How can contamination be avoided when compounding sterile preparations?

How can contamination be avoided when compounding sterile preparations?

What is the most common cause of contamination of a pharmacy compounded sterile product preparation? When cleaning sterile preparation areas, always start with the dirtiest areas first and end with the cleanest. Most contamination arises from compounding personnel violating procedures, such as improper garbing. Most contamination arises from defective HEPA filters.

What provides the guidelines for compounding sterile preparations? These guidelines are a revi- sion of the 2000 ASHP Guidelines on Quality Assurance of Pharmacy-Prepared Sterile Products,14 with the goals of providing more current recommendations and harmoniz- ing the ASHP guidelines with United States Pharmacopeia (USP) chapter 797, Pharmaceutical Compounding—Sterile Preparations.

What is a compounded sterile preparation? 1. Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP that will be administered whether to multiple patients or to one patient on multiple occasions. Page 5 of 17. Page 6. Rules for Compounded Sterile Preparations (CSPs)

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How can contamination be avoided when compounding sterile preparations? – Related Questions

How can we prevent drug contamination?

Proper protective apparel could include lab coats and gowns, masks, eye protection, gloves, hair and beard covers, and shoe covers. Your employees should always wear new gloves when they begin repackaging a new drug lot, and remove protective gowning before entering bathrooms or areas where food is consumed.

What is the correct order of Garbing?

A. Gowning/garbing should take place in this order: placement of shoe covers, hair cover, face mask, proper hand washing technique, donning of gown, and finally the donning of sterile gloves.

What is the primary source of contamination inside a buffer area?

__________contamination is the principle source of compounded sterile preparations contamination. Cleaner air reduces the risk of contamination during compounding. Compounding isolators incorporate a different set of techniques than laminar airflow workbenches.

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.

Which item should be taken off first after preparing a compound?

Shoe covers, hair and beard covers, and the face mask are donned first. If an eye covering is used, it is also one of the first items donned. Nails must be kept cut short and smooth to avoid tearing the gloves. After the gown is donned the hands are cleaned (again) with an alcohol-based surgical hand scrub.

What is the most common means of CSP contamination?

what is the most common source of microbial contamination in CSPs? -entering the sterile compounding area after your lunch break. -being cut by a broken ampule. -spilling 10 ml of IV penicillin on your hand.

What is the difference between sterile compounding and aseptic technique?

Aseptic processing doesn’t create a sterile condition; it only maintains sterility. While sterile means the complete absence of bacteria, viruses, and fungi along with spores, it doesn’t distinguish between specific pathogens. A sterilization technique aims to rid an environment of all living microorganisms.

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What is the difference between sterile and non sterile compounding?

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.

Which flow hood is completely sealed and can be used to compound chemotherapy?

A vertical laminar flow hood works in mostly the same way, but the air is blown from the top of the hood straight down. This prevents hazardous chemicals, such as chemotherapy chemicals, from being directed at the person working at the hood.

What is the difference between contamination and cross-contamination?

Contamination is caused by improper handling, storage and preparing of food, improper sanitization and cleaning, contamination pests and insects. On the other hand, cross-contamination occurs when products that contain allergens to allergen-free products or raw foods to ready-to-eat foods.

What are the consequences of contamination?

Some pesticides have the potential to harm humans, wildlife, and native plants if they are exposed to high enough levels for a long enough period of time. Depending on the chemical and concentrations, possible health effects include cancer, reproductive or nervous-system disorders, and acute toxicity.

What is meant by contamination?

the act of contaminating, or of making something impure or unsuitable by contact with something unclean, bad, etc. the act of contaminating, or of rendering something harmful or unusable by the addition of radioactive material: the contamination of food following a nuclear attack.

What are the 4 sources of contamination?

There are four main types of contamination: chemical, microbial, physical, and allergenic. All food is at risk of contamination from these four types.

Which preparations are prone to microbial contamination?

Source of Microbial Contamination in Pharmaceutical products include: During manufacture, raw materials used, environmental sources, cleaning equipment, packaging, containers that are frequently re-used, repackaging of products, processing, storage and transportation.

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When working in a sterile hood one must?

When working in a horizontal laminar flow hood, all work must be performed at a distance of no less than 6 inches from the front edge of the work surface. At a distance of less than 6 inches, laminar flow air begins to mix with the outside air and contamination is possible.

How often should laminar flow hood be cleaned?

What is the most important part of the laminar hood? Why is the HEPA filter the most important part? Laminar flow hoods should be inspected and/or serviced every _________? 6 months or sooner, if damage is suspected, or if the hood is moved.

What should the minimum percent of isopropyl alcohol be to prevent contamination of an IV?

The use of Isopropyl Alcohol is important as a means to prevent contamination of an IV product. What should the minimum percent of Isopropyl Alcohol used be? 70%.

Which is the most correct order in which to don PPE when sterile compounding?

The correct order is to don a sterile gown and cleanse the hands with sterile foamed 70% Isopropyl alcohol.

What it the difference between a buffer room versus an ante room?

An anteroom between a primary room and corridor ensures a safe airflow buffer zone between the controlled pressurized space and an unclean area. The two spaces are separated by a completely walled area with a door. However, in some applications an ante area without walls or a door can achieve the same effect.

What is the minimum amount of time that a BSC must be turned on prior to compounding?

A BSC must be turned on at least 10 minutes before use.

When batch compounding how frequently must you disinfect your gloves?

Sterile gloves should be aseptically donned, disinfected frequently as specified in the process instructions, and changed every 20 – 30 minutes. The work surface should also be cleaned and disinfected and the minimum frequency should also be specified.

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