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  Product Master Files - List of Product Names.pdf (size 435.3 KB)
IBTS/PMF/SPEC/0201  Product Master Files - General Requirements.pdf (size 744.4 KB)
IBTS/PMF/SPEC/0203  Whole Blood suitable for neonatal use.pdf (size 564.7 KB)
IBTS/PMF/SPEC/0204  Whole Blood Autologous.pdf (size 500.4 KB)
IBTS/PMF/SPEC/0205  Red Cells.pdf (size 553 KB)
IBTS/PMF/SPEC/0206  Red Cells washed.pdf (size 571.3 KB)
IBTS/PMF/SPEC/0207  Whole Blood Reconstituted, suitable for neonatal use.pdf (size 595 KB)
IBTS/PMF/SPEC/0208  Whole Blood Suitable for Neonatal Use for 5 Days After Blood Drawn.pdf (size 672.1 KB)
IBTS/PMF/SPEC/0209  Red cells Suitable for Neonatal Use.pdf (size 749.4 KB)
IBTS/PMF/SPEC/0210  Red Cells suitable for Intrauterine Transfusion Irradiated.pdf (size 557.4 KB)
IBTS/PMF/SPEC/0212  Red Cells Resuspended.pdf (size 539.1 KB)
IBTS/PMF/SPEC/0213  Platelets Adult Dose and Paediatric Dose.pdf (size 643.8 KB)
IBTS/PMF/SPEC/0214  Platelets Adult Dose with Plasma PAS Irradiated.pdf (size 532.7 KB)
IBTS/PMF/SPEC/0215  Platelets, Adult dose, Washed, Irradiated.pdf (size 621.1 KB)
IBTS/PMF/SPEC/0216  Platelets Suitable for Neonatal Use.pdf (size 652.2 KB)
IBTS/PMF/SPEC/0217  Platelets, Adult Dose, Suitable for Neonatal Use, Washed, Irradiated.pdf (size 603.3 KB)
IBTS/PMF/SPEC/0218  Platelets, Hyperconcentrated, Suitable for Neonatal Use, Irradiated.pdf (size 586.9 KB)
IBTS/PMF/SPEC/0220  Fresh Frozen Plasma.pdf (size 557.1 KB)
IBTS/PMF/SPEC/0221  Fresh Frozen Plasma Suitable for Neonatal Use.pdf (size 568.6 KB)
IBTS/PMF/SPEC/0224  Cryoprecipitate Suitable for Neonatal Use.pdf (size 555.8 KB)
IBTS/PMF/SPEC/0226  Leucocytes Pooled Irradiated (Source of Granulocytes).pdf (size 573.5 KB)
IBTS/PMF/SPEC/0227  Leucocytes Pooled, Red Cell Reduced, Irradiated (Source of Granulocytes).pdf (size 544.7 KB)
IBTS/PMF/SPEC/0232  Red cells Suitable for Neonatal Use for 5 days After Date Drawn.pdf (size 571.7 KB)
IBTS/PMF/SPEC/0236  Apheresis Convalescent Plasma Covid-19.pdf (size 582.8 KB)