Related Experiment Video
Updated: Aug 14, 2026
Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
I.V. admixture contamination rates: traditional practice site versus a class 1000 cleanroom
Mark Thomas1, Michael D Sanborn, Rick Couldry
1Cook Children's Medical Center, Fort Worth, TX 75246, USA.
Purpose:
The contamination rates associated with the preparation of medium-risk i.v. admixtures in a traditional practice site and in a class 1000 cleanroom were compared.
Methods:
Simulated product media fills served as the samples. Each investigator, a pharmacist and a pharmacy technician, prepared 500 vials and 500 small-volume parenteral (SVP) bags in five separate runs at a traditional practice site and in a cleanroom. United States Pharmacopeia chapter 797 medium-risk compounding procedures were followed, and strict adherence to aseptic technique was employed. Single-strength tryptic soy broth was substituted for the drug and diluent in the admixtures. Positive and negative controls were also prepared and stored for the duration of the study. The pharmacist and technician prepared a total of 4057 samples: 2027 samples (1014 vials and 1013 SVP bags) were prepared in a class 1000 cleanroom, and 2030 (1014 vials and 1016 SVP bags) were prepared at a traditional practice site.
Results:
Contamination rates did not significantly differ between the traditional practice site (0.296%) and the cleanroom environment (0.344%) (p = 1.0). A significant difference in the number of contaminated samples was found between the two investigators (2 of 2057 were contaminated by the pharmacist and 11 of 2000 were contaminated by the technician) (p = 0.012). Contamination rates by the pharmacist (p = 1.0) and technician (p = 1.0) did not significantly differ between sites.
Conclusion:
The most important variable affecting microbial contamination of admixtures was the aseptic technique of personnel, not the environment in which the drugs were compounded.
Insights
Personnel’s aseptic technique, not the compounding environment, significantly impacts microbial contamination rates in medium-risk intravenous admixtures. Strict adherence to sterile procedures is crucial for preventing contamination.
Area of Science:
- Pharmaceutical Compounding
- Microbial Contamination Control
- Healthcare Quality Improvement
Background:
- Medium-risk intravenous (IV) admixtures require stringent aseptic techniques to prevent microbial contamination.
- Evaluating the impact of compounding environments versus personnel technique is critical for optimizing sterile preparation practices.
Purpose of the Study:
- To compare microbial contamination rates in medium-risk IV admixture preparation between a traditional site and a Class 1000 cleanroom.
- To identify key factors influencing contamination during sterile compounding.
Main Methods:
- Simulated product media fills were conducted by a pharmacist and a pharmacy technician.
- Compounding occurred in both a traditional site and a Class 1000 cleanroom, following USP chapter 797 guidelines.
- A total of 4057 samples were prepared and analyzed for microbial contamination.
Main Results:
- No significant difference in contamination rates was observed between the traditional site (0.296%) and the cleanroom (0.344%).
- A significant difference in contamination was noted between the two investigators (pharmacist: 0.097%, technician: 0.55%).
- Contamination rates did not significantly differ between sites for either the pharmacist or the technician.
Conclusions:
- Personnel’s aseptic technique is the primary determinant of microbial contamination in IV admixture preparation.
- Environmental controls, such as cleanrooms, are less critical than rigorous adherence to aseptic technique by compounding personnel.
- Focusing on training and adherence to aseptic techniques can effectively reduce contamination risks in sterile compounding.
Related Concept Videos
01:25Transmission-based Precautions II: Airborne and Protective Environment
Airborne precautions:
Use airborne precautions when treating patients known or suspected to have diseases that spread through the air—for example, tuberculosis or measles. These organisms are present in smaller droplets expelled by an infected person and...
01:26Standard Precaution
Hand hygiene is the most crucial means to prevent the transmission of disease. Employers are legally required to provide their workers with personal protective equipment (PPE) to minimize exposure or contact with...
01:30Cleaning, Sterilization, and Disinfection
Cleaning
The cleaning process usually involves using water with detergents or enzymatic cleaner and removing foreign material from objects and surfaces, including organic material such as body fluids or inorganic material like soil. Cleaning is performed before high-level disinfection and sterilization because foreign materials on the cover of the devices interfere with process...
01:17Transmission-based Precautions I: Contact, Enteric, and Droplets
Contact Precautions:
Contact precautions are the measures taken to prevent the transmission of infectious agents, especially epidemiologically important microorganisms such as MRSA or influenza, primarily transmitted through direct or indirect contact with an...
01:22Healthcare Associated Infections II: Preventive Measures
The best practices for preventing healthcare-associated infections include hand hygiene, patient risk...
01:14Scale-Up Processes