Industrial pharmacy assignment

1. Maharishi Dayanand University Rohtak
Department of Pharmaceutical Science
Industrial pharmacy assignment
Formulation of lyophilized product production
and facilities for Parenterals
Submitted to
Mrs. Prerna Kaushik
Submitted by
Deepender
Roll no 1444
B.Pharm 5thsem
Batch- A

2. Definition
A stabilizing process in which
a substance is first frozen
and then the quantity of the
solvent is reduced, first by
sublimation (primary drying
stage) and then desorption
(secondary drying stage) to
values that will no longer
support biological activity or
chemical reactions.
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3. Principle
× Lyophilization is carried out using a simple principle of physics
sublimation. Sublimation is the transition of a substance from the solid to
the vapour state, without first passing through an intermediate liquid
phase.
× Lyophilization is performed at temperature and pressure conditions
below the triple point, to enable sublimation of ice.
× The entire process is performed at low temperature and pressure by
applying vacuum, hence is suited for drying of thermolabile compounds.
× The concentration gradient of water vapour between the drying
× front and condenser is the driving force for removal of water during
lyophilization.
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4. Objective of lyophilized process
To preserve the biological activity of a product.
To reduce the product weight to lower the
transportation cost.
• To extend the shelf life or stability. To dry
thermolabile materials.
• To eliminate the need for refrigerated storage.
. To get accurate, sterile dosing into the final product
container.
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5. Processing
× Fundamental process steps are:
× 1. Freezing: the product is frozen. This provides a necessary condition for low
temperature
× 2. Vacuum: after freezing, the product is placed under vacuum. This enables
the frozen solvent in t product to vaporize without passing through liquid
phase, a process known asSUBLIMATION.
× 3. Heat: Heat is applied to the frozen product to accelerate sublimation.
× 4. Condensation: Low-temperature condenser plates remove
× the vaporized solvent from the vacuum chamber by
× converting it back to a solid. This completes the process
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6. • Freezing the product solution to a temperature below its
eutectic temperature.
Decrease the shelf temperature to -50°c.
Low temperature and low atmospheric pressure are
maintained. Freons are used as refrigerant.
Formation of ice crystals occurs. The rate of ice
crystallization define the freezing process and efficiency of
primary drying.
Freeze Drying
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7. Primary Drying (Sublimation)
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× Heat is introduced from shelf to the product
under graded
× control by electrical resistance coils or
circulating silicone.
× The temperature and pressure should be
below the triple point of water i.e., 0.0098°C
and 4.58mmHg.
× The driving force is vapor pressure difference
between the evaporating surface and the
condenser.
× Easily removes moisture up to 98% to 99%.

8. Packaging
After drying the vacuum is
replaced by filtered dry air
or nitrogen to establish
atmospheric pressure
Ampoules are sealed by
either tip sealing or pull
sealing method
Vials and bottles are
sealed with rubber
closures and aluminum
caps
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9. Freeze Dry Product
Characteristics
• Sufficient strength
• Uniform color
• Sufficiently dry
• Sufficiently porous
. Sterile
• Free of pyrogens and particulates
• Chemically stable both in dry state and
reconstituti 9

10. Advantages of Lyophilization
Removal of water at low temperature
Thermolabile materials can be dried.
.Compatible with aseptic operations
More precise fill weight control
Sterility can be maintained. Reconstitution is easy
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11. Disadvantages of Lyophilization
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× Many biological molecules are damaged by the stress
associated with freezing, freeze-drying, or both.
× The product is prone to oxid due to high porosity and
large surface area. Therefore the product should be
packed in vacuum or using inert gas or in a container
impervious to gases.
× Cost may be an issue, depending on the productLong
time process

12. 12
Production Facilities of Parenterals:
The production area where the parenteral preparations are manufactured can be
divided into five section
1. Clean up area:
• It is not aseptic area
• All the parenteral products must be free from foreign particles and microorganism
• Clean up area should be withstand moistute, dust & detergent.
• This area should be kept clean so that contamination may not carried out into aseptic
area
2. 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 precaution are required to prevent
anycontamination from outside.
3. Aseptic area:
• The parenteral preparation are filtered filled into final container & sealed should be in
aseptic area.
• The entry of personal into aseptic area should be limited & through an air lock.
• Celling, wall & floor of that area should be sealed

13. Quarantine area
After filling, sealing & sterilization the parental product are
held up in quarantine area. Randomly samples were kept
for evaluation.
The batch or product pass the evaluation tests are transfer
into finishing or packaging area.
Finishing & packaging area:
Parenteral products are properly labelled and packed.
Properly packing is essential to provide protection against
physical damage. • Ampoules should be packed in partition
boxes.
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14. References
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http://www.slideshare.net/ceutics1315/lyophilization-
39635366?from_m_app=android
http://www.slideshare.net/sangrammaskar/preparation-of-
large-volume-and-small-volume-parenteral-
235629944?from_m_app=android

15. Thanks!
Any questions?
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