Assessment Requirements for FBPPHM3004 Clean and sanitise facilities and equipment

Release: 1

Assessment Requirements for FBPPHM3004 Clean and sanitise facilities and equipment

Modification History

Release	Comments
Release 1	This version released with FBP Food, Beverage and Pharmaceutical Training Package Version 2.0.

Performance Evidence

An individual demonstrating competency must satisfy all of the elements and performance criteria in this unit.

There must be evidence that, the individual has cleaned and sanitised facility surfaces and equipment of at least one manufacturing environment, including:

accessed cleaning schedules or other workplace information to identify cleaning requirements

interpreted workplace procedures applicable to cleaning operations, including pictorial and written signs/instructions

identified soil types present in the following work surfaces, and selected cleaning equipment and agents required to clean the surfaces:

floors

walls

ceilings

benches

outer surfaces of equipment

door handles and door frames

light switches

vents

grills

pass-through cabinets

identified hazards and controlled risks, including contamination hazards encountered in pharmaceutical manufacturing environments

confirmed supply of necessary cleaning and sanitising equipment and services

replenished different types of consumables used in cleaning processes

selected and prepared cleaners and sanitisers according to workplace procedures

selected, fitted and used personal protective equipment (PPE) required for tasks

prepared equipment for cleaning according to manufacturers’ instructions, including:

rendered equipment safe to clean

cleared product and waste materials

covered motors and instrumentation where steam or water hoses are used

dismantled and reassembled equipment parts for cleaning according to operation and maintenance manual

applied correct cleaning and sanitising procedures to equipment and surfaces

taken samples and conducted tests according to workplace procedures

inspected equipment to identify equipment condition and cleanliness

stored cleaners, sanitisers and related equipment according to workplace procedures.

Knowledge Evidence

An individual must be able to demonstrate the knowledge required to perform the tasks outlined in the elements and performance criteria of this unit. This includes knowledge of:

responsibilities of cleaning staff and procedures for cleaning teams

common types of microbiological, physical and chemical contaminants in pharmaceutical processing facilities

Good Manufacturing Practice (GMP) requirements and role of cleaning and sanitising in preventing contamination of materials and products, and in the protection of personnel and external contractors

risks associated with cleaning and sanitising operations and cross contamination prevention

personal hygiene, clothing and footwear requirements,

clothing storage and disposal for working in and moving between work areas

terminology relating to chemical cleaning and decontamination, including:

cleaners

disinfectants

sanitisers

sterilants

fogging

fumigation

services used in a pharmaceutical manufacturing process, including:

potable and purified water

steam

compressed and instrumentation air

types of cleaning equipment suitable for use in a pharmaceutical processing environment, including their use and storage,

different cleaning methods:

clean-in-place (CIP)

clean-out-of place (COP)

manual cleaning

purpose and basic principles of CIP, including the use and functions of caustic and acid solutions, and cleaning sequence and stages

advantages and disadvantage of automated and semi-automated CIP systems

types of cleaning equipment include:

CIP spray balls

bottle brushes

disinfecting solutions

non-shedding wipes

hygienic vs unhygienic design features of facilities and equipment, including inserts and dead legs

the differences between:

cleaning

disinfecting

sanitising

sterilising

properties and functions of different cleaning and sanitising agents for pharmaceutical industry

different levels of cleaning requirements depending on the reason for cleaning, and whether equipment is dedicated or shared

the influence of the time between manufacture and cleaning (dirty hold time), and the time between cleaning and use (clean hold time) on a cleaning process

acceptance criteria used to evaluate cleaning quality, including:

how cleaning is measured

commonly used sampling and testing

considerations when choosing and using cleaning chemicals including:

the correct selection of chemicals for the surface being cleaned

the chemical and physical properties of the soils or residues to be removed

the interactions between cleaning chemicals and the surfaces they may adhere to

the solubility of the soil/residue in the cleaning solution

the need to rotate sanitisers

the frequency of cleaning and sanitising

manual, semi-automated and fully automated cleaning methods

the variable factors that influence cleaning effectiveness and performance

critical parameters in a cleaning and sanitising process including:

time

temperature

concentration

GMP requirements for the validation of cleaning processes

waste related to pharmaceutical manufacturing processes, including:

cleaning material

product waste

hazardous waste

general processing and laboratory waste

waste collection, recycling and handling procedures relevant to own work responsibilities

procedures for responding to out-of-limits or unacceptable performance or outcomes

common practices inconsistent with GMP found in cleaning and sanitising operations, including:

damage to plant or equipment

failure of cleaning regime

signs of pest infestation

missing or inaccurate records

failure to follow workplace procedures

purpose of keeping records and the recording requirements of GMP, including the legal significance of certifying and verifying GMP records.

Assessment Conditions

Assessment of skills must take place under the following conditions:

physical conditions:

skills must be demonstrated in a commercial pharmaceutical or complementary medicine manufacturing workplace setting or an environment that accurately represents workplace conditions

resources, equipment and materials:

personal protective equipment

equipment and surfaces to be cleaned

chemicals and/or automated chemical addition system services and their related safety data sheets

data collection forms and information recording systems

specifications:

cleaning procedures and related advice on equipment operation that comply with GMP requirements

workplace health and safety procedures related to cleaning and sanitising pharmaceutical manufacturing equipment

cleaning schedule

data collection and information recording requirements and procedures.

Assessors of this unit must satisfy the requirements for assessors in applicable vocational education and training legislation, frameworks and/or standards.

Links

Companion Volume Implementation Guides are found in VETNet: - https://vetnet.gov.au/Pages/TrainingDocs.aspx?q=78b15323-cd38-483e-aad7-1159b570a5c4