Manufacture

Production facilities of parenterals
• The production area where the parenteral preparation are manufactured can be divided into five
sections: Clean-up area Preparation area Aseptic area Quarantine area Finishing & packaging area
Clean-up area:
It is not aseptic area.  All the parenteral products must be free from foreign particles & microorganism.
 Clean-up area should be withstand moisture, dust & detergent.  This area should be kept clean so
that contaminants may not be carried out into aseptic area.
Preparation area:
In this area the ingredients of the parenteral preparation are mixed & preparation is made for filling
operation.  It is not essentially aseptic area but strict precautions are required to prevent any
contamination from outside.
Aseptic area:
The parenteral preparations are filtered, filled into final container & sealed should be in aseptic area. 
The entry of personnel into aseptic area should be limited & through an air lock.  Ceiling, wall & floor of
that area should be sealed & painted.  The air in the aseptic area should be free from fibers, dust and
microorganism.  The High efficiency particulate air filters (HEPA) is used for air.  UV lamps are fitted in
order to maintain sterility.
Quarantine area: 
After filling, sealing & sterilization the parenteral product are held up in quarantine area.  Randomly
samples were kept foe evaluation.  The batch or product pass the evaluation tests are transfer in to
finishing or packaging area.
Finishing & packaging area:
 Parenteral products are properly labelled and packed.  Properly packing is essential to provide
protection against physical damage.  The labelled container should be packed in cardboard or plastic
container.  Ampoules should be packed in partitioned boxes
Material Requirement (contd.)
• Taking formula and determination of quantity of chemical required for final production • Putting data
on a summary sheet • Dividing the budget period into four quarter allowing the purchasing group to
utilize good purchasing techniques.
7. Manufacturing Capacity
• Availability of Pharmacist to him • Capability of the machineries for the production
8. Manufacturing Equipment and its source

• Equipments varies from one institution to another • Depends on – Length of time for production –
Availability of personnel – Availability of physical facilities
9. Manufacturing Staff
• The lower the personnel, the lower the overall manufacturing cost • Trained personnel needed – May
be trained by pharmacists about bottling, filtering, labeling, etc
10. Operating Cost •
Operating costs can be described as the expenses which are related to manufacturing program in
hospital pharmacies. • Consists of – Direct labor – Cost of material – Indirect cost
11. Quality Control
• Quality control or statistical quality control is the application of statistics for control of sizes, weights
and other physical characteristics of articles undergoing mass production. • But is case of hospital,
quality control will ensure the integrity of the label which is done by developing a series of checks and
laboratory analysis.
Dispensing: Each ingredient in the tablet formula is weighed and accurately dispensed as per dose. This
is one of the critical steps in any type of formulation process and should be done under technical
supervision.
Sizing: Formulation ingredients must be in finely divided form, otherwise, size reduction should be
carried out for better flow property and easy mixing.
Powder blending: Powders are mixed using a suitable blender to obtain a uniform and homogeneous
powder mix. The drug substance and excipients are mixed in geometric dilution.
Granulation: Here small powder particles are gathered together into layers, and permanent aggregates
to render them into free-flowing states.
Drying and dry screening: Screened wet granules need to be dried for a particular time period in tray dry
or fluid bed dryer at controlled temperature not exceeding 550C. Dried granules are screened through
the appropriate mesh screen.
Tablet compression: This step involves the compression of granules into a flat or convex, round, oblong,
or unique shaped, scored or unscored tablets; engraved with an identifying symbol and/ or code number
using tablet press.
Coating: Tablets and granules are coated if there is need to mask the unpleasant taste/odour of some
drug substance or to increase the aesthetic appeal of uncoated tablets as well as to modify the release
or control the release of drug substance from tablets. This is achieved by enclosing or covering the core
tablet or granules with coating solutions.

Manufacture

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Production facilities of parenterals

Finishing & packaging area:

Material Requirement (contd.)

• Availability of Pharmacist to him • Capability of the machineries for the production

8. Manufacturing Equipment and its source

10. Operating Cost •

11. Quality Control

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