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.

IBTS/PMF/SPEC/0200 [7] Product Master Files - List of Product Names.pdf (size 435.3 KB)

IBTS/PMF/SPEC/0201 [3] Product Master Files - General Requirements.pdf (size 744.4 KB)

IBTS/PMF/SPEC/0203 [4] Whole Blood suitable for neonatal use.pdf (size 564.7 KB)

IBTS/PMF/SPEC/0204 [4] Whole Blood Autologous.pdf (size 500.4 KB)

IBTS/PMF/SPEC/0205 [4] Red Cells.pdf (size 553 KB)

IBTS/PMF/SPEC/0206 [5] Red Cells washed.pdf (size 571.3 KB)

IBTS/PMF/SPEC/0207 [3] Whole Blood Reconstituted, suitable for neonatal use.pdf (size 595 KB)

IBTS/PMF/SPEC/0208 [5] Whole Blood Suitable for Neonatal Use for 5 Days After Blood Drawn.pdf (size 672.1 KB)

IBTS/PMF/SPEC/0209 [5] Red cells Suitable for Neonatal Use.pdf (size 749.4 KB)

IBTS/PMF/SPEC/0210 [4] Red Cells suitable for Intrauterine Transfusion Irradiated.pdf (size 557.4 KB)

IBTS/PMF/SPEC/0212 [4] Red Cells Resuspended.pdf (size 539.1 KB)

IBTS/PMF/SPEC/0213 [4] Platelets Adult Dose and Paediatric Dose.pdf (size 643.8 KB)

IBTS/PMF/SPEC/0214 [6] Platelets Adult Dose with Plasma PAS Irradiated.pdf (size 532.7 KB)

IBTS/PMF/SPEC/0215 [5] Platelets, Adult dose, Washed, Irradiated.pdf (size 621.1 KB)

IBTS/PMF/SPEC/0216 [4] Platelets Suitable for Neonatal Use.pdf (size 652.2 KB)

IBTS/PMF/SPEC/0217 [5] Platelets, Adult Dose, Suitable for Neonatal Use, Washed, Irradiated.pdf (size 603.3 KB)

IBTS/PMF/SPEC/0218 [3] Platelets, Hyperconcentrated, Suitable for Neonatal Use, Irradiated.pdf (size 586.9 KB)

IBTS/PMF/SPEC/0220 [3] Fresh Frozen Plasma.pdf (size 557.1 KB)

IBTS/PMF/SPEC/0221 [3] Fresh Frozen Plasma Suitable for Neonatal Use.pdf (size 568.6 KB)

IBTS/PMF/SPEC/0224 [3] Cryoprecipitate Suitable for Neonatal Use.pdf (size 555.8 KB)

IBTS/PMF/SPEC/0226 [5] Leucocytes Pooled Irradiated (Source of Granulocytes).pdf (size 573.5 KB)

IBTS/PMF/SPEC/0227 [4] Leucocytes Pooled, Red Cell Reduced, Irradiated (Source of Granulocytes).pdf (size 544.7 KB)

IBTS/PMF/SPEC/0232 [4] Red cells Suitable for Neonatal Use for 5 days After Date Drawn.pdf (size 571.7 KB)

IBTS/PMF/SPEC/0236 [2] Apheresis Convalescent Plasma Covid-19.pdf (size 582.8 KB)