A3.11.3: Storage

For general guidelines, see chapter 6.7.

• The component should be stored at a core temperature of 2–25°C for a maximum of 6 months.
• The component should be rehydrated with 200 mL sterile water for injection (SWFI) according to a validated procedure.
• After reconstitution, and at the time of administration, the content should be inspected to ensure that no insoluble plasma is visible and that the container is intact.
• Once rehydrated, the component must not be frozen and should be transfused as soon as possible. If delay is unavoidable, the component should be transfused within 6 hours.

---

A3.11.4: Testing

In addition to the mandatory and other tests required for blood donations described in chapter 9, and leucocyte counting (see chapter 6.3 and chapter 7.1.1), a minimum of 75% of those components tested for the parameters shown in Table A3.11 shall meet the specified values with the exception of FVIII:C.

Table A3.11: Dried Plasma, LD – additional tests

Parameter	Specification	Frequency of test
Parameter Volume (1)	Specification Within locally defined nominal range	Frequency of test 10 units per month of production
Parameter Total protein	Specification ≥50 g/L	Frequency of test 10 units per month of production
Parameter Platelet count (2,3)	Specification <30×109/L	Frequency of test 10 units per month of production
Parameter Red cell count (2,3)	Specification <6×109/L	Frequency of test 10 units per month of production
Parameter FVIII:C (4)	Specification Mean ≥0.60 IU/mL	Frequency of test 10 units per month of production
Parameter vWF RiCof	Specification Mean ≥0.40 IU/mL	Frequency of test 10 units per month of production
Parameter Fibrinogen	Specification Mean ≥2 g/L	Frequency of test 10 units per month of production
Parameter Bacterial screening	Specification Negative	Frequency of test 10 units per month of production
Parameter Leucocyte count (3,6)	Specification <1×106/unit	Frequency of test As per chapter 6.3 and chapter 7.1.1

---

A3.11.5: Transportation

For general guidelines, see chapter 6.11.

Every effort should be made to maintain the core storage temperature of ≤25°C during transportation.