This presentation discusses about Parenteral Preparation processing and it's production facilities.

1. Industrial Pharmacy Unit IV
Parenteral Products
Unit -IV
B.Pharmacy 5th semester
Presented By
Miss Sudipta Roy
Designation: Associate Professor
B.Pharmacy & Master of Pharmacy
(Pharmaceutics)
Agra public pharmacy college Artoni

2. Contents
 Processing of Parenteral Preparation:
1. Cleaning of containers, closures and
equipment.
2. Collection of materials.
3. Preparation of Parenteral products.
4. Filtration.
5. Filling the preparation in final containers.
6. Sealing the containers.
7. Sterilization.
8. Evaluation of Parenteral preparation.
9. Labeling and packaging.

3. Cleaning of containers, closures
and equipment.
Containers , Closures and equipment must be
thoroughly cleaned with detergents and water
followed by cleaned distilled water and finally rinsed
with water for injection.
Rubber closures are being washed with hot solution
of 0.5% sodium pyrophosphate in water, closures are
then removed from the solution washed with water
followed by rinsing with filtered water for injection.
On small scale washing is done manually but on a
large scale automatic washing machines are used.

4. Collection of materials.
 The various ingredients for Parenteral
formulation are being weighed and
collected, like raw materials, water for
injections etc.
Parenteral
preparations
may require
the use of
biocompatible
excipients
that are
selected
according to
the specific
application
To prevent
the
degradation
of the drug
substances
(stabiliser)
To ensure
or
increase
the drug
substance’s
solubility
To provide
adequate
antimicrobi
al
preservatio
n (only
applicable
to
multidose
preparation
s).
to make
the
preparation
isotonic
with
respect to
blood
(glucose/de
xtrose,
mannitol,
sodium
chloride)
To adjust
the pH to
physiological
levels
(mineral or
organic acids
or salts)
To prevent
the
degradation
of the drug
substances
(stabiliser)

5. Preparation of Parenteral product.
 After accurately weighing the each
ingredients of formulation separately,
dissolved in the vehicle and preparation
must be done under strictly aseptic
condition.

6. Filtration .
 The Parenteral solution so formed is
passed through bacteria proof filter such
as filter candle, seitz filter, membrane
filter and sintered glass filter to make
preparation free from foreign particles
avoiding contamination of filtered solution
to transfer into final container and sealed.

7. Filling the preparation in final
container.
 The filtered product is filled into final container such as ampoules, vials,
transfusion bottles previously cleaned and dried. On small/laboratory
scale filling is done manually by hypodermic syringe and needle, On large
scale filling is done by automatic filling machine. Powders must be filled
into containers by individual weighing/semi or automatic filling machine
and under aseptic condition .
Ampoules used for filling
single doses. In filling
ampoules the care
should be taken that the
solution should be filled
below the neck of
ampoules, untouchable
to the neck of ampoules
that prevent cracking
and staining of the neck
of ampoules at time of
sealing.
Vials are used
for filling multi
doses.
Bottles used
for filling
transfusion
fluids.

8. Sealing the containers.
The vials and transfusion bottles are sealed by closing its opening with a rubber closures that is
placed by crimping the aluminium caps manually or by mechanical means.
On small scale- sealing is done by manually rotating the neck of the ampoule in the flames of
bunsen burner.
On large scale sealing is done to ampoule using ampoule sealing machine.
Firstly Fill the container.
Then Seal the container.
Ampoules are sealed manually on small
scale.

9. Sterilisation.
Thermostable
preparation.
• Sealing the container then sterilizing the final container.
• For thermostable medicament the Parenteral products are sterilized either by autoclaving
at room temp. of 115 degree centigrade to 116 degree centigrade for 30 minutes or 121
degree centigrade for 20 minutes or in hot air oven at 160 degree centigrade for two
hours.
Thermo labile
preparation.
• The thermo labile preparations are sterilized by filtration through a suitable bacteria
proof membrane filter like filter leaf, seitz filter , in such cases a suitable bacteriostatic
agents may be added to prevent growth of microorganism. In case of intravenous or
intrathecal injection in doses exceeding 15 ml, the bacteriostatic agent must br
prohibited
Final stage
• Filtration, filling and sealing are done under aseptic conditions.

10. Production Facilities
 The manufacturing of Parenteral preparation
requires special precautions and facilities in
order to maintain sterility and freedom from
particulate matter. The production area can
be divided into five sections:-
 1. Clean up area
 2. Preparation area
 3.Aseptic Area
 4.Quarantine Area
 5. Finishing and packaging area.

11. Preparation area
Aseptic Filling
Area
Quarantine
area
Packaging
and
finishing.
Storage
and its
disposal.
Store room
for material
and
equipment.
Clean up area Sterilisation.

12. Clean up area: All the Parenteral products must be free from
foreign particles and microbes, the area and atmosphere of the
room must be free from dust, fibres and microbes, clean up area
should be constructed to withstand moisture, steam and detergent.
Ceiling and walls can be coated with materials which should prevent
the accumulation of dust and microbes. Exhaust fans should be
fitted to remove heat and humidity for the comforts of persons in
this area. The area should be kept clean so that contaminants may
not be carried into aseptic area. The containers and closures are
properly washed and dried in this area.
Preparation Area: The ingredients of the Parenteral products are
mixed and preparation is made for filling operation. This area
should be aseptic, cabinets and counters should be made of steel
and they are filled in such a way that no space is left for the dirt to
accumulate. Ceiling walls and floor should be sealed and suitably
painted to keep them thoroughly clean.

13. Aseptic Area: From preparation area the Parenteral formulation will
be transferred to aseptic filling area. The Parenteral preparations are
filtered, filled into final containers and subsequently sealed. The entry
of personnel into aseptic area should be through an air lock. Workers
in working at sterile area must be neat, clean, orderly, reliable
required to wear sterile clothes, physically examined time to time if
they are carrier of any infectious diseases. Ceiling, walls and floors of
aseptic area should be sealed, painted to wash or treat with aseptic
solution or sprayed before use. Stainless steel counter should be
fitted on walls, Aseptic area must be maintained by using high
efficiency particulate air filters (HEPA) that can remove particles up
to 0.3 micron. Hepa filters are fitted in laminar air flow system, in
which air is free from dust and microbes flows with uniform velocity.
Ultraviolet lamps are fitted in order to maintain sterility.
Quarantine Area: A batch of Parenteral products after its filling,
sealing and sterilization are held up in the area. Products that
passes all the quality control tests are transferred into finishing or
packaging area.

14.  Finishing and packaging area:
 The Parenteral products are properly
labeled and packed. Proper packaging is
essential to provide protection against
physical damage from transportation,
handling and storage. The labeled
containers should be packed in cardboard
or plastic containers. Ampoules should be
packed in partitioned boxes.