This section guides guidelines for the testing of operator competencies to prepare pharmaceuticals in pharmacy isolators for patient administration. Staff training should be carried out on recruitment and at regular planned intervals in accordance with a formal program prepared by a qualified person. The program should include theoretical and practical aspects leading to qualification of staff performance.
These guidelines are provided by Esco for informational purposes only. Information is presented as a checklist for adoption or adaptation in different workplaces. Training requirements many vary from state to state, and certainly country to country. When local guidelines exist, they should be observed.
A. Principles of Basic Theory, Design and Siting of Isolators
Operators should have an understanding of:
1. Principles of isolator design
2. Different types of isolators
3. Airflow patterns inside isolators
4. Background environments for isolators
5. Entering, working in and leaving the background environment
B. Hand Washing Techniques and Protective Clothing
Operators should be able to demonstrate appropriate hand washing and gowning techniques designed to minimize bacterial contamination.
C. Operation of Isolators
1. Pre-use checks
2. Entry, use and exit of access devices including gloves and sleeves
3. General operation
4. Use of equipment inside isolators
5. Maintenance and servicing
6. Failure and troubleshooting
Operator training is required both for working in positive pressure isolators where the primary objective is protection of the product and for working in negative pressure isolators where protection extends to the operator, the environment, the product and service personnel. Operators working in negative pressure isolators may need to undertake specific training procedures directly related to the products prepared.
E. Gloves and Sleeves
When applicable, operators should be able to demonstrate the ability to change gloves and sleeves in an aseptic manner whilst maintaining a closed system.
F. Transfer System
Operators should demonstrate:
1. An understanding of surface sanitization processes
2. Transfer of materials into controlled and critical areas
3. The ability to transfer items into and out of the isolator without contamination of the isolator interior (positive and negative pressure isolators) or the external environment (negative pressure isolators).
4. An understanding of the airflow pattern and air change rates of the individual transfer device for each isolator.
5. The transfer of materials out of controlled and critical areas
6. Removal of waste including hazardous waste
G. Aseptic Technique
Operators should understand the concept of asepsis and the potential sources of contamination and demonstrate the necessary aseptic manipulations for the preparation of sterile admixtures. Specific techniques required for the handling of cytotoxic drugs or radiopharmaceuticals, e.g. spill control, should also be demonstrated if these items are to be prepared.
Operators should understand the need to validate cleaning and disinfection procedures with appropriate agents, and the potential need to vary agents used.
Operators should understand the difference between cleaning and sanitization, and be competent in following SOPs for:
1. Cleaning and sanitization of background environments
2. Cleaning and sanitization of isolators
3. Decontamination of isolators after use of or spillage of hazardous materials
Operators should be able to demonstrate the ability to clean and disinfect the interior of the isolator without compromising its integrity.
Cleaning can be demonstrated by simulated admixture preparations containing fluorescein followed by examination of the surfaces with ultraviolet light.
Operators should have their aseptic technique qualified before preparing items for patient administration and at regular intervals thereafter. A suggested initial step is the manipulation of at least 50 samples of microbiological growth medium into containers mimicking the actual work to be carried out e.g. syringe to syringe transfer, syringe to bag transfer. The containers should then be incubated and show no growth after 14 days at 35Â°C. The results should be reviewed and assessed with regard to the number of challenges to sterility involved in the overall manipulation. Continuing validation should occur after every 25 preparations or daily and should consist of the manipulation of at least 5 samples and incubated as above.
J. Environmental Monitoring
Operators should understand potential sources of contamination. They should also understand what corrective actions they have to take in the event of alert levels and action levels being indicated.
Operators should understand, and be competent in following SOPs for:
1. Particulate monitoring
2. Active microbiological monitoring
3. Passive microbiological monitoring
4. Monitoring of chemical contamination
5. Radiation contamination monitoring (if applicable)
Operators should understand and be competent in SOPs for actions in the event of emergency, e.g. loss of complete glove.
L. Documentation and Change Control
Operators should understand all the documentation that they are required to complete. They should also understand the principles and procedures for change control. One of the principles of change control is that before any change is implemented, any staff affected by such change, receive appropriate training which should be documented as part of the change control process.