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Sterile Injectable Manufacturing Overview

The document outlines the principles of sterile manufacturing, emphasizing stringent specifications for sterility and apyrogenicity, particularly in IV additive programs and parenteral hyperalimentation. It details the preparation and administration of intravenous fluids, the use of laminar flow hoods, and the importance of stability, compatibility, and proper training in TPN preparation. Additionally, it discusses the handling of cytotoxic agents, including safe preparation practices and waste disposal procedures.

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Sam Ali
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7 views9 pages

Sterile Injectable Manufacturing Overview

The document outlines the principles of sterile manufacturing, emphasizing stringent specifications for sterility and apyrogenicity, particularly in IV additive programs and parenteral hyperalimentation. It details the preparation and administration of intravenous fluids, the use of laminar flow hoods, and the importance of stability, compatibility, and proper training in TPN preparation. Additionally, it discusses the handling of cytotoxic agents, including safe preparation practices and waste disposal procedures.

Uploaded by

Sam Ali
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd

Sterile Manufacturing

The sterile manufacturing involves the same


basic principles as required for bulk
compounding only difference of more stringent
specifications, sterility and apyrogenecity.
IV additive program
• An IV additive program deals with polices and
procedures for both preparation and
administration of intravenous fluids to which
drugs are to be added.
• IV additive service is a part of IV additive
program and refers only to the preparation of
the product.
Laminar flow hoods
Cabinet that provides a constant outward flow
of micro-filtered air over entire work area,
which clear off bacteria and dust particles
from the ambient atmosphere so creating a
sterilized environment in the hood.
Parenteral hyperalimentation
Intravenous administration of sufficient nutrients above
the usual basal requirements to achieve tissue synthesis,
positive nitrogen balance and anabolism for specific
patients unable to tolerate any form of enteral feeding
for long term basis
TPN
The pharmacist must have knowledge of preparation
methods, stability and compatibility, facilities
equipments and environment required for this program.
• Stability and compatibility
• Facility and environment
• Personnel and training
• Documentation
• Manufacturing procedures
The preparation of TPN is initiated on receipt of
the request for TPN after checking of the
feasibility and stability
• Collection of materials and preparation
• Formulation
• Inspection
• Labeling
• Storage
2-6 C
Cytotoxic agents
The cytotoxic drugs are capable of killing cells and
employed in the treatment of cancer
Most of the injectable cytotoxics are powdered
preparations that need reconstituting before use
Areas of skill needed for pharmacist
• Safe handling
• Preparation areas
The cytotoxic cabinet should be reserved solely for
preparation of cytotoxic agents.
Prevention of aerosol formation from
cytotoxic vials
It should always be prevented and achieved
by equalizing pressure between syringe and
vial.
The replacing of the volume of fluid drawn out
of vial with an equal volume of air from the
syringe equalizes the pressure
• Coping with spills and waste disposal
Detailed procedures for coping with spills and
waste disposal must be distributed to all staff
handling cytotoxic agents

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