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ОРИГИНАЛ
3.2.P.3.3.2 Equipment
3.2.P.3.3.3 Manufacturing directions for
[drug 1] 2 mg / Indapamide 0.625 mg
tablets,
[drug 1] 4 mg / Indapamide 1.25 mg
tablets and
[drug 1] 8 mg / Indapamide 2.5 mg tablets
Information referring to sieves, mixing and
tabletting process, is as follows:
Raw material is sieved using sieve openings
0.8 mm or equivalent. Sieving of the raw
material process is equivalent at all
manufacturing places. Raw material is sieved
in case larger agglomerates are present.
On the basis of the batch size and available
equipment at the manufacturing places
mixing process can be obtained either in
conical or in high shear mixers.
The parameters are written bellow. The
results of process parameters, shows the
suitability and equivalency of mixing in both
mixer types.
ПЕРЕВОД
In scale up process stainless-steel mixers of
different size can be used, depending on
batch size.
Tabletting process is performed on rotary
tablet press with speed of tabletting machine
up to 120 rpm. Tabletting process is
equivalent at all manufacturing places.
The suitability of mixing process in
production-scale and different manufacturing
places will be confirmed in validation process
for each scale-up and each manufacturing
place.
On the basis of the batch size and available
equipment at the manufacturing places
mixing, process parameters (mixer type,
capacity, mixing time) can differ between
manufacturing places.
In order to optimize the process performance
in production-scale (also manufacturing
places), they can- after production of a
sufficient number of batches- also be object
of change in certain extent.
Meaning that, the process is optimized
without any negative impact on quality of the
medicinal product.
Preparation of the granulate and compression
mixture is the same for [drug 1] 2 mg /
Indapamide 0.625 mg tablets, [drug 1] 4 mg /
Indapamide 1.25 mg tablets and [drug 1] 8
mg / Indapamide 2.5 mg tablets where the
same equipment is used under the same
manufacturing directions. [drug 1] 8 mg /
Indapamide 2.5 mg tablets and [drug 1] , 4
mg / Indapamide 1.25 mg tablets are linear
increase of [drug 1] 2 mg / Indapamide 0.625
mg tablets. One standard batch of
compression mixture can therefore be used
for preparation of all strengths.
01 Dry granulate
Cellulose, Microcrystalline
Colloidal hydrated silica
Are sieved in case of larger agglomerates are
present and blended in the mixer
02 Magnesium Stearate
is passed through the sieve, added to the
mixture and homogeneously mixed.
03 IPC of compression mixture
04
Compressing
The
compression
mixture
is
compressed using rotary tabletting
machine to a target tablet mass. The
rotation speed of tabletting machine is
up to 120 rpm.
Setting up the tabletting machine for
Perindorpil 2 mg / Indapamide 0.625 mg
tablets
Upper punch: round,  = 5 mm, slightly
concave, bevel-edged with a score
Lower punch: round,  = 5 mm,
slightly concave, bevel-edged
Weight:
Thickness:
0.050 g
1.6 – 2.8 mm
Hardness:
n.l.t. 15 N
Setting up the tabletting machine for
Perindorpil 4 mg tablets / Indapamide 1.25
mg tablets
Upper punch: round,  = 6.5 mm, slightly
concave, bevel-edged, with a score
Lower punch: round,  = 6.5 mm,
slightly concave, bevel-edged
Weight:
Thickness:
0.100 g
2.1 – 3.6 mm
Hardness:
n.l.t. 20 N
Setting up the tabletting machine for
Perindorpil 8 mg tablets / Indapamide 2.5 mg
tablets
Upper punch: round,  = 8 mm, slightly
concave, bevel-edged, with a score
Lower punch: round,  = 8 mm,
slightly concave, bevel-edged
05
Weight:
Thickness:
0.200 g
2.7 – 4.4 mm
Hardness:
n.l.t. 20 N
IPC of tablets
IPC control is performed on
automatically IPC unit on tablet press
machine. The normal frequency of
automatically
IPC
control
is
determined in standard operative
procedure for tabletting process. The
normal IPC control on automatically
unit is performed every 15 to 30
minutes. Disintegration time and
friability are performed according to
standard operative procedure.
06
Bulk tablets are packed into PE bag
inserted which is in Alu-bag. Firmly
close a PE bag and place desiccant
between PE bag and Alu bag.
Following the sealing of the the Alu
bag.
07
The tablets are packed OPA/Al/PVC
foil – Alu foil or PVC/PE/PVDC –
Alu foil and are then packed into
folding cartons together with the
instruction leaflet.