Sterile Preparations

Injections

Sterile, pyrogen-free preparations intended to be administered parenterally

Parenteral

refers to injectable routes of administration

Sterile

Absence of microorganisms

Sterile

free from bacteria or other living microorganisms

Sterilization

as applied to pharmaceutical preparations, means destruction of all living organisms and their spores or their complete removal from the preparation

Steam sterilization

Employs “steam under pressure” in an AUTOCLAVE

Steam sterilization

Applicable to pharmaceutical preparations and materials that can withstand the required temperatures and are penetrated but not adversely affected by moisture

Steam sterilization

Uses 121⁰C at 15 psi for 20 minutes setting.

Dry heat sterilization

Employs “convective heat” in OVENS

Dry heat sterilization

Less effective than steam sterilization.

Dry heat sterilization

Uses 150⁰C to 170⁰C for hours

Dry heat

also an effective method for sterilizing glassware and surgical instruments.

Dry heat

the method of choice when dry apparatus or dry containers are required, as in the handling of packaging of dry chemicals or nonaqueous solutions

Sterilization by Filtration

Applicable to heat-labile parenterals.

Sterilization by Filtration

Involves removal of microorganisms by adsorption on a filter medium or by sieving mechanism.

Sterilization by Filtration

Uses a membrane filter or cellulose ester membrane filter.

Gas Sterilization

Applicable to sterile powders and plastic containers.

Gas Sterilization

The material is autoclaved first, then the gases are introduced.

Gas Sterilization

useful in sterilization of medical and surgical supplies and appliances such as catheters, needles, and plastic disposable syringes

Gas Sterilization

Uses the ff. sterilizing gases: Ethylene oxide/ Propylene oxide

Sterilization by Ionizing Radiation

Exposes the material to RADIATION – EMITTING ISOTOPES, such as; gamma rays, cathode rays, beta rays

Biologic Indicator

is a characterized preparation of specific microorganisms resistant to a particular sterilization process

Bacillus stearothermophilus

Bacteria used for testing sterility on STEAM & ETHYLENE OXIDE

Bacillus subtilis

Bacteria used for testing sterility on DRY-

B. pumilus, B. stearothermophilus, B. subtilis

Bacteria used for testing sterility on ionizing radiation

Pyrogens

bacterial endotoxins

Pyrogens

Fever –producing organic substances arising from microbial contamination (gram negative bacteria) of a parenteral product.

Pyrogens

Usually produces fever-like reactions

Healthy rabbits, Limulus amebocyte lysate (LAL) test

Pyrogen Testing includes _____ and _____

Intraarticular

Parenteral route administer in joints

Intraspinal

Parenteral route administer in joint fluid area

Intrathecal

Parenteral route administer in Spinal fluid

Intra-arterial

Parenteral route administer in Arteries

Intracardiac

Parenteral route administer in Heart

Intravenous, IV

Parenteral route administer in Veins

Intramuscular, IM

Parenteral route administer in Muscle

Intradermal, ID; intracutaneous

Parenteral route administer into the skin

subcutaneous, SC

Parenteral route administer Under the skin

IM route

less rapid but generally longer lasting than those obtained from IV administration

SC Route

Commonly used as self-administration by diabetic patient used for injection of small amounts of medication

ID Route

0.1ml for diagnostic

Water for Injection

Used by manufacturer

Water for Injection

Not sterilized but pyrogen free

Water for Injection

The water is intended to be used in the manufacture of injectable products to be sterilized after preparation

Water for Injection

Should be used within 24 hours after collection