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Pharma

Pharma

Sterile Pharma Manufacturing

Compunding Manufacturing

Holding / Filtration

Filling

CIP

Chilled Wfi

Wfi Charging in Vessel

Raw
Material

Addition of API/RM

SIP

Addetives if
Any

Mixing & Temp
Control

Volume Make
Up & Mixing

In Line
Homogeniation

ETP

Transfer to
Holding

QC Sampling

Holding the Batch

Product Recirculation

Mixing / Temp Control

Transfer to Filling

Sterile Filtration

Serge/ Buffer Vessel

Filling Line

Primary
Filtartion

Sterile
Filtartion

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
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