21944
28-Jun-16
1 of 4
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Demonstrate knowledge of air quality
for pharmaceutical and allied products
manufacturing
level:
2
credit:
3
planned review date:
August 2007
sub-field:
Pharmaceutical and Allied Products
purpose:
People credited with this unit standard are able to
demonstrate knowledge of air quality for pharmaceutical and
allied products manufacturing.
entry information:
Recommended: Unit 21943, Demonstrate basic knowledge
of engineering for pharmaceutical and allied products
manufacturing, or demonstrate equivalent knowledge and
skills.
accreditation option:
Evaluation of documentation by NZQA.
moderation option:
A centrally established and directed national moderation
system has been set up by Competenz.
special notes:
1
This unit standard applies to non-sterile manufacturing.
2
Current Good Manufacturing Practice (cGMP) is the
term used to define the latest best practice for the
manufacture of pharmaceutical and allied products in
various countries around the world. In New Zealand,
this requirement is set out in the New Zealand Code of
Good Manufacturing Practice for Manufacture and
Distribution of Therapeutic Goods published by the
Ministry of Health (refer
www.medsafe.govt.nz/regulatory/guidelines.htm). In
practice, these provisions mean compliance with the
requisite domestic and/or international legislation and
regulations.
3
Enterprise means the organisation where training
and/or assessment is taking place. This may or may
not be where the trainee is employed.
 New Zealand Qualifications Authority 2016
21944
28-Jun-16
2 of 4
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Demonstrate knowledge of air quality
for pharmaceutical and allied products
manufacturing
4
The air filter classification systems that apply to
performance criteria 1.4 are referred to in the following
standards:
Eurovent/Cecomaf Technical Secretariat, Eurovent 4/5
– 1992 Method Of Testing Air Filters Used In General
Ventilation; Eurovent/Cecomaf Technical Secretariat,
Eurovent 4/8 – 1985 In Situ Leak Test Of High
Efficiency Filters In Clean Spaces (D.O.P. Aerosol
Test); European Committee for Standardisation, BS EN
779:2002 Particulate Air Filters for General Ventilation –
Determination of the Filtration Performance; European
Committee for Standardisation, CEN EN 1822-1:1998
High efficiency air filters (HEPA and ULPA).
Classification, Performance Testing, Marking.
5
References that apply to 1.1 are:
International Organisation for Standardisation, ISO
14644:1999 Cleanrooms and Associated Controlled
Environments – Part 1 Classification of Air Cleanliness;
Standards Australia, AS 1386.1-1989 Cleanrooms and
Clean Workstations – Principles of Clean Space
Control.
6
Competenz unit designation is PAME2.2.
 New Zealand Qualifications Authority 2016
21944
28-Jun-16
3 of 4
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Demonstrate knowledge of air quality
for pharmaceutical and allied products
manufacturing
Elements and Performance Criteria
element 1
Demonstrate knowledge of air quality for pharmaceutical and allied products
manufacturing.
performance criteria
1.1
The class system is explained with reference to the applicable air classification
standard for the enterprise, and the class of each zone within the enterprise
manufacturing facility is identified.
Range:
classifications must comply with the requisite domestic and
international standards such as – Annex 1 of the New Zealand
Code of Good Manufacturing Practice for Manufacture and
Distribution of Therapeutic Goods, ISO 14644:1999, AS 1386.11989.
1.2
The air pressure differentials and airflow directions within the enterprise
manufacturing facility are identified, and their purpose is explained.
1.3
The applicable specifications for temperature and humidity within the enterprise
manufacturing facility are identified, and their purpose is explained.
1.4
The basic concepts of the classification system for air filters are explained.
Range:
1.5
classification system – coarse (EU3, EU4; G3, G4); medium (EU5EU7; F5-F7); fine (EU8-EU10; F8-F10); absolute (EU11 – EU14;
H11- H14.
The major components of an air distribution system that complies with cGMP
are identified, and their purpose is explained.
Range:
major components – air plenum, pre-filters, supply and return fans,
heating and cooling coils, humidifiers and dehumidifiers,
condensate drains, air filters and housings, dampers, ducting,
access hatches, grilles, registers, diffusers, silencers, control and
monitoring instruments and equipment.
 New Zealand Qualifications Authority 2016
21944
28-Jun-16
4 of 4
PHARMACEUTICAL AND ALLIED
PRODUCTS MANUFACTURING
Demonstrate knowledge of air quality
for pharmaceutical and allied products
manufacturing
1.6
The routine monitoring and maintenance requirements for an air distribution
system that complies with cGMP are identified and explained.
Range:
1.7
requirements – pressure differentials (room, filter and system),
particle counting, microbiological levels, temperature, humidity,
airflow.
The certification requirements and frequency for an air distribution system that
complies with cGMP are explained.
Range:
certification requirements – air balancing, pressure differentials,
air-change rates, particulate testing, filter integrity testing,
calibration, temperature and humidity performance testing.
Comments on this unit standard
Please contact Competenz if you wish to suggest changes to the content of this unit
standard.
Please Note
Providers must be accredited by the Qualifications Authority or a delegated interinstitutional body before they can register credits from assessment against unit standards
or deliver courses of study leading to that assessment.
Industry Training Organisations must be accredited by the Qualifications Authority before
they can register credits from assessment against unit standards.
Accredited providers and Industry Training Organisations assessing against unit standards
must engage with the moderation system that applies to those standards.
Accreditation requirements and an outline of the moderation system that applies to this
standard are outlined in the Accreditation and Moderation Action Plan (AMAP). The
AMAP also includes useful information about special requirements for providers wishing to
develop education and training programmes, such as minimum qualifications for tutors and
assessors, and special resource requirements.
This unit standard is covered by AMAP 0134 which can be accessed at
http://www.nzqa.govt.nz/site/framework/search.html.
 New Zealand Qualifications Authority 2016