What is non-sterile compounding?
Non-sterile compounding is defined as the process of combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer’s labeling, or otherwise altering a drug or bulk drug substance to create a non-sterile preparation (adapted from the latest draft of USP <795>).
What is a containment segregated compounding area?
Containment Segregated Compounding Area (C-SCA): A type of C-SEC with nominal airflow (12 ACPH) and room pressurization requirements (negative pressure between 0.01 – 0.03 inches of water column) as they pertain to HD compounding.
What are compounded sterile preparations?
Sterile compounding is further defined by USP to include any manipulation of a sterile or nonsterile product intended to produce a sterile final product. The Food and Drug Administration (FDA) recognizes compounding as a part of pharmacy practice, which does not fall within the agency’s authority.
Is TPN high risk compounding?
final does, a TPN, a combination of several sterile ingredients into one final dose. High Risk Level Compounding: Sterile products compounded from non-sterile ingredients and/or compounded using any non-sterile devices, containers, or equipment.
What is the difference between non-sterile and sterile?
Sterile compounding is used when there is a high risk of infection, such as drugs given as an injection, through an IV, or directly into the eyes. Non-sterile compounding medications include pills, liquids, gels, lotions, ointments, creams, shampoos, lip balms, and more.
What are some advantages of non-sterile compounding?
What are the advantages of non-sterile compounding? customizable options available with non-sterile compounding are: Custom-made strength or dosage: Commercially available products come in a set range of doses, meaning you may be getting more or less of the medication than your body needs.
What is a containment secondary engineering control?
Containment secondary engineering control (C-SEC)—the room in which the C-PEC is placed, including the anteroom/buffer room suite or a containment segregated compounding area (C-SCA).
What is the difference between CAI and CACI?
Compounding Aseptic Isolators (CAI) are used to protect product. Compounding Aseptic Containment Isolators (CACI) are used to protect product and personnel. The “containment” part of the name refers to the negative pressure environment that is needed when compounding hazardous drugs.
What is sterile compounding and aseptic technique?
Aseptic technique is critical to patient safety and all personnel involved with sterile compounding should be aware of the proper processes and procedures. This activity focuses on the basics of garbing, handwashing, cleaning of work areas, as well as identification of critical sites and causes of contamination.
What does a sterile compounding technician do?
Advanced Role Description: The Sterile Compounding Coordinator is responsible for ensuring all compounding rooms, devices, supplies, and personnel are compliant with USP Chapter <797> and USP Chapter <800> regulations as well as any applicable state Board of Pharmacy regulations.
What is considered high risk compounding?
High-risk compounding would include making a solution that will be terminally sterilized from non-sterile bulk drug or nutrient powders or measuring or mixing sterile ingredients in a non-sterile device prior to sterilization.
What are the 4 risk levels that compounded sterile preparations can be classified as?
The revised chapter changed the categorization of Compounded Sterile Preparations (CSPs) from microbial contamination risk levels (i.e. low-, medium-, and high-risk level) to Category 1 and Category 2 CSPs.
What is the temperature resistance of HVC round caps?
Flexible Round Caps – Flex500™ The HVC series Flex 500™ vinyl caps are temperature-resistant and protect up to 500°F (intermittent) or 300°F (continuous). Extremely flexible and durable Ideal for use as thread protectors, dust and moisture seals, and as masking caps during painting, plating or powder coating operations
What is the composition of a PVC compound?
PVC COMPOUNDS: PVC compounds are based on the combination of the polymer and additives that give the formulation. necessary for the end-user. The convention in recording the additive concentration is based on parts per hundred of the PVC resin (phr).
What are flexflexible PVC compounds?
Flexible PVC compounds contain plasticizers, softening agents which help give them “rubber like” properties.
Why do we need additives for the processing of PVC?
PVC cannot be processed on its own due to its very low thermal stability and high melt viscosity. Therefore, it is necessary to combine with the polymer a number of suitable additives to give a wide and varied range of properties to satisfy many different end-use applications.