Sterile Preparations

Sterile preparations are pyrogen-free, particulate-free and without viable microorganism
are intended to be administered parenterally. Parenteral drug product or injectable refers
to a sterile drug indented to be administered into the body other than by way of the
intestines and include intradermal, subcutaneous, intramuscular, intravenous, or
intraspinal route of administration. Large Volume Parenteral (LVP) is a sterile
pharmaceutical preparation intended for the parenteral administration packed in
containers of more than 100 milliliters. While the Small Volume Parenteral (SVP) is the
injection packed in containers of 100 milliliters or less. A parenteral must be complied
with the required standards. Clarity or free from the particulate matter is one of the
standards for injectable.
Types of parenteral preparations
• Sterile Solutions
• Sterile Emulsions
• Sterile Suspensions
• Sterile Liquid concentrates
• Sterile Powders for injection
• Ophthalmic preparation
o Sterile eye drops (Solution)
o Sterile Ointments
o Sterile Creams
• Transdermal patches • Or any product, the label of which
states “sterile”
FEATURES OF STERILE PRODUCTS
The features of the parenteral products are following.
• Sterile
• Apyrogenic
• Clear and free from particulate
• Isotonic, particularly for large volume
products
• With adjusted pH, particularly for large
volume products
COMPONENTS OF STERILE PREPARATIONS
The components that are incorporated into the sterile dosage forms have very strict
specifications and standards. Due to these requirements, extensive analytical and animal
testing is required to ensure that the product is safe for use in terms of its sterility,
apyrogenicity and toxicity. For parenteral use, testing is usually carried out on the
individual components as well as on the final dosage form. Based upon such qualities as
ultra purity, safety and lack of (minimum) pharmacological effects required of the
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additives, the sterile formulations are restricted to a very few materials as excipients,
preservatives, suspending agents and surfactants, etc.