1. Sterile products

2. Parenteral Parenteral refers injectable route of administration.
It derived from Greek words Para (Outside) and enteron (Intestine).
So it is a route of administration other than the oral route. This route of administration bypasses the alimentary canal

3. PRIMARY PARENTERAL ROUTES
Usual volume
(mL)
Needle
commonly used
Formulation
constraints
Types of medication administered
SVP
Sub cutaneous
0.5-2
5/8 in. ,
23 gauge
Need to be isotonic
Insulin, vaccines
Intra muscular
1.5 in. ,
Can be solutions, emulsions, oils or suspensions
Isotonic preferably
Nearly all drug classes
Intra venous
1-100
Vein puncture
20-22 gauge
Solutions, emulsions and liposomes
LVP (LARGE VOL. PAR.)
101 and larger
(infusion unit)
Venoclysis
18-19 gauge
Solutions and some emulsions

4. S. No.
ADVANTAGES
DISVANTAGES 1.
Quick onset
Wrong dose or over dose can be fatal 2.
Vomiting and unconscious patients can take
Pain at site 3.
Prolonged action by modified formulation
( Depot)
Trained person required 4.
Nutritive fluids (glucose, electrolytes) can be given
Expensive 5.
Drugs with poor absorption or instability from GIT
NECESSITY OF ASEPTIC CONDITIONS IN PRODUCTION, COMPOUNDING AND ADMINISTRATION

5. 1. Glass: A. Containers: Highly Resistant Borosilicate Glass
Treated Soda lime Glass
Regular Soda Lime Glass
N.P (Non-parenteral) Glass
Type 4 is not used for parenteral packaging, others all are used for parenteral packaging.

6. 2. Plastic:
Plastic containers are used but they face following problems
Permeation
Sorption
Leaching
Softening
3. Rubber:
To provide closure for multiple dose vials, IV fluid bottles, plugs for disposable syringes and bulbs for ophthalmic pipettes, rubber is the material of choice.
Problems associated with rubber closures are
Incompatibility
Chemical instability
Physical instability

7. Intravenous Admixture System
“Admixture system” refers to sterile IV solutions that are prepared by using one or more medications or electrolytes and will be administered via the parenteral route.
It requires the measured addition of a medication to a 50 ml or larger bag or bottle of IV fluid.
It can be provided to the patient in his/her home.
Many hospitals involved in compounding IV solutions and medications to patient.

8. PROCESSING OF PARENTERALS
S.No.
STEPS 1.
Cleaning of containers, closures and equipments 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

9. Formulation of parenteral products
In the preparation of parenteral products, the following substances are added to make a stable preparation:
The active drug
Vehicles
Aqueous vehicle (e.g. water for injection, water for injection free from CO2 )
Non-aqueous vehicle (e.g. Ethyl alcohol, propylene glycol, almond oil)
Adjuvants
Solubilizing agents (e.g. Tweens & polysorbates)
Stabilizers & antioxidants (e.g. thiourea, ascorbic acid, tocopherol)
Buffering agents (e.g. citric acid, sodium citrate)
Antibacterial agents (e.g. benzyl alcohol, metacresol, phenol)
Chelating agents (e.g. EDTA)
Suspending, emulsifying & wetting agents (e.g. MC, CMC)
Tonicity factor (e.g. sodium chloride, dextrose)

10. Production facilities of parenterals
The production area where the parenteral preparation are manufactured can be divided into five sections:
Clean-up area
Preparation area
Aseptic area
Quarantine area
Finishing & packaging area

11. Clean-up area: Preparation area: It is not aseptic area.
All the parenteral products must be free from foreign particles & microorganism.
Clean-up area should be withstand moisture, dust & detergent.
This area should be kept clean so that contaminants may not be carried out into aseptic area.
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 strict precautions are required to prevent any contamination from outside.

12. Aseptic area:
The parenteral preparations are filtered, filled into final container & sealed should be in aseptic area.
The entry of personnel into aseptic area should be limited & through an air lock.
Ceiling, wall & floor of that area should be sealed & painted.
The air in the aseptic area should be free from fibers, dust and microorganism.
The High efficiency particulate air filters (HEPA) is used for air.
UV lamps are fitted in order to maintain sterility.

13. Quarantine area: Finishing & packaging area:
After filling, sealing & sterilization, the parenteral product are held up in quarantine area.
Randomly samples were kept for evaluation.
The batch or product pass the evaluation tests are transfer in to finishing or packaging area.
Finishing & packaging area:
Parenteral products are properly labelled and packed.
Properly packing is essential to provide protection against physical damage.
The labelled container should be packed in cardboard or plastic container.
Ampoules should be packed in partitioned boxes

14. EVALUATION OF PARENTERAL PREPARATIONS
The finished parenteral products are subjected to the following tests, in order to maintain quality control:
A) Sterility test
B)Clarity test
C)Leakage test
D)Pyrogen test
1) rabbit method
2)LAL test (Limulus amebocyte lysate)
E)Assay

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