July 2018

Process Control

PIP PCEHP001
Guidelines for Selecting Hygienic Instrumentation
 PURPOSE AND USE OF PROCESS INDUSTRY PRACTICES

In an effort to minimize the cost of process industry facilities, this Practice has
been prepared from the technical requirements in the existing standards of major
industrial users, contractors, or standards organizations. By harmonizing these technical
requirements into a single set of Practices, administrative, application, and engineering
costs to both the purchaser and the manufacturer should be reduced. While this Practice
is expected to incorporate the majority of requirements of most users, individual
applications may involve requirements that will be appended to and take precedence over
this Practice. Determinations concerning fitness for purpose and particular matters or
application of the Practice to particular project or engineering situations should not be
made solely on information contained in these materials. The use of trade names from
time to time should not be viewed as an expression of preference but rather recognized
as normal usage in the trade. Other brands having the same specifications are equally
correct and may be substituted for those named. All Practices or guidelines are intended
to be consistent with applicable laws and regulations including OSHA requirements. To
the extent these Practices or guidelines should conflict with OSHA or other applicable
laws or regulations, such laws or regulations must be followed. Consult an appropriate
professional before applying or acting on any material contained in or suggested by the
Practice.

This Practice is subject to revision at any time.

© Process Industry Practices (PIP), Construction Industry Institute, The University of

Texas at Austin, 3925 West Braker Lane (R4500), Austin, Texas 78759. PIP Member
Companies and Subscribers may copy this Practice for their internal use. Changes or
modifications of any kind are not permitted within any PIP Practice without the express
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PUBLISHING HISTORY
July 2018 Issued

Not printed with State funds

 July 2018

Process Control

PIP PCEHP001
Guidelines for Selecting Hygienic Instrumentation
Table of Contents
1. Scope ...........................................2 6. Piping Connection Methods.......6
2. References ..................................2 7. CIP, SIP, Pigging and Gas Purging
Applications ................................6
3. Definitions ...................................2
8. Instrumentation Location ...........7
4. Hygienic Instrumentation
Considerations ............................3 9. Current Good Manufacturing
Practices (cGMPs) ......................7
5. Sensitivity Environments ...........4

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 PIP PCEHP001
Guidelines for Selecting Hygienic Instrumentation July 2018

1. Scope
This Practice provides guidelines for selecting instrumentation used in hygienic process applications
such as food and pharmaceutical facilities. This Practice includes all types of hygienic
instrumentation. Non-hygienic instrumentation is not covered (e.g., black and gray utilities).

2. References
Applicable parts of the following industry codes and standards shall be considered an integral part
of this Practice. The edition in effect on the date of contract award shall be used, except as
otherwise noted. Short titles are used herein where appropriate.

2.1 Industry Codes and Standards

 American Society of Mechanical Engineers (ASME)
 ASME BPE – Bioprocessing Equipment
 3-A Sanitary Standards, Inc.
 3-A Sanitary Standards
 3-A Accepted Practices
 P3-A Sanitary Standards
 Compressed Gas Association
 CGA C-4.1 Cleaning Equipment for Oxygen Service

3. Definitions
cGMP: Current Good Manufacturing Process. Regulations enforced by the US Food and Drug
Administration. cGmps provide for systems that assure proper design, monitoring and control of
manufacturing processes and facilities.

clean in place (CIP): Procedure using detergent, acid, caustic or other cleaning solution to clean and
sanitize process instrumentation, piping, equipment, and vessels without disassembling any piping

DI: Deionized water.

gas purging system: Piping system that provides nitrogen or clean compressed air to remove any
liquids or solids from a process line

hygienic clamp union: Provide connections between process components (e.g., pipe fittings, tank
fitting, and instruments) to ensure the process integrity in maintained

O2 Clean: A process to remove contaminants that can reduce the temperature of autoignition in a
process. O2 cleaning of pipe is required for any pipe used to transport pure or nearly pure oxygen,
but is also used in hygienic processes as it assures hydrocarbon contaminants are removed from
the pipe.

pigging: Use of a device called a "pig" to clean or inspect the inside of pipes

Ra: Surface reading calculated as the roughness average measured in microscopic peaks and valleys

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 PIP PCEHP001
Guidelines for Selecting Hygienic Instrumentation July 2018

sensitivity: Cleanliness requirements of the process (i.e., low-, medium- and high-sensitivity) and
not the measurement quality of the instrumentation

steam in place (SIP): Procedure using steam to clean and sanitize process instrumentation, piping,
equipment, and vessels without disassembling any piping. Either black steam (i.e., typical boiler
house steam) or clean steam (i.e., steam made from deinonized or better-quality water) is used to
sanitize the process.

surface finishes: Mechanically polished and electro polished surface finishes in accordance with
ASME BPE designations SF0 through SF6

USP: Purified or sterile water

WFI: Water for injection

Wipe test: A final quality procedure in which a lint free white cloth or swab is wiped across the
process surface to assure the cleaning process is complete.

4. Hygienic Instrumentation Considerations

4.1 Hygienic instrumentation is used in food or pharmaceutical facilities if required by the
process.
4.2 ASME BPE, Part PI (Process Instrumentation) should be used to select, specify,
configure, and install hygienic instrumentation for high-sensitivity applications (e.g.,
pharmaceutical).
4.3 3-A Sanitary Standards, 3-A Accepted Practices, or P3-A Sanitary Standards should be
used to select, specify, configure, and install hygienic instrumentation for low-, medium-,
or high-sensitivity applications (e.g., Dairy).
4.4 The following instrumentation requirements should be considered for sensitivity environments:
a. Typical characterization and applications
b. Piping connection methods
c. Piping specifications
d. Polish (internal and external)
e. Ra surface reading
f. Surface designation
g. Wetted surfaces
h. Exterior surfaces (non-wetted)
i. Gasket material
j. CIP, SIP, pigging and gas purging applications
k. Location of instrumentation
l. Electrical Hazardous Area Classification
m. Applicable codes and laws

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 PIP PCEHP001
Guidelines for Selecting Hygienic Instrumentation July 2018

5. Sensitivity Environments
5.1 The sensitivity environment directly impacts the selection, specification, configuration,
and installation of hygienic instrumentation related to equipment configuration and
operational practices.
5.2 Hygienic processes have varying levels of precision to address bioburden and cleanability
and production requirements for low-, medium-, and high-sensitivity environments. See
Table 1 for guidance regarding sensitivity environments for production steps for several
process applications.
5.3 Hygienic instrumentation requirements are different for the three sensitivity
environments. (See Table 2 for guidance regarding instrumentation requirements related
to the sensitivity environments.)
5.4 Low-sensitivity environment characteristics:
a. Some control of sanitation and contamination
b. Low grade of process-wetted surface finish (i.e., SF0 – SF1)
5.5 Medium-sensitivity environment characteristics:
a. Good control of sanitation and contamination
b. Medium grade of process-wetted surface finish (i.e., SF1 – SF4)
c. Instrument exterior material selection may need to be considered
d. Expect entire process area and/or room to be cleaned
e. Instrumentation is typically located in a utility core or room to separate
instrumentation from the exterior cleaning requirements of the process area
5.6 High-sensitivity environment characteristics:
a. Exact control of sanitation and contamination
b. High grade of process-wetted surface finish (i.e., SF4 or greater)
c. Instrument exterior material selection should be considered
d. Expect entire process area and/or room to be cleaned
e. Instrumentation is typically located in a utility core or room to separate
instrumentation from the exterior cleaning requirements of the process area

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 PIP PCEHP001
Guidelines for Selecting Hygienic Instrumentation July 2018

Table 1 – Sensitivity Environment Selection Guideline

Production Step
Process Application Crude Processing Purification Finished Goods
Biologic Pharma High High High
Chemical Pharma Low Medium High
Dairy Medium Medium High
Food Medium Medium High
Clean Utilities: DI Water Low Low Low
Clean Utilities: USP Water Medium Medium Medium
Clean Utilities: WFI High High High
Clean Utilities: Clean Steam Medium Medium High
Clean Utilities: Clean Air Medium Medium High

Table 2 – Hygienic Instrumentation Requirements

Sensitivity Environments
Instrumentation
LOW MEDIUM HIGH
Requirements
Typical characteristics Ancillary systems, CIP More basic active Most critical,
and applications skids, chillers, steam Ingredients, standard biotechnology
generators processes sensitive to
contamination and
high value active
ingredients
Pipe Connection Methods Hygienic Clamp Union Weld and polish, tri- Weld and polish, tri-
or flanges may be clamp clamp
used
Polish Mechanical Mechanical and Electro
(Internal and external) electro
Ra Surface Reading ≥ 0.51 µm 0.38 to 0.51 µm 0.38 µm
Surface designation SF0 – SF1 SF1 – SF4 SF4 – SF6
(ASME BPE)
Wetted surfaces Stainless steels, 316L, PTFE, PVDF, Super alloys, 316L,
various polymers PFA and others specialized polymers
Exterior Surfaces (non- Manufacturer standard Manufacturer Based on location of
wetted) standard the instrument clean
room or utility space
Gasket Material PTFE, PFA, and other PTFE, PFA, EPDM, Specialized polymers
(By piping spec) polymers other specific where permitted
polymers

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 PIP PCEHP001
Guidelines for Selecting Hygienic Instrumentation July 2018

6. Piping Connection Methods

6.1 Each instrument process connection should meet the sensitivity environment and piping
specification requirements.
6.2 The gasket or internal elastomer material is typically specified by piping and should meet
piping specification.
6.3 Each instrument is typically specified with a hygienic clamp union process connection to
allow the instrument to be isolated from piping and equipment that needs to be cleaned
and sanitized.
6.4 Flanges may be used in low-sensitive processes (threaded pipe should not be used)
6.5 Each instrument process connection should consider the following:
a. Ease of removal
b. CIP or SIP
c. Pigging
d. Gas purging

7. CIP, SIP, Pigging and Gas Purging Applications

7.1 CIP
7.1.1 All instrumentation materials of construction should meet the specified CIP
requirements for both wetted surfaces and external housings.
7.1.2 External cleaning of the process instrumentation, piping, equipment, and vessels
should be considered.
7.1.3 A quality assurance “wipe test” is typically used to prove the process is clean and
contaminant-free.
7.2 SIP
7.2.1 All instrumentation materials of construction should meet the specified SIP
requirements for both wetted surfaces and external housings.
7.2.2 Maximum steam temperature is a major consideration for specifying
instrumentation.
7.2.3 External cleaning of the process instrumentation, piping, equipment, and vessels
with steam should be considered.
7.2.4 A quality assurance “wipe test” is typically used to prove the process is clean and
contaminant-free.
7.3 Pigging
7.3.1 A pig launching station is used to insert the pig into the pipe and the process flow
moves the pig through the pipe to the receiving trap where it is taken out of the piping.
7.3.2 Instrumentation should not protrude into the piping because of the possibly of
damage by the pig or to the pig.

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 PIP PCEHP001
Guidelines for Selecting Hygienic Instrumentation July 2018

7.3.3 Pigs should only be used in piping designed with full port valves and instruments
that do not protrude into the pipe.
7.3.4 Flush mounting of instruments should be considered to avoid pockets or voids
that the pig cannot clean.
7.4 Gas Purging Systems
7.4.1 The design pressure of the purging system depends on the amount of pressure
required to push the material through the piping system to the removal destination.
7.4.2 Instrumentation should be designed to withstand the maximum pressure of the
compressed gas (e.g., PSV or rupture disk setting).

8. Instrumentation Location
8.1 The exterior finish of instrument enclosures should meet the sensitivity environment
requirements.
8.1.1 Instruments located in clean rooms should have polished stainless enclosures to
permit cleaning.
8.1.2 Instruments located in non-clean rooms or utility rooms can be manufacturer’s
standard exterior finish.
8.1.3 Instrument enclosure material of construction should be suitable for the cleaning
material being used (e.g., acids, caustic).
8.2 Instruments should be connected to the process piping, vessel, or equipment with limited
pocketing for trapping material that could cause contamination.
Comment: Consider using instrument installation details from ASME BPE or 3-A
Sanitary Standards, Inc.
8.3 Instruments should be in accordance with the location’s Electrical Hazardous Area
Classification.
8.4 Instruments should be installed in accordance with applicable codes and laws.

9. Current Good Manufacturing Practices (cGMPs)

9.1 Instrumentation in direct contact with process or required for product quality should be
verified using the manufacturer’s quality program.
9.2 The manufacturer’s quality program should include documentation to prove compliance
of the instrumentation material of construction and finishes to required instrument
specifications.
9.3 The following documents (electronic or hardcopy) should be requested from the supplier
at the time of order of an instrument:
a. Calibration Certificate: National Institute of Standards and Technology (NIST) for
US facilities or International Organizations for Standards (ISO) for non-US facilities
traceable certificates of calibration and instrument performance over the required
operating range
b. Casting Records: Record linage of a valve or instrument casting from liquid metal
poured into the mold to the final milling

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 PIP PCEHP001
Guidelines for Selecting Hygienic Instrumentation July 2018

c. Heat Number: Identification coupon number stamped on a material plate after it is

removed from the ladle and rolled at a steel mill that provides traceability to the exact
composition of the metal
d. O2 Clean Certificate: Instruments located and operated in an oxygen enriched
environment should have all combustible hydrocarbon traces cleaned from the instrument
and a certificate provided to certify the cleaning was performed in accordance with
approved procedures (e.g., CGA G-4.1 cleaning equipment for O2 service)
e. Polish Records: Data about the mechanical or electro polish, including machine used
to preform polish, machine calibration certificate number and certifying agency, and
the date of the polish work.
Comment: If the manufacturer cannot provide these documents, a qualified or
certified third party can provide certification for the missing
documents
9.4 Tamper-proof packaging (e.g., plastic bag) should be used for cleaned or highly polished
instruments to prevent damage during shipment and ensure the integrity of the instrument.
9.5 An inspection of all instruments upon receipt should be in accordance with the owner’s
quality program and may include the following:
a. Packaging should be inspected for visible external damage during shipping.
Comment: Non-tamper proof packaging should be opened to ensure no damage to
the instrument.
b. Tamper-proof packaging should only be opened under correct conditions for that
instrument (e.g., O2 clean).
c. Remove any quality certifications or records documentation (electronic or hardcopy)
shipped with the instrument and send it to the appropriate personnel responsible for
the quality program.

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