Modification History
Not applicable.
Unit Descriptor
Unit descriptor |
This unit of competency covers the skills and knowledge required to set up, operate, adjust and shut down a chromatography process where this process is used in production contexts. |
Application of the Unit
Application of the unit |
This unit applies to production operators working in the pharmaceutical sector. This person would typically work within defined Good Manufacturing Practice (GMP) programs and procedures. |
Licensing/Regulatory Information
Not applicable.
Pre-Requisites
Prerequisite units |
||
FDFOP2032A |
Work in a clean room environment |
|
Employability Skills Information
Employability skills |
This unit contains employability skills. |
Elements and Performance Criteria Pre-Content
Elements describe the essential outcomes of a unit of competency. |
Performance criteria describe the performance needed to demonstrate achievement of the element. Where bold italicised text is used, further information is detailed in the required skills and knowledge section and the range statement. Assessment of performance is to be consistent with the evidence guide. |
Elements and Performance Criteria
ELEMENT |
PERFORMANCE CRITERIA |
1. Prepare the chromatography equipment for operation |
1.1. Workplace documentation relevant to work area activities is identified and followed 1.2. Equipment is cleaned, assembled and adjusted to meet operational requirements 1.3. Equipment components and related instrumentation are set to meet production requirements 1.4. Column status is checked and ready for operation 1.5. Pre-start checks are carried out as required by work practices 1.6. Equipment status reports are completed as required by workplace system |
2. Prepare the samples and load product |
2.1. Pre-sampling tests are conducted according to test method to confirm column operation 2.2. Tests results are interpreted 2.3. Out-of-specification results are identified, investigated to identify cause and reported according to workplace procedures 2.4. Product is loaded into columns |
3. Operate and monitor the column operation |
3.1. The process is started and operated according to work practices 3.2. Equipment is monitored to confirm that process cycles occur in the correct sequence 3.3. Variation in equipment operation and process outcomes is identified and promptly reported according to workplace reporting procedures 3.4. Separation of solution meets specifications 3.5. Workplace documentation is maintained according to workplace reporting requirements 3.6. Work is conducted in accordance with workplace environmental guidelines |
4. Shut down the column process |
4.1. The process is shut down according to workplace procedures 4.2. Maintenance requirements are identified and reported according to workplace reporting requirements |
Required Skills and Knowledge
REQUIRED SKILLS AND KNOWLEDGE |
This section describes the skills and knowledge required for this unit. |
Required skills |
Ability to :
|
Required knowledge |
Knowledge of :
|
Evidence Guide
EVIDENCE GUIDE |
|
The Evidence Guide provides advice on assessment and must be read in conjunction with the performance criteria, required skills and knowledge, range statement and the Assessment Guidelines for the Training Package. |
|
Overview of assessment |
Assessment must be carried out in a manner that recognises the cultural and literacy requirements of the assessee and is appropriate to the work performed. Competence in this unit must be achieved in accordance with food safety standards and regulations. |
Critical aspects for assessment and evidence required to demonstrate competency in this unit |
Evidence of ability to:
|
Context of and specific resources for assessment |
Assessment must occur in a real or simulated workplace where the assessee has access to:
|
Method of assessment |
Assessors must be satisfied that the person can consistently perform the unit as a whole, including all elements, performance criteria, and required skills and knowledge. A holistic approach should be taken to the assessment. Assessment of this unit would typically involve observation of the operator preparing, operating and shutting down the separation process to meet production requirements. Observation should be sufficient to confirm consistent performance. |
Guidance information for assessment |
To ensure consistency in one's performance, competency should be demonstrated on more than one occasion over a period of time in order to cover a variety of circumstances, cases and responsibilities, and where possible, over a number of assessment activities. |
Range Statement
RANGE STATEMENT |
|
The range statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Bold italicised wording, if used in the performance criteria, is detailed below. Essential operating conditions that may be present with training and assessment (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) may also be included. |
|
Policies and procedures |
Work activities are carried out according to company policies and procedures, regulatory and licensing requirements, legislative requirements and industrial awards and agreements |
Legislative requirements |
Legislative requirements are typically reflected in procedures and specifications. Legislation relevant to this industry includes:
|
Workplace documentation |
Workplace documentation relevant to work area activities include:
|
Equipment |
Chromatography equipment includes:
Methods may include:
|
Unit Sector(s)
Unit sector |
Pharmaceutical manufacturing |
Competency field
Competency field |
Co-requisite units
Co-requisite units |
||