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Evidence Guide: MSL975009A - Apply routine chromatographic techniques

Student: __________________________________________________

Signature: _________________________________________________

Tips for gathering evidence to demonstrate your skills

The important thing to remember when gathering evidence is that the more evidence the better - that is, the more evidence you gather to demonstrate your skills, the more confident an assessor can be that you have learned the skills not just at one point in time, but are continuing to apply and develop those skills (as opposed to just learning for the test!). Furthermore, one piece of evidence that you collect will not usualy demonstrate all the required criteria for a unit of competency, whereas multiple overlapping pieces of evidence will usually do the trick!

From the Wiki University

 

MSL975009A - Apply routine chromatographic techniques

What evidence can you provide to prove your understanding of each of the following citeria?

Establish client needs and schedule analysis

  1. Liaise with client or sample provider to determine client needs and sample history
  2. Record sample description, compare with specification and record and report discrepancies
  3. Identify non-routine samples and the possible need to vary enterprise procedures
  4. Seek advice from supervisor about any proposed variations and document all approved changes
  5. Schedule analysis using enterprise procedures
Liaise with client or sample provider to determine client needs and sample history

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Record sample description, compare with specification and record and report discrepancies

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify non-routine samples and the possible need to vary enterprise procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Seek advice from supervisor about any proposed variations and document all approved changes

Completed
Date:

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Schedule analysis using enterprise procedures

Completed
Date:

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Prepare samples and standards

  1. Obtain a representative analytical portion of the laboratory sample
  2. Prepare sample in accordance with testing requirements
  3. Prepare validation checks for analytical portion
Obtain a representative analytical portion of the laboratory sample

Completed
Date:

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Prepare sample in accordance with testing requirements

Completed
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Prepare validation checks for analytical portion

Completed
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Set up and optimise instrument

  1. Perform pre-use and safety checks in accordance with enterprise procedures
  2. Start up and condition the instrument using enterprise procedures
  3. Optimise instrumental parameters to suit sample and test requirements
  4. Check calibration status of instrument and perform calibration using specified standards and procedures, if applicable
Perform pre-use and safety checks in accordance with enterprise procedures

Completed
Date:

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Start up and condition the instrument using enterprise procedures

Completed
Date:

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Optimise instrumental parameters to suit sample and test requirements

Completed
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Check calibration status of instrument and perform calibration using specified standards and procedures, if applicable

Completed
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Perform analysis

  1. Measure analyte response for standards, validation checks and samples
  2. Conduct sufficient measurements to obtain reliable data
  3. Return instruments to standby or shutdown condition, as required
Measure analyte response for standards, validation checks and samples

Completed
Date:

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Conduct sufficient measurements to obtain reliable data

Completed
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Return instruments to standby or shutdown condition, as required

Completed
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Process and analyse data

  1. Confirm data is the result of valid measurements
  2. Perform required calculations and ensure results are consistent with standards or estimations and expectations
  3. Record results with the appropriate accuracy, precision and units
  4. Analyse trends in data and/or results and report out of specification or atypical results promptly to appropriate personnel
  5. Troubleshoot analytical procedure or equipment problems which have led to atypical data or results
Confirm data is the result of valid measurements

Completed
Date:

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Perform required calculations and ensure results are consistent with standards or estimations and expectations

Completed
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Record results with the appropriate accuracy, precision and units

Completed
Date:

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Analyse trends in data and/or results and report out of specification or atypical results promptly to appropriate personnel

Completed
Date:

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Troubleshoot analytical procedure or equipment problems which have led to atypical data or results

Completed
Date:

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Maintain a safe work environment

  1. Identify risks, hazards, safety equipment and control measures associated with sample handling, preparation and analytical method
  2. Use personal protective equipment and safety procedures specified for test method and materials to be tested
  3. Minimise the generation of wastes and environmental impacts
  4. Ensure the safe disposal of laboratory wastes
  5. Clean, care for and store equipment and consumables in accordance with enterprise procedures
Identify risks, hazards, safety equipment and control measures associated with sample handling, preparation and analytical method

Completed
Date:

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Use personal protective equipment and safety procedures specified for test method and materials to be tested

Completed
Date:

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Minimise the generation of wastes and environmental impacts

Completed
Date:

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Ensure the safe disposal of laboratory wastes

Completed
Date:

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Clean, care for and store equipment and consumables in accordance with enterprise procedures

Completed
Date:

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Maintain laboratory records

  1. Enter approved data and results into laboratory information management system (LIMS)
  2. Maintain equipment logs in accordance with enterprise procedures
  3. Maintain security and confidentiality of laboratory data and enterprise information
  4. Communicate results to appropriate personnel
Enter approved data and results into laboratory information management system (LIMS)

Completed
Date:

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Maintain equipment logs in accordance with enterprise procedures

Completed
Date:

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Maintain security and confidentiality of laboratory data and enterprise information

Completed
Date:

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Communicate results to appropriate personnel

Completed
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Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

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

Critical aspects for assessment and evidence required to demonstrate competency in this unit

Assessors should ensure that candidates can:

interpret client requests, test methods and procedures accurately

safely set up and shut down equipment using enterprise procedures

check calibration/qualification status of equipment

prepare standards and samples appropriately

install and maintain a variety of chromatographic columns

choose and optimise procedures and equipment settings to suit sample/test requirements

operate equipment to obtain valid and reliable data

make approved adjustments to procedures for non-routine samples

recognise atypical data/results

troubleshoot common procedure and equipment problems

apply theoretical knowledge to interpret data and makes relevant conclusions

record and report data/results in accordance with enterprise procedures

maintain security, integrity and traceability of samples and documentation

follow OHS procedures and principles of GLP.

Context of and specific resources for assessment

This unit of competency is to be assessed in the workplace or simulated workplace environment.

This unit of competency may be assessed with:

MSL925001A Analyse data and report results.

Resources may include:

standard laboratory equipped with routine chromatographic equipment, laboratory reagents and equipment

SOPs and test methods.

Method of assessment

The following assessment methods are suggested:

review of test data/results obtained by the candidate over time to ensure accuracy, consistency and timeliness of results

inspection of test records and workplace documentation completed by the candidate

feedback from peers and supervisors

observation of candidate applying a range of routine chromatographic techniques

oral or written questioning of chemical principles and concepts, chromatographic techniques and enterprise procedures.

In all cases, practical assessment should be supported by questions to assess underpinning knowledge and those aspects of competency which are difficult to assess directly.

Where applicable, reasonable adjustment must be made to work environments and training situations to accommodate ethnicity, age, gender, demographics and disability.

Access must be provided to appropriate learning and/or assessment support when required.

The language, literacy and numeracy demands of assessment should not be greater than those required to undertake the unit of competency in a work like environment.

This competency in practice

Industry representatives have provided the case studies below to illustrate the practical application of this unit of competency and to show its relevance in a workplace setting.

Manufacturing

Technicians who conduct chemical synthesis frequently use chromatographic methods such as thin-layer chromatography (TLC), gas chromatography (GC), high performance liquid chromatography (HPLC) and other instrumental techniques to check the identity and purity of the material they have produced. For example, a technician reacted an amine with acetic anhydride to form the acylated amine to prepare a pilot batch of material for a new application. After completing the reaction, the technician collected the product in a Buchner funnel using vacuum assisted filtration, and used chromatographic techniques to purify the material. The product was then analysed by HPLC using a number of stationary phases and solvent systems. In each case, a reference standard was run. These tests confirmed the identity and purity of the material.

Biotechnology

Technicians in research facilities often prepare a protein by extracting it from tissue. This extraction process introduces impurities that must be removed before the purified protein is ready for use or the characterisation of its purity and molecular weight. Impurities such as salt, detergents and other proteins are sequentially removed by passing the protein extract through gel filtration columns of differing grades of chromatographic gel. For antibodies, the final column used is an affinity chromatography column. Demonstration of the purity of the protein is by the presence of one single band on an SDS-PAGE gel. The molecular weight of the protein can also be determined from the SDS gel.

Environment

An environmental protection authority was required to sample an oil slick off Australia's coast and to take oil samples from all ships which docked in Australian ports in the 48 hours after the discovery of the oil slick. The samples were analysed by column chromatography and compared with the oil slick 'finger print' of the oil samples from all ships which may have been in the area of the oil slick. Given that the analysis involved unknown oil samples and the results would be used in court proceedings, the analysts were careful to optimise the chromatographic system for the unknown samples, ensure that appropriate quality and control procedures were employed and that the sample and analyses were performed quickly before potentially polluting ships left Australian waters. The analysts were careful to ensure that all record keeping procedures would be able to stand up to court scrutiny.

Required Skills and Knowledge

Required skills

Required skills include:

interpreting client requests, test methods and procedures

setting up and shutting down equipment using enterprise procedures

checking the calibration/qualification status of equipment

preparing standards and samples

installing and maintaining a variety of chromatographic columns

choosing and optimising procedures and equipment settings to suit sample/test requirements

operating equipment to obtain valid and reliable data

making approved adjustments to procedures for non-routine samples

recognising atypical data/results

identifying and calculating potential sources of uncertainty

troubleshooting common procedure and equipment problems

applying theoretical knowledge to interpret data and makes relevant conclusions

recording and reporting data/results in accordance with enterprise procedures

maintaining security, integrity and traceability of samples and documentation

followingoccupational health and safety (OHS) procedures and principles of good laboratory practice (GLP)

Required knowledge

Required knowledge includes:

chromatographic principles and concepts related to instrumentation operation, material preparation and testing

handling of unstable or hazardous chemicals and samples and/or the fragile/labile nature of biological material

sample preparation procedures

use of chromatographic techniques for qualitative and quantitative analysis

function of key components of the instrument

use of different chromatographic methods for analysis and preparation of specific samples

effects on outputs and results of modifying instrumental variables (e.g. injection temperature, gas flow rate, column pressures, column type and detector type)

procedure for optimising separation through changing operation parameters (e.g. injection technique, solvent type, sample size and sample preparation)

basic procedure and equipment troubleshooting techniques

preparation and use of calibration charts and/or standards

calculation steps to give results in appropriate precision and units

enterprise and/or legal traceability requirements

basic equipment maintenance procedures

relevant health, safety and environment requirements

Specific industry

Additional knowledge requirements may apply for different industry sectors. For example:

Biomedical and environmental services:

techniques that capitalise on biological properties to assist in chromatographic separations

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.

Codes of practice

Where reference is made to industry codes of practice, and/or Australian/international standards, it is expected the latest version will be used

Standards, codes, procedures and/or enterprise requirements

Standards, codes, procedures and/or enterprise requirements may include:

Australian and international standards, such as:

AS ISO 17025-2005 General requirements for the competence of testing and calibration laboratories

AS/NZS 2243 Set:2006 Safety in laboratories set

AS/NZS 2982.1:1997 Laboratory design and construction - General requirements

AS/NZS ISO 14000 Set:2005 Environmental management standards set

AS/NZS ISO 9000 Set:2008 Quality management systems set

AS ISO 1000-1998 The international system of units (SI) and its application

Eurachem/CITAC Guide CG4 Quantifying uncertainty in analytical measurement

Australian code of good manufacturing practice for medicinal products (GMP)

calibration and maintenance schedules

cleaning, hygiene and personal hygiene requirements

data quality procedures

enterprise procedures, SOPs and operating manuals

enterprise recording and reporting procedures

equipment startup, operation and shutdown procedures

incident and accident/injury reports

material safety data sheets (MSDS)

material, production and product specifications

national measurement regulations and guidelines

principles of GLP

production and laboratory schedules

quality manuals, equipment and procedure manuals

quality system and continued improvement processes

safety requirements for equipment, materials or products

sampling procedures (labelling, preparation, storage, transport and disposal)

schematics, work flows and laboratory layouts

statutory and enterprise OHS requirements

stock records and inventory

test procedures (validated and authorised)

training program contents

waste minimisation, containment, processing and disposal procedures

Routine chromatographic techniques

Routine chromatographic techniques include both analytical and preparative procedures, and may include:

standard sample introduction systems

paper such as ascending and descending

thin-layer such as ascending, high performance, radical and descending

column chromatography

affinity chromatography and gel filtration chromatography

gas liquid and gas solid chromatography

high performance liquid chromatography, such as liquid-liquid (LLC), liquid-solid (LSC), ion (IC) and size exclusion (SEC)

Tests

Tests may include methods for:

control of starting materials, in-process materials and finished products (e.g. manufacturing, petroleum and biotechnology)

selection of appropriate separation technique, such as suitable substrate and support solvent, buffer, temperature, flow rate, column length and detection method

forensic testing

environmental monitoring of pollutants in air, water and soil

troubleshooting enterprise processes

Sample preparation

Sample preparation may include:

identification of any hazards associated with samples and/or analytical chemicals

grinding, dissolving, extraction, filtration, refluxing, centrifuging, evaporation, washing and drying

determination of and, if appropriate, removal of any contaminants, impurities or interfering substances

Common procedure and equipment problems

Common procedure and equipment problems may include:

problems with interfering substances

poor resolution of peaks

inappropriate selection of column or operating parameters (flow rate and temperature)

unsuitable substrate or support solvent

lack of suitable reference standards

Hazards

Hazards may include:

electric shock

biohazards, such as microbiological organisms and agents associated with soil, air, water, blood and blood products, and human or animal tissue and fluids

transformed cultures/organisms and genetically altered organisms

chemicals, such as acids, phenol, benzene and ammonium persulphide

sharps and broken glassware

sources of ignition and hot surfaces, such as burners

aerosols from broken centrifuge tubes and pipetting

flammable liquids and gases (e.g. hydrogen)

cryogenics such as dry ice and liquid nitrogen

disturbance or interruption of services

Addressing hazards

Addressing hazards may involve:

use of MSDS

labelling of samples, reagents, aliquoted samples and hazardous materials

use of personal protective equipment, such as gloves, safety glasses and coveralls

use of fumehoods, direct extraction of vapours and waste gases

use of appropriate equipment, such as biohazard containers, laminar flow cabinets, Class I, II and III biohazard cabinets

use of Class PCII, PCIII and PCIV physical containment laboratories

handling and storage of all hazardous materials and equipment in accordance with labelling, MSDS and manufacturer's instructions

Occupational health and safety (OHS) and environmental management requirements

OHS and environmental management requirements:

all operations must comply with enterprise OHS and environmental management requirements, which may be imposed through state/territory or federal legislation - these requirements must not be compromised at any time

all operations assume the potentially hazardous nature of samples and require standard precautions to be applied

where relevant, users should access and apply current industry understanding of infection control issued by the National Health and Medical Research Council (NHMRC) and State and Territory Departments of Health