This unit of competency describes the skills and knowledge required to set up, operate, adjust and shut down a sterilisation process using an autoclave in a pharmaceutical manufacturing facility.

The unit applies to individuals who apply Good Manufacturing Practice (GMP) and operating principles to the sterilisation process using an autoclave. Individuals work under broad direction and take responsibility for their own work.

No occupational licensing, legislative or certification requirements apply to this unit at the time of publication.

You may want to include more information here about the target group and the purpose of the assessments (eg formative, summative, recognition)

List each assessment task's title, type (eg project, observation/demonstration, essay, assingnment, checklist) and due date here

Assessment task 1: [title]      Due date:

(add new lines for each of the assessment tasks)

Copy and paste from the following data to produce each assessment task. Write these in plain English and spell out how, when and where the task is to be carried out, under what conditions, and what resources are needed. Include guidelines about how well the candidate has to perform a task for it to be judged satisfactory.

This section specifies different work environments and conditions that may affect performance. Essential operating conditions that may be present (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) are included.

Pre-start checks must include:

carrying out required area or line clearances inspecting equipment condition to identify signs of wear confirming all safety equipment is in place and operational confirming that equipment is clean or sanitised confirming that equipment is correctly configured for processing requirements.

Copy and paste from the following performance criteria to create an observation checklist for each task. When you have finished writing your assessment tool every one of these must have been addressed, preferably several times in a variety of contexts. To ensure this occurs download the assessment matrix for the unit; enter each assessment task as a column header and place check marks against each performance criteria that task addresses.

Observation Checklist

Tasks to be observed according to workplace/college/TAFE policy and procedures, relevant legislation and Codes of Practice	Yes	No	Comments/feedback
Confirm autoclave and wrapping, cleaning and material items are available and meet load pattern requirements
Prepare autoclave and position load probe according to load pattern requirements and standard operating procedure
Enter operating parameters according to safety and sterilisation requirements
Conduct pre-start checks according to workplace requirements
Load wrapping, cleaning and material items according to load pattern requirements
Start up and monitor autoclave to confirm specifications are within required limits
Identify and report out of limit materials or processes according to workplace procedures
Maintain work area according to workplace cleaning standards
Conduct process according to safety and environmental requirements
Complete documentation according to workplace procedures
Confirm the workplace procedures for shutting down the process
Safely shut down the process
Remove items from autoclave
Check chemical indication to confirm items are dry
Ensure segregation of sterile and non-sterile items
Complete records according to workplace procedures

Assessment Cover Sheet

FBPPHM3016 - Operate a sterilisation process using an autoclave

Assessment task 1: [title]

Student name:

Student ID:

I declare that the assessment tasks submitted for this unit are my own work.

Student signature:

Result: Competent Not yet competent

Feedback to student

 

 

 

 

 

 

 

 

Assessor name:

Signature:

Date:

Assessment Record Sheet

FBPPHM3016 - Operate a sterilisation process using an autoclave

Student name:

Student ID:

Assessment task 1: [title] Result: Competent Not yet competent

(add lines for each task)

Feedback to student:

 

 

 

 

 

 

 

 

Overall assessment result: Competent Not yet competent

Assessor name:

Signature:

Date:

Student signature:

Date: