Validation of Staff on Cytotoxic Preparation Techniques

Scope-
This standard specifies recommendations and requirements for validating pharmacy personnel in cytotoxic preparation technique.

Objectives-
The objectives of this standard is to provide validation procedures for ensuring that processes consistently result in sterile products of acceptable quality and for assessing the adequacy of staff on safe handling technique.

Referenced document-
The following articles were referred to in this guideline.

•	Competence Assessment Tools for Health-System Pharmacies. Lee B. Murdaugh 1998
•	Handling Cytotoxic Drugs in Health Care Establishments. New South Wales Government 1995
•	ASHP Technical assistance bulletin on handling of cytotoxic and hazardous drugs. Am J Hosp Pharm 1990; 47: 1033-49
•	SHPA Guidelines for the safe handling of cytotoxic drugs in Pharmacy Departments. Aust J Hosp Pharm 1990; 20(5): 391-4
•	OSHA Work-practice guidelines for personnel dealing with cytotoxic (antineoplastic) drugs. Am J Hosp Pharm 1986; 43: 1193-1204

Definitions-
For the purpose of this standard, the definitions below apply.

1. Aseptic technique
    The technique involving procedures designed to preclude contamination     (of drugs, packaging, equipment or supplies) by microorganism during     processing.

2. Growth media
    A substance used to support the growth of microorganism or any cells.     The growth media selected should be capable of supporting the growth     of a broad spectrum of microorganism likely to be production-    associated  contaminants in the pharmacy.

3. Positive control
    A quality control check to ensure that the growth media used in the     validation process is capable of supporting growth of microorganisms.     The growth promotion of media should be determined with a range of     appropriate microorganisms. Media must be able to support growth     when inoculated with less than 100 colony-forming units of the     challenged microorganisms.

4. Negative control
    A quality control check to ensure that the growth media used in the     validation process is sterile. The sterility of the growth media is     demonstrated with the use of a biological indicator. The biological     indicator is introduced into a sample container during the sterilisation     cycle of the growth media.

5. Validation process
    Planned testing, in accordance with the principles of good     manufacturing practice, designed to demonstrate that microorganisms     will be effectively prevented from inadvertently being introduced by     personnel or by process related activities.

6. Examiner
    An examiner is a person who invigilates the entire validation process.

7. 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.

8. Work area/zone
    That part of the controlled work space where containers are opened and     the product is exposed. Particulate and microbial contamination in the     area should be reduced to levels appropriate for the intended use.

9. ‘Open window’
    Any opening that provides a direct pathway between a critical surface     and the laminar airflow directly from the HEPA filter.

10. HEPA filter
     A high efficiency particulate air (HEPA) filter compose of pleats of filter      medium separated by rigid sheets of corrugated paper or aluminum      foil that direct the flow of air through the filter in a uniform parallel      flow. HEPA filters remove 99.97% of all air particles 0.3 um or larger.

11. ‘No touch’ technique
     A method of manipulation whereby operators avoid contact of critical      surfaces during the preparation of sterile products.