Sterile Vs. Non-Sterile Compounding

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Everything You Need to Know About Sterile and Non-Sterile Compounding


USP (United States Pharmacopeia) is in charge of overseeing the preparation or compounding of prescription drugs in pharmacies, clinics, and hospitals. Such drugs are not meant for mass production but are rather meant to be taken in doses from a mix of different ingredients. There are two types of compounding: sterile compounding and non-sterile compounding. There are different regulations that cover the two types of compounding. USP Chapter 975 covers for non-sterile compounding and includes different forms such as liquid forms of drugs/salves and ointments. USP 800, on the other hand, outlines the regulations for mixing dangerous drugs. A common example is radiopharmaceuticals and chemotherapy drugs.



Sterile Drug Blending


The third category has to do with sterile drug blending which is regulated under USP Chapter 797. Compliance is crucial and the aseptic regimen will be beneficial to both patient and the technician. Fungal or bacterial contamination can affect both efficacy and safety. There needs to be proper preparation to avoid such an occurrence. The main preparation used is referred to as total parenteral nutrition (TPN). Other methods of preparation include antibiotic injections and drug infusions used in sterile compounding. The Aseptic procedure will require the use of highly specialized equipment. You need to look for clean rooms that meet ISO 8 specifications for ante-rooms and ISO 7 for the buffer rooms. The facility should also have Primary Engineering Controls (PECs). Such controls include laminar floor woods and compounding aseptic isolators that certify ISO 5 environments. The labs will need equipment and supplies during the sterile preparation so as to store and package the drugs safely. You need a provider that is able to adhere to the strict protocols in order to be compliant with the regulations.




There are specified time periods that are to be followed strictly in order to guarantee sterility. The time period will depend on the facility but there are some technical specifications that need to be followed in order to ensure consistency.


Laminar Floor cleaning:  It should be done at the beginning, before, and after every batch is processed.


HEPA Filter- After every day or every shift


Temperature: Should be checked daily Air Sampling- It is involving and should be done every six months.

Gloved Fingertip Test


You need to be aware of the three different levels. The risk of contamination increases with each level. This means that the duration for testing decreases with time. It starts with everyone getting tested. The facility will be ranked low, medium, and high-risk depending on the type of compounding tests that are carried out. The discussion of sterile and non-sterile compounding is subjective to some extent. You can’t say facilities will follow the exact same procedures when it comes to compounding. It is important that you get the basics so that the output is consistent. The process of compounding will require specific equipment and filtration. You should make sure the products you use are compliant. You can check out for more information.  


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