Dr. M. R. PATEL
Principale & HOD in
SAHILHUSEN I . JETHARA
M. PHARM – I (2013-14)
ROLL NO. - 02
Definition of sterile dosage form
Type of sterile preparations
COMPONETS of PARENTERAL DOSAGE FORMS
QUALITATIVE DEPARTMENTAL LAYOUT
Diagram of flow material
Typical parenteral plant layout with space requirement
Qualitative Layout Of Parentral Manufacturing
(circular flow & parallel flow)
Quntitative Departmental Layout
Simpler Flow Diagram Showing Arrangement Of Different Area
“Sterile dosage forms include parenteral (i.e. Solution, suspension
etc. ,) , non parenteral (i.e. implant, ophthalmic etc.,)
irrigation preprations dosage forms.”
All the dosage forms should meet their standard requirements of purity,
identity, sterility and stability.
When the term sterile dosage form is used, intrefers to a product of a general
group of pharmaceuticals having in common the characteristic of sterility. i.e.
freedom from living micro-organisms.
Sterility is a required characteristic of these pharmaceuticals because of the
method, site, or rout of administration.
Sterile products are the dosage form of therapeutic agent that are free from
Sterile - Absolute term as the state of
freedom from all viable organism.
(a). Parenteral preparations.
Parenterals are divided into two groups.
(i). Small volume parenterals (volume less than 100 ml).
(ii). Large volume parenterals (volume 100ml or more than 100ml).
(b). Ophthalmic preparations.
(i). Eye drops
(ii). Eye ointments
(c). Irrigation solutions.
(d). Dialysis solutions & allergenic extracts.
(e). Diagnostic agent
Para: Beyond & Enteron: intestine i.e. beside the
These are preparations given by other than oral routes.
PARENTRAL PRODUCTS are sterile preparations
intended to be administered by injection under or
through one or more layers of skin or mucous
Therapeutic Agents : API
b. Vehicle(Solvent): Aq., Water miscible , Non-Aq.
c. Additives: Tonicity adjacent Preservative, Antimicrobial etc.
Container : Glass, Plastic(Thermoplastic)
Closure: Rubber ( Elastomer , Natural)
1.THE CLEAN UP AREA
Clean up area
1.Garment ,container and shelving
4.Vacuum bachout rig
9.Class 4 laser
11.Laminar air flow cabinet
12.Granite surface table
14.Cleanroom table cabinet
16.Laminar flow cabinet
20.Optical allignment rig.
QUALITIES OF CLEAN ROOM
The room should undergo 15-20 air changes per hour.
HEPA filters are to clean the air entering the room.
HEPA filters remove all airborne particles of size 0.3 or larger with an efficiency of
Maintaining higher air pressure(+ve pressure) within the critical area to minimize
infiltration of airborne contaminants from outside.
Care should be taken to ensure that air flows do not distribute particles from a
particle-generating person, operation or equipment to a zone of higher product
risk. A warning system should be provided to indicate failure in the air supply.
Adjacent rooms of different grades should have a pressure differential of
10 - 15 Pascals.
Counters in the clean room should be made of stainless steel or other nonporous,
easily cleaned material.
Walls and floors should be free from cracks or crevices and have rounded corners.
If the walls or floors are to be painted, epoxy paint is used.
The air flow should move with uniform velocity along parallel lines. The velocity of
the air flow is 90 ± 20 ft/m3.
Providing temp. & humidity controls appropriate to the product being
HEPA filter, Laminar Air Flow, Class 100 Area.DOP test
•PERSONNEL & GOWNING
A. HORIZONTAL LAMINAR FLOW
B. APPROPRIATE UNIFORM FOR OPERATORS
ENTERING IN ASEPTIC FILLING ROOM
A. LAMINAR AIR FLOW UNIT
HEPA (HIGH EFFICIENCY PARTICULATE AIR filtration)
HEPA filters are composed of a mat of randomly arranged fibers
(polyvinylidene fluoride -PVDF)
Key metrics affecting function are fiber density and diameter, and
There are four basic mechanism in which fibrous air filter remove
contamination from the air stream.
1. Straining or Sieving
Laminar flow hoods:
These are clean air work benches are specially designed to
ensure the aseptic preparation of sterile products. Laminar air
flow hoods are generally used in conjunction with clean rooms.
For laminar air flow work station the air flow rates shall be 0.3
meter per second (vertical) and 0.45 (horizontal)
Introduction of personnel, equipment, and material into the work
area provides sources of particulate matter which may
contaminate the product.
Very small particles are not heavy enough to settle due only to the
force of gravity, but instead are carried and directed by air
currents. and if there is turbulent air, particles may be driven into
Laminar air flow velocity satisfactorily sweeps the area yet does
not create unacceptable turbulence.
B. FILLING AREA :
It is the most critical area in parenteral plant, where the product
& sterilized components are exposed to room environment.
Therefore these areas are specially constructed, filtered, and
maintained to prevent environmental contamination.
Single filling area :EQUIPMENT PREPARATION
Multiple use filling Area:Equipment
PERSONNEL & GOWNING
No. of workers should kept to a minimum.
Training of personal
Personal hygiene:-All employees should be in good health, Subjected
to Physical examination, Understood their responsibilities to report
own illness like cold, a sore throat, or other infection.
Clothing :Uniform is made up of Dacron and Span polyethylene.
Hats & masks are sometimes made of special parchment paper.
Foot wears -plastic and rubber material.
C. Layout for Terminal Sterilization
Clean Filling Area
Clean Filling Area
4.THE QUARANTINE AREA
Final product is stored in the quarantine area
5.FINISHING or PACKAGING AREA
Total 150 M2 manufacturing area +100M2 ancillary for SVP or +150 M2 for LVP
All employees should be
• in good health
• Subjected to Physical examination
• Understood their responsibilities to report own illness like cold, a sore
throat, or other infection.
Personnel entering the aseptic areas should be required to follow a definite
Uniform is made up of Dacron and Span polyethylene. →hats & masks are
sometimes made of special parchment paper.
personnel working in equipment wash rooms, (sterilizing rooms) & packaging
areas are normally required to wear clean uniforms daily and to be conscious
of cleanliness, but are not required to meet the special requirements for
personnel entering the aseptic areas.
TYPE OF PRODUCTION LINE
INTEGRATED PRODUCTION LINE
6 functional areas;
1.Warehousing or Procurement
3.Material support area
According to flow diagram
4.Aseptic filling area
Warehousing or Procurement → Compounding area
Material support area → Aseptic filling area
DIFFERENT TYPE OF PRODUCTION LINE
Fig; ASEPTIC FILLING AREA
Ophthalmics are defined as the dosage forms intended to be
administered on to the external surface of the eye (known as
topical preparations), inside (known as intraocular preparations)
or adjacent to the eye (known as periocular preparations) or
those used in combination with ocular appliances.
Ophthalmics are used therapeutically or prophylactically.
Therapeutically useful in the treatment of intraocular or surface
conditions like conjunctivitis or inflammation, infections of the eye
or eyelids etc.
Prophylactically useful in post surgical and post trauma
TYPES/CLASSES OF OPHTHALMIC DOSAGE FORMS :
7. Non-erodible inserts
-best of drug with slow dissolution
-prolonged release of drug from
-enhanced pulsed entry.
-Flexibility in drug choice
-improved drug stability
-increased tissue contact time.
-inhibition of dilution by tears.
-less blurred vision than ointment.
-flexiblility in drug type & dissolution
-need only be introduced into eye &
-controlled rate of release
-flexibility for type of drug selected.
-rapid corneal elimination.
-loss of drug by drainage.
No sustained action
-drug properties decide performance.
-loss of both solution & suspended
-patient non compliance.
-possible oil entrapment.
-sticking of eyelids.
-poor patient compliance
-no true sustained effect.
-no rate control on diffusion.
-matted eyelids after use.
-requires patient insertion
-irritation to eye
pH approximately equal to 7.4 (near to tear fluid)
Purity and stability
Preservation to prevent the growth of microorganisms
Sterile and particle-free.
Iso-osmotic with the lachrymal secretion.
When raw material are rendered sterile before manufacturing process,the
reactivity of raw material with sterilizing medium must be completely
evaluated & sterilization must be validated.
In most sterile dasage form largest proportion is of “water”
For the preparation intended for parenteral administration ,U.S.P. xxii
requires the use of
All of above are produced by distillation or reverse osmosis & circulation at
relatively high temperature up to 800c, or alternatively its disposal at every
24 hrs, in all S.S. equipment of highest attainable , corrosion resistant quality
Pharmaceutical dosage forms (Parenteral Preparation) by Kenneth E. Avis,
Leon Lachman, Vol-1.
Pharmaceutical dosage forms (Parenteral Preparation) by Kenneth E. Avis,
Leon Lachman, Vol-2.
Drugs & Cosmetics Act 1940.
The theory and Industrial pharmacy by Leon Lachman, Third edition
Pharmaceutical science by Remington, 20th edition
Pharmaceutical process Validation by Loftus & Nash: 29-90.
Remington-The science and practice of pharmacy 21st edition volume I
Good manufacturing practices for pharmaceuticals-A plan for total quality
Sterile Pharmaceutical Manufacturing by Groves Gisan
Ph. No. :- +918460378336
Address:- 44, Assiyana Society;
Taluko & City : Modasa
BEST OF LUCK TO ALL . . . . . . . . . .