Why are some pharmaceutical products required to be sterile?
Chapter: Pharmaceutical Microbiology: Sterile Pharmaceutical Products. Parenteral drug delivery systems and many medicinal products, such as dressings and sutures, must be sterile in order to avoid the possibilities of microbial degradation or infection occurring as a result of their use.
Why is sterile compounding important?
The primary standard for the compounding of sterile medications is USP chapter 〈797〉 Pharmaceutical Compounding: Sterile Preparations, which specifies the conditions and practices that should be used to prevent harm to patients from microbial contamination, bacterial endotoxins, chemical and physical contaminants, and
What is sterile preparation?
Sterile preparation means any dosage form of a drug, including parenteral products free of viable microorganisms, made using currently accepted aseptic compounding techniques under acceptable compounding conditions.
What pharmaceutical products must be compounded using sterile compounding?
Compounded biologics, diagnostic, drugs, nutrients, and radiopharmaceuticals, including but not limited to the following dosage forms that must be sterile when they are administered to patients; aqueous bronchial and nasal inhalations, baths and soaks for live organs and tissues, injections (e.g. colloidal dispersions,
What are non sterile products?
Sterile compounded medications are intended to be used as injections, infusions, or application to the eye. Non-sterile medications include the production of solutions, suspensions, ointments, creams, powders, suppositories, capsules, and tablets.
What are the common injectable routes of administration?
Administration by injection ( parenteral administration ) includes the following routes:
- Subcutaneous (under the skin)
- Intramuscular (in a muscle)
- Intravenous (in a vein)
- Intrathecal (around the spinal cord)
What are the dangers of carelessness in compounding?
In addition, poor compounding practices can result in serious drug quality problems, such as contamination or a drug that contains too much active ingredient. This can lead to serious patient injury and death.
How do I get sterile compounding certification?
To be eligible, you must complete a PTCB-recognized sterile compounding training program and have one year of compounded sterile preparation (CSP) work experience OR have 3 years of CSP work experience.
What are the hazards and risks of extemporaneous compounding?
Off-label dosing in vulnerable patient populations could lead to unexpected adverse events or reduced efficacy. The dangers of extemporaneous formulations include the potential for incorrect dosing and a lack of information.
What is the difference between sterile and non sterile hand sanitizer?
The Food and Drug Administration website says a product labeled as nonsterile doesn’t necessarily mean the product is contaminated, it just means the contents haven’t been sterilized or treated with a process during manufacturing to eliminate all potential microorganisms.
What is the difference between sterile and non sterile alcohol?
Sterile conditions require the complete absence of microorganisms including bacteria, fungus, and their spores. For cleanroom applications, that means that a 70% IPA solution doesn’t kill bacterial or fungal spores, and therefore not an effective sterilant.
Why ophthalmic preparations must be sterile?
Every ophthalmic product must be sterile in its final container to prevent microbial contamination of the eye. Preservatives are added to the formulation to maintain sterility once the container has been opened. When aqueous suspensions are used, the particle size is kept to a minimum to prevent irritation of the eye.
How often do sterile compounding hoods need to be certified?
A facility must certify any new PEC and continue to certify the PEC every 6 months. A PEC must also be certified when it is moved or altered, when there are identified problems with end products or staff technique and in response to issues with compounded preparations such as patient infections.
Which standard defines the legal requirements for sterile compounding?
As a standard established by the United States Pharmacopeia Convention ( USP ), a scientific nonprofit organization dedicated to ensuring the quality of the American drug supply, USP 797 also outlines the required procedures for compounding sterile drug preparations.
What is the correct order of Garbing?
General Gowning Order covers, face covers, shoe covers and then to step over the line from dirty to clean. proceeds from those activities considered the dirtiest to those considered the cleanest.