1. GUIDED BY:
Dr. M. R. PATEL
Principale & HOD in
pharmaceutics
PRESENTEDE BY:
SAHILHUSEN I . JETHARA
M. PHARM – I (2013-14)
ROLL NO. - 02
2.
Definition of sterile dosage form
Type of sterile preparations
PARENTERALS
INTRODUCTION
COMPONETS of PARENTERAL DOSAGE FORMS
QUALITATIVE DEPARTMENTAL LAYOUT
Plant Layout
Diagram of flow material
Typical parenteral plant layout with space requirement
Qualitative Layout Of Parentral Manufacturing
(circular flow & parallel flow)
Quntitative Departmental Layout
OPTHALMIC PREPARATION
Definition
Types
Requirenments
Simpler Flow Diagram Showing Arrangement Of Different Area
REFERANCES
3.
“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
viable micro-organisms.
Sterile - Absolute term as the state of
freedom from all viable organism.
4. (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
(f). Surgicals
6.
Para: Beyond & Enteron: intestine i.e. beside the
intestine.
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
membranes..
7. 1.
Content(Formulations):
a.
Therapeutic Agents : API
b. Vehicle(Solvent): Aq., Water miscible , Non-Aq.
c. Additives: Tonicity adjacent Preservative, Antimicrobial etc.
2.
Container : Glass, Plastic(Thermoplastic)
3.
Closure: Rubber ( Elastomer , Natural)
8. 1.THE CLEAN UP AREA
Clean up area
Entrance
ENTER ROOM
DARK
CLEAN
ROOM
FIRE EXIT
WHITE
CLEAN
ROOM
FIRE EXIT
1.Garment ,container and shelving
2.Seating bench
3.Cleanroom computers
4.Vacuum bachout rig
5.CCD cryostat
6.Monochromator
7.Sputter coater
8.Work bench
9.Class 4 laser
10.Work bench
11.Laminar air flow cabinet
12.Granite surface table
13.Work bench
14.Cleanroom table cabinet
15.Cabinet
16.Laminar flow cabinet
17.Cabinet
18.Work bench
19.Work bench
20.Optical allignment rig.
26
9. 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
99.97%.
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
manufactured.
13. A. LAMINAR AIR FLOW UNIT
HEPA (HIGH EFFICIENCY PARTICULATE AIR filtration)
HEPA Filter
HEPA filters are composed of a mat of randomly arranged fibers
(polyvinylidene fluoride -PVDF)
Key metrics affecting function are fiber density and diameter, and
filter thickness
There are four basic mechanism in which fibrous air filter remove
contamination from the air stream.
1. Straining or Sieving
2. Impaction
3. Interception
4. Diffusion
14. 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
product.
Laminar air flow velocity satisfactorily sweeps the area yet does
not create unacceptable turbulence.
15. 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.
16. Single filling area :EQUIPMENT PREPARATION
PRODUCT
MATERIAL
FILLING AREA
GOWNING AREA
PERSONAL
Multiple use filling Area:Equipment
Equipment preparation
Filling
MATERIAL
Filling
Product
Filling
Filling
Personal
17.
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.
18. C. Layout for Terminal Sterilization
Terminal
Sterilization
Clean Filling Area
Unidirectional
Solution
Clean Prep.
Area
Changing
area
Clean Zone
Equipment &
Component prepn
Clean Filling Area
Area
Clean
Changing
Equipment &
Component prepn
Area
Comp.
Entry
area
Material
Entry
19. 4.THE QUARANTINE AREA
Final product is stored in the quarantine area
until distributed
5.FINISHING or PACKAGING AREA
25. PERSONNEL
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
preparatory procedure.
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.
26. TYPE OF PRODUCTION LINE
Compounding
Unit
packaging
Container
washing
Packaging
Depyrogenation
Filling
Terminated
sterilization
Inspection
29. PROCESSING
6 functional areas;
1.Warehousing or Procurement
2.Compounding area
3.Material support area
According to flow diagram
4.Aseptic filling area
5.Packaging area
Warehousing or Procurement → Compounding area
↓
6.Quarantine area
Material support area → Aseptic filling area
↓
Packaging area
↓
Quarantine area
30. DIFFERENT TYPE OF PRODUCTION LINE
Equip. Prep.
Equip. Prep.
Filling
Material
Filling
Gowning
Personnel
Product
Material
Filling
Product
Gowning Product
Product
Equip. Prep.
Fig; ASEPTIC FILLING AREA
33.
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
preparations.
35. TYPES/CLASSES OF OPHTHALMIC DOSAGE FORMS :
DOSAGE FORMS
1. Solutions
2. Suspensions
3. Emulsions
4. Ointments
5. Gels
6.Erodible inserts
7. Non-erodible inserts
2009-10
ADVANTAGES
-convenience
-patient compliance
-best of drug with slow dissolution
-prolonged release of drug from
vehicle.
-enhanced pulsed entry.
-Flexibility in drug choice
-improved drug stability
-increased tissue contact time.
-inhibition of dilution by tears.
-comfortable
-less blurred vision than ointment.
-effective
-flexiblility in drug type & dissolution
rate
-need only be introduced into eye &
not removed.
-controlled rate of release
-prolonged delivery
-flexibility for type of drug selected.
-sustained release
PAPER 910201/vijay/m.pharm-1/LMCP
DISADVANTAGES
-rapid corneal elimination.
-loss of drug by drainage.
No sustained action
-drug properties decide performance.
-loss of both solution & suspended
solid.
-patient non compliance.
-Blurred vision
-possible oil entrapment.
-sticking of eyelids.
-poor patient compliance
-blurred vision
-no true sustained effect.
-no rate control on diffusion.
-matted eyelids after use.
--patient discomfort
-requires patient insertion
-occasional product.
-patient discomfort
-irritation to eye
-tissue fibrosis
35
36. Clarity
Isotonicity
pH approximately equal to 7.4 (near to tear fluid)
Purity and stability
Sterility
Viscosity
Surface activity
Preservation to prevent the growth of microorganisms
Sterile and particle-free.
Iso-osmotic with the lachrymal secretion.
Optimum viscosity
38. Highest quality
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
→WFI
→ SWFI
→ BWFI
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
40.
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
control.Marcel Dekker
www.getthatmag.com
www.fabtecheng.com
www.ahind.com
www.nkambica.com
Sterile Pharmaceutical Manufacturing by Groves Gisan
41. Ph. No. :- +918460378336
Address:- 44, Assiyana Society;
Dugarvada Road,
Taluko & City : Modasa
State: Gujarat
Country: India
Email: sahil.pharm4@gmail.com
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