Under supervision of
Mrs. Nimisha Srivastva
Sterile products are the dosage forms of therapeutic
agents that are free of viable microorganisms.
Principally, these inc...


Nasal & ear products



Ophthalmic solutions and ointments



Inhalation/ Aerosols.



Bladder irrigating solutions
...
Parenteral (Gk, para enteron, beside the intestine)
dosage forms differ from all other drug dosage
forms, because they are...
INTRADERMAL OR INTRACUTANEOUS
INJECTIONS
 INTRASYNOVIAL AND INTRA-ARTICULAR
INJECTIONS
 INTRATHECAL INJECTIONS(CSF)
 SU...
All products must be sterile.
 All products must be free from pyrogenic (endotoxin)
contamination.
 Injectable solutions...


An immediate physiological response can be achieved
if necessary, which can be of prime consideration in
clinical condi...


Drug for uncooperative, nauseous or unconscious
patients must be administered by injection.



When

desirable,

paren...
Parenteral
drugs
are
formulated
as
solutions, suspensions, emulsions, liposome, microsph
eres, nanosystems, and powders to...
Drug products administered by injection are
characterized by three qualities possessed by no other
type of pharmaceutical ...
Ingredients

Quantity

Property

L-C ysteine

0.5 g

Antioxidant

Agar, granulated (moisture
Nutrient and viscosity conten...
The DT method is the more traditional sterility test
method. Basically, the DT method involves three steps:
1. Aseptically...
Five basic steps are involved in the use of the MF
sterility test method:
1.The filter unit
must be properly assembled and...
After a complete arrangement allow injecting the sample by
following ways as USP:1. Rest the ear against the fingers of th...
FIG NO. 01RABBITS SITUATED IN INDIVIDUAL
RESTRAINING BOXES.


VISUAL INSPECTION: MANUAL METHODS

FIG NO. 02 VISUAL INSPECTION BY LIGHT BEAM
Pour the ampules in
1% Methylene Blue Solution
Rinsing well if leakage found
Color from the dye will be visible within a l...


Purified water



Water for injection(WFI)



Sterile purified water



Sterile water for injection



Bacteriostat...
FIG NO 03 A SCHEMATIC OF A TYPICAL PROCESS USED TO CONVERT
POTABLE WATER TO WATER FOR INJECTION
FIG NO. 04 VAPOR COMPRESSION DISTILLATION
FIG NO. 05 REVERSE OSMOSIS
Contaminants, such as dust, lint, and other particles and
micro-organisms, are found floating in the air, lying on
counter...
Grade

Classification

Pharm. Eng.
Description

per m 3
>/= 0.5 μm

per m 3 >/=
5 μm

A

100

CRITICAL

3500

0

B

100

C...
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parenterals....formulation & evaluation

  1. 1. Under supervision of Mrs. Nimisha Srivastva
  2. 2. Sterile products are the dosage forms of therapeutic agents that are free of viable microorganisms. Principally, these include parenteral, ophthalmic and irrigating preparations of these parenteral products are unique among dosage forms of drugs because they are injected through the skin or mucous membrane into internal body compartments. Thus because they have circumvented the highly efficient first line of body defense ,i.e. the skin and mucous membrane, they must be free from microbial contamination and toxic components ,as well as possess an exceptionally high level of purity1. Although parenteral are comes under category of sterile products but all sterile products can’t say as parenterals.
  3. 3.  Nasal & ear products  Ophthalmic solutions and ointments  Inhalation/ Aerosols.  Bladder irrigating solutions  Suppositories
  4. 4. Parenteral (Gk, para enteron, beside the intestine) dosage forms differ from all other drug dosage forms, because they are injected directly into body tissue through the primary protective systems of the human body, the skin, and mucous membranes.  As per USP Parenteral articles are preparations intended for injection through the skin or other external boundary tissue, so that the active substance they contain are administered using gravity or force, directly into a blood vessel, organ, tissue or lesion. 
  5. 5. INTRADERMAL OR INTRACUTANEOUS INJECTIONS  INTRASYNOVIAL AND INTRA-ARTICULAR INJECTIONS  INTRATHECAL INJECTIONS(CSF)  SUBCUTANEOUS AND INTRAMUSCULAR INJECTIONS  SUBCUTANEOUS INFUSIONS/PUMPS  INTRA-ARTERIAL INFUSION ADMINISTRATION  PERFUSION (EXTRA CORPOREAL OR ISOLATION PERFUSION) ADMINISTRATION  INTRAOSSEOUS INFUSION (IO) 
  6. 6. All products must be sterile.  All products must be free from pyrogenic (endotoxin) contamination.  Injectable solutions must be free from visible particulate matter. This includes reconstituted sterile powders.  Products should be isotonic, although strictness of isotonicity depends on the route of administration. Products administered into the cerebrospinal fluid must be isotonic . 
  7. 7.  An immediate physiological response can be achieved if necessary, which can be of prime consideration in clinical condition such as cardiac arrest, asthma and shock .  Parenteral therapy is required for drugs that are not effective orally or that are destroyed by digestive secretions such as insulin other hormones and antibiotics.
  8. 8.  Drug for uncooperative, nauseous or unconscious patients must be administered by injection.  When desirable, parenteral therapy gives the physician control of the drug since the patient must return for continued treatment, also in some cases the patient cannot be relied upon to take oral administration.  Parenteral administration can results in local effect for drugs when desired as in dentistry and anesthesiology.
  9. 9. Parenteral drugs are formulated as solutions, suspensions, emulsions, liposome, microsph eres, nanosystems, and powders to be reconstituted as solutions.  WATER  WATER-MISCIBLE VEHICLES  NON-AQUEOUS VEHICLES  SOLUTE  ADDED SUBSTANCES (SURFACTANTS,TONICITY ADJUSTER,ANTIOXIDANTS,PRESERVATIVE)  ANTIMICROBIAL AGENTS
  10. 10. Drug products administered by injection are characterized by three qualities possessed by no other type of pharmaceutical dosage form: sterility, freedom from pyrogenicity, and freedom from particulate matter. Method involved in quality control are –  STERILITY TEST Ex.- SAMPLING CULTURE MEDIA Fluid Thioglycollate Medium (FTM) Soybean-Casein Digest (SCD)
  11. 11. Ingredients Quantity Property L-C ysteine 0.5 g Antioxidant Agar, granulated (moisture Nutrient and viscosity content 15%) 0.75 g Nutrient and viscosity inducer Sodium chloride 2.5 g Isotonic agent Dextrose 5.5 g Nutrient Yeast extract 5.0 g Nutrient Pancreatic digest of casein 15.0 g Nutrient Sodium thioglycollate or thioglycollic acid 0.5 g 0.3 ml Antioxidant Resazurin sodium solution (1:1000), freshly prepared 1.0 ml Oxidation indicator Purified water QS 1000 ml **pH after sterilization 7.1+ 0.2
  12. 12. The DT method is the more traditional sterility test method. Basically, the DT method involves three steps: 1. Aseptically opening each sample container from a recently sterilized batch of product. 2. Using a sterile syringe and needle to withdraw the required volume of sample for both media from the container 3. Injecting one-half of the required volume sample into a test tube containing the required volume of FTM and the other half volume of sample into a second test tube containing the required volume of SCD. 
  13. 13. Five basic steps are involved in the use of the MF sterility test method: 1.The filter unit must be properly assembled and sterilized prior to use. 2.The contents of the prescribed number of units are transferred to the filter assembly under strict aseptic conditions. 3.The contents are filtered with the aid of a vacuum or pressure differential system. 4. The membrane is removed aseptically and cut in half. 5.One-half of the membrane is placed in a suitable volume (usually 100 ml) of FTM, and the other membrane half is placed in an equal volume of SCD.
  14. 14. After a complete arrangement allow injecting the sample by following ways as USP:1. Rest the ear against the fingers of the left hand and hold the ear down with the thumb. 2. Introduce the needle with the bevel edge upward near the tip of the ear vein. 3. Slowly inject a small amount of sample to determine if the needle is within the vein. If not, a bubble will form or backpressure will be felt. Withdrawing the needle slightly and moving it forward again should place it in proper position. 4.Maintain steady pressure on the syringe plunger and complete the injection within 10 minutes. Usually, the time duration for infusion is much less than 10 minutes. 5. Withdraw the needle and apply pressure with the thumb at the site of injection to retard bleeding and scarring.
  15. 15. FIG NO. 01RABBITS SITUATED IN INDIVIDUAL RESTRAINING BOXES.
  16. 16.  VISUAL INSPECTION: MANUAL METHODS FIG NO. 02 VISUAL INSPECTION BY LIGHT BEAM
  17. 17. Pour the ampules in 1% Methylene Blue Solution Rinsing well if leakage found Color from the dye will be visible within a leaker
  18. 18.  Purified water  Water for injection(WFI)  Sterile purified water  Sterile water for injection  Bacteriostatic Water for injection  Sterile water for irrigation
  19. 19. FIG NO 03 A SCHEMATIC OF A TYPICAL PROCESS USED TO CONVERT POTABLE WATER TO WATER FOR INJECTION
  20. 20. FIG NO. 04 VAPOR COMPRESSION DISTILLATION
  21. 21. FIG NO. 05 REVERSE OSMOSIS
  22. 22. Contaminants, such as dust, lint, and other particles and micro-organisms, are found floating in the air, lying on counters and other surfaces, attached to clothing and body surfaces of personnel, concentrated in the exhaled breath of personnel, and deposited on the floor. The design and control of an aseptic area is directed toward reducing the presence of these contaminants, so they are no longer a hazard to aseptic filling. The classifications used in pharmaceutical practice normally range from Class 100,000 (Grade D) for materials support areas to Class 100 (Grade A) for aseptic areas.
  23. 23. Grade Classification Pharm. Eng. Description per m 3 >/= 0.5 μm per m 3 >/= 5 μm A 100 CRITICAL 3500 0 B 100 CLEAN 3500 0 C 10,000 CONTROLLED 35,000 2,000 D 100,000 PHARMACEUTICAL 3500000 20,000
  24. 24. THANK YOU!..
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