GAP analysis of EN 17141:2020 & ISO 14698
EN 17141:2020 ISO 14698 Result Evidence
Cleanrooms and associated Cleanrooms and associated
controlled environments - controlled environments -
Biocontamination control Biocontamination control
Scope Establishes requirements, The principles and basic methods 1.For environmental
recommendations, methods, of a formal biological pollution Differences, EN monitoring, the working
and validation control system are established. 17141:2020 has been environment control
requirements for the Ways of monitoring risk areas added Selection of program is established.
control of microbial and methods required for control sampling methods for See Annex SPQP-26
contamination in a clean, measures applicable to the environmental working environment
controlled environment degree of risk involved; monitoring (EM), control program file.
The informative annex Assess and control biological management of collected
provides further guidance contamination in clean rooms data 2 、 For the management
on biological pollution Instructions for efficiency of of collected data,
control laboratory cleaning or identification and
Selection of sampling disinfection operations traceability control
methods for environmental procedures have been
monitoring (EM), established. See Annex
management and trend SPQP-12 identification
analysis of collected data and traceability control
and control related to the program file.
role of alternative and
real-time microbial
detection systems
Establishment Establishing a formal Establishing a formal system for Same /
of system for microbiological microbiological control：
microbiological control： 1.Identification of all
control 1.Identification of all potential sources and routes of
potential sources and microbiological contamination
routes of microbiological 2.Risk assessment
contamination 3.Establishment of
2.Risk assessment microbiological environmental
3.Establishment of monitoring plan and conduct
microbiological simultaneous testing
environmental monitoring 4.Establishment of alert and
plan and conduct action limits
simultaneous testing 5.Establishment of
4.Establishment of alert documentation system
and action limits 6.Personnel education and
5.Establishment of training
documentation system
6.Personnel education and
training
Verification of 1.Periodically check the 1.Periodically check the Differences, Risk free
the formal monitoring results of monitoring results of microbial There is Nothing in ISO 1.For OOS investigation,
microbiological microbial environment environment 14698: the nonconforming
control system 2.Out of specification 2.Records ： All regular and product control
(OOS) investigation ， The periodical checks of methods, 1.(OOS) investigation ， procedure was
objective of investigating instruments and internal The objective of established. See Annex
an OOS result is to audits, as well as records of investigating an OOS SPQP-19 nonconforming
determine if there has been original observations, result is to determine if product control
a real change in the calculations, derived data and there has been a real procedure.
occurrence of final reports should be change in the occurrence
microbiological appropriately filed and of microbiological
2.For product tracking,
contamination. retained for an agreed period. contamination. identification and
3.Records：All regular and It is essential that the records traceability control
periodical checks of include the identity of 2.Sample tracking，Create program files have been
methods, instruments and personnel involved in the program file established. See Annex
internal audits, as well as monitoring, preparation, SPQP-12 identification
records of original testing, evaluation and and traceability control
observations, reporting. It should be possible program file.
calculations, derived data to conduct an audit trail to show
and final reports should be the details of how and when any
appropriately filed and results have been changed.
retained for an agreed Records of signatures, initials
period. It is essential or signs should be maintained
that the records include and updated as appropriate. It
the identity of personnel is essential that appropriate
involved in the monitoring, protection of data and records,
preparation, testing, including any electronic
evaluation and reporting. records held on a computer, be
It should be possible to provided.
conduct an audit trail to 3.Integrity of results
show the details of how and 4.Data recording ： Ensure data
when any results have been are readily available and
changed. Records of establish record control
signatures, initials or procedures
signs should be maintained 5.Data evaluation：this may be
and updated as appropriate. done in a qualitative way by
It is essential that grouping the measurements to
appropriate protection of form frequency tables and charts
data and records, including or by using descriptive
any electronic records held statistics.
on a computer, be provided.
4.Sample tracking ， Create
program file
5.Integrity of results
6.Data recording ： Ensure
data are readily available
and establish record
control procedures
7.Data evaluation：this may
be done in a qualitative way
by grouping the
measurements to form
frequency tables and charts
or by using descriptive
statistics.
8.Trend analysis：Chart
Microbiological 1.Choice of sampling method 1.Choice of sampling method Same meaning, different /
measurement 2.Volumetric air samplers 2.Culture media and incubation description
methods 3.Culture media and 3.Incubators
incubation 4.Sampling devices ： passive
4.Incubators sampling devices; active
sampling devices
Annex 1、Annex A Guidance for life 1 、 Annex A Guidance on Differences Risk free
science pharmaceutical and determining airborne Annex A does not apply
biopharmaceutical biocontamination Annex B ： For
applications 2、Annex B Guidance on validating environmental
2、Annex B Guidance for life air samplers monitoring, the working
science medical device 3 、 Annex C Guidance on environment control
applications： determining biocontamination of program file is
Microbiological surfaces established. See Annex
Environmental Monitoring 4 、 Annex D Guidance on SPQP-26 working
(EM) plan: See table B.2 and determining biocontamination of environment control
table B.3 textiles program file. The
3 、 Annex C Guidance for 5、Annex E Guidance on validating company's sampling
healthcare/hospital laundering processes points are based on ISO
applications 6 、 Annex F Guidance on 14644-1:2015, See Table
4、Annex D Guidance for food determining biocontamination of A.1
applications liquids Annex C does not apply
5 、 Annex E Guidance on 7、Annex G Guidance on training Annex D does not apply
culture based Annex E :For the
microbiological measurement and
measurement methods and method of
sampler verification microorganism, the
a. Volumetric air samplers： working environment
Direct impaction air control procedure is
sampling — — Cascade established. See Annex
sampler (multiple sieve SPQP-26 working
sampler) ； Single sieve to environment control
agar sampler；Slit to agar program file.
sampler ； Centrifugal
sampler. Annex F does not apply
Indirect impaction
samplers — — Membrane
filter；Liquid impingement；
Remote air sampling ；
Settle plates.
b. Surface sampling — —
Contact plates and strips；
Swabs and sponges.
c. Microbiological growth
media——Media suitability
(media sterility and
ability to support growth)；
Media dehydration ； Media
disinfectant inhibition ；
Plate incubation。
d. Validation of air
samplers — — Physical and
biological collection
efficiency.
e. Experimental method——
Aerosol chamber method ；
Simplified laboratory
method ； Incubation ；
Collection efficiency
calculations from testing
results ； Air sampler
revalidation
6 、 Annex F Rapid
microbiological methods
(RMM) and alternative real
time microbiological
detection methods (AMMs)—
— Implementation of RMMs
and AMMs
Method for / 1.Test medium application and Differences, /
measuring the (option) biofilm formation EN 17141:2020 does not.
efficiency of 2.Implementation of the process
cleaning and/or 3.Count of tracer
disinfection Test equipment and instruments:
processes 1, test medium 2, test medium
adherent 3, microbial biofilm
tracer 4, cleaning tracer 5,
surface 6, incubator 7, counting
tracer recovery
Procedure: 1. Coating of the
test medium on the test surface;
2. Hatching and formation of
biofilm; 3. Implementation of
the test process 4. Counting of
tracer 5.Result 6.Report
编制人/日期（aurhorized personnel/Date）
： 2021.5.9
审核人/日期（auditor/Date）： 2021.5.9
