GENERAL ORGANIZATION OF A PHARMACEUTICAL UNIT - INSIGHT OF A PHARMACEUTICAL UNIT OPERATION

Visualization Of A Pharmaceutical Industry, Dry Section, Wet

Section, Quality Control Unit.

                                ( A BRIEF OVERVIEW )



A Pharmaceutical Factory
broadly is divided into main sections in respect of its manufacturing function;

a) Dry Section
b) Wet Section

a) Dry Section :

is concerned with the manufacturing of tablets,capsules and
sachets of the drugs. It has sub-sections like

1. A storage Area

where the raw material for the dry section is stored after its
arrival from abroad. In this subsection, it is kept under quarantine
to ensure the standard of the raw material. If it is found substandard
or deteriorated or adulterated, then it is discarded at this stage.

2. Dispensing Area

here dispensing/distribution of passed raw material to the
concerned manufacturing units is done and record of the raw material
regarding its quality and quantity and transfer to manufacturing unit
is maintained.

3. Sieving

is performed after receiving the raw material from store. Size
of the seive is 60 mesh i.e. 60 by 60/sq inch. The apparatus used for
seiving is called " Mechanical Schiffer. "

4. Granulation Unit

is concerned with the mixing and chopping of raw material with
the help of mixers and choppers. Actual material is mixed with some
other suitable substances, the adjuvants, corrective and flavouring
agents etc. For instance, in the preparation of Nivaquine Tablets,
choloroquin phosphate is mixed with gelatin, starch base and lactose.
There are TWO type of granulation.

i. Dry Granulation

( in this type of granulation, aromatic LTD granulation " Feiwitt
Granulation " is used. Mixing is done for 15 min. )

ii. Wet Granulation

( it is done for 15 min. Lubricants and stearic acid are added.
This is to measure the flow rate which decreases due to friction. )

5. Compression

is applied by the " Rotatory Machine. " It may have 27 or 33
punches. At this time, shape of the tablet is formed.

6. Sugar Coating

is done on the tablets having bitter taste. Thickness of the
coating is measured in mm. e.g. Sugar coating for Phenergan tab. is
0.25 mm.

7. Film Coating

is usually done by cellulose. It is not more than a few microns,
so weight and size of tablet is not increased so much.

8. Packaging

is done at the end of all processes involved in the
manufacturing of tablets. Blisters are made in PVC film with the help
of a machine. Finally these blister packs are covered with wrappers to
provide extra protection to the tablets from deterioration by sunlight
and moisture.

b. WET SECTION

It is concerned with the manufacturing of syrups, suspensions
and emulsions.

1. Storage Area

Liquid raw material is stored and evaluated for quality in this section.

2. Filtering

of liquids is done passing liquid raw material through two
filters, one being coarse and the other is fine. These are called "
Meta Fibers."

3. Mixing

of various components of liquids is performed to make syrups and
suspensions in the shakers of 2000 and 5000 liters capacity. Many
things are added like sugar, sodium benzoate, sodium sulphide, and
meta sulphide ( preservative ), sodium citrate, citric acid, etc. At
the end, active principle like Promethazine HCL is added and
Promethazine syrup is prepared.

4. Air Is Blown

through the liquids to clear impurities etc.

5. Filling of Liquids

into the glass or plastic bottles is done with the help of
automatic machine at the final stage. But the whole process remains
under obervation to ensure quality. These filled bottles are capped,
labeled, and sealed.

QUALITY CONTROL UNIT ( LABORATORY )

It is the most important organ of pharmaceutical factory as it keeps
the quality of the products of the factory up to standards laid down
by various Pharmacopeias and WHO. Usually high qualified and skilled
scientists are at service along with sophisticated scientific
apparatus like HLPC apparatus, Spectrophotometers, Atomic absorption
Spectrophotometers, Flame photometers, Moisture analyzers, pH meters,
Dissolution Apparatus and Computers, for the qualitative and
quantitative analysis of the manufactured drugs in the quality control
unit.





Handbook of APPLIED PHARMACOLOGY
By:

M.Munir Ahmad khan &
Muzammil Hassan Najmi


Dept. Of Pharmacology & Therapeutics.
Army Medical College,
Rawalpindi, Pakistan

Posted in: PHARMACOLOGY