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1. Layout of facilities.
2. Materials flow.
3. Quality assurance procedures.
4. Design of facilities.
5. Construction consideration.
6. Equipment consideration.
7. Environmental consideration.
8. Material management and inventory control.
§ What is layout?
A plan or design of something that is laid out.
§ Purpose:
To control cross contamination.
Advantage:
Space conservation by virtue of having the supply areas close to the areas being supplied.
Disadvantage:
Chances of contamination or mix up b/c of crossover traffic pattern of material.
Advantage:
Since the flow is circular so it eliminates much of crossover traffic.
Advantage:
Minimal crossover of materials.
Disadvantage:
Additional space required to accommodate this configuration.
Receiving
Quarantine
(First Storage)
Final Storage
Granulation
Compression
Bulk Quarantine
10
Shipping
1. Receipt of materials.
3. The material should be quarantine-designated and moved to a quarantine area. Quarantining should
be carried out by either full physical examination or utilization of suitable paper system.
7. On notification of release by quality control, materials should be released and moved into final
storage area for use. Locator books or sheets should be setup and adherence to the policy of FIFO
should be followed.
9. Weighed batch quantities and packaging components are assembled in a staging area.
11.Materials for the batch are moved to granulating area, appropriately verified on manufacturing
documents and placed in the mixing equipment.
13.After granulation, material is dried, milled and blended, then stored in an in-process storage area or
moved directly to compressing area.
15.Compressing machine may be fed in a variety of ways, including scooping, direct fed from inverted
drums, bin fed, etc.
17.The bulk product is collected in appropriate containers and moved to bulk quarantine.
19.On quality control release, the containers are approve-labeled, the yield verified, documentation
completed and product moved to bulk stock.
11
Quality Assurance Procedure
Purchase or manufacture raw material to specifications
ingredients
§Ideally the area should be an enclosed facility adjacent to manufacturing area, using approx. the
same construction materials utilized in the manufacturing areas.
§Each room has a self – contained, air – handling unit and moves air from left to right across the
work area through perforated plates located on each side of room, at a velocity of 90 to 110 ft/min.
§The air should filtered through a bank of prefilters and then through HEPA filters before return to
room.
§Make up air should be conditioned to maintain a temperature of 75 – 78˚F and returned to room.
§An equal amount of air is removed after HEPA filters to maintain room balance.
§Weighing is performed in the deepest part of room to prevent any dust migration.
§If the operation is small, standard dial or digital readout scales may be used.
§For larger operation minicomputerized digital readout weighing systems are used.
§Monthly schedule for calibration and inspection of scales by outside scale contractor should be
performed.
§Space should be available for storage of weighing batch quantities until they are required in processing
areas.
§ Wet granulation has some basic steps in common with dry granulation:
a) Comminution.
b) Blending.
c) Milling.
d) Lubrication.
§ The additional steps necessary are the preparation and addition of a granulation solution, wet
screening, and drying.
§ Granulating liquid may be deionized water, deionized water and alcohol, or other appropriate liquid.
§ Granulating liquid may be used to introduce binders, such as gums or starches or coloring agents.
§ After addition of granulating liquid, mixing or kneading continues until uniform dispersion of liquid is
attained.
§ Wet screening or milling may be employed to break up moist mass into appropriate size granules
for drying.
§ Lubricants may have been included in the wet stage; if not they may be incorporated at this time,
prior to final batch blending.
§ Other procedures for wet granulation may be employed. Basically, all these methods combine wetting
the powders to form granules and then drying the granules in the same piece of equipment.
§ These includes:
a) Spray dryer.
b) Fluid bed dryer.
c) Air suspension technique.
3) Slugging: A tablet press, utilizing flat – faced punches, is used to compact the blend of finely divided
powders into large compacted masses known as “slugs”. The slugs then are screened or milled to
produce a granular material which can be compressed as tablets.
5) Chilsonator: It turns out a steady, continues flow of compacted mass aggregates resembling a thin
cake. The aggregates then are screened or milled to produce granules.
Direct Compression:
Granulating Room:
§It should be preferably 12*22 ft and large enough to accommodate all materials, equipments and
personnel.
§It should also accommodate drying racks or fluid bed dryer bowls.
§Similar rooms of suitable size should be provided for the milling and sizing and blending operation.
Granulating solutions:
§It can be prepared in granulating room or in a centralized granulating solution preparing room.
§It should be available with suitable heat control and recording devices.
§In case of overnight drying there should be installment of a temperature limit alarms.
§Solid reduction, milling, grinding equipment should be allocated to enable mesh patterns or particle size
determination to be made against a standard.
§A centralized washing facility should be provided in granulating area for cleaning portable equipment.
1) Liebermen.H.A; Lachman.L; “Pharmaceutical Dosage Form: Tablets”; Vol. 3; 1982; Page.277 – 297.