Preparation Aspects
Scope-
This standard specifies recommendations and requirements for preparation
of cytotoxic drugs by pharmacy personnel.
Objective-
The objective of this standard is to provide guidelines on safe
handling of cytotoxic drugs during preparation.
Referenced documents-
The references are listed in appendix 4.
Definitions-
For the purpose of this standard, the definitions below
apply.
| 1. |
Anteroom A room attached to a clean room which provides access to the clean room for personnel, equipment and operating components. It also provides facilities for scrubbing and gowning before entry into clean room. |
2. |
Clean room A specially constructed enclosed area environmentally controlled with respect to airborne particles, temperature, humidity, air pressure, air flow patterns, air motion and lighting. |
| 3. |
Biological safety cabinet A vertical laminar airflow cabinet that provides a clean working environment and protection to operators. |
| 4. |
Isolator A self-contained enclosed cabinet that provides a clean working environment and protection to operators. Manipulation within the work zone is performed through fitted glove ports. |
| 5. |
Aseptic technique The technique involving procedures designed to preclude contamination(of drugs, packaging, equipment or supplies) by microorganisms during processing. |
| 6. |
Critical surface Any surface that comes into contact with previously sterilised products or containers. It is also surface of the work part to be protected from particulate and microbial contamination |
| 7. |
Negative pressure technique A Method used to manipulate vials to ensure negative pressure in vial during preparation. |
| 8. |
Luer-lock devices Equipment (syringes) used to mix and administer drugs which are less prone to separate, and reduce risk of leakage or spills. |
