STERILE PHARMA / PARENTERELS:
What is Parenteral?
These are the medicinal preparations which are not given through oral routs. (Besides the intestine).
Parenteral preparations are the sterile preparations which may consists of one or more active ingredients intended for administration by injection, infusion or implantations into the body.
Since they are not oral, it is must to have it sterile, pyrogen free preparations, hence the sterility in the process design & operations is the key aspect.
The design of process solutions, transfers, filtration, cleaning, sterilization & packaging everything is critical as the product administered through parenteral routs.
Types of parenteral
Depending on their unit dose volumes they are divided into two main types.
Small volume parenteral ( SVP):
It is a unit dose of volume less than 100ml. These are the doses in smaller volumes. Primarily used for delivering medications
They are usually used when the drug can cause local irritation on administration.
SVP are usually available in the following forms:
- · Ampoules
- · Vials
- · Double Chambered Vials
- · Sterile Ophthalmic Solutions
- · Optic Solutions
- · Nasal Solutions
Large volume parenteral (LVP):
When the unit dose containing volume of 101ml to 1000ml, it is called as large volume parenteral –LVP
Tt is normally used to provide nutrition, fluids, calories, electrolytes or combination of all these.
Usually available in the following forms: –
- · IV infusions
- · Irrigating Solutions
- · Peritoneal Dialysates
- · Ringer (isotonic)Solutions
- · Distilled Water