Sterile Products

The presentation describes types advantages, disadvantages of parenteral preparations, route of administration, general requirement, evaluation, labeling & packaging, containers & their types etc

1. “Sterile Products” By, Prof. Prashant B. Patil Assistant Professor, H R Patel Institute of Pharmaceutical Education and Research, Shirpur

2. Introduction: Parenteral preparation are the preparation that are given by other than orally. Injections and transfusion fluids are come under the parental preparation. Injections should be sterile, isotonic, and free from the foreign particles, such as dust, fibers etc.

3. Injections are the sterile solution and suspension of drug in aqueous or oily vehicle meant for introduction in to the body by means of an injectable needle under or through one or more layer of skin or mucous membrane.

4. Advantages of Parenteral Preparation: The drug which are can not be administered by oral route, can administered by this route. The patient who are vomiting or suffering form unconscious condition, can not able to take the drugs by orally, can administered by this route. The drug action is quick and rapid Drug action can be prolonged by modifying the formulation Transfusion fluid are also contain nutritive like glucose and electrolytes.

5. Disadvantages: The trained person is required to administer the drug Injection causes the pain at the side of injection The administration of drug from wrong route of injection may very dangerous. The chances of sensitivity reaction or allergic reaction of the drug by an individual.

6. Route of Administration: Intradermal Injection (IC) Hypodermis Injection (SC) Intramuscular Injection (IM) Intravenous Injection (IV) Intra Arterial Injection Intracardiac Injection Intrathecal Injection (surrounding to spinal cord)

7. Intracisternal Injection (between first & second cervical vertebrae) for withdrawing cerebrospinal fluid Peridural Injection (inner aspect of vertebra) Intra- articular Injection (in bones joint) Intracerebral Injection (Cerebrum)

8. General Requirement for Parenteral Preparation: PP required careful consideration of the following requirement: Stability Sterility Free from Pyrogen Free from foreign particles

9. Isotonicity Specific Gravity Chemical Purity

10. Types of Parenteral Preparation: Solution or Emulsions of medicament for suitable injections Sterile solids Sterile Suspension Transfusion Fluid

11. Formulation of Parenteral Preparation: The formulation of parental preparation is the careful need of planning, through knowledge of the medicament and adjuvant to be used. Following formulating agents are used in the preparation of parental such as

12. Vehicle Adjuvant - Solubilising Agents - Stabilizers - Buffering Agents - Antibacterial Agents - Chelating Agents - Suspending, Emulsifying and wetting agents - Tonicity Agents

13. Units of Concentration: Weight per unit volume: Prednisolone 25 mg/ml, Atropine sulphate injection 60 mg/ml Percentage weight per volume: Dextrose Intravenous Infusion 5 % w/v, Sodium Chloride Intravenous Infusion 0.9 % w/v Millimoles per unit volume: Sodium bicarbonate iv infusion 150 m.mol each of Na + and HCO 3 /liter

14. Container and Closer: The glass and plastic containers are generally used for dispensing of parental preparation. The pharmacopeia required the following conditions for a container and closure to be used for parental preparation:

15. Conditions are as follows: It should not yield foreign substances to the product. It should be sufficient transparent to allow visual inspection of the content in it. It should not have any adverse effect on the product. It should prevent diffusion in or across the wall.

16. Following three types glasses are used: Borosilicate Glass or Natural Glass Soda lime silicate Glass with hydrolytic resistance Soda lime Glass with only moderate hydrolytic resistance.

17. Container of type II and III glass should be used once only. Containers for human blood and blood components must not be reused. Plastics are synthetic polymers are used as containers for injectables. The standard plastic container for parental product are given in IP

18. Processing of Parenteral Product: Following steps are involved in the processing of parental products: Cleansing of Container, closer and equipment Collection of Material Preparation of parental product Filtration Filling the preparation in final container Sealing of Container Sterilization Evaluation of parental preparation Labeling and packing

19. Evaluation of Parenteral Preparation: Sterility Test Clarity Test Leakage Test Pyrogen Test Assay

20. Sterility Test: - All the Parenteral preparation are supplied in sterile form. The sterility test is strictly carried out under the aseptic condition in order to avoid accidental contamination. The Sterility test is must be carried out either by, Membrane Filtration Method Direct Inoculation Method

21. Steps of Sterility Testing: Selection of sample size Selection of quantity of product to be used Method of testing Observation and result

22. Clarity Test: Clarity test id performed to ensure that the Parenteral products are free from foreign particles. Each Parenteral prepares is passes form the clarity test.

23. Leakage Test: This test is performed only for the ampoules which have been sealed by the fusion. Leak test is performed in the vacuum chamber, the ampoules are dipped in methylene blue in vacuum chamber i.e. Leak test apparatus. Then vacuum is applied. When vacuum is released the color solution will entered with defective sealing The presence of dyes in the ampoule, confirm the leakage and hence rejected .

24. Pyrogen Test: These test is perform for the check the presence or absence of pyrogen in the Parenteral Preparation. These test is involves the measurement of the rise in body temperature of rabbits following intravenous injection in marginal ear vein of a sterile solution of Parenteral preparation is examined.

25. Assay: - Assay is performed according to the method is given in the monograph of that Parenteral Preparation in pharmacopeia. Assay is done to check the quantity of medicament present in that preparation A= abc a ( absobtivity ), b ( pathlength ), c (Concentration)

26. Labeling and packing: The label should state: Name of Preparation Quantity of the preparation Mfg. license No. Batch no. Date of manufacture Date of Expiry Storage Condition Retail Prize Manufacturers address

27. Production Facilities: The manufacture of Parenteral preparation require special precautions' and facilities in order to maintain sterility and freedom from particulate matter. The production area can be divided in to five sections such as:

28. Clean Up area Preparation area Aseptic area Quarantine area Finishing and packing area

29. Preparation of Intravenous Fluids: Dextrose Injection IP – These are available in conc. of 5, 10, 25 and 50 % w/v/ solution. Nacl and Dextrose Injection IP: It contain Nacl from 0.11 to 0.9 % and dextrose from 2.5 to 25 % Nacl Injection IP: It contain 0.9 % Nacl , is also called as normal saline solution. Sodium Lactose Injection: It contain 1.75 % to 1.95 % w/v of sodium lactose. Used as electrolyte replenisher .

30. Particular Matter Monitoring: Following methods are commonly used for the monitoring particulate matter contamination Visual Method Coulter Counter Method Filtration Method Light Blockage method

31. Thank You….