Product Master File

IBTS Product Master File

 The IBTS Product Master File is a list of specifications for Blood Products and Blood Components issued to the hospitals. These include specifications for General Requirements, Red Cells, Platelets Pooled, and Platelets Apheresis.The IBTS Product Master File specifications apply to single donor and small pool components prepared from units of whole blood or collected by apheresis appliances.

Each Product Master File specification includes information on the following :

·        Name of Product

·        IBTS Component Code

·        General Description

·        General Specification

·        Requirements for Labelling, Storage, Irradiation and Transport

·        Indications for use

·        Precautions for use

·        Adverse Effects

·        Reporting of Serious Adverse Reactions

See list of product masterfiles below

IBTS Product Master File - ISBT-128

The new IBTS product Master File (effective date 1st June 2015) will have the same contents as listed above  but in addition will now also contain the following:

  • Each Product Master File will have a 0200 series number. Previous Product Master File number 0105 will become 0205 in the new numbering system
  • Each Product component will have an updated Codabar code (some will remain the same as they were before) as well as a new ISBT-128 Code assigned to it.
  • Each product component will have a new E Progesa Name assigned to it.
  • Product Master File 0200 is an index of all of the Products and also explains the transition from the previous product master file to the new one.
  • Splits 1 to 5 of a component will be denoted by A0, B0, C0, D0 and E0 in the last two digits of the ISBT-128 Code.
  • Product Master Files that become obsolete will be notified as this occurs and will be removed from the website on their expiry date.

Apheresis Convalescent Plasma - Covid 19.pdf (size 592.6 KB)

Cryoprecipitate suitable for neonatal use.pdf (size 255.8 KB)
Fresh Frozen Plasma suitable for neonatal use.pdf (size 260 KB)
Fresh Frozen Plasma.pdf (size 252.8 KB)
General Requirements.pdf (size 776.1 KB)

Leucocytes Pooled Irradiated - Source of Granulocytes.pdf (size 579.4 KB)
Leucocytes Pooled, Red Cell Reduced, Irradiated source of granulocytes.pdf (size 245.9 KB)
List of Products Names.pdf (size 416 KB)
Platelets Adult Dose and Paediatric Dose.pdf (size 751.8 KB)
Platelet Adult Dose with Plasma, PAS, Irradiated.pdf (size 302 KB)
Platelets suitable for neonatal use.pdf (size 782.7 KB)
Platelets Adult dose Washed Irradiated.pdf (size 398.7 KB)
Platelets Adult Dose Suitable for Neonatal Use Washed.pdf (size 411.9 KB)
Platelets Hyperconcentrated suitable for neonatal use Irradiated.pdf (size 401 KB)
Red Cells suitable for Intrauterine Transfusion Irradiated.pdf (size 250.2 KB)
Red cells resuspended.pdf (size 240.4 KB)
Red cells suitable for neonatal use for 5 days after date drawn.pdf (size 312.9 KB)
Red cells suitable for neonatal use.pdf (size 803.7 KB)
Red Cells washed.pdf (size 305.8 KB)
Red Cells.pdf (size 299.6 KB)
Whole Blood Autologous.pdf (size 238.2 KB)
Whole Blood suitable for neonatal use.pdf (size 311.5 KB)
Whole Blood Reconstituted, suitable for neonatal use.pdf (size 304.2 KB)
Whole Blood suitable for neo nate use for 5 days after blood drawn.pdf (size 713.7 KB)