Detailed Project Report on small volume parenteral (svp)

Brief Introduction to SVPs

The term ‘parenteral’ refers to injectable route of administration. It is actually derived from Greek words ‘Para’ which means ‘Outside’ and ‘Enteron’ which means ‘Intestine’. In other words, the word ‘parenteral’ refers to a route of administration other than the alimentary canal. The usual routes include the sub-cutaneous, intra-muscular, intra venous and SVP as well as LVP. It is an injection that is packaged in containers (or vials, cartridges, syringes, bottles, ampoules) labeled as containing 100 ml or less. As per the USP 24/NF 19, the definition of small volume parenteral is “Those preparations intended for injection through the skin or other external boundary tissue, rather than the alimentary canal – so that the active substances are administered using gravity or force directly into the blood vessel, organ, tissue or lesion”. 

 

Details of Kinds of SVPs

The main kinds of SVPs are described below: 

1. AMPOULES

These refer to sealed glass containers with an elongated neck that must be broken off. For easy breaking, most of the ampoules are weakened around the neck. These usually have a colored band around the neck. 

 

Usually, to draw the contents of an ampule into a syringe, a 5 micron filter needle should be used. This is because there is a possibility that glass particles may have fallen inside the ampule when the top was snapped off. At times, it is advisable to wrap a small piece of gauze or alcohol wipe around the top of the ampule before breaking it. 

 

2. VIALS

Various additives and drugs are packaged in vials either as liquids or lyophilized powders. There are usually sealed with a rubber stop and are made of glass or plastic. Usually, a needle is used to add or withdraw the contents. 

 

Before withdrawal of contents, usually, equal volume of air is injected into the vial to pressurize it and assist in content withdrawal. 

 

3. DRY POWDERS

These refer to freeze-dried or lyophilized formulations that must be reconstituted with some suitable solvent to make a liquid formulation. Drugs which are usually not stable in liquid form are put in powder form for use. 

 

4. PREFILLED SYRINGES

These refer to syringes which are prefilled with drug solution. These consist of two kinds: cartridge type package and needle unit. Once the needle of the syringe is used, they are discarded. However, the holder is put to use again with a new unit. 

 

Other Related Details of SVPs

Parenteral injections could include various products such as pharmaceutical products, biological products, biotechnology products, genetically engineered products, allergenic extracts, liposome and lipid products, radiopharmaceutical products, and others. The types of preparations could be drug injection, drug injectable emulsion, drug injectable suspension and others. 

 

The containers usually used for parenteral packaging are glass, plastic and rubber. Parenterals are usually processed well before being put to use. These steps include: cleaning of containers, collection of materials, preparation of parenteral products, filtration, filling preparation in containers, sealing containers, sterilization, evaluation of parenteral preparation, labeling and packaging.