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Rouge in Pharmaceutical Water and Steam Systems
Rouge in Pharmaceutical Water and Steam Systems
This article
presents the Rouge in Pharmaceutical Water and
outcome of
a series of Steam Systems
workshops
on the effects
of rouging in by ISPE Critical Utilities D/A/CH COP
pharmaceutical
water and
steam systems.
Introduction
T
Pickling, passivation, rinsing
he ISPE Critical Utilities D/A/CH
COP held a series of workshops on Each method should be executed, tested, and
pharmaceutical water and steam. The documented in accordance with a Standard
discussions focused on three aspects of Operating Procedure (SOP). The SOP can be
rouge, including: created with the support of the expert/qualified
company. The responsibility for the execution
Choice of materials, quality control should be defined in the SOP.
Engineering, system design
Service and maintenance Methods
Compressed air
Fifty experts participated in the workshops Removal of large debris
with a range of experience in various fields, Check for blockage
including OEM, engineering, material produc-
tion, instrument manufacturing, consulting, QC, Rinsing
and pharmaceutical manufacturing. Rinsing is used to remove:
- Loose debris or water soluble substances
Choice of Materials, QC-Service - Detergents, etc.
System Startup Rinse after each treatment step.
The desired condition for new systems (zero or The water quality for each rinse step should
initial-state) should be well defined. be defined individually. Purified Water (PW)
is usually sufficient.
Sufficiently detailed specifications should The PW should have a pH of five to seven at
be available for all components (material, the end of the rinsing cycle.
surface roughness, and tolerances) and these
should be tested during the qualification Degreasing with Alkaline Detergents
phase. The thermal and chemical resis- Removal of debris
tance also should be checked. Furthermore, Wash out fatty or oily substances
special care should be taken regarding the
cleanliness of all components from the time Chemical Cleaning/Pickling
of delivery onward. The makeup of the chemical solution should
If possible (cost feasibility), the materials be suitable for the surface roughness of the
for pipes, fittings, and valves should be the system (qualified SOP).
Reprinted from same to avoid different behavior (welding). Removal of contaminants (nonalloyed ferrous
PHARMACEUTICAL components, shavings (alloy and nonalloy),
ENGINEERING Definition of Treatment construction dust, discoloration, etc.)
The Official Magazine of ISPE At the end of the installation phase, the entire In special cases, such as surface damage,
assembly must be dry. removal by chemical reaction (erosive)
July/August 2009, The following methods are considered treat- Electro polished systems, if pickled, are pick-
Vol. 29 No.4 ments: led without material removal (see following
Copyright ISPE 2009 comments).
www.ISPE.org Removal of any installation debris, i.e., using Pickling:
compressed air, degreasing, etc. Pickling (cleaning) with weak acids (citric acid,
ISPE
The passive layer doesnt normally need to be tested since
it is naturally present.
There is no regulatory requirement to test the passive Facility of the Year:
layer.
The thickness of the passive layer is dependant on the
Innovation Showcase
surrounding conditions; therefore, varies according to the
23 November
conditions in the pipe (for example, if the pipe is filled with
liquid or air). Due to this variability, testing the thickness
of the passive layer only gives information on the state of Ulm, Germany
the layer at the time of the testing.
Possible measuring methods can be conducted by quali- Learn about the latest
fied experts. Laboratory tests (destructive testing), such state-of-the-art developments
as X-ray photoelectron spectroscopy, are time consuming being implemented by
and expensive. manufacturers in the region.
Non-destructive online measurements, which character-
ize the condition of the material, have been proven in the Seminar on innovation in pharmaceutical engineering
chemical industry. These are indirect measurements, using
and manufacturing
Case studies on innovation presented by recent
sensors made of the same material, which are evaluated Facility of the Year Awards winners
using complex algorithms. Background on projects
Q&A sessions
Final Rinse Networking reception
With water for injection, highly purified water, or purified
Site visits to award-winning sites
water the minimum required water quality should be
defined (potential cost savings). This quality should be at Sponsorship and Table Top Exhibit
least equal to the operating medium. For instance, if WFI Opportunities Available
The SOP can be developed with qualified experts. Specific characteristics of individual alloys:
The responsibility for the execution should be decided in 1.4404 somewhat less Mo (0.5%), slightly reduced corro-
advance. sion resistance in hot systems. Good availability (tubing,
fittings, instruments, valves, etc.)
The recipe should be based on the following: 1.4435 limited availability of fittings and instruments.
Expensive material. Also susceptible to rouging.
Current state (see above)
Suitability tests (effectiveness) should influence the choice Other alloys also are possible; however, they may be more
of the process. difficult to procure and are significantly more expensive.
1.4539, 1.4462 (Ferritic-Austenitic Duplexsteel), Ni-Basic-
The frequency of derouging should be based on the following Alloy, Alloy 33 (high content of chromium), Titanium.
criteria: Pros:
These special materials could be more resistance to roug-
In accordance with monitoring results (months, years) ing; however, this has not been proven yet.
In accordance with experience and knowledge of the instal- 1.4462 is resistant to rouging for a wide redox range in
lation pure water systems, but doesnt solve all problems.
Dependent on the state Optimizing the passive layer through higher chromium
content. The Alloy 33 with 33% Cr shows a chromium
Testing and documentation can be assigned to the contract- content in the passive layer of 83% after exposure to 95C
ing company. pure water.
No experience with Nickel based alloys. Rouging has been
Visual inspection in accordance with agreed acceptance observed with Hastelloy C-276, which is not surprising
criteria (colors, film, etc.) considering the lower Cr content.
Wipe test Titanium stabilized materials: valves and regulating valves
Photos, etc. in WFI systems are often made of 316Ti.
Cons:
Choice of Materials and Due to cost and availability, 1.4539 und 1.4462 are only
Processing/Machining used in special cases.
The choice of materials influences the formation of rouging.
Delta Ferrite Content
Plastics The delta ferrite criteria can be traced back to the BN
Pros: 2 (Basler Norm, a guideline of the Swiss Chemical and
No rouging because it is a nonmetallic material Pharmaceutical Industries), where a very low delta ferrite
Cons: content of 0.5% is defined. The original intention of BN2
Thermal deformation from variance in temperature (hot was to just take the delta ferrite content into account. The
operation or sanitization) delta ferrite limit was specified as a preventive measure
New design of piping supports (high expansion value) and is not based on scientific proof. The limit is too strict
Aging stability (hot sanitizations) and is not practical. It dictates the use of steel, which is
Not always feasible for hot systems. Pressure and vacuum considerably more expensive and compliant welds are
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