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G 52 Pure Steam System Commissioning and Qualification - Sampling Plans

The document provides guidance on sampling plans for commissioning and qualifying clean/pure steam systems. It recommends a risk-based approach and defines three phases of qualification: Phase 1 demonstrates production and delivery over 3 days; Phase 2 demonstrates stable production over 1 week; Phase 3 continues testing for 4 weeks with modified sampling. Additional steam quality tests are needed if steam will be used for sterilizing porous loads for European markets.

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Doan Chi Thien
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1K views5 pages

G 52 Pure Steam System Commissioning and Qualification - Sampling Plans

The document provides guidance on sampling plans for commissioning and qualifying clean/pure steam systems. It recommends a risk-based approach and defines three phases of qualification: Phase 1 demonstrates production and delivery over 3 days; Phase 2 demonstrates stable production over 1 week; Phase 3 continues testing for 4 weeks with modified sampling. Additional steam quality tests are needed if steam will be used for sterilizing porous loads for European markets.

Uploaded by

Doan Chi Thien
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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Title: Clean/Pure Steam System Commissioning and Qualification -Sampling Plans

Guidance Number: 052


Prepared by: Date: Supersedes:
Checked by: Date: Date Issued:
Approved by: Date: Review Date:

Clean/Pure Steam System Commissioning and Qualification - Sampling Plans

Introduction
This document recommends sampling locations, frequencies, and testing activities
associated with the commissioning and qualification of new installations or major
revisions of Clean/Pure Steam Systems (e.g. the addition of new subloops or other
system wide retrofitting).

This guidance defines the sampling location, frequency, and testing activities utilizing
a risk based approach for supporting the commissioning and qualification for a
clean/pure steam system. The recommended practices are derived from the latest
edition of the ISPE Good Practices Guide “Commissioning and Qualification of
Pharmaceutical Water and Steam Systems”.

Clean Steam is defined to be steam that does not contain any additives (e.g., boiler
additives), 1 is used where the steam and/or condensate have direct contact with
product, and the steam condensate meets USP/EP WFI requirements. In addition,
clean steam that is used for sterilization applications of “porous loads” for
international manufacturing also should meet the requirements of European Standard
EN 285. The USP states that “Pure Steam [Clean] is prepared from suitably pre-
treated source water analogously to either the pre-treatment used for Purified Water or
Water for Injection”.

This guidance does not cover the additional commissioning and qualification activities
associated with other aspects of system validation (e.g., drawing development, system
equipment/component installation/testing activities, cleaning/passivation, monitoring
equipment, etc.). Ongoing operations (i.e. routine monitoring) after qualification
activities are also outside of the scope of this guidance.

Recommendations & Rationale


The results of the commissioning and qualification demonstrate the equipment,
personnel, and operating procedures are capable of consistently providing Clean
Steam meeting the necessary steam quality requirements.

Regarding the quality of water feeding the clean steam generator, consider the
requirements for Bacterial Endotoxin Testing (BET) validation studies in order to
assure that there is no Bacterial Endotoxinbeing carried over in the steam during
generation for those applications that have an endotoxin specification.

For example, clean steam that is strictly used for the production of ophthalmic
products or non-sterile products would typically not have defined
bacterial endotoxin specification requirements.

The testing of clean steam systems includes the Generation System and associated
Distribution System piping starting with commissioning activities through the three
phases of qualification studies that is synonymous with high-purity water
systems. 1,2,3,4

Commissioning
Commissioning is defined in the ISPE Good Practice Guide as “a well planned,
documented, and managed engineering approach to the start-up and turnover of
facilities, systems, and equipment to the end-user that results in a safe functional
environment that meets established design requirements and stakeholder
expectations”. Sampling and monitoring of the Generation and Distribution Systems
for Clean Steam Systems during commissioning are considered Good Engineering
Practice. These activities help to define operational and maintenance practices and
procedures that will be challenged later during qualification. 3 The sampling and
testing activities include chemical testing as appropriate for the unit operation with the
maximum acceptable chemical levels of the condensate meeting the applicable
WFI compendial limits as determined by the associated compendial methods.

In addition, bacterial endotoxin testing, as needed, to identify


bacterial endotoxin levels (if any) within the system based on the intended use of the
system. Finally, the quality of the feedwater should be verified both microbiologically
and chemically to ensure that the clean steam condensate will meet USP and
international WFI specifications as required.4
Typically, the duration of commissioning activities may vary depending upon the
complexity and size of the system. Once the entire system is operating, each unit of
operation should be tested at least once during the commissioning phase. It is the
ability to complete this testing of use test points at least once during this phase, which
determines the total time necessary to complete commissioning sampling.

Qualification (3 Phase Approach)


Qualification is an adjunct to commissioning and serves to provide documented
evidence with oversight by Quality Assurance personnel that a clean steam system
will consistently produce the appropriate quality of steam to end users in accordance
with regulatory expectations.
Furthermore, it is important to note that activities performed as part of qualification do
not necessarily have to repeat work that was already conducted during commissioning
of the clean steam system if the commissioning documentation is prepared according
to established site quality documentation practices. Depending upon the quality of the
initial commissioning plan, the subsequent qualification can simply serve as
verification that the system will consistently produce quality product (i.e. steam). The
data collected as part of the commissioning sampling phase can be used to directly
justify the sampling plan developed for qualification if the acceptance criterion has
been pre-approved by the appropriate Quality Assurance representative.
Phase 1 (approximately 3 Days)
Per current industry practice, the Phase 1 Qualification study lasts a minimum of three
days with samples being taken at least once from each point of use and the outlet of
the generation system.
The Phase 1 or “start-up” activities are to demonstrate production and delivery of
clean steam meeting the necessary quality requirements. It is also very important
during Phase 1 activities to finalize appropriate operating ranges for critical process
parameters and to finalize Standard Operating Procedures (SOPs) for the system
operation, cleaning, and maintenance.
Phase 2 (approximately 1 Week)
The Phase 2 or “system consistency/stability” activities typically last for one week
following completion of Phase 1 sampling. 4 The sampling and testing frequency are
nearly identical to the activities in Phase 1 with the exception of the sampling of the
outlet of the generator. Current industry practice is to sample the outlet of the clean
steam generator more than once during the Phase 2 testing activities such as a
bracketing approach (e.g. once during the start of Phase 2 sampling and again at the
end of Phase 2 sampling).
The purpose of Phase 2 is to further demonstrate stable and consistent production and
delivery of clean steam of the required quality with consistent operation within the
established ranges when using SOPs. The use of steam for production is permissible
during the qualification phase as long as the data collected demonstrates system
stability, the steam produced is of the appropriate quality and that this approach has
been approved by the appropriate site Quality Assurance representative.

Phase 3 (approximately 4 weeks)


The Phase 3 or “deviations” portion of the clean steam system qualification activities
generally continue for an additional four weeks. Typically, the Phase 3 sampling plan
is modified from the Phase 1 and Phase 2 schedule with the sampling and testing
activities consisting of sampling the outlet of the clean steam generator on a weekly
basis with additional samples being taken from the use test points on a weekly basis
such that each use test point is sampled at a minimum of every 2 weeks during the
Phase 3 studies.

As for clean steam quality tests, prior to plant usage of the clean steam within
autoclaves for “porous loads” (as defined by the site) for products marketed in
Europe, there needs to be testing of the following quality attributes, with the test
conditions and specifications being listed within

Health Technical Memorandum (HTM) 20108:


1) Superheat
2) Dryness Fraction
3) Noncondensible Gases

It is important to clarify that these additional steam tests may not be initially required
as part of the installation of a new clean steam system or clean steam generator if the
initial application of clean steam will not involve the use of autoclave sterilization.
This testing may be deferred and documented within appropriate validation
documentation until such time that an autoclave installation and subsequent validation
is planned and connected to the clean steam system.

Risk Based Approach


A risk based approach to commissioning and qualification may be utilized to develop
the sampling strategy. For example, impact assessments may be used to determine
what components, equipment, or process functions of the Clean Steam System are
considered critical.

A Clean Steam quality attribute may be defined as critical based upon the need to
meet specific quality requirements where the quality is not enhanced further by
additional downstream operating steps. For example, conductivity is a critical attribute
that is measured at the outlet of a Clean Steam Generation System (e.g., condensate
outlet of the clean steam generator) for verifying the results meet necessary steam
quality requirements. Sampling the conductivity at this point would occur both during
commissioning and qualification activities. For details regarding the design of a
condensate collection apparatus for testing, refer to European Standard EN 285 –
Sterilization-Steam Sterilizers – Large Sterilizers.

Appendix:

Table 1: Clean Pure Steam Generation System Sampling Location,


Frequency and Test Type.

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